{"title":"hipolipemiante","description":"","products":[{"product_id":"rosucard-20mg-compfilm","title":"Rosucard 20mg comp.film.","description":"\u003cp\u003eROSUCARD 10 mg comprimate filmate\u003cbr\u003eROSUCARD 20 mg comprimate filmate\u003cbr\u003eROSUCARD 40 mg comprimate filmate\u003cbr\u003e\u003cbr\u003eRosuvastatină\u003cbr\u003e\u003cbr\u003eCitiţi cu atenţie şi în întregime acest prospect înainte de a începe să luaţi acest medicament deoarece conţine informaţii importante pentru dumneavoastră.\u003cbr\u003e- Păstraţi acest prospect. S-ar putea să fie necesar să-l recitiţi.\u003cbr\u003e- Dacă aveţi orice întrebări suplimentare, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003cbr\u003e- Acest medicament a fost prescris numai pentru dumneavoastră. Nu trebuie să-l daţi altor persoane. Le poate face rău, chiar dacă au aceleaşi semne de boală ca dumneavoastră.\u003cbr\u003e- Dacă manifestaţi orice reacţii adverse, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003c\/p\u003e\r\n\u003cp\u003eAcestea includ orice posibile reacţii adverse nemenţionate în acest prospect. Vezi pct. 4.\u003cbr\u003e\u003cbr\u003eCe găsiţi în acest prospect:\u003cbr\u003e1. Ce este ROSUCARD şi pentru ce se utilizează\u003cbr\u003e2. Ce trebuie să ştiţi înainte să luaţi ROSUCARD\u003cbr\u003e3. Cum să luaţi ROSUCARD\u003cbr\u003e4. Reacţii adverse posibile\u003cbr\u003e5. Cum se păstrează ROSUCARD\u003cbr\u003e6. Conţinutul ambalajului şi alte informaţii\u003cbr\u003e\u003cbr\u003e1. Ce este ROSUCARD şi pentru ce se utilizează\u003cbr\u003eROSUCARD aparţine unui grup de medicamente numite statine.\u003cbr\u003e\u003cbr\u003eVi s-a prescris ROSUCARD deoarece:\u003cbr\u003e- aveţi valori mari ale colesterolului. Aceasta înseamnă că aveţi risc de a face un infarct miocardic sau un accident vascular cerebral.\u003cbr\u003eVi s-a recomandat să luaţi o statină, deoarece dieta pe care aţi urmat-o şi exerciţiul fizic nu au fost suficiente pentru a corecta valoarea colesterolului. Trebuie să urmaţi în continuare dieta pentru reducerea colesterolului şi exerciţiul fizic în timp ce luaţi ROSUCARD. \u003cbr\u003eSau\u003cbr\u003e- aveţi alţi factori care cresc riscul de a face un infarct miocardic, accident vascular cerebral sau probleme de sănătate legate de acestea.\u003cbr\u003eInfarctul miocardic, accidentul vascular cerebral şi alte probleme de sănătate pot fi cauzate de o afecţiune numită ateroscleroză. Ateroscleroza se produce ca urmare a depunerii de grăsime la nivelul arterelor.\u003cbr\u003e\u003cbr\u003eDe ce este important să continuaţi să luaţi ROSUCARD?\u003cbr\u003eROSUCARD este utilizat pentru corectarea valorilor grăsimilor din sânge numite lipide, dintre care cel mai frecvent este colesterolul.\u003cbr\u003eExistă mai multe tipuri de colesterol în sânge –colesterolul „rău” (LDL-C) şi colesterolul „bun” (HDL-C).\u003cbr\u003e- ROSUCARD poate reduce colesterolul „rău” şi poate creşte colesterolul „bun”.\u003cbr\u003e- ROSUCARD acţionează prin blocarea producerii colesterolului „rău” în corpul dumneavoastră şi îmbunătăţeşte capacitatea organismului dumneavoastră de a-l elimina din sânge. \u003cbr\u003e\u003cbr\u003ePentru majoritatea persoanelor, valorile crescute ale colesterolului nu afectează modul în care vă simţiţi deoarece nu determină niciun simptom. Cu toate acestea, dacă este netratat, depozitele de grăsime se pot depune pe pereții vaselor dumneavoastră de sânge determinând îngustarea lor.\u003cbr\u003eUneori, aceste vase îngustate se pot bloca, ceea ce întrerupe irigarea cu sânge a inimii sau creierului, determinând un infarct miocardic sau un accident vascular cerebral. Dacă scădeți valoarea colesterolului, puteţi reduce riscul de a avea un infarct miocardic sau un accident vascular cerebral sau probleme de sănătate legate de acestea.\u003cbr\u003eTrebuie să continuaţi să luaţi ROSUCARD chiar dacă colesterolul dumneavoastră a ajuns la valoarea normală deoarece preveniţi ca valorile colesterolului să crească din nou şi să determine depunerea de grăsimi.\u003cbr\u003eCu toate acestea, trebuie să întrerupeţi tratamentul dacă medicul dumneavoastră vă spune acest lucru sau dacă aţi rămas gravidă.\u003c\/p\u003e\r\n\u003cp\u003e2. Ce trebuie să ştiţi înainte să luaţi ROSUCARD\u003cbr\u003eNu luaţi ROSUCARD:\u003cbr\u003e- Dacă sunteţi alergic la rosuvastatină sau la oricare dintre celelalte componente ale acestui medicament (enumerate la punctul 6);\u003cbr\u003e- Dacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în timp ce luaţi ROSUCARD, întrerupeţi imediat tratamentul şi spuneţi-i medicului dumneavoastră. Femeile trebuie să evite să rămână gravide în timpul tratamentului cu ROSUCARD folosind metode de contracepţie corespunzătoare.\u003cbr\u003e- Dacă aveţi afecţiuni ale ficatului;\u003cbr\u003e- Dacă aveţi afecţiuni severe ale rinichilor;\u003cbr\u003e- Dacă aveţi dureri de muşchi repetate sau inexplicabile;\u003cbr\u003e- Dacă luaţi un medicament numit ciclosporină (folosit, de exemplu, după transplantul de organe).\u003cbr\u003e\u003cbr\u003eDacă oricare dintre cele de mai sus sunt valabile în cazul dumneavoastră (sau dacă aveţi nelămuriri), vă rugăm să discutaţi cu medicul dumneavoastră.\u003cbr\u003e\u003cbr\u003eÎn plus, nu luaţi ROSUCARD 40 mg (doza cea mai mare):\u003cbr\u003e- Dacă aveţi afecţiuni moderate ale rinichilor (dacă aveţi nelămuriri, vă rugăm să vă adresaţi medicului dumneavoastră);\u003cbr\u003e- Dacă glanda dumneavoastră tiroidă nu funcţionează corespunzător;\u003cbr\u003e- Dacă aţi avut în trecut dureri de muşchi repetate sau inexplicabile, un istoric personal sau familial de afecţiuni ale muşchilor, sau un istoric de probleme musculare când aţi mai luat în trecut medicamente care scad colesterolul;\u003cbr\u003e- Dacă consumaţi periodic cantităţi mari de alcool etilic;\u003cbr\u003e- Dacă sunteţi de origine asiatică (japonez, chinez, filipinez, vietnamez, coreean şi indian);\u003cbr\u003e- dacă luaţi alte medicamente numite fibraţi pentru a vă reduce valoarea colesterolului.\u003cbr\u003e\u003cbr\u003eDacă oricare dintre cele de mai sus sunt valabile în cazul dumneavoastră (sau dacă aveţi nelămuriri), vă rugăm să discutaţi cu medicul dumneavoastră.\u003cbr\u003e\u003cbr\u003eAtenţionări şi precauţii\u003cbr\u003eÎnainte să luaţi ROSUCARD, adresaţi-vă medicului dumneavoastră sau farmacistului:\u003cbr\u003e- dacă aveţi afecţiuni ale rinichilor;\u003cbr\u003e- dacă aveţi afecţiuni ale ficatului;\u003cbr\u003e- dacă aţi avut în trecut dureri de muşchi repetate sau inexplicabile, un istoric personal sau familial de probleme musculare, sau un istoric de afecţiuni ale muşchilor când aţi mai luat în trecut medicamente care scad colesterolul. Spuneţi-i imediat medicului dumneavoastră dacă aveţi dureri musculare inexplicabile, în special dacă nu vă simţiţi bine sau aveţi febră. De asemenea, spuneţi medicului dumneavoastră sau farmacistului dacă aveţi o slăbiciune musculară care este constantă.\u003cbr\u003e- dacă consumaţi periodic cantităţi mari de alcool etilic;\u003cbr\u003e- dacă glanda dumneavoastră tiroidă nu funcţionează corespunzător; \u003cbr\u003e- dacă aveţi insuficienţă respiratorie severă;\u003cbr\u003e- dacă luaţi alte medicamente numite fibraţi pentru a vă scădea colesterolul. Vă rugăm citiţi cu atenţie acest prospect, chiar dacă aţi mai luat în trecut medicamente pentru reducerea colesterolului.\u003cbr\u003e- dacă luaţi medicamente folosite pentru tratamentul infecţiei cu HIV, de exemplu ritonavir cu lopinavir şi\/sau atazanavir, vă rugăm citiţi „ROSUCARD împreună cu alte medicamente”.\u003cbr\u003e- dacă luaţi sau aţi luat în ultimele 7 zile un medicament numit acid fusidic, (un medicament pentru infecţii bacteriene) pe cale orală sau sub formă de injecţii. Combinaţia de acid fusidic şi ROSUCARD poate să ducă la probleme ale muşchilor (rabdomioliză).\u003cbr\u003e- dacă aveţi vârsta peste 70 de ani (deoarece medicul trebuie să stabilească doza cea mai bună de ROSUCARD pentru începerea tratamentului dumneavoastră).\u003cbr\u003e- dacă sunteţi de origine asiatică – adică japonez, chinez, filipinez, vietnamez, coreean sau indian.\u003cbr\u003e\u003cbr\u003eMedicul trebuie să decidă doza cea mai bună de ROSUCARD pentru începerea tratamentului dumneavoastră.\u003cbr\u003e\u003cbr\u003eCopii şi adolescenţi\u003cbr\u003e- dacă pacientul are vârsta sub 10 ani: ROSUCARD nu trebuie administrat la copii cu vârsta sub 10 ani.\u003cbr\u003e- dacă pacientul are vârsta sub 18 ani: Comprimatele de ROSUCARD 40 mg nu sunt adecvate pentru a fi utilizate la copii şi adolescenţi cu vârsta sub 18 ani.\u003cbr\u003e\u003cbr\u003eDacă oricare dintre cele de mai sus sunt valabile în cazul dumneavoastră (sau dacă aveţi nelămuriri)\u003cbr\u003e- Nu luaţi ROSUCARD 40 mg (doza cea mai mare) şi discutaţi cu medicul dumneavoastră sau cu farmacistul înainte de a începe tratamentul cu Rosucard.\u003cbr\u003eLa un număr mic de persoane, statinele pot afecta ficatul. Acest efect poate fi identificat printr-un test simplu care determină valori crescute ale enzimelor hepatice în sânge. Din acest motiv, medicul dumneavoastră vă va face periodic acest test de sânge (testul pentru funcţia ficatului) înainte de şi în timpul tratamentului cu ROSUCARD.\u003c\/p\u003e\r\n\u003cp\u003eCât timp sunteţi în tratament cu acest medicament medicul dumneavoastră vă va monitoriza atent dacă aveţi diabet sau aveţi factori de risc pentru apariţia diabetului. Sunteți la risc pentru apariţia diabetului zaharat dacă aveţi o concentraţie crescută de zahăr şi grăsimi în sânge, sunteţi supraponderal sau aveţi tensiune arterială crescută.\u003c\/p\u003e\r\n\u003cp\u003eROSUCARD împreună cu alte medicamente\u003cbr\u003eSpuneţi medicului dumneavoastră sau farmacistului dacă luaţi, aţi luat recent sau s-ar putea să luaţi orice alte medicamente.\u003cbr\u003eSpuneţi-i medicului dumneavoastră dacă luaţi oricare dintre următoarele medicamente: ciclosporină (folosită de exemplu, după transplantul de organe), warfarină (sau orice alte medicamente folosite pentru subţierea sângelui), fibraţi (cum sunt gemfibrozil sau fenofibrat) sau orice alte medicamente folosite pentru scăderea colesterolului (precum ezetimib), medicamente pentru indigestie (folosite pentru neutralizarea acidului din stomacul dumneavoastră), eritromicină (un antibiotic), un contraceptiv oral (pilula), terapie de substituţie hormonală sau ritonavir cu lopinavir şi\/sau atazanavir (folosite pentru tratamentul infecţiei cu HIV – vă rugăm să citiţi „Atenţionări şi precauţii”). Efectele acestor medicamente pot fi modificate de ROSUCARD sau ele pot modifica efectele ROSUCARD.\u003cbr\u003e\u003cbr\u003eDacă este necesar să luaţi acid fusidic pe cale orală pentru tratamentul unei infecţii bacteriene va trebui să opriţi temporar utilizarea acestui medicament. Medicul dumneavoastră vă va spune când este sigur să reluaţi tratamentul cu ROSUCARD. Administrarea concomitentă a ROSUCARD împreună cu acid fusidic poate să ducă rareori la slăbiciune musculară, sensibilitate sau durere (rabdomioliză). Vezi informaţiile cu privire la rabdomioliză de la pct. 4.\u003cbr\u003e\u003cbr\u003eROSUCARD împreună cu alcool\u003cbr\u003eNu trebuie să consumaţi regulat cantitaţi mari de alcool.\u003cbr\u003e\u003cbr\u003eSarcina, alăptarea şi fertilitatea\u003cbr\u003eDacă sunteţi gravidă sau alăptaţi, credeţi că aţi putea fi gravidă sau intenţionaţi să rămâneţi gravidă, adresaţi-vă medicului pentru recomandări înainte de a lua acest medicament.\u003cbr\u003e\u003cbr\u003eNu luaţi ROSUCARD dacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în timp ce luaţi ROSUCARD, întrerupeţi imediat tratamentul şi spuneţi-i medicului dumneavoastră. Femeile trebuie să evite să rămână gravide în timpul tratamentului cu ROSUCARD, folosind metode de contracepţie corespunzătoare.\u003cbr\u003e\u003cbr\u003eConducerea vehiculelor şi folosirea utilajelor\u003cbr\u003eMajoritatea persoanelor pot conduce vehicule şi pot folosi utilaje în timpul tratamentului cu ROSUCARD – nu le va afecta capacitatea. Cu toate acestea, unele persoane pot avea ameţeli în timpul tratamentului cu ROSUCARD. Dacă vă simţiţi ameţit, adresaţi-vă medicului dumneavoastră înainte de a încerca să conduceţi vehicule sau să folosiţi utilaje.\u003cbr\u003e\u003cbr\u003eROSUCARD conţine lactoză monohidrat\u003cbr\u003eROSUCARD 10 mg comprimate filmate conţine lactoză monohidrat 60 mg.\u003cbr\u003eROSUCARD 20 mg comprimate filmate conţine lactoză monohidrat 120 mg.\u003cbr\u003eROSUCARD 40 mg comprimate filmate conţine lactoză monohidrat 240 mg.\u003cbr\u003eDacă medicul dumneavoastră v-a atenţionat că aveţi intoleranţă la unele categorii de glucide, vă rugăm să-l întrebaţi înainte de a lua acest medicament.\u003cbr\u003e\u003cbr\u003e3. Cum să luaţi ROSUCARD\u003cbr\u003eLuaţi întotdeauna acest medicament exact aşa cum v-a spus medicul dumneavoastră sau farmacistul.\u003cbr\u003eDiscutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur.\u003cbr\u003eDoza recomandată la adulţi\u003cbr\u003eDacă luaţi ROSUCARD pentru valorile mari ale colesterolului\u003cbr\u003eDoza de iniţiere: Tratamentul dumneavoastră cu ROSUCARD trebuie să înceapă cu doza de 5 mg sau 10 mg, chiar dacă aţi luat o doză mai mare dintr-o altă statină în trecut.\u003cbr\u003e\u003cbr\u003eAdministrarea unei doze de 5 mg poate fi realizată prin ruperea comprimatului de 10 mg de-a lungul liniei mediane.\u003cbr\u003e\u003cbr\u003eStabilirea dozei dumneavoastră de început va depinde de:\u003cbr\u003e- Valoarea colesterolului dumneavoastră.\u003cbr\u003e- Gradul de risc pe care îl aveţi de a face un infarct miocardic sau un accident vascular cerebral.\u003cbr\u003e- Dacă aveţi vreun factor care v-ar putea face mai sensibil la posibilele reacţii adverse.\u003cbr\u003e\u003cbr\u003eVă rugăm discutaţi cu medicul dumneavoastră sau cu farmacistul pentru a vedea care este doza de început cea mai potrivită pentru dumneavoastră.\u003cbr\u003e\u003cbr\u003eMedicul dumneavoastră poate decide să vă administreze doza cea mai mică (5 mg) dacă:\u003cbr\u003e- Sunteţi de origine asiatică (japonez, chinez, filipinez, vietnamez, coreean sau indian).\u003cbr\u003e- Aveţi vârsta peste 70 de ani.\u003cbr\u003e- Funcţia rinichilor dumneavoastră este moderat afectată.\u003cbr\u003e- Aveţi risc de dureri musculare (miopatie).\u003cbr\u003e\u003cbr\u003eCreşterea dozei şi doza zilnică maximă:\u003cbr\u003eEste posibil ca medicul dumneavoastră să decidă să vă crească doza, pentru ca dumneavoastră să luaţi doza de ROSUCARD care vă este potrivită. Dacă aţi început cu doza de 5 mg, medicul dumneavoastră poate decide să o dubleze la 10 mg, apoi la 20 mg şi apoi la 40 mg, dacă este necesar. Dacă aţi început cu doza de 10 mg, medicul dumneavoastră poate decide să o dubleze la 20 mg şi apoi la 40 mg, dacă este necesar. Va exista o perioadă de patru săptămâni între fiecare modificare a dozei.\u003cbr\u003eDoza zilnică maximă de ROSUCARD este 40 mg. Această doză este numai pentru pacienţii cu valori mari ale colesterolului şi cu risc crescut de infarct miocardic sau accident vascular cerebral, ale căror valori de colesterol nu sunt scăzute suficient de doza de 20 mg.\u003cbr\u003eDacă luaţi ROSUCARD pentru reducerea riscului de a face infarct miocardic, accident vascular cerebral sau probleme de sănătate legate de acestea:\u003cbr\u003eDoza recomandată este 20 mg zilnic. Cu toate acestea, medicul dumneavoastră poate decide să vă administreze o doză mai mică dacă aveţi oricare dintre factorii de risc menţionaţi mai sus. \u003cbr\u003e\u003cbr\u003eUtilizarea la copii şi adolescenţi cu vârsta cuprinsă între 10 şi 17 ani\u003cbr\u003eDoza iniţială recomandată este de 5 mg. Medicul dumneavoastră vă poate creşte doza pentru a vedea care este doza de ROSUCARD potrivită pentru dumneavoastră. Doza zilnică maximă de ROSUCARD este 20 mg. Luaţi doza o dată pe zi. Comprimatele ROSUCARD 40 mg nu trebuie utilizate la copii şi adolescenţi.\u003c\/p\u003e\r\n\u003cp\u003eAdministrarea comprimatelor\u003cbr\u003eÎnghiţiţi fiecare comprimat întreg, cu apă.\u003cbr\u003eLuaţi ROSUCARD zilnic, o dată pe zi. Puteţi să luaţi comprimatul în orice moment al zilei, cu sau fără alimente.\u003cbr\u003eÎncercaţi să luaţi comprimatul în acelaşi moment în fiecare zi pentru a vă aduce aminte să îl luaţi.\u003cbr\u003e\u003cbr\u003eDeterminări periodice ale colesterolului\u003cbr\u003eEste important să mergeţi periodic la medicul dumneavoastră pentru verificări ale colesterolului, pentru a vă asigura că valorile colesterolului dumneavoastră au ajuns la nivelul corect şi se menţin.\u003cbr\u003eEste posibil ca medicul dumneavoastră să decidă să vă crească doza, pentru ca dumneavoastră să luaţi doza de ROSUCARD care vă este potrivită.\u003cbr\u003eDacă luaţi mai mult ROSUCARD decât trebuie\u003cbr\u003eAdresaţi-vă medicului dumneavoastră sau celui mai apropiat spital.\u003cbr\u003eDacă mergeţi la spital sau sunteţi tratat pentru o altă afecţiune, spuneţi personalului medical că luaţi\u003cbr\u003eROSUCARD.\u003cbr\u003eDacă uitaţi să luaţi ROSUCARD\u003cbr\u003eNu vă îngrijoraţi, luaţi următoarea doză la ora corectă. Nu luaţi o doză dublă pentru a compensa doza uitată.\u003cbr\u003eDacă încetaţi să luaţi ROSUCARD\u003cbr\u003eDiscutaţi cu medicul dumneavoastră dacă vreţi să încetaţi să luaţi ROSUCARD. Este posibil ca valorile colesterolului dumneavoastră să crească din nou dacă opriţi tratamentul cu ROSUCARD.\u003cbr\u003eDacă aveţi orice întrebări suplimentare cu privire la acest medicament, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003cbr\u003e\u003cbr\u003e4. Reacţii adverse posibile\u003cbr\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele.\u003cbr\u003eEste important să cunoaşteţi care sunt aceste reacţii adverse. Acestea sunt, de regulă, uşoare şi dispar după puţin timp.\u003cbr\u003eOpriţi tratamentul cu ROSUCARD şi adresaţi-vă imediat unui medic dacă aveţi oricare dintre următoarele reacţii alergice:\u003cbr\u003e- Dificultăţi în respiraţie, însoţite sau nu de umflarea feţei, buzelor, limbii şi\/sau gâtului.\u003cbr\u003e- Umflarea feţei, a buzelor, limbii şi\/sau gâtului, care pot determina dificultăţi la înghiţire.\u003cbr\u003e- Mâncărime severă la nivelul pielii (cu umflături).\u003cbr\u003e\u003cbr\u003eDe asemenea, întrerupeţi tratamentul cu ROSUCARD şi adresaţi-vă imediat medicului dumneavoastră dacă aveţi dureri neobişnuite ale muşchilor care durează de mai mult timp decât v-aţi fi aşteptat. Simptomele la nivelul muşchilor apar mai frecvent la copii şi adolescenţi comparativ cu adulţii. Ca şi în cazul altor statine, un număr foarte mic de persoane au avut efecte adverse la nivel muscular şi, rar, aceste efecte au evoluat către o afectare musculară care poate pune viaţa în pericol numită rabdomioliză (reacţie adversă rară). \u003cbr\u003e\u003cbr\u003eUrmătoarele reacţii adverse au fost raportate în cazul folosirii rosuvastatinei (substanţa activă din ROSUCARD):\u003cbr\u003e\u003cbr\u003eReacţii adverse frecvente (pot afecta până la 1 din 10 persoane):\u003cbr\u003e- Durere de cap\u003cbr\u003e- Durere de stomac\u003cbr\u003e- Constipaţie\u003cbr\u003e- Greaţă\u003cbr\u003e- Durere musculară\u003cbr\u003e- Senzaţie de slăbiciune\u003cbr\u003e- Ameţeli\u003cbr\u003e- O creştere a cantităţii de proteine în urină – aceasta revine, de regulă, la normal de la sine, fără a fi nevoie să întrerupeţi tratamentul cu ROSUCARD comprimate (numai pentru ROSUCARD 40 mg).\u003cbr\u003e- Diabet zaharat. Apariţia acestei reacţii adverse este mai probabilă dacă aveţi valori mari ale zahărului şi grăsimilor din sânge, sunteţi supraponderal sau aveţi tensiune arterială crescută.\u003cbr\u003eMedicul dumneavoastră vă va monitoriza cât timp luaţi acest medicament.\u003c\/p\u003e\r\n\u003cp\u003eReacţii adverse mai puţin frecvente (pot afecta până la 1 din 100 de persoane):\u003cbr\u003e- Erupţie trecătoare pe piele, mâncărime sau alte reacţii la nivelul pielii\u003cbr\u003e- O creştere a cantităţii de proteine în urină – aceasta revine, de regulă, la normal de la sine, fără a fi nevoie să întrerupeţi tratamentul cu ROSUCARD comprimate (numai pentru ROSUCARD 10 mg şi 20 mg).\u003cbr\u003e\u003cbr\u003eReacţii adverse rare (pot afecta până la 1 din 1000 de persoane):\u003cbr\u003e- Reacţii alergice severe – semnele includ umflarea feţei, buzelor, limbii şi\/sau gâtului, dificultăţi la înghiţire şi în respiraţie, mâncărime severă la nivelul pielii (cu umflături). Dacă credeţi că aveţi o reacţie alergică, atunci întrerupeţi tratamentul cu ROSUCARD şi adresaţi-vă imediat unui medic.\u003cbr\u003e- Afectare musculară la adulţi – ca măsură de precauţie, întrerupeţi tratamentul cu ROSUCARD şi adresaţi-vă imediat medicului dumneavoastră dacă aveţi orice dureri musculare neobişnuite care durează de mai mult timp decât v-aţi fi aşteptat.\u003cbr\u003e- Durere abdominală severă (pancreas inflamat).\u003cbr\u003e- Creşterea concentraţiei enzimelor hepatice în sânge.\u003cbr\u003e\u003cbr\u003eReacţii adverse foarte rare (pot afecta până la 1 din 10000 de persoane):\u003cbr\u003e- Icter (colorarea în galben a pielii şi a albului ochilor)\u003cbr\u003e- Hepatită (ficat inflamat).\u003cbr\u003e- Dureri articulare.\u003cbr\u003e- Urme de sânge în urină.\u003cbr\u003e- Afectarea nervilor de la nivelul picioarelor şi braţelor dumneavoastră (precum amorţeală).\u003cbr\u003e- Pierderi de memorie.\u003cbr\u003e- Ginecomastie (mărire a sânilor la bărbaţi).\u003cbr\u003e\u003cbr\u003eReacţiile adverse cu frecvenţă necunoscută (frecvenţa nu poate fi estimată din datele disponibile) pot include:\u003cbr\u003e- Depresie.\u003cbr\u003e- Slăbiciune musculară care este constantă.\u003cbr\u003e- Leziuni ale tendoanelor.\u003cbr\u003e- Tulburări ale somnului, inclusiv insomnie şi coşmaruri.\u003cbr\u003e- Diaree (scaune moi).\u003cbr\u003e- Sindrom Stevens-Johnson (afecţiune gravă însoţită de vezicule la nivelul pielii, gurii, ochilor şi zonei genitale).\u003cbr\u003e- Tuse.\u003cbr\u003e- Dificultăţi la respiraţie.\u003cbr\u003e- Edeme (umflare).\u003cbr\u003e- Tulburări sexuale.\u003cbr\u003e- Probleme de respiraţie, incluzând tuse persistentă şi\/sau dificultăţi la respiraţie sau febră. \u003cbr\u003e\u003cbr\u003e5. Cum se păstrează ROSUCARD\u003cbr\u003eNu lăsaţi acest medicament la vederea şi îndemâna copiilor.\u003cbr\u003eNu utilizaţi acest medicament după data de expirare înscrisă pe cutie după EXP. Data de expirare se referă la ultima zi a lunii respective.\u003cbr\u003eA se păstra la temperaturi sub 25°C, în ambalajul original pentru a fi protejat de lumină şi umiditate.\u003cbr\u003eNu aruncaţi niciun medicament pe calea apei sau a reziduurilor menajere. Întrebaţi farmacistul cum să aruncaţi medicamentele pe care nu le mai folosiţi. Aceste măsuri vor ajuta la protejarea mediului.\u003cbr\u003e\u003cbr\u003e6. Conţinutul ambalajului şi alte informaţii\u003cbr\u003eCe conţine ROSUCARD\u003cbr\u003eSubstanţa activă este rosuvastatina.\u003cbr\u003eUn comprimat filmat conţine rosuvastatină 10 mg\/20 mg\/40 mg, sub formă de rosuvastatină calcică.\u003cbr\u003eCelelalte componente sunt:\u003cbr\u003eNucleu: lactoză monohidrat, celuloză microcristalină, croscarmeloză sodică, dioxid de siliciu coloidalanhidru, stearat de magneziu.\u003cbr\u003eFilm: hipromeloză 2910\/5, macrogol 6000, dioxid de titan talc, oxid roşu de fer (E172).\u003c\/p\u003e\r\n\u003cp\u003eCum arată ROSUCARD şi conţinutul ambalajului\u003cbr\u003eROSUCARD 10 mg comprimate filmate: comprimate filmate ovale, biconvexe, de culoare roz deschis, prevăzute cu o linie mediană, cu lungimea de aproximativ 8,8 mm şi lăţimea de aproximativ 4,5 mm. Comprimatul poate fi divizat în doze egale.\u003cbr\u003eROSUCARD 20 mg comprimate filmate: comprimate filmate ovale, biconvexe, de culoare roz cu lungimea de aproximativ 11,1 mm şi lăţimea de aproximativ 5,6 mm.\u003cbr\u003eROSUCARD 40 mg comprimate filmate: comprimate filmate ovale, biconvexe, de culoare roz închis cu lungimea de aproximativ 14,0 mm şi lăţimea de aproximativ 7,0 mm.\u003cbr\u003eMărimi de ambalaj: 28, 30, 84, 90 comprimate filmate.\u003cbr\u003eEste posibil ca nu toate dimensiunile de ambalaj să fie comercializate.\u003cbr\u003e\u003cbr\u003eDeţinătorul autorizaţiei de punere pe piaţă\u003cbr\u003eZentiva, k.s.\u003cbr\u003eU kabelovny 130, Praga 10, Dolnì Měcholupy 102 37\u003cbr\u003eRepublica Cehă\u003cbr\u003e\u003cbr\u003eFabricanţii\u003cbr\u003eZentiva, k.s.\u003cbr\u003eU kabelovny 130, Praga 10, Dolnì Měcholupy 102 37\u003cbr\u003eRepublica Cehă\u003cbr\u003eUAB „Oriola Vilnius”\u003cbr\u003eLaisvės pr. 75, LT-06144 Vilnius\u003cbr\u003eLituania \u003c\/p\u003e","brand":"Zentiva Labormed","offers":[{"title":"Default Title","offer_id":43907860693132,"sku":"20695","price":95.63,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/20695.jpg?v=1750850365"},{"product_id":"rosucard-10mg-compfilm","title":"Rosucard 10mg comp.film.","description":"\u003cp\u003eROSUCARD 10 mg comprimate filmate\u003cbr\u003eROSUCARD 20 mg comprimate filmate\u003cbr\u003eROSUCARD 40 mg comprimate filmate\u003cbr\u003e\u003cbr\u003eRosuvastatină\u003cbr\u003e\u003cbr\u003eCitiţi cu atenţie şi în întregime acest prospect înainte de a începe să luaţi acest medicament deoarece conţine informaţii importante pentru dumneavoastră.\u003cbr\u003e- Păstraţi acest prospect. S-ar putea să fie necesar să-l recitiţi.\u003cbr\u003e- Dacă aveţi orice întrebări suplimentare, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003cbr\u003e- Acest medicament a fost prescris numai pentru dumneavoastră. Nu trebuie să-l daţi altor persoane. Le poate face rău, chiar dacă au aceleaşi semne de boală ca dumneavoastră.\u003cbr\u003e- Dacă manifestaţi orice reacţii adverse, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003c\/p\u003e\r\n\u003cp\u003eAcestea includ orice posibile reacţii adverse nemenţionate în acest prospect. Vezi pct. 4.\u003cbr\u003e\u003cbr\u003eCe găsiţi în acest prospect:\u003cbr\u003e1. Ce este ROSUCARD şi pentru ce se utilizează\u003cbr\u003e2. Ce trebuie să ştiţi înainte să luaţi ROSUCARD\u003cbr\u003e3. Cum să luaţi ROSUCARD\u003cbr\u003e4. Reacţii adverse posibile\u003cbr\u003e5. Cum se păstrează ROSUCARD\u003cbr\u003e6. Conţinutul ambalajului şi alte informaţii\u003cbr\u003e\u003cbr\u003e1. Ce este ROSUCARD şi pentru ce se utilizează\u003cbr\u003eROSUCARD aparţine unui grup de medicamente numite statine.\u003cbr\u003e\u003cbr\u003eVi s-a prescris ROSUCARD deoarece:\u003cbr\u003e- aveţi valori mari ale colesterolului. Aceasta înseamnă că aveţi risc de a face un infarct miocardic sau un accident vascular cerebral.\u003cbr\u003eVi s-a recomandat să luaţi o statină, deoarece dieta pe care aţi urmat-o şi exerciţiul fizic nu au fost suficiente pentru a corecta valoarea colesterolului. Trebuie să urmaţi în continuare dieta pentru reducerea colesterolului şi exerciţiul fizic în timp ce luaţi ROSUCARD. \u003cbr\u003eSau\u003cbr\u003e- aveţi alţi factori care cresc riscul de a face un infarct miocardic, accident vascular cerebral sau probleme de sănătate legate de acestea.\u003cbr\u003eInfarctul miocardic, accidentul vascular cerebral şi alte probleme de sănătate pot fi cauzate de o afecţiune numită ateroscleroză. Ateroscleroza se produce ca urmare a depunerii de grăsime la nivelul arterelor.\u003cbr\u003e\u003cbr\u003eDe ce este important să continuaţi să luaţi ROSUCARD?\u003cbr\u003eROSUCARD este utilizat pentru corectarea valorilor grăsimilor din sânge numite lipide, dintre care cel mai frecvent este colesterolul.\u003cbr\u003eExistă mai multe tipuri de colesterol în sânge –colesterolul „rău” (LDL-C) şi colesterolul „bun” (HDL-C).\u003cbr\u003e- ROSUCARD poate reduce colesterolul „rău” şi poate creşte colesterolul „bun”.\u003cbr\u003e- ROSUCARD acţionează prin blocarea producerii colesterolului „rău” în corpul dumneavoastră şi îmbunătăţeşte capacitatea organismului dumneavoastră de a-l elimina din sânge. \u003cbr\u003e\u003cbr\u003ePentru majoritatea persoanelor, valorile crescute ale colesterolului nu afectează modul în care vă simţiţi deoarece nu determină niciun simptom. Cu toate acestea, dacă este netratat, depozitele de grăsime se pot depune pe pereții vaselor dumneavoastră de sânge determinând îngustarea lor.\u003cbr\u003eUneori, aceste vase îngustate se pot bloca, ceea ce întrerupe irigarea cu sânge a inimii sau creierului, determinând un infarct miocardic sau un accident vascular cerebral. Dacă scădeți valoarea colesterolului, puteţi reduce riscul de a avea un infarct miocardic sau un accident vascular cerebral sau probleme de sănătate legate de acestea.\u003cbr\u003eTrebuie să continuaţi să luaţi ROSUCARD chiar dacă colesterolul dumneavoastră a ajuns la valoarea normală deoarece preveniţi ca valorile colesterolului să crească din nou şi să determine depunerea de grăsimi.\u003cbr\u003eCu toate acestea, trebuie să întrerupeţi tratamentul dacă medicul dumneavoastră vă spune acest lucru sau dacă aţi rămas gravidă.\u003c\/p\u003e\r\n\u003cp\u003e2. Ce trebuie să ştiţi înainte să luaţi ROSUCARD\u003cbr\u003eNu luaţi ROSUCARD:\u003cbr\u003e- Dacă sunteţi alergic la rosuvastatină sau la oricare dintre celelalte componente ale acestui medicament (enumerate la punctul 6);\u003cbr\u003e- Dacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în timp ce luaţi ROSUCARD, întrerupeţi imediat tratamentul şi spuneţi-i medicului dumneavoastră. Femeile trebuie să evite să rămână gravide în timpul tratamentului cu ROSUCARD folosind metode de contracepţie corespunzătoare.\u003cbr\u003e- Dacă aveţi afecţiuni ale ficatului;\u003cbr\u003e- Dacă aveţi afecţiuni severe ale rinichilor;\u003cbr\u003e- Dacă aveţi dureri de muşchi repetate sau inexplicabile;\u003cbr\u003e- Dacă luaţi un medicament numit ciclosporină (folosit, de exemplu, după transplantul de organe).\u003cbr\u003e\u003cbr\u003eDacă oricare dintre cele de mai sus sunt valabile în cazul dumneavoastră (sau dacă aveţi nelămuriri), vă rugăm să discutaţi cu medicul dumneavoastră.\u003cbr\u003e\u003cbr\u003eÎn plus, nu luaţi ROSUCARD 40 mg (doza cea mai mare):\u003cbr\u003e- Dacă aveţi afecţiuni moderate ale rinichilor (dacă aveţi nelămuriri, vă rugăm să vă adresaţi medicului dumneavoastră);\u003cbr\u003e- Dacă glanda dumneavoastră tiroidă nu funcţionează corespunzător;\u003cbr\u003e- Dacă aţi avut în trecut dureri de muşchi repetate sau inexplicabile, un istoric personal sau familial de afecţiuni ale muşchilor, sau un istoric de probleme musculare când aţi mai luat în trecut medicamente care scad colesterolul;\u003cbr\u003e- Dacă consumaţi periodic cantităţi mari de alcool etilic;\u003cbr\u003e- Dacă sunteţi de origine asiatică (japonez, chinez, filipinez, vietnamez, coreean şi indian);\u003cbr\u003e- dacă luaţi alte medicamente numite fibraţi pentru a vă reduce valoarea colesterolului.\u003cbr\u003e\u003cbr\u003eDacă oricare dintre cele de mai sus sunt valabile în cazul dumneavoastră (sau dacă aveţi nelămuriri), vă rugăm să discutaţi cu medicul dumneavoastră.\u003cbr\u003e\u003cbr\u003eAtenţionări şi precauţii\u003cbr\u003eÎnainte să luaţi ROSUCARD, adresaţi-vă medicului dumneavoastră sau farmacistului:\u003cbr\u003e- dacă aveţi afecţiuni ale rinichilor;\u003cbr\u003e- dacă aveţi afecţiuni ale ficatului;\u003cbr\u003e- dacă aţi avut în trecut dureri de muşchi repetate sau inexplicabile, un istoric personal sau familial de probleme musculare, sau un istoric de afecţiuni ale muşchilor când aţi mai luat în trecut medicamente care scad colesterolul. Spuneţi-i imediat medicului dumneavoastră dacă aveţi dureri musculare inexplicabile, în special dacă nu vă simţiţi bine sau aveţi febră. De asemenea, spuneţi medicului dumneavoastră sau farmacistului dacă aveţi o slăbiciune musculară care este constantă.\u003cbr\u003e- dacă consumaţi periodic cantităţi mari de alcool etilic;\u003cbr\u003e- dacă glanda dumneavoastră tiroidă nu funcţionează corespunzător; \u003cbr\u003e- dacă aveţi insuficienţă respiratorie severă;\u003cbr\u003e- dacă luaţi alte medicamente numite fibraţi pentru a vă scădea colesterolul. Vă rugăm citiţi cu atenţie acest prospect, chiar dacă aţi mai luat în trecut medicamente pentru reducerea colesterolului.\u003cbr\u003e- dacă luaţi medicamente folosite pentru tratamentul infecţiei cu HIV, de exemplu ritonavir cu lopinavir şi\/sau atazanavir, vă rugăm citiţi „ROSUCARD împreună cu alte medicamente”.\u003cbr\u003e- dacă luaţi sau aţi luat în ultimele 7 zile un medicament numit acid fusidic, (un medicament pentru infecţii bacteriene) pe cale orală sau sub formă de injecţii. Combinaţia de acid fusidic şi ROSUCARD poate să ducă la probleme ale muşchilor (rabdomioliză).\u003cbr\u003e- dacă aveţi vârsta peste 70 de ani (deoarece medicul trebuie să stabilească doza cea mai bună de ROSUCARD pentru începerea tratamentului dumneavoastră).\u003cbr\u003e- dacă sunteţi de origine asiatică – adică japonez, chinez, filipinez, vietnamez, coreean sau indian.\u003cbr\u003e\u003cbr\u003eMedicul trebuie să decidă doza cea mai bună de ROSUCARD pentru începerea tratamentului dumneavoastră.\u003cbr\u003e\u003cbr\u003eCopii şi adolescenţi\u003cbr\u003e- dacă pacientul are vârsta sub 10 ani: ROSUCARD nu trebuie administrat la copii cu vârsta sub 10 ani.\u003cbr\u003e- dacă pacientul are vârsta sub 18 ani: Comprimatele de ROSUCARD 40 mg nu sunt adecvate pentru a fi utilizate la copii şi adolescenţi cu vârsta sub 18 ani.\u003cbr\u003e\u003cbr\u003eDacă oricare dintre cele de mai sus sunt valabile în cazul dumneavoastră (sau dacă aveţi nelămuriri)\u003cbr\u003e- Nu luaţi ROSUCARD 40 mg (doza cea mai mare) şi discutaţi cu medicul dumneavoastră sau cu farmacistul înainte de a începe tratamentul cu Rosucard.\u003cbr\u003eLa un număr mic de persoane, statinele pot afecta ficatul. Acest efect poate fi identificat printr-un test simplu care determină valori crescute ale enzimelor hepatice în sânge. Din acest motiv, medicul dumneavoastră vă va face periodic acest test de sânge (testul pentru funcţia ficatului) înainte de şi în timpul tratamentului cu ROSUCARD.\u003c\/p\u003e\r\n\u003cp\u003eCât timp sunteţi în tratament cu acest medicament medicul dumneavoastră vă va monitoriza atent dacă aveţi diabet sau aveţi factori de risc pentru apariţia diabetului. Sunteți la risc pentru apariţia diabetului zaharat dacă aveţi o concentraţie crescută de zahăr şi grăsimi în sânge, sunteţi supraponderal sau aveţi tensiune arterială crescută.\u003c\/p\u003e\r\n\u003cp\u003eROSUCARD împreună cu alte medicamente\u003cbr\u003eSpuneţi medicului dumneavoastră sau farmacistului dacă luaţi, aţi luat recent sau s-ar putea să luaţi orice alte medicamente.\u003cbr\u003eSpuneţi-i medicului dumneavoastră dacă luaţi oricare dintre următoarele medicamente: ciclosporină (folosită de exemplu, după transplantul de organe), warfarină (sau orice alte medicamente folosite pentru subţierea sângelui), fibraţi (cum sunt gemfibrozil sau fenofibrat) sau orice alte medicamente folosite pentru scăderea colesterolului (precum ezetimib), medicamente pentru indigestie (folosite pentru neutralizarea acidului din stomacul dumneavoastră), eritromicină (un antibiotic), un contraceptiv oral (pilula), terapie de substituţie hormonală sau ritonavir cu lopinavir şi\/sau atazanavir (folosite pentru tratamentul infecţiei cu HIV – vă rugăm să citiţi „Atenţionări şi precauţii”). Efectele acestor medicamente pot fi modificate de ROSUCARD sau ele pot modifica efectele ROSUCARD.\u003cbr\u003e\u003cbr\u003eDacă este necesar să luaţi acid fusidic pe cale orală pentru tratamentul unei infecţii bacteriene va trebui să opriţi temporar utilizarea acestui medicament. Medicul dumneavoastră vă va spune când este sigur să reluaţi tratamentul cu ROSUCARD. Administrarea concomitentă a ROSUCARD împreună cu acid fusidic poate să ducă rareori la slăbiciune musculară, sensibilitate sau durere (rabdomioliză). Vezi informaţiile cu privire la rabdomioliză de la pct. 4.\u003cbr\u003e\u003cbr\u003eROSUCARD împreună cu alcool\u003cbr\u003eNu trebuie să consumaţi regulat cantitaţi mari de alcool.\u003cbr\u003e\u003cbr\u003eSarcina, alăptarea şi fertilitatea\u003cbr\u003eDacă sunteţi gravidă sau alăptaţi, credeţi că aţi putea fi gravidă sau intenţionaţi să rămâneţi gravidă, adresaţi-vă medicului pentru recomandări înainte de a lua acest medicament.\u003cbr\u003e\u003cbr\u003eNu luaţi ROSUCARD dacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în timp ce luaţi ROSUCARD, întrerupeţi imediat tratamentul şi spuneţi-i medicului dumneavoastră. Femeile trebuie să evite să rămână gravide în timpul tratamentului cu ROSUCARD, folosind metode de contracepţie corespunzătoare.\u003cbr\u003e\u003cbr\u003eConducerea vehiculelor şi folosirea utilajelor\u003cbr\u003eMajoritatea persoanelor pot conduce vehicule şi pot folosi utilaje în timpul tratamentului cu ROSUCARD – nu le va afecta capacitatea. Cu toate acestea, unele persoane pot avea ameţeli în timpul tratamentului cu ROSUCARD. Dacă vă simţiţi ameţit, adresaţi-vă medicului dumneavoastră înainte de a încerca să conduceţi vehicule sau să folosiţi utilaje.\u003cbr\u003e\u003cbr\u003eROSUCARD conţine lactoză monohidrat\u003cbr\u003eROSUCARD 10 mg comprimate filmate conţine lactoză monohidrat 60 mg.\u003cbr\u003eROSUCARD 20 mg comprimate filmate conţine lactoză monohidrat 120 mg.\u003cbr\u003eROSUCARD 40 mg comprimate filmate conţine lactoză monohidrat 240 mg.\u003cbr\u003eDacă medicul dumneavoastră v-a atenţionat că aveţi intoleranţă la unele categorii de glucide, vă rugăm să-l întrebaţi înainte de a lua acest medicament.\u003cbr\u003e\u003cbr\u003e3. Cum să luaţi ROSUCARD\u003cbr\u003eLuaţi întotdeauna acest medicament exact aşa cum v-a spus medicul dumneavoastră sau farmacistul.\u003cbr\u003eDiscutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur.\u003cbr\u003eDoza recomandată la adulţi\u003cbr\u003eDacă luaţi ROSUCARD pentru valorile mari ale colesterolului\u003cbr\u003eDoza de iniţiere: Tratamentul dumneavoastră cu ROSUCARD trebuie să înceapă cu doza de 5 mg sau 10 mg, chiar dacă aţi luat o doză mai mare dintr-o altă statină în trecut.\u003cbr\u003e\u003cbr\u003eAdministrarea unei doze de 5 mg poate fi realizată prin ruperea comprimatului de 10 mg de-a lungul liniei mediane.\u003cbr\u003e\u003cbr\u003eStabilirea dozei dumneavoastră de început va depinde de:\u003cbr\u003e- Valoarea colesterolului dumneavoastră.\u003cbr\u003e- Gradul de risc pe care îl aveţi de a face un infarct miocardic sau un accident vascular cerebral.\u003cbr\u003e- Dacă aveţi vreun factor care v-ar putea face mai sensibil la posibilele reacţii adverse.\u003cbr\u003e\u003cbr\u003eVă rugăm discutaţi cu medicul dumneavoastră sau cu farmacistul pentru a vedea care este doza de început cea mai potrivită pentru dumneavoastră.\u003cbr\u003e\u003cbr\u003eMedicul dumneavoastră poate decide să vă administreze doza cea mai mică (5 mg) dacă:\u003cbr\u003e- Sunteţi de origine asiatică (japonez, chinez, filipinez, vietnamez, coreean sau indian).\u003cbr\u003e- Aveţi vârsta peste 70 de ani.\u003cbr\u003e- Funcţia rinichilor dumneavoastră este moderat afectată.\u003cbr\u003e- Aveţi risc de dureri musculare (miopatie).\u003cbr\u003e\u003cbr\u003eCreşterea dozei şi doza zilnică maximă:\u003cbr\u003eEste posibil ca medicul dumneavoastră să decidă să vă crească doza, pentru ca dumneavoastră să luaţi doza de ROSUCARD care vă este potrivită. Dacă aţi început cu doza de 5 mg, medicul dumneavoastră poate decide să o dubleze la 10 mg, apoi la 20 mg şi apoi la 40 mg, dacă este necesar. Dacă aţi început cu doza de 10 mg, medicul dumneavoastră poate decide să o dubleze la 20 mg şi apoi la 40 mg, dacă este necesar. Va exista o perioadă de patru săptămâni între fiecare modificare a dozei.\u003cbr\u003eDoza zilnică maximă de ROSUCARD este 40 mg. Această doză este numai pentru pacienţii cu valori mari ale colesterolului şi cu risc crescut de infarct miocardic sau accident vascular cerebral, ale căror valori de colesterol nu sunt scăzute suficient de doza de 20 mg.\u003cbr\u003eDacă luaţi ROSUCARD pentru reducerea riscului de a face infarct miocardic, accident vascular cerebral sau probleme de sănătate legate de acestea:\u003cbr\u003eDoza recomandată este 20 mg zilnic. Cu toate acestea, medicul dumneavoastră poate decide să vă administreze o doză mai mică dacă aveţi oricare dintre factorii de risc menţionaţi mai sus. \u003cbr\u003e\u003cbr\u003eUtilizarea la copii şi adolescenţi cu vârsta cuprinsă între 10 şi 17 ani\u003cbr\u003eDoza iniţială recomandată este de 5 mg. Medicul dumneavoastră vă poate creşte doza pentru a vedea care este doza de ROSUCARD potrivită pentru dumneavoastră. Doza zilnică maximă de ROSUCARD este 20 mg. Luaţi doza o dată pe zi. Comprimatele ROSUCARD 40 mg nu trebuie utilizate la copii şi adolescenţi.\u003c\/p\u003e\r\n\u003cp\u003eAdministrarea comprimatelor\u003cbr\u003eÎnghiţiţi fiecare comprimat întreg, cu apă.\u003cbr\u003eLuaţi ROSUCARD zilnic, o dată pe zi. Puteţi să luaţi comprimatul în orice moment al zilei, cu sau fără alimente.\u003cbr\u003eÎncercaţi să luaţi comprimatul în acelaşi moment în fiecare zi pentru a vă aduce aminte să îl luaţi.\u003cbr\u003e\u003cbr\u003eDeterminări periodice ale colesterolului\u003cbr\u003eEste important să mergeţi periodic la medicul dumneavoastră pentru verificări ale colesterolului, pentru a vă asigura că valorile colesterolului dumneavoastră au ajuns la nivelul corect şi se menţin.\u003cbr\u003eEste posibil ca medicul dumneavoastră să decidă să vă crească doza, pentru ca dumneavoastră să luaţi doza de ROSUCARD care vă este potrivită.\u003cbr\u003eDacă luaţi mai mult ROSUCARD decât trebuie\u003cbr\u003eAdresaţi-vă medicului dumneavoastră sau celui mai apropiat spital.\u003cbr\u003eDacă mergeţi la spital sau sunteţi tratat pentru o altă afecţiune, spuneţi personalului medical că luaţi\u003cbr\u003eROSUCARD.\u003cbr\u003eDacă uitaţi să luaţi ROSUCARD\u003cbr\u003eNu vă îngrijoraţi, luaţi următoarea doză la ora corectă. Nu luaţi o doză dublă pentru a compensa doza uitată.\u003cbr\u003eDacă încetaţi să luaţi ROSUCARD\u003cbr\u003eDiscutaţi cu medicul dumneavoastră dacă vreţi să încetaţi să luaţi ROSUCARD. Este posibil ca valorile colesterolului dumneavoastră să crească din nou dacă opriţi tratamentul cu ROSUCARD.\u003cbr\u003eDacă aveţi orice întrebări suplimentare cu privire la acest medicament, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003cbr\u003e\u003cbr\u003e4. Reacţii adverse posibile\u003cbr\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele.\u003cbr\u003eEste important să cunoaşteţi care sunt aceste reacţii adverse. Acestea sunt, de regulă, uşoare şi dispar după puţin timp.\u003cbr\u003eOpriţi tratamentul cu ROSUCARD şi adresaţi-vă imediat unui medic dacă aveţi oricare dintre următoarele reacţii alergice:\u003cbr\u003e- Dificultăţi în respiraţie, însoţite sau nu de umflarea feţei, buzelor, limbii şi\/sau gâtului.\u003cbr\u003e- Umflarea feţei, a buzelor, limbii şi\/sau gâtului, care pot determina dificultăţi la înghiţire.\u003cbr\u003e- Mâncărime severă la nivelul pielii (cu umflături).\u003cbr\u003e\u003cbr\u003eDe asemenea, întrerupeţi tratamentul cu ROSUCARD şi adresaţi-vă imediat medicului dumneavoastră dacă aveţi dureri neobişnuite ale muşchilor care durează de mai mult timp decât v-aţi fi aşteptat. Simptomele la nivelul muşchilor apar mai frecvent la copii şi adolescenţi comparativ cu adulţii. Ca şi în cazul altor statine, un număr foarte mic de persoane au avut efecte adverse la nivel muscular şi, rar, aceste efecte au evoluat către o afectare musculară care poate pune viaţa în pericol numită rabdomioliză (reacţie adversă rară). \u003cbr\u003e\u003cbr\u003eUrmătoarele reacţii adverse au fost raportate în cazul folosirii rosuvastatinei (substanţa activă din ROSUCARD):\u003cbr\u003e\u003cbr\u003eReacţii adverse frecvente (pot afecta până la 1 din 10 persoane):\u003cbr\u003e- Durere de cap\u003cbr\u003e- Durere de stomac\u003cbr\u003e- Constipaţie\u003cbr\u003e- Greaţă\u003cbr\u003e- Durere musculară\u003cbr\u003e- Senzaţie de slăbiciune\u003cbr\u003e- Ameţeli\u003cbr\u003e- O creştere a cantităţii de proteine în urină – aceasta revine, de regulă, la normal de la sine, fără a fi nevoie să întrerupeţi tratamentul cu ROSUCARD comprimate (numai pentru ROSUCARD 40 mg).\u003cbr\u003e- Diabet zaharat. Apariţia acestei reacţii adverse este mai probabilă dacă aveţi valori mari ale zahărului şi grăsimilor din sânge, sunteţi supraponderal sau aveţi tensiune arterială crescută.\u003cbr\u003eMedicul dumneavoastră vă va monitoriza cât timp luaţi acest medicament.\u003c\/p\u003e\r\n\u003cp\u003eReacţii adverse mai puţin frecvente (pot afecta până la 1 din 100 de persoane):\u003cbr\u003e- Erupţie trecătoare pe piele, mâncărime sau alte reacţii la nivelul pielii\u003cbr\u003e- O creştere a cantităţii de proteine în urină – aceasta revine, de regulă, la normal de la sine, fără a fi nevoie să întrerupeţi tratamentul cu ROSUCARD comprimate (numai pentru ROSUCARD 10 mg şi 20 mg).\u003cbr\u003e\u003cbr\u003eReacţii adverse rare (pot afecta până la 1 din 1000 de persoane):\u003cbr\u003e- Reacţii alergice severe – semnele includ umflarea feţei, buzelor, limbii şi\/sau gâtului, dificultăţi la înghiţire şi în respiraţie, mâncărime severă la nivelul pielii (cu umflături). Dacă credeţi că aveţi o reacţie alergică, atunci întrerupeţi tratamentul cu ROSUCARD şi adresaţi-vă imediat unui medic.\u003cbr\u003e- Afectare musculară la adulţi – ca măsură de precauţie, întrerupeţi tratamentul cu ROSUCARD şi adresaţi-vă imediat medicului dumneavoastră dacă aveţi orice dureri musculare neobişnuite care durează de mai mult timp decât v-aţi fi aşteptat.\u003cbr\u003e- Durere abdominală severă (pancreas inflamat).\u003cbr\u003e- Creşterea concentraţiei enzimelor hepatice în sânge.\u003cbr\u003e\u003cbr\u003eReacţii adverse foarte rare (pot afecta până la 1 din 10000 de persoane):\u003cbr\u003e- Icter (colorarea în galben a pielii şi a albului ochilor)\u003cbr\u003e- Hepatită (ficat inflamat).\u003cbr\u003e- Dureri articulare.\u003cbr\u003e- Urme de sânge în urină.\u003cbr\u003e- Afectarea nervilor de la nivelul picioarelor şi braţelor dumneavoastră (precum amorţeală).\u003cbr\u003e- Pierderi de memorie.\u003cbr\u003e- Ginecomastie (mărire a sânilor la bărbaţi).\u003cbr\u003e\u003cbr\u003eReacţiile adverse cu frecvenţă necunoscută (frecvenţa nu poate fi estimată din datele disponibile) pot include:\u003cbr\u003e- Depresie.\u003cbr\u003e- Slăbiciune musculară care este constantă.\u003cbr\u003e- Leziuni ale tendoanelor.\u003cbr\u003e- Tulburări ale somnului, inclusiv insomnie şi coşmaruri.\u003cbr\u003e- Diaree (scaune moi).\u003cbr\u003e- Sindrom Stevens-Johnson (afecţiune gravă însoţită de vezicule la nivelul pielii, gurii, ochilor şi zonei genitale).\u003cbr\u003e- Tuse.\u003cbr\u003e- Dificultăţi la respiraţie.\u003cbr\u003e- Edeme (umflare).\u003cbr\u003e- Tulburări sexuale.\u003cbr\u003e- Probleme de respiraţie, incluzând tuse persistentă şi\/sau dificultăţi la respiraţie sau febră. \u003cbr\u003e\u003cbr\u003e5. Cum se păstrează ROSUCARD\u003cbr\u003eNu lăsaţi acest medicament la vederea şi îndemâna copiilor.\u003cbr\u003eNu utilizaţi acest medicament după data de expirare înscrisă pe cutie după EXP. Data de expirare se referă la ultima zi a lunii respective.\u003cbr\u003eA se păstra la temperaturi sub 25°C, în ambalajul original pentru a fi protejat de lumină şi umiditate.\u003cbr\u003eNu aruncaţi niciun medicament pe calea apei sau a reziduurilor menajere. Întrebaţi farmacistul cum să aruncaţi medicamentele pe care nu le mai folosiţi. Aceste măsuri vor ajuta la protejarea mediului.\u003cbr\u003e\u003cbr\u003e6. Conţinutul ambalajului şi alte informaţii\u003cbr\u003eCe conţine ROSUCARD\u003cbr\u003eSubstanţa activă este rosuvastatina.\u003cbr\u003eUn comprimat filmat conţine rosuvastatină 10 mg\/20 mg\/40 mg, sub formă de rosuvastatină calcică.\u003cbr\u003eCelelalte componente sunt:\u003cbr\u003eNucleu: lactoză monohidrat, celuloză microcristalină, croscarmeloză sodică, dioxid de siliciu coloidalanhidru, stearat de magneziu.\u003cbr\u003eFilm: hipromeloză 2910\/5, macrogol 6000, dioxid de titan talc, oxid roşu de fer (E172).\u003c\/p\u003e\r\n\u003cp\u003eCum arată ROSUCARD şi conţinutul ambalajului\u003cbr\u003eROSUCARD 10 mg comprimate filmate: comprimate filmate ovale, biconvexe, de culoare roz deschis, prevăzute cu o linie mediană, cu lungimea de aproximativ 8,8 mm şi lăţimea de aproximativ 4,5 mm. Comprimatul poate fi divizat în doze egale.\u003cbr\u003eROSUCARD 20 mg comprimate filmate: comprimate filmate ovale, biconvexe, de culoare roz cu lungimea de aproximativ 11,1 mm şi lăţimea de aproximativ 5,6 mm.\u003cbr\u003eROSUCARD 40 mg comprimate filmate: comprimate filmate ovale, biconvexe, de culoare roz închis cu lungimea de aproximativ 14,0 mm şi lăţimea de aproximativ 7,0 mm.\u003cbr\u003eMărimi de ambalaj: 28, 30, 84, 90 comprimate filmate.\u003cbr\u003eEste posibil ca nu toate dimensiunile de ambalaj să fie comercializate.\u003cbr\u003e\u003cbr\u003eDeţinătorul autorizaţiei de punere pe piaţă\u003cbr\u003eZentiva, k.s.\u003cbr\u003eU kabelovny 130, Praga 10, Dolnì Měcholupy 102 37\u003cbr\u003eRepublica Cehă\u003cbr\u003e\u003cbr\u003eFabricanţii\u003cbr\u003eZentiva, k.s.\u003cbr\u003eU kabelovny 130, Praga 10, Dolnì Měcholupy 102 37\u003cbr\u003eRepublica Cehă\u003cbr\u003eUAB „Oriola Vilnius”\u003cbr\u003eLaisvės pr. 75, LT-06144 Vilnius\u003cbr\u003eLituania \u003c\/p\u003e","brand":"Zentiva Labormed","offers":[{"title":"Default Title","offer_id":43907860791436,"sku":"20717","price":74.02,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/20717.jpg?v=1750850368"},{"product_id":"rosulip-10mg-compfilm","title":"Rosulip 10mg comp.film.","description":"\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eROSULIP\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003ecomprimate filmate \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eDenumirea comercială\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosulip \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eDCI-ul substanţei active\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatinum \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003ch1 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCompoziţia \u003c\/span\u003e\u003c\/span\u003e\u003c\/h1\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e1 comprimat filmat conţine:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003esubstanţa activă: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003erosuvastatină 5 mg (sub formă de rosuvastatină de zinc 5,34 mg), rosuvastatină 10 mg (sub formă de rosuvastatină de zinc 10,68 mg), rosuvastatină 20 mg (sub formă de rosuvastatină de zinc 21,36 mg), rosuvastatină 40 mg (sub formă de rosuvastatină de zinc 42,72 mg),\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eexcipienţi: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003emonohidrat de lactoză, povidonă, crospovidonă, stearat de magneziu, alcool polivinilic, dioxid de titan, macrogol 3350, talc.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eForma farmaceutică\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e \u003c\/h2\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eDESCRIEREA MEDICAMENTULUI\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cu\u003eRosulip 5 mg\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate de culoare albă sau aproape albă, rotunde, uşor biconvexe, cu sau practic fără miros, cu marcarea literei stilizate E pe una din părţi şi numărul 591 pe altă parte a comprimatului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eRosulip 10 mg\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate de culoare albă sau aproape albă, rotunde, uşor biconvexe, cu sau practic fără miros, cu marcarea literei stilizate E pe una din părţi şi numărul 592 pe altă parte a comprimatului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eRosulip 20 mg\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate de culoare albă sau aproape albă, rotunde, uşor biconvexe, cu sau practic fără miros, cu marcarea literei stilizate E pe una din părţi şi numărul 593 pe altă parte a comprimatului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eRosulip 40 mg\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate de culoare albă sau aproape albă, ovale, uşor biconvexe, cu sau practic fără miros, cu marcarea literei stilizate E pe una din părţi şi numărul 594 pe altă parte a comprimatului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eGRUPA FARMACOTERAPEUTICĂ şi codul ATC\u003c\/span\u003e\u003c\/span\u003e\u003c\/h2\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eInhibitori ai HMG - CoA reductazei, C10AA07\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eProprietăţiLE farmacologice\u003c\/span\u003e\u003c\/span\u003e\u003c\/h2\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eProprietăţi farmacodinamice\u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eMecanism de acţiune\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina este un inhibitor selectiv şi competitiv al HMG-CoA reductazei, enzima care limitează conversia din 3-hidroxil-3-metilglutaril coenzima A în mevalonat, un precursor al colesterolului. Locul principal de acţiune al rosuvastatinei este ficatul, organul ţintă pentru scăderea nivelului de colesterol în organism.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina creşte numărul receptorilor lipoproteinelor cu densitate mică (LDL) de pe suprafaţa celulelor hepatice, crescând captarea şi catabolismul LDL şi inhibă sinteza hepatică de lipoproteine cu densitate foarte mică (VLDL), reducând în acest mod numărul total al particulelor de VLDL şi LDL.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eEfecte farmacodinamice\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina scade concentraţiile crescute de LDL-colesterol, colesterol total şi trigliceride, de asemenea creşte nivelul colesterolului lipoproteinelor cu densitate mare (HDL-colesterolul).\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe asemenea, rosuvastatina scade concentraţia apolipoproteinei B (Apo-B), non HDL-C, VLDL-C, VLDL-TG şi creşte nivelul apolipoproteinei A-I (ApoA-I).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe asemenea, rosuvastatina scade rapoartele LDL-C\/HDL-C, colesterol total\/HDL-C, non HDL-C\/HDL-C şi Apo-B\/ApoA-I.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003e\u003cu\u003eTabelul 1. Răspunsul pacienţilor cu hipercolesterolemie primară (tip IIa şi IIb) în funcţie de doză\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e \u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003e(modificarea procentuală medie faţă de valoarea iniţială ajustată)\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003ctable width=\"604\" cellspacing=\"0\" cellpadding=\"5\"\u003e\r\n\u003ctbody\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eDoză \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e \u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eN\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eLDL-C \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e \u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eColesterol total\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eHDL-C \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e \u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eTrigliceride \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eNonHDL-C \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eАpo-В\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eАpoА‑I\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr valign=\"top\"\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003ePlacebo \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e13\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-7\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-5\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e3\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-3\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-7\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-3\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e0\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr valign=\"top\"\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e5 mg\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e17\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-45\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-33\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e13\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-35\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-44\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-38\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e4\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr valign=\"top\"\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e10 mg\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e17\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-52\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-36\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e14\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-10\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-48\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-42\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e4\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr valign=\"top\"\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e20 mg\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e17\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-55\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-40\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e8\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-23\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-51\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-46\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e5\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr valign=\"top\"\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e40 mg\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e18\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-63\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-46\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e10\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-28\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-60\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-54\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e0\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003c\/tbody\u003e\r\n\u003c\/table\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eEfectul terapeutic se obţine într-o săptămână de la instituirea tratamentului şi 90% din răspunsul maxim este atins după 2 săptămâni. Răspunsul maxim este atins de obicei după 4 săptămâni şi se menţine ulterior.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eProprietăţi farmacocinetice\u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eAbsorbţie \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eConcentraţia plasmatică maximă de rosuvastatină se realizează peste 5 ore de la administrarea pe cale orală. Biodisponibilitatea absolută este de aproximativ 20%.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eDistribuţie\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRosuvastatina este captată intensiv de ficat, care este principalul loc de sinteză a colesterolului şi eliminare pentru LDL-C. Volumul aparent de distribuţie al rosuvastatinei este de aproximativ 134 l. Aproximativ 90% din rosuvastatină se leagă de proteinele plasmatice, în principal de albumină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eMetabolizare \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRosuvastatina este metabolizată limitat (aproximativ 10%). Studiile \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003ein vitro\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e privind metabolismul, în care au fost utilizate hepatocite umane au arătat că rosuvastatina este un substrat slab pentru metabolizarea dependentă de citocromul P450. În metabolismul preparatului participă preponderent CYP2C9, iar izoenzimele 2C19, 3A4 şi 2D6 au fost implicate într-o măsură mai mică. Principalii metaboliţi identificaţi sunt N-desmetil- şi lacton-metaboliţii. Metabolitul N-desmetil este cu aproximativ 50% mai puţin activ decât rosuvastatina, în timp ce metabolitul sub formă de lactonă este considerat inactiv clinic. Rosuvastatina este responsabilă de inhibarea activităţii a mai mult de 90% din HMG-CoA reductază circulantă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEliminare \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAproximativ 90% din doza de rosuvastatină se excretă nemodificată cu materiile fecale (constând în substanţă activă absorbită şi neabsorbită), iar restul se excretă prin urină. Aproximativ 5% se excretă nemodificat prin urină. Timpul de înjumătăţire plasmatică prin eliminare este de aproximativ 19 ore. Timpul de înjumătăţire nu creşte la administrarea unor doze mai mari. Media geometrică a clearance-ului plasmatic este de aproximativ 50 l\/oră (coeficient de variaţie 21,7%). Ca şi în cazul altor inhibitori de HMG-CoA reductază, captarea hepatică a rosuvastatinei implică proteina transportatoare membranară a anionilor organici de tip C (OATP-C). Acest sistem de transport este important pentru eliminarea hepatică a rosuvastatinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eLinearitate\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e \u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003e\/Non-linearitate\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eBiodisponibilitatea sistemică la rosuvastatină creşte proporţional cu doza administrată. Administrarea mai multor doze zilnice, nu este urmată de modificări ale parametrilor farmacocinetici.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eGrupe speciale de pacienţi\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eVârstă şi sex\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eNu s-a constatat nici o modificare semnificativă clinic, legată de vârstă sau de sex, în ceea ce priveşte farmacocinetica rosuvastatinei. Farmacocinetica rosuvastatinei la copii şi adolescenţi cu hipercolesterolemie familială heterozigotă a fost similară celei de la voluntarii adulţi (vezi mai jos „Copii şi adolescenţi”).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eRasă\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eStudii de farmacocinetică au evidenţiat o creştere de aproximativ 2 ori a mediei ariei de sub curba concentraţiei plasmatice în funcţie de timp (ASC) şi a Cmax la subiecţii asiatici (japonezi, chinezi, filipinezi,vietnamezi şi coreeni) comparativ cu populaţia de tip caucazian; indienii-asiatici prezintă o creştere de aproximativ 1,3 ori a ASC şi Cmax.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eO analiză de farmacocinetică populaţională, nu a relevat diferenţe semnificative clinic privind farmacocinetica între grupele de populaţie de tip caucazian şi cele de culoare (neagră).\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003ePacienţi cu insuficienţă renală\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eConform rezultatelor studiilor clinice efectuate pe pacienţii cu afectarea funcţiei renale, insuficienţa renală uşoară până la moderată nu influenţează concentraţia plasmatică a rosuvastatinei sau a metabolitului său N-desmetil.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSubiecţii cu insuficienţă renală severă (clearance-ul la creatinină \u0026lt; 30 ml\/min) au prezentat o concentraţie plasmatică de rosuvastatină de 3 ori mai mare şi o concentraţie plasmatică a metabolitului N-desmetil de 9 ori mai mare, comparativ cu voluntarii sănătoşi. Concentraţiile plasmatice ale rosuvastatinei, la starea de echilibru, la pacienţii supuşi hemodializei au fost cu aproximativ 50% mai mari comparativ cu cele de la voluntarii sănătoşi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003ePacienţi cu insuficienţă hepatică\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eConform rezultatelor studiilor clinice efectuate pe pacienţii cu diferit grad de afectare hepatică, nu s-a evidenţiat creşterea expunerii la rosuvastatină la pacienţii cu un scor Child-Pugh de 7 sau mai mic.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCu toate acestea, 2 subiecţi cu scoruri Child-Pugh de 8 şi 9 au prezentat o creştere a expunerii sistemice la rosuvastatină de cel puţin de 2 ori mai mare comparativ cu pacienţii care prezentau scoruri Child-Pugh mai mici. Nu există experienţă în ceea ce priveşte pacienţii cu scoruri Child-Pugh mai mari de 9.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003ePolimorfism genetic\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eProteinele transportatoare OATP1B1 şi BCRP participă la eliminarea inhibitorilor ai HMG - CoA reductazei, inclusiv şi a rosuvastatinei. La pacienţii cu polimorfism genetic SLCO1B1 (OATP1B1) şi\/sau ABCG2 (BCRP) există risc de creştere a expoziţiei rosuvastatinei. Pentru polimorfismul individual SLCO1B1 c.521CC şi ABCG2 c.421AA este caracteristică creşterea expoziţiei (ASC) a rosuvastatinei de 1,7 ori şi 2,4 ori, corespunzător, în comparaţie cu genotipurile SLCO1B1 c.521TT şi ABCG2 c.421CC.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eCopii şi adolescenţi\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e \u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eParametrii farmacocinetici la pacienţii copii şi adolescenţi cu hipercolesterolemie familială heterozigotă cu vârsta între 10 şi 17 ani nu au fost complet caracterizaţi. Un studiu mic de farmacocinetică cu rosuvastatină (administrată ca şi comprimate) la 18 pacienţi copii şi adolescenţi a demonstrat că expunerea la pacienţii copii şi adolescenţi pare comparabilă cu expunerea la pacienţii adulţi. În plus, rezultatele indică faptul că nu se aşteaptă o deviere mare în ceea ce priveşte proporţionalitatea dozei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eIndicaţii terapeutice\u003c\/span\u003e\u003c\/span\u003e\u003c\/h2\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eTratamentul hipercolesterolemiei\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ePreparatul este indicat la adulţi, adolescenţi şi copii cu vârsta de 10 ani sau mai mare, cu hipercolesterolemie primară (tip IIa, inclusiv şi hipercolesterolemie familială heterozigotă) sau dislipidemie mixtă (tip IIb), în asociere cu dieta atunci când răspunsul la dietă şi la alte metode non-farmacologice (de exemplu exerciţii fizice, scădere ponderală) este inadecvat. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eTratamentul hipercolesterolemiei familiale homozigote\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eHipercolesterolemie familială homozigotă, în asociere cu dieta şi alte tratamente hipolipemiante (de exemplu afereza LDL) sau dacă astfel de tratamente nu sunt adecvate. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eProfilaxia evenimentelor cardiovasculare \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eProfilaxia evenimentelor cardiovasculare majore la pacienţii încadraţi cu risc înalt de a prezenta un prim eveniment cardiovascular, în asociere cu corecţia celorlalţi factori de risc.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eTratamentul aterosclerozei\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e la pacienţii, care necesită scăderea nivelului de lipide, cu scop de a încetini progresia şi retenţia dezvoltării patologiei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eDoze şi mod de administrare\u003c\/span\u003e\u003c\/span\u003e\u003c\/h2\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎnainte de iniţierea tratamentului pacientului se indică o dietă standard, cu conţinut scăzut de colesterol, care e necesar de respectat şi pe durata tratamentului cu rosuvastatină. Doza se selectează în mod individual în dependenţă de scopul terapiei şi rezultatul obţinut. La ajustarea dozei se utilizează ghidurile actuale de tratament acceptate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eRegimul de dozare\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eTratamentul hipercolesterolemiei\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"color: #000080;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDoza iniţială recomandată este de 5 sau 10 mg administrată pe cale orală, o dată pe zi, atât pacienţilor fără tratament anterior cât şi celor transferaţi de la un tratament cu un alt inhibitor de HMG-CoA reductază. La ajustarea dozei iniţiale a preparatului, trebuie să ţină cont de colesterolemia individuală a pacientului, de riscul dezvoltării patologiilor cardiovasculare, de asemenea de riscul potenţial de dezvoltare a reacţiilor adverse (vezi mai jos).\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan lang=\"ro-RO\"\u003e Ajustarea dozei, dacă este necesară, poate fi făcută la intervale de cel puţin 4 săptămâni. În legătură cu riscul sporit al dezvoltării reacţiilor adverse la doza de 40 mg, trecerea la doza maximă (40 mg) se va efectua doar la pacienţii cu hipercolesterolemie gravă şi risc înalt de apariţie a patologiilor cardiovasculare (îndeosebi la pacienţii cu hipercolesterolemie familială), dacă nu a fost obţinut rezultatul scontat la administrarea dozei de 20 mg. Trecerea la doza de 40 mg se va efectua cu condiţia că pacienţii se vor afla sub o supraveghere standard. În plus, iniţierea tratamentului cu preparatul Rosulip, comprimate filmate, cu doze de 40 mg se recomandă de efectuat sub supravegherea medicului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eProfilaxia evenimentelor cardiovasculare\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎn studiul de reducere a riscului de evenimente cardiovasculare, doza utilizată a fost de 20 mg zilnic.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eCopii şi adolescenţi\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eUtilizarea la copii şi adolescenţi trebuie efectuată de către specialişti. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCopii şi adolescenţi cu vârsta între 10 şi 17 ani (băieţi stadiul Tanner II şi peste acest stadiu şi fete care sunt la cel puţin un an după menarhă): \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eLa copii şi adolescenţi cu hipercolesterolemie familială heterozigotă doza de iniţiere uzuală este de 5 mg zilnic. Doza uzuală variază între 5-20 mg administrate pe cale orală o dată pe zi. Titrarea trebuie efectuată în funcţie de răspunsul şi tolerabilitatea la pacienţii copii şi adolescenţi, aşa cum este specificat în recomandările de tratament pediatric. Copiii şi adolescenţii trebuie să înceapă o dietă hipolipemiantă înainte de iniţierea tratamentului cu rosuvastatină; această dietă trebuie continuată în timpul tratamentului cu rosuvastatină. Siguranţa şi eficacitatea dozelor mai mari de 20 mg nu au fost studiate la această populaţie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eComprimatele de 40 mg nu se vor administra la copii şi adolescenţi. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eCopii cu vârsta mai mică de 10 ani \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eExperienţa la copii cu vârsta mai mică de 10 ani este limitată la un număr mic de copii (cu vârste între 8 şi 10 ani) cu hipercolesterolemie familială homozigotă. De aceea, rosuvastatina nu este recomandată pentru utilizare la copii cu vârsta mai mică de 10 ani.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eVârstnici \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eDoza iniţială recomandată la pacienţi cu vârste peste 70 de ani este 5 mg. Nu este necesară nici o altă ajustare a dozei în funcţie de vârstă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003ePacienţi cu insuficienţă renală\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eNu este necesară ajustarea dozelor la pacienţi cu insuficienţă renală uşoară sau moderată. Doza iniţială recomandată la pacienţi cu insuficienţă renală moderată (clearance-ul creatininei \u0026lt;60 ml\/min) constituie 5 mg. Doza de 40 mg este contraindicată la pacienţi cu insuficienţă renală moderată. Administrarea de Rosulip la pacienţi cu insuficienţă renală severă este contraindicată indiferent de doză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003ePacienţi cu insuficienţă hepatică\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eNu s-a constatat creşterea expunerii sistemice la rosuvastatină în cazul pacienţilor cu scoruri Child-Pugh de 7 sau mai mici. Totuşi, creşterea expunerii sistemice a fost observată la pacienţi cu scoruri Child-Pugh de 8 şi 9. La aceşti pacienţi trebuie avută în vedere evaluarea funcţiei renale. Nu există experienţă clinică la subiecţi cu scoruri Child-Pugh peste 9.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina este contraindicată la pacienţii cu boală hepatică activă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eRasă\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eLa subiecţii de origine asiatică a fost remarcată creşterea expunerii sistemice.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eDoza iniţială recomandată pentru pacienţii de origine asiatică este de 5 mg. Doza de 40 mg este contraindicată la pacienţii de origine asiatică.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003ePolimorfism genetic\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eGenotipurile SLCO1B1 (OATP1B1) c.521CC şi ABCG2 (BCRP) c.421AA sunt însoţite cu o expoziţie mai mare a rosuvastatinei, în comparaţie cu genotipurile SLCO1B1 c.521TT şi ABCG2 c.421CC. La pacienţii cu genotipul necunoscut c.521CC sau c.421AA doza maximă de Rosulip, comprimate filmate, constituie 20 mg pe zi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eDoze la pacienţii cu factori de risc predispozanţi la miopatie\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eDoza iniţială recomandată la pacienţii cu factori de risc predispozanţi la miopatie este de 5 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDoza de 40 mg este contraindicată la unii din aceşti pacienţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eAdministrarea concomitentă cu alte preparate\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRosuvastatina este un substrat pentru diferite proteine transportatoare (de exemplu OATP1B1 şi BCRP). Riscul dezvoltării miopatiei (inclusiv şi a rabdomiolizei) creşte la administrarea concomitentă a rosuvastatinei cu unele preparate, capabile să crească concentraţia plasmatică a rosuvastatinei în rezultatul interacţiunii cu proteinele transportatoare menţionate mai sus (de exemplu, un astfel de preparat este ciclosporina, de asemenea unele inhibitori de proteaze, inclusiv combinaţia ritonavirului cu atazanavir, lopinavir şi\/sau tipranavir). Dacă este posibil, se vor administra preparate alternative, la necesitate – se recomandă sistarea temporară a rosuvastatinei. În cazurile când administrarea concomitentă a acestor preparate nu poate fi evitată, se va evalua minuţios raportul beneficiu\/risc, legat de tratamentul combinat şi modificarea dozei rosuvastatinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eMod de administrare\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate pentru administrare internă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ePreparatul Rosulip poate fi administrat în orice moment al zilei, \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eindependent de luarea mesei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Times New Roman, serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eReacţii adverse\u003c\/span\u003e\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eReacţiile adverse care apar la administrarea de rosuvastatină sunt în general uşoare şi tranzitorii. În studiile clinice controlate, mai puţin de 4% din pacienţii trataţi cu rosuvastatină au fost excluşi din cauza manifestării de evenimente adverse.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eFrecvenţa acestor evenimente adverse a fost clasificată după cum urmează:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eFrecvente (≥1\/100 şi \u0026lt;1\/10)\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eMai puţin frecvente (≥1\/1000 şi \u0026lt;1\/100)\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRare (≥1\/10000 şi \u0026lt;1\/1000)\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eFoarte rare (\u0026lt;1\/10000)\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eCu frecvenţă necunoscută (care nu poate fi estimată din datele disponibile).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eMai jos este prezentat profilul reacţiilor adverse pe baza datelor studiilor clinice şi experien\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Cambria Math, serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eț\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eei vaste în perioada de după punerea pe pia\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Cambria Math, serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eț\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eă a preparatului. Reacţiile adverse sunt prezentate după sisteme de organe şi incidenţa frecvenţei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări hematologice şi limfatice:\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e rare – trombocitopenie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări ale sistemului imunitar: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003erare – reacţii de hipersensibilitate, inclusiv edem angioneurotic.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări endocrine:\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e frecvente – diabet zaharat\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003csup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e1\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/sup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări psihice:\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e cu frecvenţă necunoscută – depresie. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări ale sistemului nervos: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003efrecvente – cefalee, vertij; foarte rare – polineuropatie, tulburări de memorie; cu frecvenţă necunoscută – tulburări de somn, inclusiv insomnie şi coşmaruri.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări respiratorii, toracice şi mediastinale: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003ecu frecvenţă necunoscută – tuse, dispnee.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări gastrointestinale: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003efrecvente – constipaţie, greaţă, dureri abdominale;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e \u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003erare – pancreatită; cu frecvenţă necunoscută – diaree.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări hepatobiliare: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003erare – creşterea nivelului enzimelor hepatice (transaminazelor); foarte rare – icter, hepatită.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eAfecţiuni cutanate şi ale ţesutului subcutanat: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003emai puţin frecvente – prurit, erupţii cutanate, urticarie; cu frecvenţă necunoscută – sindromul Stevens-Johnson.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări musculo-scheletice şi ale ţesutului conjunctiv: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003efrecvente – mialgie;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e \u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003erare – miopatie (incluzând miozită), rabdomioliză; foarte rare – artralgie; cu frecvenţă necunoscută – miopatie necrotizantă cu caracter imun.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări renale şi ale căilor urinare:\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e foarte rare – hematurie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări ale aparatului genital şi sânului:\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e foarte rare – ginecomastie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări generale şi la nivelul locului de administrare: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003ecu frecvenţă necunoscută – edeme.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003csup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e1\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/sup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eFrecvenţa depinde de prezenţa sau lipsa factorilor de risc (nivelul glicemiei pe nemâncate ≥ 5,6 mmol\/l, indicele masei corporale \u0026gt; 30 kg\/m\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003csup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e2\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/sup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, nivel crescut de trigliceride, hipertonie în anamneză).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSimilar altor inhibitori ai HMG-CoA reductazei, incidenţa reacţiilor adverse, legate de tratamentul cu rosuvastatină, sunt dependente de doză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eTulburări renale şi ale căilor urinare\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLa unii pacienţi, care au administrat \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003erosuvastatină, a fost înregistrată proteinuria. Proteinuria a fost diagnosticată la efectuarea analizei urinei prin teste de tip dipstick. În majoritatea cazurilor proteinuria a fost de origine tubulară. Modificări ale nivelului de proteină urinară de la “fără urme” sau “ urme” la “++” sau mai mult, au fost remarcate la mai puţin de 1% din pacienţi, trataţi cu 10 mg şi 20 mg, şi la aproximativ 3% din pacienţii trataţi cu 40 mg. O creştere minoră a modificărilor de la “fără urme” sau “ urme” la “+” s-a observat la doze de 20 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎn majoritatea cazurilor, proteinuria a scăzut sau a dispărut spontan în timpul tratamentului. Evaluarea datelor din studiile clinice şi experienţa după punerea pe piaţă nu a identificat o legătură cauzală între proteinurie şi boala renală (acută sau progresivă).\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eHematuria a fost observată la pacienţii trataţi cu rosuvastatină şi datele clinice arată că incidenţa ei este redusă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eTulburări musculo-scheletice\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLa pacienţii trataţi cu rosuvastatină au fost raportate reacţii adverse din partea musculaturii scheletice, de exemplu mialgie, miopatie (inclusiv miozită) şi, în cazuri rare, rabdomioliză pentru toate dozele şi în special pentru doze mai mari de 20 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eO creştere a concentraţiilor creatinkinazei dependentă de doză a fost observată la pacienţii trataţi cu rosuvastatină. În majoritatea cazurilor aceste efecte au fost uşoare, asimptomatice şi tranzitorii. În cazul creşterii concentraţiei plasmatice de creatininkinază (de 5 ori în comparaţie LSN), tratamentul trebuie întrerupt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eTulburări hepatobiliare\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei s-a observat creşterea transaminazelor dependentă de doză, la un număr mic de pacienţi trataţi cu rosuvastatină; majoritatea cazurilor au fost uşoare, asimptomatice şi tranzitorii.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eExperienţa de după punerea pe piaţă a medicamentului:\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eÎn plus, faţă de reacţiile adverse de mai sus, în timpul perioadei de după punerea pe piaţă a medicamentului, au fost raportate următoarele efecte adverse determinate de rosuvastatină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ePentru unele statine au fost raportate următoarele reacţii adverse:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003edisfuncţii sexuale;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ecazuri foarte rare de boală pulmonară interstiţială, în special în cazul terapiei pe termen lung;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003etulburări la nivelul tendoanelor, uneori complicate cu rupturi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eFrecvenţa raportată pentru rabdomioliză, reacţiile renale grave şi reacţiile hepatice grave (care constau în principal în creşterea valorilor transaminazelor hepatice) este mai mare la doza de 40 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eCopii şi adolescenţi\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎntr-un studiu de 52 de săptămâni cu copii şi adolescenţi, au fost observate creşteri ale creatinkinazei \u0026gt;10x LSN şi simptomele musculare după exerciţiu fizic sau activitate fizică intensă, mai frecvent comparativ cu adulţii. În alte privinţe, profilul de siguranţă al rosuvastatinei a fost similar la copii şi adolescenţi comparativ cu adulţii.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eRaportarea reacţiilor adverse posibile\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRaportarea reacţiilor adverse după punerea pe piaţă a medicamentului sunt foarte importante, deoarece aceasta permite monitorizarea raportului beneficiu\/risc al acestui preparat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eContraindicaţii\u003c\/span\u003e\u003c\/span\u003e\u003c\/h2\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosulip este contraindicat:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ehipersensibilitate la rosuvastatină sau la oricare dintre excipienţi;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ela pacienţi cu boală hepatică activă, incluzând creşterea persistentă a valorilor transaminazelor plasmatice şi orice creştere a transaminazelor plasmatice care depăşeşte de 3 ori limita superioară a normei (LSN);\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ela pacienţi cu insuficienţă renală severă (clearance-ul creatininei \u0026lt; 30 ml\/min);\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ela pacienţi cu miopatie;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ela pacienţi care primesc concomitent tratament cu ciclosporină;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eîn sarcină şi perioada de alăptare, de asemenea la femei aflate în perioada fertilă, care nu utilizează măsuri contraceptive corespunzătoare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eTratamentul cu preparatul Rosulip în doză de 40 mg este contraindicat la pacienţii cu factori predispozanţi pentru miopatie\/rabdomioliză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAstfel de factori includ:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003einsuficienţă renală moderată (clearance-ul creatininei \u0026lt; 60 ml\/min);\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ehipotiroidie;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eantecedente personale sau heredocolaterale de afecţiuni musculare ereditare;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eantecedente de miopatie în cazul folosirii anterioare a unui alt inhibitor al HMG-CoA reductazei sau al unui fibrat;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eabuz de alcool;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003esituaţii în care poate să apară o creştere a concentraţiei plasmatice de rosuvastatină;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003epacienţi de origine asiatică;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eadministrarea concomitentă de fibraţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eSupradozaj \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eNu există antidot specific pentru rosuvastatină. În caz de supradozaj se va efectua tratament simptomatic şi trebuie instituite măsuri de susţinere adecvate. În plus, se recomandă monitorizarea funcţiei hepatice şi a concentraţiilor plasmatice de \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ecreatinkinază\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e. Este puţin probabil ca hemodializa să fie eficientă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eATENŢIONĂRI ŞI PRECAUŢII SPECIALE DE UTILIZARE\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEfecte renale\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLa pacienţii trataţi cu doze mari de rosuvastatină, în special cele de 40 mg, a fost observată apariţia proteinuriei, detectată prin testarea rapidă (dipstick), în principal de origine tubulară, cu caracter tranzitoriu sau intermitent în majoritatea cazurilor. Nu s-a evidenţiat că proteinuria ar fi un factor predictiv al unei boli renale acute sau progresive. Rata de raportare a reacţiilor adverse grave renale din experienţa de după punerea pe piaţă este mai mare pentru doza de 40 mg. În timpul urmăririi de rutină a pacienţilor trataţi cu doze de 40 mg trebuie avută în vedere evaluarea periodică (cel puţin la fiecare 3 luni) a funcţiei renale.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEfecte la nivelul musculaturii scheletice\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAu fost raportate efecte negative asupra musculaturii scheletice, cum sunt mialgie, miopatie, şi, rareori, rabdomioliză la pacienţii trataţi cu rosuvastatină, la toate dozele, şi în special la doze \u0026gt; 20 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAu fost raportate cazuri foarte rare de rabdomioliză în cazul utilizării de ezetimibă asociată cu inhibitori de HMG-CoA reductază. Nu poate fi exclusă o interacţiune farmacodinamică şi sunt necesare precauţii în cazul unor astfel de asocieri.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei, frecvenţa raportărilor de rabdomioliză asociată tratamentului cu rosuvastatină în perioada de după punerea pe piaţă a produsului este mai mare în cazul dozelor de 40 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eDeterminarea valorilor creatinkinazei\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eConcentraţia plasmatică de creatinkinază (CK) nu trebuie determinată după un exerciţiu fizic intens sau în prezenţa unei posibile cauze de creştere a CK, deoarece poate determina confuzie în interpretarea rezultatului. Dacă valorile CK sunt semnificativ mai mari la iniţierea tratamentului (\u0026gt; 5 x LSN) trebuie efectuat un test de confirmare în următoarele 5-7 zile. Dacă repetarea testului confirmă o valoare iniţială a CK \u0026gt; 5 x LSN, tratamentul cu rosuvastatină nu trebuie iniţiat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eÎnainte de iniţierea tratamentului\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRosulip, similar altor inhibitori ai HMG-CoA reductazei, trebuie recomandat cu prudenţă la pacienţii care prezintă factori predispozanţi pentru miopatie\/rabdomioliză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAstfel de factori includ:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- insuficienţă renală;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e- hipotiroidie:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- antecedente personale sau heredocolaterale de afecţiuni musculare ereditare;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e- antecedente de miopatie la administrarea altor inhibitori ai HMG-CoA reductazei sau a fibraţilor;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- abuz de alcool etilic;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- vârstă peste 70 ani;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- situaţii în care poate apare o creştere a concentraţiilor plasmatice de rosuvastatină;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- administrarea concomitentă a fibraţilor.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eLa astfel de pacienţi trebuie luat în considerare riscul tratamentului comparativ cu beneficiul posibil şi se recomandă monitorizarea clinică. Dacă la momentul iniţial concentraţia de CK este crescută semnificativ (\u0026gt;5 x LSN) tratamentul nu trebuie început.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eÎn timpul tratamentului\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ePacienţii trebuie să fie sfătuiţi să raporteze imediat durerile musculare inexplicabile, hipotonia musculară sau crampele, mai ales dacă acestea se asociază cu stare de slăbiciune generală sau febră. La aceşti pacienţi trebuie măsurate concentraţiile plasmatice de CK. Tratamentul trebuie întrerupt dacă: concentraţiile plasmatice ale CK sunt crescute semnificativ (\u0026gt; 5 ori limita superioară a normei) sau dacă simptomele musculare sunt severe şi determină un disconfort zilnic (chiar şi în cazul în care concentraţiile plasmatice de CK sunt ≤ 5 ori limita superioară a normei). Dacă simptomele se remit şi concentraţiile plasmatice de CK revin la normal, atunci trebuie avută în vedere reluarea tratamentului cu rosuvastatină sau cu un alt inhibitor de HMG-CoA reductază, în cea mai mică doză şi sub o monitorizare atentă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eMonitorizarea de rutină a concentraţiilor plasmatice ale CK la pacienţii asimptomatici nu este justificată.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eExistă raportări foarte rare privind dezvoltarea miopatiei necrotizante de geneză imunologică, cu manifestări clinice caracteristice sub formă de slăbiciune îndelungată a muşchilor proximali şi creşterea nivelului seric de creatinfosfokinază pe fondalul sau după întreruperea tratamentului cu statine (inclusiv şi cu rosuvastatină). În aceste cazuri poate fi necesară investigarea ulterioară a funcţiei neuro-musculare, efectuarea testelor serologice şi indicarea tratamentului imunosupresiv.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eÎn cadrul studiilor clinice, nu s-a evidenţiat o creştere a efectelor asupra musculaturii scheletice la numărul mic de pacienţi trataţi cu rosuvastatină şi o altă terapie concomitentă. Cu toate acestea, la pacienţii trataţi cu alţi inhibitori de HMG-CoA reductază, concomitent cu derivaţi ai acidului fibric (inclusiv gemfibrozil), ciclosporină, acid nicotinic, antifungice (derivaţi azolici), inhibitori ai proteazelor şi antibiotice macrolide, s-a constatat o incidenţă crescută a miozitei şi miopatiei. Gemfibrozilul creşte riscul de miopatie în cazul în care este administrat concomitent cu unii inhibitori ai HMG-CoA reductazei. De aceea, nu este recomandată asocierea de Rosulip şi gemfibrozil. Beneficiul privind scăderea suplimentară a concentraţiei plasmatice de lipide prin administrarea asociată de rosuvastatină şi fibraţi sau niacină trebuie evaluată cu atenţie pentru riscurile potenţialele ale unor astfel de asocieri. Este contraindicată asocierea dozei de 40 mg cu fibraţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina nu trebuie utilizată la niciun pacient care prezintă o afecţiune acută, gravă, sugestivă pentru miopatie sau cu predispoziţie de a dezvolta insuficienţă renală secundară rabdomiolizei (de exemplu sepsis, hipotensiune arterială, intervenţie chirurgicală majoră, traumatisme, tulburări severe metabolice, endocrine şi electrolitice; crize convulsive necontrolate).\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEfecte hepatice\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSimilar altor inhibitori ai HMG-CoA reductazei, Rosulip trebuie utilizat cu prudenţă la pacienţii care consumă cantităţi excesive de alcool etilic şi\/sau au antecedente de boală hepatică.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSe recomandă efectuare de teste pentru evaluarea funcţiei hepatice înainte de, şi la 3 luni după iniţierea tratamentului. Rosulip trebuie întrerupt sau doza trebuie scăzută dacă valoarea transaminazelor serice este de 3 ori mai mare decât limita superioară a normei. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRata de raportare a evenimentelor hepatice severe (care constau în principal în creşterea transaminazelor hepatice) după punerea pe piaţă (administrarea la un număr mare de pacienţi), este mai mare pentru doza de 40 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎn cazul pacienţilor cu hipercolesterolemie secundară datorată hipotiroidismului sau sindromului nefrotic, cauza subiacentă trebuie tratată înainte de iniţierea terapiei cu Rosulip.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eRasa\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eStudiile de farmacocinetică au evidenţiat o creştere a expunerii sistemice la subiecţii asiatici comparativ cu cei caucazieni.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eInhibitori de protează\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eUtilizarea concomitentă a diferitor inhibitori de proteaze poate creşte expunerea sistemică la rosuvastatină. La bolnavii cu HIV, care administrează inhibitori de proteaze, se va evalua raportul beneficiului de scăderea a nivelului lipidelor la administrarea de Rosulip, comprimate filmate, şi posibilitatea creşterii concentraţiei plasmatice de rosuvastatină la iniţierea tratamentului şi ulterior la ajustarea dozei preparatului la aceşti pacienţi. Nu este recomandată utilizarea concomitentă cu inhibitori de protează, cu excepţia cazurilor când se efectuează corecţia dozelor preparatului Rosulip, comprimate filmate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eBoala interstiţială pulmonară\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eA fost raportat în cazuri foarte rare boala interstiţială pulmonară la administrare de statine. De regulă aceste cazuri au fost înregistrate în cazul unui tratament îndelungat. Simptomele bolii interstiţiale pulmonare includ dispnee, tuse seacă, alterarea stării generale de sănătate (fatigabilitate, scădere ponderală şi febră). În cazul în care la un pacient există suspectarea de boală interstiţială pulmonară, tratamentul cu statine trebuie întrerupt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eIntoleranţă la lactoză\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAcest medicament conţine lactoză. Pacienţii cu afecţiuni ereditare de intoleranţă la galactoză, deficitul de lactază (Lapp) sau sindrom de malabsorbţie de glucoză-galactoză nu trebuie să utilizeze acest medicament.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eDiabet zaharat\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eExistă dovezi care sugerează că statinele cresc glicemia şi, la unii pacienţi cu risc crescut de apariţie a diabetului zaharat, pot produce hiperglicemie cu valori care să necesite măsuri considerate de rutină la pacienţii cu diabet zaharat diagnosticat. Totuşi, riscul de apariţie a hiperglicemiei este depăşit de beneficiul reducerii riscului dezvoltării maladiilor vasculare şi, prin urmare, nu există un motiv pentru întreruperea tratamentului cu statine. Pacienţii cu risc crescut de hiperglicemie (valori ale glicemiei în condiţii de repus alimentar între 5,6 şi 6,9 mmol\/l, indicele masei corporale \u0026gt;30 kg\/m\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003csup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e2\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/sup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, valori crescute ale trigliceridemiei, hipertensiune arterială) trebuie monitorizaţi clinic şi paraclinic în acord cu ghidurile naţionale.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎn studiul clinic JUPITER, frecvenţa globală raportată de apariţie a diabetului zaharat a fost de 2,8% la rosuvastatină şi de 2,3% la placebo, mai ales la pacienţii cu valori ale glicemiei între 5,6 şi 6,9 mmol\/l în condiţii de repaus alimentar.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eCopii şi adolescenţi\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLa copiii şi adolescenţii cu vârsta între 10 şi 17 ani trataţi cu rosuvastatină evaluarea creşterii liniare (înălţime), greutăţii, IMC (indice de masă corporală) şi a caracteristicilor secundare de maturizare sexuală utilizând stadializarea Tanner a fost limitată la o perioadă de un an. După 52 de săptămâni de tratament, nu au fost observate efecte asupra creşterii, greutăţii, IMC sau maturizării sexuale. Experienţa din studiile clinice la copii şi adolescenţi este limitată, iar efectele rosuvastatinei pe termen lung (\u0026gt;1 an) asupra pubertăţii nu sunt cunoscute. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎntr-un studiu clinic cu copii şi adolescenţi care au primit rosuvastatină timp de 52 de săptămâni, creşterile CK \u0026gt;10 x LSN şi simptomele musculare după exerciţiu fizic sau activitate fizică intensă au fost observate mai frecvent comparativ cu observaţiile din studiile clinice la adulţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eAdministrarea în sarcină şi perioada de lactaţie\u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina este contraindicată în sarcină şi perioada de alăptare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cu\u003eFertilitate.\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e Femeile aflate în perioada fertilă trebuie să utilizeze măsuri contraceptive adecvate în timpul tratamentului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cu\u003eSarcina.\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e Deoarece colesterolul şi alţi produşi ai biosintezei colesterolului sunt esenţiali pentru dezvoltarea fătului, riscul potenţial rezultat ca urmare a inhibiţiei HMG-CoA reductazei depăşeşte avantajele tratamentului pe perioada sarcinii. Studiile efectuate la animale oferă dovezi limitate privind toxicitatea asupra funcţiei de reproducere. Dacă o pacientă devine gravidă în perioada în care urmează tratament cu rosuvastatină, tratamentul trebuie întrerupt imediat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cu\u003eAlăptarea.\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e Rosuvastatina se excretă în laptele şobolanilor. Nu există date cu privire la excreţia în laptele uman.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eInfluenţa asupra capacităţii de a conduce vehicule sau de a folosi utilaje \u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eNu s-au efectuat studii care să determine efectul rosuvastatinei asupra capacităţii de a conduce vehicule sau de a folosi utilaje. Cu toate acestea, pe baza proprietăţilor sale farmacodinamice, Rosulip este puţin probabil să afecteze aceste abilităţi. La conducerea vehiculelor sau la folosirea utilajelor, trebuie avut în vedere că în timpul tratamentului pot să apară vertij.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eINTERACŢIUNI CU ALTE MEDICAMENTE, \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eALTE TIPURI DE INTERACŢIUNI \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eInhibitorii proteinelor transportatoare\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRosuvastatina este un substrat al unor proteine transportatoare, inclusiv a proteinei transportatoare de captare hepatică OATP1B1 şi proteinei de eflux BCRP. La administrarea concomitentă de rosuvastatină cu preparatele, inhibitoare ale proteinelor transportatoare, poate creşte concentraţia plasmatică de rosuvastatină şi riscul dezvoltării de miopatie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eCiclosporină\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eÎn timpul tratamentului concomitent cu rosuvastatină şi ciclosporină, valorile ariei de sub curba concentraţiei plasmatice în funcţie de timp (ASC) ale rosuvastatinei au fost în medie de 7 ori mai mari decât cele constatate la voluntarii sănătoşi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAdministrarea concomitentă de rosuvastatină şi ciclosporină nu au modificat concentraţiile plasmatice ale ciclosporinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eAntagonişti de vitamină K\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSimilar altor inhibitori ai HMG-CoA reductazei, iniţierea tratamentului sau creşterea treptată a dozelor de rosuvastatină la pacienţii care primesc tratament concomitent cu antagonişti ai vitaminei K (de exemplu warfarină sau alte anticoagulante cumarinice) poate determina creşterea Raportului Internaţional Normalizat (INR). Întreruperea tratamentului sau scăderea treptată a dozelor de rosuvastatină poate avea ca rezultat scăderea INR. În astfel de situaţii, este de preferat monitorizarea adecvată a valorilor INR.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eGemfibrozil şi alte hipolipemiante\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAdministrarea concomitentă a rosuvastatinei cu gemfibrozil a determinat o creştere de 2 ori a C\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003emax\u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e şi ASC pentru rosuvastatină. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAvând la bază datele din studiile de interacţiune specifice, nu se aşteaptă o interacţiune relevantă din punct de vedere farmacocinetic cu fenofibratul, cu toate acestea, poate apare o interacţiune farmacodinamică. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eGemfibrozilul, fenofibratul, alţi fibraţi şi dozele hipolipemiante (≥ 1 g\/zi) de niacină (acid nicotinic) cresc riscul de miopatie atunci când sunt administrate concomitent cu inhibitorii HMG-CoA reductazei. Probabil acest efect poate fi legat cu aceea că preparatele enumerate mai sus pot determina miopatie atunci când sunt administraţi în monoterapie (fără tratamentul concomitent cu inhibitorii HMG-CoA reductazei). Doza de 40 mg este contraindicată în situaţiile administrării concomitente cu un fibrat. De asemenea, la aceşti pacienţi tratamentul trebuie iniţiat cu o doză de 5 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEzetimib\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAdministrarea concomitentă de rosuvastatină şi ezetimib nu a determinat nici o modificare a ASC şi a C\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003emax\u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e ale acestor preparate. La administrarea concomitentă de rosuvastatină 10 mg şi ezetimib 10 mg la pacienţii cu hipercolesterolemie a fost înregistrată creşterea de 1,2 ori a indicilor ASC (vezi tabelul 1). Totuşi, din punct de vedere a dezvoltării reacţiilor adverse nu poate fi exclusă interacţiunea farmacodinamică între rosuvastatină şi ezetimib.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eInhibitori de protează\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDeşi nu se cunoaşte exact mecanismul de interacţiune, administrarea concomitentă a inhibitorilor de protează determină o creştere semnificativă a expunerii la rosuvastatină. În cadrul unui studiu farmacocinetic, administrarea concomitentă a 20 mg rosuvastatină şi un medicament combinat cu doi inhibitori de protează (400 mg lopinavir \/ 100 mg ritonavir) la voluntari sănătoşi, a fost asociată cu o creştere de aproximativ 2 ori, respectiv 5 ori pentru rosuvastatină a ASC\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e(0-24) \u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eşi C\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003emax\u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e la starea de echilibru. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eConform rezultatelor altui studiu farmacocinetic, administrarea concomitentă a 20 mg rosuvastatină şi un medicament combinat cu doi inhibitori de protează (300 mg atazanavir \/ 100 mg ritonavir) la voluntari sănătoşi, a fost asociată cu o creştere de aproximativ 3 ori, pentru rosuvastatină a ASC\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e(0-24) \u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ela starea de echilibru. Asocierea de rosuvastatină şi cu inhibitori de protează este posibilă numai în cazul modificării bine gândite a dozelor de rosuvastatină, reieşind din posibilitatea creşterii expoziţiei a ultimului (vezi tabelul 1).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ePrin urmare, utilizarea concomitentă a Rosulip, comprimate filmate la pacienţii cu HIV cărora li se administrează inhibitori de protează nu este recomandată.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eAntiacide \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAdministrarea concomitentă de rosuvastatină cu o suspensie antiacidă, care conţine hidroxid de aluminiu şi magneziu, a determinat o scădere a concentraţiei plasmatice a rosuvastatinei de aproximativ 50%. Acest efect a fost diminuat atunci când antiacidul a fost administrat la 2 ore după administrarea rosuvastatinei. Relevanţa clinică a acestei interacţiuni nu a fost studiată.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEritromicină\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAdministrarea concomitentă de rosuvastatină cu eritromicina a determinat o scădere de 20% a ASC\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e(0-t)\u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e şi o scădere de 30% a C\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003emax\u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e pentru rosuvastatină. Această interacţiune poate fi determinată de creşterea motilităţii intestinale produse de eritromicină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eContraceptive orale\/terapie de substituţie hormonală (TSH\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAdministrarea concomitentă de rosuvastatină cu contraceptive orale a determinat o creştere a ASC pentru etinilestradiol şi norgestrel de 26%, respectiv 34%. Această creştere a nivelelor plasmatice trebuie avută în vedere atunci când se aleg dozele de contraceptive orale. Nu există date farmacocinetice disponibile la femeile care iau concomitent rosuvastatină şi TSH şi, prin urmare, un efect similar nu poate fi exclus. Cu toate acestea, administrarea concomitentă a fost folosită extensiv la femei în cadrul studiilor clinice şi a fost bine tolerată.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eAlte medicamente\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ePe baza datele din studiile de interacţiune specifice, nu se aşteaptă interacţiuni relevante din punct de vedere clinic a rosuvastatinei cu digoxina.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEnzimele citocromului P450 \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRezultatele studiilor \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003ein vivo\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e şi \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003ein vitro\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e au arătat că rosuvastatina nu este nici un inhibitor şi nici un inductor al izoenzimelor citocromului P450. În plus, rosuvastatina este un substrat slab pentru aceste izoenzime. Nu au fost observate interacţiuni relevante din punct de vedere clinic între rosuvastatină şi fluconazol (un inhibitor al CYP2C9 şi CYP3A4) sau ketoconazol (un inhibitor al CYP2A6 şi CYP3A4). Administrarea concomitentă a itraconazolului (un inhibitor al CYP3A4) cu rosuvastatina a determinat o creştere de 28% a ASC pentru rosuvastatină. Această creştere mică nu este considerată semnificativă clinic. Prin urmare, nu sunt de aşteptat interacţiuni medicamentoase care să rezulte din metabolizarea în relaţie cu citocromul P450.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eInteracţiuni, care necesită modificarea dozei de rosuvastatină \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLa necesitatea administrării concomitente a rosuvastatinei cu preparatele, despre care se cunoaşte că ele măresc expoziţia rosuvastatinei, doza ultimei trebuie modificată. Dacă se anticipează creşterea expoziţiei ASC de 2 sau 3 ori, atunci rosuvastatina se va administra în doză iniţială de 5 mg. Doza maximă nictemerală de rosuvastatină trebuie modificată astfel, încât expoziţia anticipată de rosuvastatină să nu depăşească indicii, înregistraţi la administrarea rosuvastatinei în doză de 40 mg fără alte preparate, care determină interacţiune (de exemplu, rosuvastatină în doză de 20 mg cu gemfibrozil – creşterea de 1,9 ori; rosuvastatină în doză de 10 mg cu combinaţia de ritonavir\/atazanavir – creşterea de 3,1 ori).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eTabelul 1 Efectul preparatelor administrate concomitent asupra expoziţiei rosuvastatinei (asupra ASC în ordinea descrescătoare a efectului) pe baza studiilor clinice publicate.\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003ctable width=\"623\" cellspacing=\"0\" cellpadding=\"7\"\u003e\r\n\u003ctbody\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eRegimul de dozare a preparatului, care determină interacţiune\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eRegimul de dozare a rosuvastatinei\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eModificarea indicilor ASC a rosuvastatinei*\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCiclosporină de la 75 mg de 2 ori pe zi până la 200 mg de 2 ori pe zi, 6 luni\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg o dată pe zi, \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 7,1-ori\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAtazanavir 300 mg\/ritonavir 100 mg \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eo dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 8\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 3,1-ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLopinavir 400 mg\/ritonavir 100 mg de 2 ori pe zi, 17 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e20 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 2,1- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eGemfibrozil 600 mg de 2 ori pe zi, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e80 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,9- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eEltrombopag 75 mg, o dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 10\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,6- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDarunavir 600 mg\/ritonavir 100 mg\u003cbr\u003ede 2 ori pe zi, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg o dată pe zi, \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,5- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eTipranavir 500 mg\/ritonavir 200 mg\u003cbr\u003ede 2 ori pe zi, 11 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,4- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eDronedaron 400 mg de 2 ori pe zi\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eNu există date\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,4- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eItraconazol 200 mg o dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 5\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,4- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e**\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eEzetimib 10 mg o dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 14\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg o dată pe zi, \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e14 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,2- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e**\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eFosamprenavir 700 mg\/ritonavir 100 mg\u003cbr\u003ede 2 ori pe zi, 8 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAleglitazar 0,3 mg, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e40 mg, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eSilimarină (extract de Silbyum marianum) 140 mg de 3 ori pe zi, 5 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eFenofibrat 67 mg de 3 ori pe zi, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRifampin 450 mg o dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 7\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e20 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eKetoconazol 200 mg de 2 ori pe zi, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e80 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eFluconazol 200 mg o dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 11\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e80 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eEritromicină 500 mg de 4 ori pe zi, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e80 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e28%\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↓\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eBaicalin 50 mg de 3 ori pe zi\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e20 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e47%\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↓\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003c\/tbody\u003e\r\n\u003c\/table\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e*Datele, prezentate ca modificări de x-ori, sunt un raport simplu între rezultatele, obţinute în cazul asocierii şi la administrarea numai a rosuvastatinei. Datele prezentate ca modificări %-ale indică diferenţa %-ală, în comparaţie cu monoterapia cu rosuvastatină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e↑ \u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e- creşterea, \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↓\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e - reducerea, \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↔\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e modificări nu sunt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e**Unele studii pentru interacţiune au fost efectuate cu diferite doze de rosuvastatină. În tabel sunt prezentate cel mai important raport.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eCopii şi adolescenţi\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eStudiile de interacţiuni au fost efectuate numai la adulţi. Gradul de interacţiuni la copii nu se cunoaşte.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003ePREZENTARE, AMBALAJ\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eComprimate filmate 5 mg, 10 mg, 20 mg, 40 mg \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eCâte 7 comprimate în blister. Câte 2 (14 comprimate), 4 (28 comprimate) şi 8 (56 comprimate) blistere împreună cu instrucţiunea pentru administrare în cutie de carton.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003ePĂSTRARE\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eA se păstra la temperatura sub 30\u003c\/span\u003e\u003c\/span\u003e\u003csup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eo\u003c\/span\u003e\u003c\/span\u003e\u003c\/sup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eC, în ambalajul original. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eA nu se lăsa la îndemâna şi vederea copiilor!\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eTERMEN DE VALABILITATE \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e3 ani.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eA nu se utiliza după data de expirare indicată pe ambalaj.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eStatutul legal\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCu prescripţie medicală.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eData ultimei \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eREVIZUIRI \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003ea textului\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSeptembrie 2013\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eDEŢINĂTORUL CERTIFICATULUI DE INREGISTRARE\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eEGIS Pharmaceuticals PLC., Ungaria.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e1106 or. Budapesta, str. Kereszturi 30-38.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"en-US\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eLa apariţia oricărei reacţii adverse informaţi secţia de farmacovigilenţă a\u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eAgenţiei Medicamentului şi Dispozitivelor Medicale \u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003e\u003cstrong\u003etel. 022-88-43-38\u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"Egis Pharmaceuticals PLC","offers":[{"title":"Default Title","offer_id":43907909845132,"sku":"33839","price":65.73,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/products\/33839.jpg?v=1635167453"},{"product_id":"rosulip-20mg-compfilm","title":"Rosulip 20mg comp.film.","description":"\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eROSULIP\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003ecomprimate filmate \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eDenumirea comercială\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosulip \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eDCI-ul substanţei active\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatinum \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003ch1 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCompoziţia \u003c\/span\u003e\u003c\/span\u003e\u003c\/h1\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e1 comprimat filmat conţine:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003esubstanţa activă: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003erosuvastatină 5 mg (sub formă de rosuvastatină de zinc 5,34 mg), rosuvastatină 10 mg (sub formă de rosuvastatină de zinc 10,68 mg), rosuvastatină 20 mg (sub formă de rosuvastatină de zinc 21,36 mg), rosuvastatină 40 mg (sub formă de rosuvastatină de zinc 42,72 mg),\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eexcipienţi: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003emonohidrat de lactoză, povidonă, crospovidonă, stearat de magneziu, alcool polivinilic, dioxid de titan, macrogol 3350, talc.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eForma farmaceutică\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e \u003c\/h2\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eDESCRIEREA MEDICAMENTULUI\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cu\u003eRosulip 5 mg\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate de culoare albă sau aproape albă, rotunde, uşor biconvexe, cu sau practic fără miros, cu marcarea literei stilizate E pe una din părţi şi numărul 591 pe altă parte a comprimatului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eRosulip 10 mg\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate de culoare albă sau aproape albă, rotunde, uşor biconvexe, cu sau practic fără miros, cu marcarea literei stilizate E pe una din părţi şi numărul 592 pe altă parte a comprimatului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eRosulip 20 mg\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate de culoare albă sau aproape albă, rotunde, uşor biconvexe, cu sau practic fără miros, cu marcarea literei stilizate E pe una din părţi şi numărul 593 pe altă parte a comprimatului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eRosulip 40 mg\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate de culoare albă sau aproape albă, ovale, uşor biconvexe, cu sau practic fără miros, cu marcarea literei stilizate E pe una din părţi şi numărul 594 pe altă parte a comprimatului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eGRUPA FARMACOTERAPEUTICĂ şi codul ATC\u003c\/span\u003e\u003c\/span\u003e\u003c\/h2\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eInhibitori ai HMG - CoA reductazei, C10AA07\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eProprietăţiLE farmacologice\u003c\/span\u003e\u003c\/span\u003e\u003c\/h2\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eProprietăţi farmacodinamice\u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eMecanism de acţiune\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina este un inhibitor selectiv şi competitiv al HMG-CoA reductazei, enzima care limitează conversia din 3-hidroxil-3-metilglutaril coenzima A în mevalonat, un precursor al colesterolului. Locul principal de acţiune al rosuvastatinei este ficatul, organul ţintă pentru scăderea nivelului de colesterol în organism.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina creşte numărul receptorilor lipoproteinelor cu densitate mică (LDL) de pe suprafaţa celulelor hepatice, crescând captarea şi catabolismul LDL şi inhibă sinteza hepatică de lipoproteine cu densitate foarte mică (VLDL), reducând în acest mod numărul total al particulelor de VLDL şi LDL.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eEfecte farmacodinamice\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina scade concentraţiile crescute de LDL-colesterol, colesterol total şi trigliceride, de asemenea creşte nivelul colesterolului lipoproteinelor cu densitate mare (HDL-colesterolul).\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe asemenea, rosuvastatina scade concentraţia apolipoproteinei B (Apo-B), non HDL-C, VLDL-C, VLDL-TG şi creşte nivelul apolipoproteinei A-I (ApoA-I).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe asemenea, rosuvastatina scade rapoartele LDL-C\/HDL-C, colesterol total\/HDL-C, non HDL-C\/HDL-C şi Apo-B\/ApoA-I.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003e\u003cu\u003eTabelul 1. Răspunsul pacienţilor cu hipercolesterolemie primară (tip IIa şi IIb) în funcţie de doză\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e \u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003e(modificarea procentuală medie faţă de valoarea iniţială ajustată)\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003ctable width=\"604\" cellspacing=\"0\" cellpadding=\"5\"\u003e\r\n\u003ctbody\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eDoză \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e \u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eN\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eLDL-C \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e \u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eColesterol total\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eHDL-C \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e \u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eTrigliceride \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eNonHDL-C \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eАpo-В\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eАpoА‑I\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr valign=\"top\"\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003ePlacebo \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e13\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-7\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-5\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e3\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-3\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-7\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-3\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e0\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr valign=\"top\"\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e5 mg\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e17\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-45\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-33\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e13\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-35\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-44\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-38\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e4\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr valign=\"top\"\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e10 mg\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e17\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-52\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-36\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e14\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-10\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-48\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-42\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e4\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr valign=\"top\"\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e20 mg\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e17\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-55\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-40\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e8\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-23\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-51\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-46\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e5\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr valign=\"top\"\u003e\r\n\u003ctd width=\"63\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e40 mg\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"24\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e18\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"39\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-63\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"83\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-46\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"41\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e10\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"93\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-28\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"73\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-60\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"40\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e-54\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"57\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e0\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003c\/tbody\u003e\r\n\u003c\/table\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eEfectul terapeutic se obţine într-o săptămână de la instituirea tratamentului şi 90% din răspunsul maxim este atins după 2 săptămâni. Răspunsul maxim este atins de obicei după 4 săptămâni şi se menţine ulterior.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eProprietăţi farmacocinetice\u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eAbsorbţie \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eConcentraţia plasmatică maximă de rosuvastatină se realizează peste 5 ore de la administrarea pe cale orală. Biodisponibilitatea absolută este de aproximativ 20%.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eDistribuţie\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRosuvastatina este captată intensiv de ficat, care este principalul loc de sinteză a colesterolului şi eliminare pentru LDL-C. Volumul aparent de distribuţie al rosuvastatinei este de aproximativ 134 l. Aproximativ 90% din rosuvastatină se leagă de proteinele plasmatice, în principal de albumină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eMetabolizare \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRosuvastatina este metabolizată limitat (aproximativ 10%). Studiile \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003ein vitro\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e privind metabolismul, în care au fost utilizate hepatocite umane au arătat că rosuvastatina este un substrat slab pentru metabolizarea dependentă de citocromul P450. În metabolismul preparatului participă preponderent CYP2C9, iar izoenzimele 2C19, 3A4 şi 2D6 au fost implicate într-o măsură mai mică. Principalii metaboliţi identificaţi sunt N-desmetil- şi lacton-metaboliţii. Metabolitul N-desmetil este cu aproximativ 50% mai puţin activ decât rosuvastatina, în timp ce metabolitul sub formă de lactonă este considerat inactiv clinic. Rosuvastatina este responsabilă de inhibarea activităţii a mai mult de 90% din HMG-CoA reductază circulantă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEliminare \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAproximativ 90% din doza de rosuvastatină se excretă nemodificată cu materiile fecale (constând în substanţă activă absorbită şi neabsorbită), iar restul se excretă prin urină. Aproximativ 5% se excretă nemodificat prin urină. Timpul de înjumătăţire plasmatică prin eliminare este de aproximativ 19 ore. Timpul de înjumătăţire nu creşte la administrarea unor doze mai mari. Media geometrică a clearance-ului plasmatic este de aproximativ 50 l\/oră (coeficient de variaţie 21,7%). Ca şi în cazul altor inhibitori de HMG-CoA reductază, captarea hepatică a rosuvastatinei implică proteina transportatoare membranară a anionilor organici de tip C (OATP-C). Acest sistem de transport este important pentru eliminarea hepatică a rosuvastatinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eLinearitate\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e \u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003e\/Non-linearitate\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eBiodisponibilitatea sistemică la rosuvastatină creşte proporţional cu doza administrată. Administrarea mai multor doze zilnice, nu este urmată de modificări ale parametrilor farmacocinetici.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eGrupe speciale de pacienţi\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eVârstă şi sex\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eNu s-a constatat nici o modificare semnificativă clinic, legată de vârstă sau de sex, în ceea ce priveşte farmacocinetica rosuvastatinei. Farmacocinetica rosuvastatinei la copii şi adolescenţi cu hipercolesterolemie familială heterozigotă a fost similară celei de la voluntarii adulţi (vezi mai jos „Copii şi adolescenţi”).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eRasă\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eStudii de farmacocinetică au evidenţiat o creştere de aproximativ 2 ori a mediei ariei de sub curba concentraţiei plasmatice în funcţie de timp (ASC) şi a Cmax la subiecţii asiatici (japonezi, chinezi, filipinezi,vietnamezi şi coreeni) comparativ cu populaţia de tip caucazian; indienii-asiatici prezintă o creştere de aproximativ 1,3 ori a ASC şi Cmax.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eO analiză de farmacocinetică populaţională, nu a relevat diferenţe semnificative clinic privind farmacocinetica între grupele de populaţie de tip caucazian şi cele de culoare (neagră).\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003ePacienţi cu insuficienţă renală\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eConform rezultatelor studiilor clinice efectuate pe pacienţii cu afectarea funcţiei renale, insuficienţa renală uşoară până la moderată nu influenţează concentraţia plasmatică a rosuvastatinei sau a metabolitului său N-desmetil.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSubiecţii cu insuficienţă renală severă (clearance-ul la creatinină \u0026lt; 30 ml\/min) au prezentat o concentraţie plasmatică de rosuvastatină de 3 ori mai mare şi o concentraţie plasmatică a metabolitului N-desmetil de 9 ori mai mare, comparativ cu voluntarii sănătoşi. Concentraţiile plasmatice ale rosuvastatinei, la starea de echilibru, la pacienţii supuşi hemodializei au fost cu aproximativ 50% mai mari comparativ cu cele de la voluntarii sănătoşi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003ePacienţi cu insuficienţă hepatică\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eConform rezultatelor studiilor clinice efectuate pe pacienţii cu diferit grad de afectare hepatică, nu s-a evidenţiat creşterea expunerii la rosuvastatină la pacienţii cu un scor Child-Pugh de 7 sau mai mic.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCu toate acestea, 2 subiecţi cu scoruri Child-Pugh de 8 şi 9 au prezentat o creştere a expunerii sistemice la rosuvastatină de cel puţin de 2 ori mai mare comparativ cu pacienţii care prezentau scoruri Child-Pugh mai mici. Nu există experienţă în ceea ce priveşte pacienţii cu scoruri Child-Pugh mai mari de 9.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003ePolimorfism genetic\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eProteinele transportatoare OATP1B1 şi BCRP participă la eliminarea inhibitorilor ai HMG - CoA reductazei, inclusiv şi a rosuvastatinei. La pacienţii cu polimorfism genetic SLCO1B1 (OATP1B1) şi\/sau ABCG2 (BCRP) există risc de creştere a expoziţiei rosuvastatinei. Pentru polimorfismul individual SLCO1B1 c.521CC şi ABCG2 c.421AA este caracteristică creşterea expoziţiei (ASC) a rosuvastatinei de 1,7 ori şi 2,4 ori, corespunzător, în comparaţie cu genotipurile SLCO1B1 c.521TT şi ABCG2 c.421CC.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eCopii şi adolescenţi\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e \u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eParametrii farmacocinetici la pacienţii copii şi adolescenţi cu hipercolesterolemie familială heterozigotă cu vârsta între 10 şi 17 ani nu au fost complet caracterizaţi. Un studiu mic de farmacocinetică cu rosuvastatină (administrată ca şi comprimate) la 18 pacienţi copii şi adolescenţi a demonstrat că expunerea la pacienţii copii şi adolescenţi pare comparabilă cu expunerea la pacienţii adulţi. În plus, rezultatele indică faptul că nu se aşteaptă o deviere mare în ceea ce priveşte proporţionalitatea dozei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eIndicaţii terapeutice\u003c\/span\u003e\u003c\/span\u003e\u003c\/h2\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eTratamentul hipercolesterolemiei\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ePreparatul este indicat la adulţi, adolescenţi şi copii cu vârsta de 10 ani sau mai mare, cu hipercolesterolemie primară (tip IIa, inclusiv şi hipercolesterolemie familială heterozigotă) sau dislipidemie mixtă (tip IIb), în asociere cu dieta atunci când răspunsul la dietă şi la alte metode non-farmacologice (de exemplu exerciţii fizice, scădere ponderală) este inadecvat. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eTratamentul hipercolesterolemiei familiale homozigote\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eHipercolesterolemie familială homozigotă, în asociere cu dieta şi alte tratamente hipolipemiante (de exemplu afereza LDL) sau dacă astfel de tratamente nu sunt adecvate. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eProfilaxia evenimentelor cardiovasculare \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eProfilaxia evenimentelor cardiovasculare majore la pacienţii încadraţi cu risc înalt de a prezenta un prim eveniment cardiovascular, în asociere cu corecţia celorlalţi factori de risc.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eTratamentul aterosclerozei\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e la pacienţii, care necesită scăderea nivelului de lipide, cu scop de a încetini progresia şi retenţia dezvoltării patologiei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eDoze şi mod de administrare\u003c\/span\u003e\u003c\/span\u003e\u003c\/h2\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎnainte de iniţierea tratamentului pacientului se indică o dietă standard, cu conţinut scăzut de colesterol, care e necesar de respectat şi pe durata tratamentului cu rosuvastatină. Doza se selectează în mod individual în dependenţă de scopul terapiei şi rezultatul obţinut. La ajustarea dozei se utilizează ghidurile actuale de tratament acceptate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eRegimul de dozare\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eTratamentul hipercolesterolemiei\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"color: #000080;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDoza iniţială recomandată este de 5 sau 10 mg administrată pe cale orală, o dată pe zi, atât pacienţilor fără tratament anterior cât şi celor transferaţi de la un tratament cu un alt inhibitor de HMG-CoA reductază. La ajustarea dozei iniţiale a preparatului, trebuie să ţină cont de colesterolemia individuală a pacientului, de riscul dezvoltării patologiilor cardiovasculare, de asemenea de riscul potenţial de dezvoltare a reacţiilor adverse (vezi mai jos).\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan lang=\"ro-RO\"\u003e Ajustarea dozei, dacă este necesară, poate fi făcută la intervale de cel puţin 4 săptămâni. În legătură cu riscul sporit al dezvoltării reacţiilor adverse la doza de 40 mg, trecerea la doza maximă (40 mg) se va efectua doar la pacienţii cu hipercolesterolemie gravă şi risc înalt de apariţie a patologiilor cardiovasculare (îndeosebi la pacienţii cu hipercolesterolemie familială), dacă nu a fost obţinut rezultatul scontat la administrarea dozei de 20 mg. Trecerea la doza de 40 mg se va efectua cu condiţia că pacienţii se vor afla sub o supraveghere standard. În plus, iniţierea tratamentului cu preparatul Rosulip, comprimate filmate, cu doze de 40 mg se recomandă de efectuat sub supravegherea medicului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eProfilaxia evenimentelor cardiovasculare\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎn studiul de reducere a riscului de evenimente cardiovasculare, doza utilizată a fost de 20 mg zilnic.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eCopii şi adolescenţi\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eUtilizarea la copii şi adolescenţi trebuie efectuată de către specialişti. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCopii şi adolescenţi cu vârsta între 10 şi 17 ani (băieţi stadiul Tanner II şi peste acest stadiu şi fete care sunt la cel puţin un an după menarhă): \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eLa copii şi adolescenţi cu hipercolesterolemie familială heterozigotă doza de iniţiere uzuală este de 5 mg zilnic. Doza uzuală variază între 5-20 mg administrate pe cale orală o dată pe zi. Titrarea trebuie efectuată în funcţie de răspunsul şi tolerabilitatea la pacienţii copii şi adolescenţi, aşa cum este specificat în recomandările de tratament pediatric. Copiii şi adolescenţii trebuie să înceapă o dietă hipolipemiantă înainte de iniţierea tratamentului cu rosuvastatină; această dietă trebuie continuată în timpul tratamentului cu rosuvastatină. Siguranţa şi eficacitatea dozelor mai mari de 20 mg nu au fost studiate la această populaţie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eComprimatele de 40 mg nu se vor administra la copii şi adolescenţi. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eCopii cu vârsta mai mică de 10 ani \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eExperienţa la copii cu vârsta mai mică de 10 ani este limitată la un număr mic de copii (cu vârste între 8 şi 10 ani) cu hipercolesterolemie familială homozigotă. De aceea, rosuvastatina nu este recomandată pentru utilizare la copii cu vârsta mai mică de 10 ani.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eVârstnici \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eDoza iniţială recomandată la pacienţi cu vârste peste 70 de ani este 5 mg. Nu este necesară nici o altă ajustare a dozei în funcţie de vârstă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003ePacienţi cu insuficienţă renală\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eNu este necesară ajustarea dozelor la pacienţi cu insuficienţă renală uşoară sau moderată. Doza iniţială recomandată la pacienţi cu insuficienţă renală moderată (clearance-ul creatininei \u0026lt;60 ml\/min) constituie 5 mg. Doza de 40 mg este contraindicată la pacienţi cu insuficienţă renală moderată. Administrarea de Rosulip la pacienţi cu insuficienţă renală severă este contraindicată indiferent de doză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003ePacienţi cu insuficienţă hepatică\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eNu s-a constatat creşterea expunerii sistemice la rosuvastatină în cazul pacienţilor cu scoruri Child-Pugh de 7 sau mai mici. Totuşi, creşterea expunerii sistemice a fost observată la pacienţi cu scoruri Child-Pugh de 8 şi 9. La aceşti pacienţi trebuie avută în vedere evaluarea funcţiei renale. Nu există experienţă clinică la subiecţi cu scoruri Child-Pugh peste 9.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina este contraindicată la pacienţii cu boală hepatică activă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eRasă\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eLa subiecţii de origine asiatică a fost remarcată creşterea expunerii sistemice.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eDoza iniţială recomandată pentru pacienţii de origine asiatică este de 5 mg. Doza de 40 mg este contraindicată la pacienţii de origine asiatică.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003ePolimorfism genetic\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eGenotipurile SLCO1B1 (OATP1B1) c.521CC şi ABCG2 (BCRP) c.421AA sunt însoţite cu o expoziţie mai mare a rosuvastatinei, în comparaţie cu genotipurile SLCO1B1 c.521TT şi ABCG2 c.421CC. La pacienţii cu genotipul necunoscut c.521CC sau c.421AA doza maximă de Rosulip, comprimate filmate, constituie 20 mg pe zi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eDoze la pacienţii cu factori de risc predispozanţi la miopatie\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eDoza iniţială recomandată la pacienţii cu factori de risc predispozanţi la miopatie este de 5 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDoza de 40 mg este contraindicată la unii din aceşti pacienţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eAdministrarea concomitentă cu alte preparate\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRosuvastatina este un substrat pentru diferite proteine transportatoare (de exemplu OATP1B1 şi BCRP). Riscul dezvoltării miopatiei (inclusiv şi a rabdomiolizei) creşte la administrarea concomitentă a rosuvastatinei cu unele preparate, capabile să crească concentraţia plasmatică a rosuvastatinei în rezultatul interacţiunii cu proteinele transportatoare menţionate mai sus (de exemplu, un astfel de preparat este ciclosporina, de asemenea unele inhibitori de proteaze, inclusiv combinaţia ritonavirului cu atazanavir, lopinavir şi\/sau tipranavir). Dacă este posibil, se vor administra preparate alternative, la necesitate – se recomandă sistarea temporară a rosuvastatinei. În cazurile când administrarea concomitentă a acestor preparate nu poate fi evitată, se va evalua minuţios raportul beneficiu\/risc, legat de tratamentul combinat şi modificarea dozei rosuvastatinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eMod de administrare\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eComprimate filmate pentru administrare internă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ePreparatul Rosulip poate fi administrat în orice moment al zilei, \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eindependent de luarea mesei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Times New Roman, serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eReacţii adverse\u003c\/span\u003e\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eReacţiile adverse care apar la administrarea de rosuvastatină sunt în general uşoare şi tranzitorii. În studiile clinice controlate, mai puţin de 4% din pacienţii trataţi cu rosuvastatină au fost excluşi din cauza manifestării de evenimente adverse.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eFrecvenţa acestor evenimente adverse a fost clasificată după cum urmează:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eFrecvente (≥1\/100 şi \u0026lt;1\/10)\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eMai puţin frecvente (≥1\/1000 şi \u0026lt;1\/100)\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRare (≥1\/10000 şi \u0026lt;1\/1000)\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eFoarte rare (\u0026lt;1\/10000)\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eCu frecvenţă necunoscută (care nu poate fi estimată din datele disponibile).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eMai jos este prezentat profilul reacţiilor adverse pe baza datelor studiilor clinice şi experien\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Cambria Math, serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eț\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eei vaste în perioada de după punerea pe pia\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Cambria Math, serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eț\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eă a preparatului. Reacţiile adverse sunt prezentate după sisteme de organe şi incidenţa frecvenţei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări hematologice şi limfatice:\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e rare – trombocitopenie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări ale sistemului imunitar: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003erare – reacţii de hipersensibilitate, inclusiv edem angioneurotic.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări endocrine:\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e frecvente – diabet zaharat\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003csup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e1\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/sup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări psihice:\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e cu frecvenţă necunoscută – depresie. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări ale sistemului nervos: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003efrecvente – cefalee, vertij; foarte rare – polineuropatie, tulburări de memorie; cu frecvenţă necunoscută – tulburări de somn, inclusiv insomnie şi coşmaruri.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări respiratorii, toracice şi mediastinale: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003ecu frecvenţă necunoscută – tuse, dispnee.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări gastrointestinale: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003efrecvente – constipaţie, greaţă, dureri abdominale;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e \u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003erare – pancreatită; cu frecvenţă necunoscută – diaree.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări hepatobiliare: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003erare – creşterea nivelului enzimelor hepatice (transaminazelor); foarte rare – icter, hepatită.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eAfecţiuni cutanate şi ale ţesutului subcutanat: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003emai puţin frecvente – prurit, erupţii cutanate, urticarie; cu frecvenţă necunoscută – sindromul Stevens-Johnson.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări musculo-scheletice şi ale ţesutului conjunctiv: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003efrecvente – mialgie;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e \u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003erare – miopatie (incluzând miozită), rabdomioliză; foarte rare – artralgie; cu frecvenţă necunoscută – miopatie necrotizantă cu caracter imun.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări renale şi ale căilor urinare:\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e foarte rare – hematurie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări ale aparatului genital şi sânului:\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e foarte rare – ginecomastie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eTulburări generale şi la nivelul locului de administrare: \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003ecu frecvenţă necunoscută – edeme.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003csup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e1\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/sup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eFrecvenţa depinde de prezenţa sau lipsa factorilor de risc (nivelul glicemiei pe nemâncate ≥ 5,6 mmol\/l, indicele masei corporale \u0026gt; 30 kg\/m\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003csup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e2\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/sup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, nivel crescut de trigliceride, hipertonie în anamneză).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSimilar altor inhibitori ai HMG-CoA reductazei, incidenţa reacţiilor adverse, legate de tratamentul cu rosuvastatină, sunt dependente de doză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eTulburări renale şi ale căilor urinare\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLa unii pacienţi, care au administrat \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003erosuvastatină, a fost înregistrată proteinuria. Proteinuria a fost diagnosticată la efectuarea analizei urinei prin teste de tip dipstick. În majoritatea cazurilor proteinuria a fost de origine tubulară. Modificări ale nivelului de proteină urinară de la “fără urme” sau “ urme” la “++” sau mai mult, au fost remarcate la mai puţin de 1% din pacienţi, trataţi cu 10 mg şi 20 mg, şi la aproximativ 3% din pacienţii trataţi cu 40 mg. O creştere minoră a modificărilor de la “fără urme” sau “ urme” la “+” s-a observat la doze de 20 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎn majoritatea cazurilor, proteinuria a scăzut sau a dispărut spontan în timpul tratamentului. Evaluarea datelor din studiile clinice şi experienţa după punerea pe piaţă nu a identificat o legătură cauzală între proteinurie şi boala renală (acută sau progresivă).\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eHematuria a fost observată la pacienţii trataţi cu rosuvastatină şi datele clinice arată că incidenţa ei este redusă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eTulburări musculo-scheletice\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLa pacienţii trataţi cu rosuvastatină au fost raportate reacţii adverse din partea musculaturii scheletice, de exemplu mialgie, miopatie (inclusiv miozită) şi, în cazuri rare, rabdomioliză pentru toate dozele şi în special pentru doze mai mari de 20 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eO creştere a concentraţiilor creatinkinazei dependentă de doză a fost observată la pacienţii trataţi cu rosuvastatină. În majoritatea cazurilor aceste efecte au fost uşoare, asimptomatice şi tranzitorii. În cazul creşterii concentraţiei plasmatice de creatininkinază (de 5 ori în comparaţie LSN), tratamentul trebuie întrerupt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eTulburări hepatobiliare\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei s-a observat creşterea transaminazelor dependentă de doză, la un număr mic de pacienţi trataţi cu rosuvastatină; majoritatea cazurilor au fost uşoare, asimptomatice şi tranzitorii.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eExperienţa de după punerea pe piaţă a medicamentului:\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eÎn plus, faţă de reacţiile adverse de mai sus, în timpul perioadei de după punerea pe piaţă a medicamentului, au fost raportate următoarele efecte adverse determinate de rosuvastatină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ePentru unele statine au fost raportate următoarele reacţii adverse:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003edisfuncţii sexuale;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ecazuri foarte rare de boală pulmonară interstiţială, în special în cazul terapiei pe termen lung;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003etulburări la nivelul tendoanelor, uneori complicate cu rupturi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eFrecvenţa raportată pentru rabdomioliză, reacţiile renale grave şi reacţiile hepatice grave (care constau în principal în creşterea valorilor transaminazelor hepatice) este mai mare la doza de 40 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eCopii şi adolescenţi\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎntr-un studiu de 52 de săptămâni cu copii şi adolescenţi, au fost observate creşteri ale creatinkinazei \u0026gt;10x LSN şi simptomele musculare după exerciţiu fizic sau activitate fizică intensă, mai frecvent comparativ cu adulţii. În alte privinţe, profilul de siguranţă al rosuvastatinei a fost similar la copii şi adolescenţi comparativ cu adulţii.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eRaportarea reacţiilor adverse posibile\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRaportarea reacţiilor adverse după punerea pe piaţă a medicamentului sunt foarte importante, deoarece aceasta permite monitorizarea raportului beneficiu\/risc al acestui preparat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003ch2 class=\"western\" lang=\"ro-RO\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eContraindicaţii\u003c\/span\u003e\u003c\/span\u003e\u003c\/h2\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosulip este contraindicat:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ehipersensibilitate la rosuvastatină sau la oricare dintre excipienţi;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ela pacienţi cu boală hepatică activă, incluzând creşterea persistentă a valorilor transaminazelor plasmatice şi orice creştere a transaminazelor plasmatice care depăşeşte de 3 ori limita superioară a normei (LSN);\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ela pacienţi cu insuficienţă renală severă (clearance-ul creatininei \u0026lt; 30 ml\/min);\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ela pacienţi cu miopatie;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ela pacienţi care primesc concomitent tratament cu ciclosporină;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eîn sarcină şi perioada de alăptare, de asemenea la femei aflate în perioada fertilă, care nu utilizează măsuri contraceptive corespunzătoare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eTratamentul cu preparatul Rosulip în doză de 40 mg este contraindicat la pacienţii cu factori predispozanţi pentru miopatie\/rabdomioliză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAstfel de factori includ:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003einsuficienţă renală moderată (clearance-ul creatininei \u0026lt; 60 ml\/min);\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ehipotiroidie;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eantecedente personale sau heredocolaterale de afecţiuni musculare ereditare;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eantecedente de miopatie în cazul folosirii anterioare a unui alt inhibitor al HMG-CoA reductazei sau al unui fibrat;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eabuz de alcool;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003esituaţii în care poate să apară o creştere a concentraţiei plasmatice de rosuvastatină;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003epacienţi de origine asiatică;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cul\u003e\r\n\u003cul\u003e\r\n\u003cli\u003e \u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/ul\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eadministrarea concomitentă de fibraţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eSupradozaj \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eNu există antidot specific pentru rosuvastatină. În caz de supradozaj se va efectua tratament simptomatic şi trebuie instituite măsuri de susţinere adecvate. În plus, se recomandă monitorizarea funcţiei hepatice şi a concentraţiilor plasmatice de \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ecreatinkinază\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e. Este puţin probabil ca hemodializa să fie eficientă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eATENŢIONĂRI ŞI PRECAUŢII SPECIALE DE UTILIZARE\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEfecte renale\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLa pacienţii trataţi cu doze mari de rosuvastatină, în special cele de 40 mg, a fost observată apariţia proteinuriei, detectată prin testarea rapidă (dipstick), în principal de origine tubulară, cu caracter tranzitoriu sau intermitent în majoritatea cazurilor. Nu s-a evidenţiat că proteinuria ar fi un factor predictiv al unei boli renale acute sau progresive. Rata de raportare a reacţiilor adverse grave renale din experienţa de după punerea pe piaţă este mai mare pentru doza de 40 mg. În timpul urmăririi de rutină a pacienţilor trataţi cu doze de 40 mg trebuie avută în vedere evaluarea periodică (cel puţin la fiecare 3 luni) a funcţiei renale.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEfecte la nivelul musculaturii scheletice\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAu fost raportate efecte negative asupra musculaturii scheletice, cum sunt mialgie, miopatie, şi, rareori, rabdomioliză la pacienţii trataţi cu rosuvastatină, la toate dozele, şi în special la doze \u0026gt; 20 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAu fost raportate cazuri foarte rare de rabdomioliză în cazul utilizării de ezetimibă asociată cu inhibitori de HMG-CoA reductază. Nu poate fi exclusă o interacţiune farmacodinamică şi sunt necesare precauţii în cazul unor astfel de asocieri.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei, frecvenţa raportărilor de rabdomioliză asociată tratamentului cu rosuvastatină în perioada de după punerea pe piaţă a produsului este mai mare în cazul dozelor de 40 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eDeterminarea valorilor creatinkinazei\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eConcentraţia plasmatică de creatinkinază (CK) nu trebuie determinată după un exerciţiu fizic intens sau în prezenţa unei posibile cauze de creştere a CK, deoarece poate determina confuzie în interpretarea rezultatului. Dacă valorile CK sunt semnificativ mai mari la iniţierea tratamentului (\u0026gt; 5 x LSN) trebuie efectuat un test de confirmare în următoarele 5-7 zile. Dacă repetarea testului confirmă o valoare iniţială a CK \u0026gt; 5 x LSN, tratamentul cu rosuvastatină nu trebuie iniţiat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eÎnainte de iniţierea tratamentului\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRosulip, similar altor inhibitori ai HMG-CoA reductazei, trebuie recomandat cu prudenţă la pacienţii care prezintă factori predispozanţi pentru miopatie\/rabdomioliză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAstfel de factori includ:\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- insuficienţă renală;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e- hipotiroidie:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- antecedente personale sau heredocolaterale de afecţiuni musculare ereditare;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e- antecedente de miopatie la administrarea altor inhibitori ai HMG-CoA reductazei sau a fibraţilor;\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- abuz de alcool etilic;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- vârstă peste 70 ani;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- situaţii în care poate apare o creştere a concentraţiilor plasmatice de rosuvastatină;\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e- administrarea concomitentă a fibraţilor.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eLa astfel de pacienţi trebuie luat în considerare riscul tratamentului comparativ cu beneficiul posibil şi se recomandă monitorizarea clinică. Dacă la momentul iniţial concentraţia de CK este crescută semnificativ (\u0026gt;5 x LSN) tratamentul nu trebuie început.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eÎn timpul tratamentului\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003ePacienţii trebuie să fie sfătuiţi să raporteze imediat durerile musculare inexplicabile, hipotonia musculară sau crampele, mai ales dacă acestea se asociază cu stare de slăbiciune generală sau febră. La aceşti pacienţi trebuie măsurate concentraţiile plasmatice de CK. Tratamentul trebuie întrerupt dacă: concentraţiile plasmatice ale CK sunt crescute semnificativ (\u0026gt; 5 ori limita superioară a normei) sau dacă simptomele musculare sunt severe şi determină un disconfort zilnic (chiar şi în cazul în care concentraţiile plasmatice de CK sunt ≤ 5 ori limita superioară a normei). Dacă simptomele se remit şi concentraţiile plasmatice de CK revin la normal, atunci trebuie avută în vedere reluarea tratamentului cu rosuvastatină sau cu un alt inhibitor de HMG-CoA reductază, în cea mai mică doză şi sub o monitorizare atentă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eMonitorizarea de rutină a concentraţiilor plasmatice ale CK la pacienţii asimptomatici nu este justificată.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eExistă raportări foarte rare privind dezvoltarea miopatiei necrotizante de geneză imunologică, cu manifestări clinice caracteristice sub formă de slăbiciune îndelungată a muşchilor proximali şi creşterea nivelului seric de creatinfosfokinază pe fondalul sau după întreruperea tratamentului cu statine (inclusiv şi cu rosuvastatină). În aceste cazuri poate fi necesară investigarea ulterioară a funcţiei neuro-musculare, efectuarea testelor serologice şi indicarea tratamentului imunosupresiv.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eÎn cadrul studiilor clinice, nu s-a evidenţiat o creştere a efectelor asupra musculaturii scheletice la numărul mic de pacienţi trataţi cu rosuvastatină şi o altă terapie concomitentă. Cu toate acestea, la pacienţii trataţi cu alţi inhibitori de HMG-CoA reductază, concomitent cu derivaţi ai acidului fibric (inclusiv gemfibrozil), ciclosporină, acid nicotinic, antifungice (derivaţi azolici), inhibitori ai proteazelor şi antibiotice macrolide, s-a constatat o incidenţă crescută a miozitei şi miopatiei. Gemfibrozilul creşte riscul de miopatie în cazul în care este administrat concomitent cu unii inhibitori ai HMG-CoA reductazei. De aceea, nu este recomandată asocierea de Rosulip şi gemfibrozil. Beneficiul privind scăderea suplimentară a concentraţiei plasmatice de lipide prin administrarea asociată de rosuvastatină şi fibraţi sau niacină trebuie evaluată cu atenţie pentru riscurile potenţialele ale unor astfel de asocieri. Este contraindicată asocierea dozei de 40 mg cu fibraţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina nu trebuie utilizată la niciun pacient care prezintă o afecţiune acută, gravă, sugestivă pentru miopatie sau cu predispoziţie de a dezvolta insuficienţă renală secundară rabdomiolizei (de exemplu sepsis, hipotensiune arterială, intervenţie chirurgicală majoră, traumatisme, tulburări severe metabolice, endocrine şi electrolitice; crize convulsive necontrolate).\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEfecte hepatice\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSimilar altor inhibitori ai HMG-CoA reductazei, Rosulip trebuie utilizat cu prudenţă la pacienţii care consumă cantităţi excesive de alcool etilic şi\/sau au antecedente de boală hepatică.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSe recomandă efectuare de teste pentru evaluarea funcţiei hepatice înainte de, şi la 3 luni după iniţierea tratamentului. Rosulip trebuie întrerupt sau doza trebuie scăzută dacă valoarea transaminazelor serice este de 3 ori mai mare decât limita superioară a normei. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRata de raportare a evenimentelor hepatice severe (care constau în principal în creşterea transaminazelor hepatice) după punerea pe piaţă (administrarea la un număr mare de pacienţi), este mai mare pentru doza de 40 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎn cazul pacienţilor cu hipercolesterolemie secundară datorată hipotiroidismului sau sindromului nefrotic, cauza subiacentă trebuie tratată înainte de iniţierea terapiei cu Rosulip.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eRasa\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eStudiile de farmacocinetică au evidenţiat o creştere a expunerii sistemice la subiecţii asiatici comparativ cu cei caucazieni.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eInhibitori de protează\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eUtilizarea concomitentă a diferitor inhibitori de proteaze poate creşte expunerea sistemică la rosuvastatină. La bolnavii cu HIV, care administrează inhibitori de proteaze, se va evalua raportul beneficiului de scăderea a nivelului lipidelor la administrarea de Rosulip, comprimate filmate, şi posibilitatea creşterii concentraţiei plasmatice de rosuvastatină la iniţierea tratamentului şi ulterior la ajustarea dozei preparatului la aceşti pacienţi. Nu este recomandată utilizarea concomitentă cu inhibitori de protează, cu excepţia cazurilor când se efectuează corecţia dozelor preparatului Rosulip, comprimate filmate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eBoala interstiţială pulmonară\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eA fost raportat în cazuri foarte rare boala interstiţială pulmonară la administrare de statine. De regulă aceste cazuri au fost înregistrate în cazul unui tratament îndelungat. Simptomele bolii interstiţiale pulmonare includ dispnee, tuse seacă, alterarea stării generale de sănătate (fatigabilitate, scădere ponderală şi febră). În cazul în care la un pacient există suspectarea de boală interstiţială pulmonară, tratamentul cu statine trebuie întrerupt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eIntoleranţă la lactoză\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAcest medicament conţine lactoză. Pacienţii cu afecţiuni ereditare de intoleranţă la galactoză, deficitul de lactază (Lapp) sau sindrom de malabsorbţie de glucoză-galactoză nu trebuie să utilizeze acest medicament.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eDiabet zaharat\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eExistă dovezi care sugerează că statinele cresc glicemia şi, la unii pacienţi cu risc crescut de apariţie a diabetului zaharat, pot produce hiperglicemie cu valori care să necesite măsuri considerate de rutină la pacienţii cu diabet zaharat diagnosticat. Totuşi, riscul de apariţie a hiperglicemiei este depăşit de beneficiul reducerii riscului dezvoltării maladiilor vasculare şi, prin urmare, nu există un motiv pentru întreruperea tratamentului cu statine. Pacienţii cu risc crescut de hiperglicemie (valori ale glicemiei în condiţii de repus alimentar între 5,6 şi 6,9 mmol\/l, indicele masei corporale \u0026gt;30 kg\/m\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003csup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e2\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/sup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, valori crescute ale trigliceridemiei, hipertensiune arterială) trebuie monitorizaţi clinic şi paraclinic în acord cu ghidurile naţionale.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎn studiul clinic JUPITER, frecvenţa globală raportată de apariţie a diabetului zaharat a fost de 2,8% la rosuvastatină şi de 2,3% la placebo, mai ales la pacienţii cu valori ale glicemiei între 5,6 şi 6,9 mmol\/l în condiţii de repaus alimentar.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eCopii şi adolescenţi\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLa copiii şi adolescenţii cu vârsta între 10 şi 17 ani trataţi cu rosuvastatină evaluarea creşterii liniare (înălţime), greutăţii, IMC (indice de masă corporală) şi a caracteristicilor secundare de maturizare sexuală utilizând stadializarea Tanner a fost limitată la o perioadă de un an. După 52 de săptămâni de tratament, nu au fost observate efecte asupra creşterii, greutăţii, IMC sau maturizării sexuale. Experienţa din studiile clinice la copii şi adolescenţi este limitată, iar efectele rosuvastatinei pe termen lung (\u0026gt;1 an) asupra pubertăţii nu sunt cunoscute. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eÎntr-un studiu clinic cu copii şi adolescenţi care au primit rosuvastatină timp de 52 de săptămâni, creşterile CK \u0026gt;10 x LSN şi simptomele musculare după exerciţiu fizic sau activitate fizică intensă au fost observate mai frecvent comparativ cu observaţiile din studiile clinice la adulţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eAdministrarea în sarcină şi perioada de lactaţie\u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eRosuvastatina este contraindicată în sarcină şi perioada de alăptare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cu\u003eFertilitate.\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e Femeile aflate în perioada fertilă trebuie să utilizeze măsuri contraceptive adecvate în timpul tratamentului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cu\u003eSarcina.\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e Deoarece colesterolul şi alţi produşi ai biosintezei colesterolului sunt esenţiali pentru dezvoltarea fătului, riscul potenţial rezultat ca urmare a inhibiţiei HMG-CoA reductazei depăşeşte avantajele tratamentului pe perioada sarcinii. Studiile efectuate la animale oferă dovezi limitate privind toxicitatea asupra funcţiei de reproducere. Dacă o pacientă devine gravidă în perioada în care urmează tratament cu rosuvastatină, tratamentul trebuie întrerupt imediat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cu\u003eAlăptarea.\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e Rosuvastatina se excretă în laptele şobolanilor. Nu există date cu privire la excreţia în laptele uman.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eInfluenţa asupra capacităţii de a conduce vehicule sau de a folosi utilaje \u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eNu s-au efectuat studii care să determine efectul rosuvastatinei asupra capacităţii de a conduce vehicule sau de a folosi utilaje. Cu toate acestea, pe baza proprietăţilor sale farmacodinamice, Rosulip este puţin probabil să afecteze aceste abilităţi. La conducerea vehiculelor sau la folosirea utilajelor, trebuie avut în vedere că în timpul tratamentului pot să apară vertij.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eINTERACŢIUNI CU ALTE MEDICAMENTE, \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eALTE TIPURI DE INTERACŢIUNI \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eInhibitorii proteinelor transportatoare\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRosuvastatina este un substrat al unor proteine transportatoare, inclusiv a proteinei transportatoare de captare hepatică OATP1B1 şi proteinei de eflux BCRP. La administrarea concomitentă de rosuvastatină cu preparatele, inhibitoare ale proteinelor transportatoare, poate creşte concentraţia plasmatică de rosuvastatină şi riscul dezvoltării de miopatie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eCiclosporină\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eÎn timpul tratamentului concomitent cu rosuvastatină şi ciclosporină, valorile ariei de sub curba concentraţiei plasmatice în funcţie de timp (ASC) ale rosuvastatinei au fost în medie de 7 ori mai mari decât cele constatate la voluntarii sănătoşi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAdministrarea concomitentă de rosuvastatină şi ciclosporină nu au modificat concentraţiile plasmatice ale ciclosporinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eAntagonişti de vitamină K\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSimilar altor inhibitori ai HMG-CoA reductazei, iniţierea tratamentului sau creşterea treptată a dozelor de rosuvastatină la pacienţii care primesc tratament concomitent cu antagonişti ai vitaminei K (de exemplu warfarină sau alte anticoagulante cumarinice) poate determina creşterea Raportului Internaţional Normalizat (INR). Întreruperea tratamentului sau scăderea treptată a dozelor de rosuvastatină poate avea ca rezultat scăderea INR. În astfel de situaţii, este de preferat monitorizarea adecvată a valorilor INR.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eGemfibrozil şi alte hipolipemiante\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAdministrarea concomitentă a rosuvastatinei cu gemfibrozil a determinat o creştere de 2 ori a C\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003emax\u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e şi ASC pentru rosuvastatină. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAvând la bază datele din studiile de interacţiune specifice, nu se aşteaptă o interacţiune relevantă din punct de vedere farmacocinetic cu fenofibratul, cu toate acestea, poate apare o interacţiune farmacodinamică. \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eGemfibrozilul, fenofibratul, alţi fibraţi şi dozele hipolipemiante (≥ 1 g\/zi) de niacină (acid nicotinic) cresc riscul de miopatie atunci când sunt administrate concomitent cu inhibitorii HMG-CoA reductazei. Probabil acest efect poate fi legat cu aceea că preparatele enumerate mai sus pot determina miopatie atunci când sunt administraţi în monoterapie (fără tratamentul concomitent cu inhibitorii HMG-CoA reductazei). Doza de 40 mg este contraindicată în situaţiile administrării concomitente cu un fibrat. De asemenea, la aceşti pacienţi tratamentul trebuie iniţiat cu o doză de 5 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEzetimib\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAdministrarea concomitentă de rosuvastatină şi ezetimib nu a determinat nici o modificare a ASC şi a C\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003emax\u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e ale acestor preparate. La administrarea concomitentă de rosuvastatină 10 mg şi ezetimib 10 mg la pacienţii cu hipercolesterolemie a fost înregistrată creşterea de 1,2 ori a indicilor ASC (vezi tabelul 1). Totuşi, din punct de vedere a dezvoltării reacţiilor adverse nu poate fi exclusă interacţiunea farmacodinamică între rosuvastatină şi ezetimib.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eInhibitori de protează\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDeşi nu se cunoaşte exact mecanismul de interacţiune, administrarea concomitentă a inhibitorilor de protează determină o creştere semnificativă a expunerii la rosuvastatină. În cadrul unui studiu farmacocinetic, administrarea concomitentă a 20 mg rosuvastatină şi un medicament combinat cu doi inhibitori de protează (400 mg lopinavir \/ 100 mg ritonavir) la voluntari sănătoşi, a fost asociată cu o creştere de aproximativ 2 ori, respectiv 5 ori pentru rosuvastatină a ASC\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e(0-24) \u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eşi C\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003emax\u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e la starea de echilibru. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eConform rezultatelor altui studiu farmacocinetic, administrarea concomitentă a 20 mg rosuvastatină şi un medicament combinat cu doi inhibitori de protează (300 mg atazanavir \/ 100 mg ritonavir) la voluntari sănătoşi, a fost asociată cu o creştere de aproximativ 3 ori, pentru rosuvastatină a ASC\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e(0-24) \u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ela starea de echilibru. Asocierea de rosuvastatină şi cu inhibitori de protează este posibilă numai în cazul modificării bine gândite a dozelor de rosuvastatină, reieşind din posibilitatea creşterii expoziţiei a ultimului (vezi tabelul 1).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ePrin urmare, utilizarea concomitentă a Rosulip, comprimate filmate la pacienţii cu HIV cărora li se administrează inhibitori de protează nu este recomandată.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eAntiacide \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eAdministrarea concomitentă de rosuvastatină cu o suspensie antiacidă, care conţine hidroxid de aluminiu şi magneziu, a determinat o scădere a concentraţiei plasmatice a rosuvastatinei de aproximativ 50%. Acest efect a fost diminuat atunci când antiacidul a fost administrat la 2 ore după administrarea rosuvastatinei. Relevanţa clinică a acestei interacţiuni nu a fost studiată.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEritromicină\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAdministrarea concomitentă de rosuvastatină cu eritromicina a determinat o scădere de 20% a ASC\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e(0-t)\u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e şi o scădere de 30% a C\u003c\/span\u003e\u003c\/span\u003e\u003csub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003emax\u003c\/span\u003e\u003c\/span\u003e\u003c\/sub\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e pentru rosuvastatină. Această interacţiune poate fi determinată de creşterea motilităţii intestinale produse de eritromicină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003eContraceptive orale\/terapie de substituţie hormonală (TSH\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAdministrarea concomitentă de rosuvastatină cu contraceptive orale a determinat o creştere a ASC pentru etinilestradiol şi norgestrel de 26%, respectiv 34%. Această creştere a nivelelor plasmatice trebuie avută în vedere atunci când se aleg dozele de contraceptive orale. Nu există date farmacocinetice disponibile la femeile care iau concomitent rosuvastatină şi TSH şi, prin urmare, un efect similar nu poate fi exclus. Cu toate acestea, administrarea concomitentă a fost folosită extensiv la femei în cadrul studiilor clinice şi a fost bine tolerată.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eAlte medicamente\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003ePe baza datele din studiile de interacţiune specifice, nu se aşteaptă interacţiuni relevante din punct de vedere clinic a rosuvastatinei cu digoxina.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003eEnzimele citocromului P450 \u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRezultatele studiilor \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003ein vivo\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e şi \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003ein vitro\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e au arătat că rosuvastatina nu este nici un inhibitor şi nici un inductor al izoenzimelor citocromului P450. În plus, rosuvastatina este un substrat slab pentru aceste izoenzime. Nu au fost observate interacţiuni relevante din punct de vedere clinic între rosuvastatină şi fluconazol (un inhibitor al CYP2C9 şi CYP3A4) sau ketoconazol (un inhibitor al CYP2A6 şi CYP3A4). Administrarea concomitentă a itraconazolului (un inhibitor al CYP3A4) cu rosuvastatina a determinat o creştere de 28% a ASC pentru rosuvastatină. Această creştere mică nu este considerată semnificativă clinic. Prin urmare, nu sunt de aşteptat interacţiuni medicamentoase care să rezulte din metabolizarea în relaţie cu citocromul P450.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eInteracţiuni, care necesită modificarea dozei de rosuvastatină \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLa necesitatea administrării concomitente a rosuvastatinei cu preparatele, despre care se cunoaşte că ele măresc expoziţia rosuvastatinei, doza ultimei trebuie modificată. Dacă se anticipează creşterea expoziţiei ASC de 2 sau 3 ori, atunci rosuvastatina se va administra în doză iniţială de 5 mg. Doza maximă nictemerală de rosuvastatină trebuie modificată astfel, încât expoziţia anticipată de rosuvastatină să nu depăşească indicii, înregistraţi la administrarea rosuvastatinei în doză de 40 mg fără alte preparate, care determină interacţiune (de exemplu, rosuvastatină în doză de 20 mg cu gemfibrozil – creşterea de 1,9 ori; rosuvastatină în doză de 10 mg cu combinaţia de ritonavir\/atazanavir – creşterea de 3,1 ori).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eTabelul 1 Efectul preparatelor administrate concomitent asupra expoziţiei rosuvastatinei (asupra ASC în ordinea descrescătoare a efectului) pe baza studiilor clinice publicate.\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003ctable width=\"623\" cellspacing=\"0\" cellpadding=\"7\"\u003e\r\n\u003ctbody\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eRegimul de dozare a preparatului, care determină interacţiune\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eRegimul de dozare a rosuvastatinei\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eModificarea indicilor ASC a rosuvastatinei*\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCiclosporină de la 75 mg de 2 ori pe zi până la 200 mg de 2 ori pe zi, 6 luni\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg o dată pe zi, \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 7,1-ori\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAtazanavir 300 mg\/ritonavir 100 mg \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eo dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 8\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 3,1-ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eLopinavir 400 mg\/ritonavir 100 mg de 2 ori pe zi, 17 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e20 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 2,1- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eGemfibrozil 600 mg de 2 ori pe zi, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e80 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,9- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eEltrombopag 75 mg, o dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 10\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,6- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDarunavir 600 mg\/ritonavir 100 mg\u003cbr\u003ede 2 ori pe zi, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg o dată pe zi, \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,5- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eTipranavir 500 mg\/ritonavir 200 mg\u003cbr\u003ede 2 ori pe zi, 11 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,4- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eDronedaron 400 mg de 2 ori pe zi\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eNu există date\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,4- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eItraconazol 200 mg o dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 5\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,4- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e**\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eEzetimib 10 mg o dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 14\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg o dată pe zi, \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e14 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eDe 1,2- ori \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↑\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e**\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eFosamprenavir 700 mg\/ritonavir 100 mg\u003cbr\u003ede 2 ori pe zi, 8 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eAleglitazar 0,3 mg, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e40 mg, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eSilimarină (extract de Silbyum marianum) 140 mg de 3 ori pe zi, 5 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eFenofibrat 67 mg de 3 ori pe zi, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e10 mg, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eRifampin 450 mg o dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 7\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e20 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eKetoconazol 200 mg de 2 ori pe zi, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e80 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eFluconazol 200 mg o dată pe zi\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000000;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e, 11\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e80 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e↔\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eEritromicină 500 mg de 4 ori pe zi, 7 zile\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e80 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e28%\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↓\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003ctr\u003e\r\n\u003ctd width=\"277\"\u003e\r\n\u003cp class=\"western\" align=\"left\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eBaicalin 50 mg de 3 ori pe zi\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"154\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e20 mg, o singură doză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003ctd width=\"147\"\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e47%\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↓\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003c\/td\u003e\r\n\u003c\/tr\u003e\r\n\u003c\/tbody\u003e\r\n\u003c\/table\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e*Datele, prezentate ca modificări de x-ori, sunt un raport simplu între rezultatele, obţinute în cazul asocierii şi la administrarea numai a rosuvastatinei. Datele prezentate ca modificări %-ale indică diferenţa %-ală, în comparaţie cu monoterapia cu rosuvastatină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e↑ \u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e- creşterea, \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↓\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e - reducerea, \u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Arial, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e↔\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e modificări nu sunt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e**Unele studii pentru interacţiune au fost efectuate cu diferite doze de rosuvastatină. În tabel sunt prezentate cel mai important raport.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cu\u003eCopii şi adolescenţi\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eStudiile de interacţiuni au fost efectuate numai la adulţi. Gradul de interacţiuni la copii nu se cunoaşte.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003ePREZENTARE, AMBALAJ\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eComprimate filmate 5 mg, 10 mg, 20 mg, 40 mg \u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eCâte 7 comprimate în blister. Câte 2 (14 comprimate), 4 (28 comprimate) şi 8 (56 comprimate) blistere împreună cu instrucţiunea pentru administrare în cutie de carton.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003ePĂSTRARE\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eA se păstra la temperatura sub 30\u003c\/span\u003e\u003c\/span\u003e\u003csup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eo\u003c\/span\u003e\u003c\/span\u003e\u003c\/sup\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eC, în ambalajul original. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003eA nu se lăsa la îndemâna şi vederea copiilor!\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eTERMEN DE VALABILITATE \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"justify\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e3 ani.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eA nu se utiliza după data de expirare indicată pe ambalaj.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eStatutul legal\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eCu prescripţie medicală.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp align=\"justify\"\u003e\u003cspan style=\"font-size: medium;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eData ultimei \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003eREVIZUIRI \u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cstrong\u003ea textului\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eSeptembrie 2013\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"justify\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cstrong\u003eDEŢINĂTORUL CERTIFICATULUI DE INREGISTRARE\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003eEGIS Pharmaceuticals PLC., Ungaria.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e1106 or. Budapesta, str. Kereszturi 30-38.\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"en-US\" align=\"left\"\u003e \u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eLa apariţia oricărei reacţii adverse informaţi secţia de farmacovigilenţă a\u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" lang=\"ro-RO\" align=\"center\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cem\u003e\u003cstrong\u003eAgenţiei Medicamentului şi Dispozitivelor Medicale \u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp class=\"western\" align=\"center\"\u003e\u003cspan style=\"font-size: small;\"\u003e\u003cspan style=\"font-family: Verdana, sans-serif;\"\u003e\u003cspan lang=\"ro-RO\"\u003e\u003cem\u003e\u003cstrong\u003etel. 022-88-43-38\u003c\/strong\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"Egis Pharmaceuticals PLC","offers":[{"title":"Default Title","offer_id":43907910140044,"sku":"33840","price":82.71,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/products\/33840.jpg?v=1635167517"},{"product_id":"mertenil-10mg-compfilm","title":"Mertenil 10mg comp.film.","description":"\u003cp style=\"text-align: justify;\"\u003eDenumirea comerciala: Mertenil\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDCI al substantei active: Rosuvastatinum\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCompozitia si forma de prezentare: 1 comprimat filmat contine:\u003cbr\u003esubstanta activa: rosuvastatina sub forma de rosuvastatina calcica 5 mg. 10 mg. 20 mg sau 40 mg: substante auxiliare:\u003cbr\u003enucleul: celuloza microcristalini 12. lactoza monohidrat. hidroxid de magneziu, crospovidona (tip Ai. stearat de magneziu: filmul: Opadry II alb (talc. macrogol-3350. dioxid de titan E171. alcool polivinilic).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDescriere: Comprimate filmate 5 mg. Comprimate filmate, rotunde, biconvexe, de culoare alba sau aproape alba. cu inscriptia ,,C33\" pe o parte a comprimatului Comprimate filmate 10 mg. Comprimate filmate, rotunde, biconvexe. de culoare alba sau aproape alba. cu inscriptia \"C34\" pe o parte a comprimatului Comprimate filmate 20 mg. Comprimate filmate, rotunde, biconvexe. de culoare alba sau aproape alba. cu inscriptia \"C35\" pe o parte a comprimatului.\u003cbr\u003eComprimate filmate 40 mg. Comprimate filmate, ovale, biconvexe de culoare alba sau aproape alba. cu inscriptia ,,C36\" pe o parte a comprimatului\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eForma farmaceutica: Comprimate filmate.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eGrupa farmacoterapeutica si codul ATC: Hipolipidemiant. Inhibitor al HMG CoA reductazei. C10AA07\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eProprietatile farmacodinamice:\u003cbr\u003eRosuvastatina este un inhibitor concurent si selectiv al 3-hidroxi-3-metilglutaril-coenzima A reductazei (HMG\u003cbr\u003e»CoA reductaza). enzimi care transforma HMG\u003cbr\u003e»CoA in mevalonat - un predecesor al colesterolului. Locul de actiune al rosuvastatinei este ficatul, unde are loc sinteza colesterolului (C) si catabolismul lipoproteinelor cu densitate joasa (LDL). Ca urmare creste numarul receptorilor \"hepatici\" pentru LDL pe suprafata celulelor, se mareste captarea si intensitatea catabolismului LDL.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eReduce sinteza colesterolului lipoproteinelor de densitate foarte joasa (C-VLDL) in celulele hepatice, scazind concentratia lor totala. Rosuvastatina scade nivelul crescut de C-LDL. colesterol total si trigliceride. mareste concentratia colesterolului lipoproteinelor de densitate inalta (C-HDL). reduce concentratia apolipoproteinei В (ApoB). C-ne-HDL. mareste nivelul de apolipoproteina A-l (ApoA-l).\u003cbr\u003eMicsoreaza raportul C-LDL\/C-HDL. colesterol total\/C-HDL. C-ne-HDL\/C-HDL si ApoB\/ApoA-l. Efectul terapeutic apare in prima saptamina de tratament cu rosuvastatina, peste 2 saptamini de tratament efectul constituie 90% din maxim posibil. Efectul maxim, de obicei, se realizeaza peste 4 saptamini si se mentine pe parcursul intregii cure.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eProprietatile farmacocinetice:\u003cbr\u003eAbsorbtia Concentratia plasmatica maxima a rosuvastatinei se realizeaza peste 5 ore dupa administrarea interna a dozei corespunzatoare. Biodisponibilitatea constituie circa 20%.\u003cbr\u003eDistributia Rosuvastatina se distribuie preponderent in ficat, unde are loc sinteza colesterolului si metabolizarea C-LDL. Volumul de distributie constituie circa 134 litri. Aproximativ 90% rosuvastatina se cupleaza cu proteinele plasmatice. preponderent cu albuminele.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eMetabolizarea Rosuvastatina e supusa unui metabolism redus (aproximativ 10%). Este un substrat nespecific pentru metabolizare prin intermediul izoenzimelor citocromului P450 in ficat. CYP2C9 este izoenzima de baza, care participa la metabolizarea rosuvastatinei, izoenzimele CYP2C19, CYP3A4 si CYP2D6 sunt implicate mai putin. Metabolitul de baza - N-desmetilul este cu 50% mar putin activ decit rosuvastatina.Metabolitii lactonici sunt farmacologic inactivi. Peste 90% din activitatea farmacologica de inhibare a HMG\u003cbr\u003e»CoA reductazei circulante este asigurata de rosuvastatina. restul - de metabolitii sai.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eEliminarea Circa 90% din doza administrata se elimina sub forma nemodificata cu fecalele (inclusiv partea absorbita si cea neabsorbita), restul - sub forma nemodificata cu urina. Timpul de injumatatire plasmatica (T ) constituie 19 ore. nu se modifica la majorarea dozei de preparat. Clearance-ul mediu plasmatic constituie 50 l\/ora (coeficient de variatie - 21.7%). Ca in cazul altor inhibitori ai HMG\u003cbr\u003e»CoA reductazei in procesul de captare hepatica a rosuvastatinei este implicat transportatorul transmembranic al colesterolului - proteina transportatoare С al anionilor organici. Acest transportator joaca un rol important in eliminarea rosuvastatinei pe cale hepatica.\u003cbr\u003eLiniaritatea Expozitia sistemica a rosuvastatinei se mareste proportional cu doza. La administrarea preparatului de citeva ori pe zi nu are loc modificarea parametrilor farmacocinetici.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eFarmacocinetica in situatii clinice speciale Virsta si sexul pacientilor Virsta si sexul pacientilor nu influenteaza asupra parametrilor farmacocinetici ai rosuvastatinei.\u003cbr\u003eGrupe etnice La pacientii de rasa asiatica se determina cresterea de 2 ori a ariei sub curba concentratie\/timp (AUC) si a timpului de atingere a concentratiei maxime TC in comparatie cu indicii reprezentantilor rasei europoide. La indieni acesti indici sunt majorati de 13 ori.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePacienti cu insuficienta renala La pacientii cu insuficienta renala usoara sau moderata concentratia plasmatica a rosuvastatinei si metabolitului N-desmetil nu se modifica substantial La pacientii cu insuficienta renala severa cu clearance-ul creatininei (CC) sub 30 ml\/min concentratia plasmatica a rosuvastatinei creste de 3 ori. iar a metabolitului N-desmetil - de 9 ori fata de voluntarii sanatosi. Concentratia plasmatica a rosuvastatinei la pacientii aflati la hemodializa este cu circa 50% mai mare decit la voluntarii sanatosi.\u003cbr\u003ePacienti cu insuficienta hepatica La pacienti cu insuficienta hepatica de divers grad (scop Child-Pugh 9.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eINDICATII TERAPEUTICE\u003cbr\u003eHipercolesterolemie primara (tip lla, inclusiv hipercolesterolemie heterozigota familiala) sau dislipidemie mixta (tip llb) in calitate de metoda asociata dietoterapi-ei. in cazul cind regimul dietetic si alte metode non-medicamentoase (de ex.. efortul fizic, reducerea masei corporale) au efect nesatisfacitor. Hipercolesterolemie homozigota familiala in calitate de remediu asociat dietoterapiei si altor metode de terapie antilipidemianta (de ex. LDL-afereza) sau in cazurile cind aceasta terapie manifesta efect insuficient.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDOZE SI MOD DE ADMINISTRARE\u003cbr\u003einainte de initierea tratamentului pacientului va respecta o dieta standard, cu continut scazut de colesterol, care e necesar de respectat si pe durata tratamentului cu rosuvastatina. Doza de preparat se ajusteaza in mod individual. in functie de scopul terapiei si rezultatul obtinut, luind in consideratie recomandarile contemporane privind nivelul de lipide.\u003cbr\u003ePreparatul se administreaza intern, independent de mese. Comprimatele se vor inghiti intregi, fara a fi mestecate, cu o cantitate suficienta de apa. Doza initiala recomandata constituie 5 mg sau 10 mg 1 data pe zi, atit pentru pacientii, care nu au administrat anterior statine, cit si pentru pacientii transferati de la terapia cu alti inhibitori ai HMG\u003cbr\u003e»CoA reductazei.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eLa stabilirea dozei initiale de preparat pentru fiecare pacient se va lua in consideratie nivelul de colesterol, riscul posibil de dezvoltare a complicatiilor din partea sistemului cardiovascular si de aparitie a efectelor adverse. Ajustarea dozei, daca este necesara, poate fi facuta peste 4 saptamini. Din cauza riscului sporit de dezvoltare a reactiilor adverse la administrarea dozei de 40 mg rosuvastatina in comparatie cu dozele mai mici, cresterea dozei pina la 40 mg se admite doar la pacientii cu hipercolesterolemie grava si risc inalt de aparitie a complicatiilor din partea sistemului cardiovascular (in special la pacientii cu hipercolesterolemie familiala).\u003c\/p\u003e","brand":"Gedeon Richter PLC","offers":[{"title":"Default Title","offer_id":43907867738252,"sku":"25939","price":73.1,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/25939.jpg?v=1750850507"},{"product_id":"mertenil-20mg-compfilm","title":"Mertenil 20mg comp.film.","description":"\u003cp\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eDenumirea comerciala:\u003c\/span\u003e\u003c\/strong\u003e Mertenil \u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003e\u003cbr\u003eDCI al substantei active:\u003c\/span\u003e\u003c\/strong\u003e Rosuvastatinum \u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003e\u003cbr\u003eCompozitia si forma de prezentare:\u003c\/span\u003e\u003c\/strong\u003e 1 comprimat filmat contine:\u003cbr\u003esubstanta activa: rosuvastatina sub forma de rosuvastatina calcica 5 mg. 10 mg. 20 mg sau 40 mg: substante auxiliare:\u003cbr\u003enucleul: celuloza microcristalini 12. lactoza monohidrat. hidroxid de magneziu, crospovidona (tip Ai. stearat de magneziu: filmul: Opadry II alb (talc. macrogol-3350. dioxid de titan E171. alcool polivinilic).\u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eDescriere:\u003c\/span\u003e\u003c\/strong\u003e Comprimate filmate 5 mg. Comprimate filmate, rotunde, biconvexe, de culoare alba sau aproape alba. cu inscriptia ,,C33\" pe o parte a comprimatului Comprimate filmate 10 mg. Comprimate filmate, rotunde, biconvexe. de culoare alba sau aproape alba. cu inscriptia \"C34\" pe o parte a comprimatului Comprimate filmate 20 mg. Comprimate filmate, rotunde, biconvexe. de culoare alba sau aproape alba. cu inscriptia \"C35\" pe o parte a comprimatului.\u003cbr\u003eComprimate filmate 40 mg. Comprimate filmate, ovale, biconvexe de culoare alba sau aproape alba. cu inscriptia ,,C36\" pe o parte a comprimatului \u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003e\u003cbr\u003eForma farmaceutica:\u003c\/span\u003e\u003c\/strong\u003e Comprimate filmate. \u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003e\u003cbr\u003eGrupa farmacoterapeutica si codul ATC:\u003c\/span\u003e\u003c\/strong\u003e Hipolipidemiant. Inhibitor al HMG CoA reductazei. C10AA07 \u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eProprietatile farmacodinamice:\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003eRosuvastatina este un inhibitor concurent si selectiv al 3-hidroxi-3-metilglutaril-coenzima A reductazei (HMG\u003cbr\u003e»CoA reductaza). enzimi care transforma HMG\u003cbr\u003e»CoA in mevalonat - un predecesor al colesterolului. Locul de actiune al rosuvastatinei este ficatul, unde are loc sinteza colesterolului (C) si catabolismul lipoproteinelor cu densitate joasa (LDL). Ca urmare creste numarul receptorilor \"hepatici\" pentru LDL pe suprafata celulelor, se mareste captarea si intensitatea catabolismului LDL.\u003cbr\u003e\u003cbr\u003eReduce sinteza colesterolului lipoproteinelor de densitate foarte joasa (C-VLDL) in celulele hepatice, scazind concentratia lor totala. Rosuvastatina scade nivelul crescut de C-LDL. colesterol total si trigliceride. mareste concentratia colesterolului lipoproteinelor de densitate inalta (C-HDL). reduce concentratia apolipoproteinei В (ApoB). C-ne-HDL. mareste nivelul de apolipoproteina A-l (ApoA-l).\u003cbr\u003eMicsoreaza raportul C-LDL\/C-HDL. colesterol total\/C-HDL. C-ne-HDL\/C-HDL si ApoB\/ApoA-l. Efectul terapeutic apare in prima saptamina de tratament cu rosuvastatina, peste 2 saptamini de tratament efectul constituie 90% din maxim posibil. Efectul maxim, de obicei, se realizeaza peste 4 saptamini si se mentine pe parcursul intregii cure. \u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eProprietatile farmacocinetice:\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003eAbsorbtia Concentratia plasmatica maxima a rosuvastatinei se realizeaza peste 5 ore dupa administrarea interna a dozei corespunzatoare. Biodisponibilitatea constituie circa 20%.\u003cbr\u003eDistributia Rosuvastatina se distribuie preponderent in ficat, unde are loc sinteza colesterolului si metabolizarea C-LDL. Volumul de distributie constituie circa 134 litri. Aproximativ 90% rosuvastatina se cupleaza cu proteinele plasmatice. preponderent cu albuminele.\u003cbr\u003e\u003cbr\u003eMetabolizarea Rosuvastatina e supusa unui metabolism redus (aproximativ 10%). Este un substrat nespecific pentru metabolizare prin intermediul izoenzimelor citocromului P450 in ficat. CYP2C9 este izoenzima de baza, care participa la metabolizarea rosuvastatinei, izoenzimele CYP2C19, CYP3A4 si CYP2D6 sunt implicate mai putin. Metabolitul de baza - N-desmetilul este cu 50% mar putin activ decit rosuvastatina.Metabolitii lactonici sunt farmacologic inactivi. Peste 90% din activitatea farmacologica de inhibare a HMG\u003cbr\u003e»CoA reductazei circulante este asigurata de rosuvastatina. restul - de metabolitii sai.\u003cbr\u003e\u003cbr\u003eEliminarea Circa 90% din doza administrata se elimina sub forma nemodificata cu fecalele (inclusiv partea absorbita si cea neabsorbita), restul - sub forma nemodificata cu urina. Timpul de injumatatire plasmatica (T ) constituie 19 ore. nu se modifica la majorarea dozei de preparat. Clearance-ul mediu plasmatic constituie 50 l\/ora (coeficient de variatie - 21.7%). Ca in cazul altor inhibitori ai HMG\u003cbr\u003e»CoA reductazei in procesul de captare hepatica a rosuvastatinei este implicat transportatorul transmembranic al colesterolului - proteina transportatoare С al anionilor organici. Acest transportator joaca un rol important in eliminarea rosuvastatinei pe cale hepatica.\u003cbr\u003eLiniaritatea Expozitia sistemica a rosuvastatinei se mareste proportional cu doza. La administrarea preparatului de citeva ori pe zi nu are loc modificarea parametrilor farmacocinetici.\u003cbr\u003e\u003cbr\u003eFarmacocinetica in situatii clinice speciale Virsta si sexul pacientilor Virsta si sexul pacientilor nu influenteaza asupra parametrilor farmacocinetici ai rosuvastatinei.\u003cbr\u003eGrupe etnice La pacientii de rasa asiatica se determina cresterea de 2 ori a ariei sub curba concentratie\/timp (AUC) si a timpului de atingere a concentratiei maxime TC in comparatie cu indicii reprezentantilor rasei europoide. La indieni acesti indici sunt majorati de 13 ori.\u003cbr\u003e\u003cbr\u003ePacienti cu insuficienta renala La pacientii cu insuficienta renala usoara sau moderata concentratia plasmatica a rosuvastatinei si metabolitului N-desmetil nu se modifica substantial La pacientii cu insuficienta renala severa cu clearance-ul creatininei (CC) sub 30 ml\/min concentratia plasmatica a rosuvastatinei creste de 3 ori. iar a metabolitului N-desmetil - de 9 ori fata de voluntarii sanatosi. Concentratia plasmatica a rosuvastatinei la pacientii aflati la hemodializa este cu circa 50% mai mare decit la voluntarii sanatosi.\u003cbr\u003ePacienti cu insuficienta hepatica La pacienti cu insuficienta hepatica de divers grad (scop Child-Pugh 9.\u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eINDICATII TERAPEUTICE\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003eHipercolesterolemie primara (tip lla, inclusiv hipercolesterolemie heterozigota familiala) sau dislipidemie mixta (tip llb) in calitate de metoda asociata dietoterapi-ei. in cazul cind regimul dietetic si alte metode non-medicamentoase (de ex.. efortul fizic, reducerea masei corporale) au efect nesatisfacitor. Hipercolesterolemie homozigota familiala in calitate de remediu asociat dietoterapiei si altor metode de terapie antilipidemianta (de ex. LDL-afereza) sau in cazurile cind aceasta terapie manifesta efect insuficient.\u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eDOZE SI MOD DE ADMINISTRARE\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003einainte de initierea tratamentului pacientului va respecta o dieta standard, cu continut scazut de colesterol, care e necesar de respectat si pe durata tratamentului cu rosuvastatina. Doza de preparat se ajusteaza in mod individual. in functie de scopul terapiei si rezultatul obtinut, luind in consideratie recomandarile contemporane privind nivelul de lipide.\u003cbr\u003ePreparatul se administreaza intern, independent de mese. Comprimatele se vor inghiti intregi, fara a fi mestecate, cu o cantitate suficienta de apa. Doza initiala recomandata constituie 5 mg sau 10 mg 1 data pe zi, atit pentru pacientii, care nu au administrat anterior statine, cit si pentru pacientii transferati de la terapia cu alti inhibitori ai HMG\u003cbr\u003e»CoA reductazei.\u003cbr\u003e\u003cbr\u003eLa stabilirea dozei initiale de preparat pentru fiecare pacient se va lua in consideratie nivelul de colesterol, riscul posibil de dezvoltare a complicatiilor din partea sistemului cardiovascular si de aparitie a efectelor adverse. Ajustarea dozei, daca este necesara, poate fi facuta peste 4 saptamini. Din cauza riscului sporit de dezvoltare a reactiilor adverse la administrarea dozei de 40 mg rosuvastatina in comparatie cu dozele mai mici, cresterea dozei pina la 40 mg se admite doar la pacientii cu hipercolesterolemie grava si risc inalt de aparitie a complicatiilor din partea sistemului cardiovascular (in special la pacientii cu hipercolesterolemie familiala).\u003c\/p\u003e","brand":"Gedeon Richter PLC","offers":[{"title":"Default Title","offer_id":43907867869324,"sku":"25940","price":107.29,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/25940.jpg?v=1750850511"},{"product_id":"mertenil-5mg-compfilm","title":"Mertenil 5mg comp.film.","description":"\u003cp\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eDenumirea comerciala:\u003c\/span\u003e\u003c\/strong\u003e Mertenil \u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003e\u003cbr\u003eDCI al substantei active:\u003c\/span\u003e\u003c\/strong\u003e Rosuvastatinum \u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003e\u003cbr\u003eCompozitia si forma de prezentare:\u003c\/span\u003e\u003c\/strong\u003e 1 comprimat filmat contine:\u003cbr\u003esubstanta activa: rosuvastatina sub forma de rosuvastatina calcica 5 mg. 10 mg. 20 mg sau 40 mg: substante auxiliare:\u003cbr\u003enucleul: celuloza microcristalini 12. lactoza monohidrat. hidroxid de magneziu, crospovidona (tip Ai. stearat de magneziu: filmul: Opadry II alb (talc. macrogol-3350. dioxid de titan E171. alcool polivinilic).\u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eDescriere:\u003c\/span\u003e\u003c\/strong\u003e Comprimate filmate 5 mg. Comprimate filmate, rotunde, biconvexe, de culoare alba sau aproape alba. cu inscriptia ,,C33\" pe o parte a comprimatului Comprimate filmate 10 mg. Comprimate filmate, rotunde, biconvexe. de culoare alba sau aproape alba. cu inscriptia \"C34\" pe o parte a comprimatului Comprimate filmate 20 mg. Comprimate filmate, rotunde, biconvexe. de culoare alba sau aproape alba. cu inscriptia \"C35\" pe o parte a comprimatului.\u003cbr\u003eComprimate filmate 40 mg. Comprimate filmate, ovale, biconvexe de culoare alba sau aproape alba. cu inscriptia ,,C36\" pe o parte a comprimatului \u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003e\u003cbr\u003eForma farmaceutica:\u003c\/span\u003e\u003c\/strong\u003e Comprimate filmate. \u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003e\u003cbr\u003eGrupa farmacoterapeutica si codul ATC:\u003c\/span\u003e\u003c\/strong\u003e Hipolipidemiant. Inhibitor al HMG CoA reductazei. C10AA07 \u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eProprietatile farmacodinamice:\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003eRosuvastatina este un inhibitor concurent si selectiv al 3-hidroxi-3-metilglutaril-coenzima A reductazei (HMG\u003cbr\u003e»CoA reductaza). enzimi care transforma HMG\u003cbr\u003e»CoA in mevalonat - un predecesor al colesterolului. Locul de actiune al rosuvastatinei este ficatul, unde are loc sinteza colesterolului (C) si catabolismul lipoproteinelor cu densitate joasa (LDL). Ca urmare creste numarul receptorilor \"hepatici\" pentru LDL pe suprafata celulelor, se mareste captarea si intensitatea catabolismului LDL.\u003cbr\u003e\u003cbr\u003eReduce sinteza colesterolului lipoproteinelor de densitate foarte joasa (C-VLDL) in celulele hepatice, scazind concentratia lor totala. Rosuvastatina scade nivelul crescut de C-LDL. colesterol total si trigliceride. mareste concentratia colesterolului lipoproteinelor de densitate inalta (C-HDL). reduce concentratia apolipoproteinei В (ApoB). C-ne-HDL. mareste nivelul de apolipoproteina A-l (ApoA-l).\u003cbr\u003eMicsoreaza raportul C-LDL\/C-HDL. colesterol total\/C-HDL. C-ne-HDL\/C-HDL si ApoB\/ApoA-l. Efectul terapeutic apare in prima saptamina de tratament cu rosuvastatina, peste 2 saptamini de tratament efectul constituie 90% din maxim posibil. Efectul maxim, de obicei, se realizeaza peste 4 saptamini si se mentine pe parcursul intregii cure. \u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eProprietatile farmacocinetice:\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003eAbsorbtia Concentratia plasmatica maxima a rosuvastatinei se realizeaza peste 5 ore dupa administrarea interna a dozei corespunzatoare. Biodisponibilitatea constituie circa 20%.\u003cbr\u003eDistributia Rosuvastatina se distribuie preponderent in ficat, unde are loc sinteza colesterolului si metabolizarea C-LDL. Volumul de distributie constituie circa 134 litri. Aproximativ 90% rosuvastatina se cupleaza cu proteinele plasmatice. preponderent cu albuminele.\u003cbr\u003e\u003cbr\u003eMetabolizarea Rosuvastatina e supusa unui metabolism redus (aproximativ 10%). Este un substrat nespecific pentru metabolizare prin intermediul izoenzimelor citocromului P450 in ficat. CYP2C9 este izoenzima de baza, care participa la metabolizarea rosuvastatinei, izoenzimele CYP2C19, CYP3A4 si CYP2D6 sunt implicate mai putin. Metabolitul de baza - N-desmetilul este cu 50% mar putin activ decit rosuvastatina.Metabolitii lactonici sunt farmacologic inactivi. Peste 90% din activitatea farmacologica de inhibare a HMG\u003cbr\u003e»CoA reductazei circulante este asigurata de rosuvastatina. restul - de metabolitii sai.\u003cbr\u003e\u003cbr\u003eEliminarea Circa 90% din doza administrata se elimina sub forma nemodificata cu fecalele (inclusiv partea absorbita si cea neabsorbita), restul - sub forma nemodificata cu urina. Timpul de injumatatire plasmatica (T ) constituie 19 ore. nu se modifica la majorarea dozei de preparat. Clearance-ul mediu plasmatic constituie 50 l\/ora (coeficient de variatie - 21.7%). Ca in cazul altor inhibitori ai HMG\u003cbr\u003e»CoA reductazei in procesul de captare hepatica a rosuvastatinei este implicat transportatorul transmembranic al colesterolului - proteina transportatoare С al anionilor organici. Acest transportator joaca un rol important in eliminarea rosuvastatinei pe cale hepatica.\u003cbr\u003eLiniaritatea Expozitia sistemica a rosuvastatinei se mareste proportional cu doza. La administrarea preparatului de citeva ori pe zi nu are loc modificarea parametrilor farmacocinetici.\u003cbr\u003e\u003cbr\u003eFarmacocinetica in situatii clinice speciale Virsta si sexul pacientilor Virsta si sexul pacientilor nu influenteaza asupra parametrilor farmacocinetici ai rosuvastatinei.\u003cbr\u003eGrupe etnice La pacientii de rasa asiatica se determina cresterea de 2 ori a ariei sub curba concentratie\/timp (AUC) si a timpului de atingere a concentratiei maxime TC in comparatie cu indicii reprezentantilor rasei europoide. La indieni acesti indici sunt majorati de 13 ori.\u003cbr\u003e\u003cbr\u003ePacienti cu insuficienta renala La pacientii cu insuficienta renala usoara sau moderata concentratia plasmatica a rosuvastatinei si metabolitului N-desmetil nu se modifica substantial La pacientii cu insuficienta renala severa cu clearance-ul creatininei (CC) sub 30 ml\/min concentratia plasmatica a rosuvastatinei creste de 3 ori. iar a metabolitului N-desmetil - de 9 ori fata de voluntarii sanatosi. Concentratia plasmatica a rosuvastatinei la pacientii aflati la hemodializa este cu circa 50% mai mare decit la voluntarii sanatosi.\u003cbr\u003ePacienti cu insuficienta hepatica La pacienti cu insuficienta hepatica de divers grad (scop Child-Pugh 9.\u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eINDICATII TERAPEUTICE\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003eHipercolesterolemie primara (tip lla, inclusiv hipercolesterolemie heterozigota familiala) sau dislipidemie mixta (tip llb) in calitate de metoda asociata dietoterapi-ei. in cazul cind regimul dietetic si alte metode non-medicamentoase (de ex.. efortul fizic, reducerea masei corporale) au efect nesatisfacitor. Hipercolesterolemie homozigota familiala in calitate de remediu asociat dietoterapiei si altor metode de terapie antilipidemianta (de ex. LDL-afereza) sau in cazurile cind aceasta terapie manifesta efect insuficient.\u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e\u003cspan class=\"title_Prospect\"\u003eDOZE SI MOD DE ADMINISTRARE\u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003einainte de initierea tratamentului pacientului va respecta o dieta standard, cu continut scazut de colesterol, care e necesar de respectat si pe durata tratamentului cu rosuvastatina. Doza de preparat se ajusteaza in mod individual. in functie de scopul terapiei si rezultatul obtinut, luind in consideratie recomandarile contemporane privind nivelul de lipide.\u003cbr\u003ePreparatul se administreaza intern, independent de mese. Comprimatele se vor inghiti intregi, fara a fi mestecate, cu o cantitate suficienta de apa. Doza initiala recomandata constituie 5 mg sau 10 mg 1 data pe zi, atit pentru pacientii, care nu au administrat anterior statine, cit si pentru pacientii transferati de la terapia cu alti inhibitori ai HMG\u003cbr\u003e»CoA reductazei.\u003cbr\u003e\u003cbr\u003eLa stabilirea dozei initiale de preparat pentru fiecare pacient se va lua in consideratie nivelul de colesterol, riscul posibil de dezvoltare a complicatiilor din partea sistemului cardiovascular si de aparitie a efectelor adverse. Ajustarea dozei, daca este necesara, poate fi facuta peste 4 saptamini. Din cauza riscului sporit de dezvoltare a reactiilor adverse la administrarea dozei de 40 mg rosuvastatina in comparatie cu dozele mai mici, cresterea dozei pina la 40 mg se admite doar la pacientii cu hipercolesterolemie grava si risc inalt de aparitie a complicatiilor din partea sistemului cardiovascular (in special la pacientii cu hipercolesterolemie familiala).\u003c\/p\u003e","brand":"Gedeon Richter PLC","offers":[{"title":"Default Title","offer_id":43907868655756,"sku":"25963","price":66.57,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/25963.jpg?v=1750850520"},{"product_id":"roswera-10mg-compfilm","title":"Roswera 10mg comp.film.","description":"\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 13.91px;\"\u003eRoswera 5 mg comprimate filmate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 10 mg comprimate filmate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 15 mg comprimate filmate\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 20 mg comprimate filmate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 30 mg comprimate filmate\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 40 mg comprimate filmate\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 13.91px;\"\u003eCOMPOZIŢIA CALITATIVĂ ŞI CANTITATIVĂ\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine rosuvastatină 5 mg (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 10 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 15 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 20 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 30 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 40 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 13.91px;\"\u003eExcipient(ţi) cu efect cunoscut: \u003c\/span\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 5 mg conţine lactoză anhidră 41,9 mg.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 10 mg conţine lactoză anhidră 41,9 mg.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 15 mg conţine lactoză anhidră 62,9 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 20 mg conţine lactoză anhidră 83,8 mg.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 30 mg conţine lactoză anhidră 125,7 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 40 mg conţine lactoză anhidră 167,6 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFORMA FARMACEUTICĂ\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eComprimat filmat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e5 mg: comprimate filmate de culoare albă, rotunde (diametrul de 7 mm), uşor biconvexe, cu margini teşite, marcate cu numărul 5 pe una dintre feţe.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e10 mg: comprimate filmate de culoare albă, rotunde (diametrul de 7,5 mm), uşor biconvexe, cu margini teşite, marcate cu numărul 10 pe una dintre feţe.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e15 mg: comprimate filmate de culoare albă, rotunde (diametrul de 9 mm), uşor biconvexe, cu margini teşite, marcate cu numărul 15 pe una dintre feţe.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e20 mg: comprimate filmate de culoare albă, rotunde (diametrul de 10 mm), cu margini teşite.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e30 mg: comprimate filmate de culoare albă, biconvexe, alungite, marcate pe ambele feţe (dimensiuni:15 mm x 8 mm). Linia mediană are numai rolul de a uşura ruperea comprimatului pentru a fi înghiţit uşor şi nu de divizare în doze egale.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e40 mg: comprimate filmate de culoare albă, biconvexe, alungite (dimensiuni: 16 mm x 8,5 mm).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDATE CLINICE\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eIndicaţii terapeutice\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eTratamentul hipercolesterolemiei\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdulţi, adolescenţi şi copii cu vârsta de 10 ani sau peste, cu hipercolesterolemie primară (tip IIa, inclusiv hipercolesterolemia familială - forma heterozigotă) sau dislipidemie mixtă (tip IIb), ca adjuvant al dietei la pacienţii care nu răspund adecvat numai la dietă şi la alte metode de tratament non-farmacologic (cum sunt exerciţiile fizice, scăderea în greutate).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eHipercolesterolemie familială - forma homozigotă, ca tratament adjuvant al dietei şi al altor metode de scădere a lipidemiei (de exemplu afereza LDL) sau în cazurile în care aceste tratamente nu sunt adecvate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrevenţia evenimentelor cardiovasculare Prevenţia evenimentelor cardiovasculare majore la pacienţii cu risc major pentru un prim eveniment cardiovascular (vezi pct. 5.1), ca tratament adjuvant în controlul altor factori de risc. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e \u003cstrong\u003eDoze şi mod de administrare\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e Doze\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎnainte de începerea tratamentului, pacientul trebuie să urmeze un regim hipocolesterolemiant standard care trebuie continuat şi în timpul tratamentului. Doza trebuie adaptată pentru fiecare pacient, în funcţie de obiectivul tratamentului şi de răspunsul pacientului, respectând recomandările din ghidurile actuale de tratament.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera poate fi administrat în orice moment al zilei, cu sau fără alimente.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEste posibil să nu fie disponibile toate concentraţiile de Roswera.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eTratamentul hipercolesterolemiei\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDoza iniţială recomandată este de 5 sau 10 mg administrată oral, o dată pe zi, atât la pacienţii care iau pentru prima dată statine, cât şi la pacienţii care trec de pe un tratament cu alt inhibitor de HMG CoA reductază. Alegerea dozei iniţiale se face în funcţie de nivelul individual al colesterolemiei şi aprecierea riscului cardiovascular, precum şi de riscul potenţial al reacţiilor adverse. Dacă este necesar, doza poate fi crescută după 4 săptămâni la 20 mg. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDatorită creşterii incidenţei reacţiilor adverse la utilizarea dozei de 40 mg, comparativ cu dozele mai scăzute, creşterea dozei de la 20 mg la 30 mg sau până la doza maximă de 40 mg trebuie luată în considerare numai la pacienţii cu hipercolesterolemie severă şi risc cardiovascular crescut (în particular la pacienţii cu hipercolesterolemie familială), care nu ating valoarea stabilită ca obiectiv al tratamentului cu doza de 20 mg, aceştia urmând a fi monitorizaţi prin teste periodice. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa iniţierea tratamentului cu dozele de 30 mg saur 40 mg este necesară monitorizare de specialitate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrevenţia evenimentelor cardiovasculare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiul clinic al reducerii riscului de evenimente cardiovasculare, doza utilizată a fost de 20 mg pe zi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţi vârstnici\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii cu vârsta \u0026gt;70 ani se recomandă o doză iniţială de 5 mg. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţi cu insuficienţă renală\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu este necesară ajustarea dozelor la pacienţi cu insuficienţă renală uşoară sau moderată. Doza iniţială recomandată la pacienţi cu insuficienţă renala moderată (clearance-ul creatininei \u0026lt;60 ml\/min) este de 5 mg. Utilizarea dozelor de 30 mg şi 40 mg este contraindicată la pacienţii cu insuficienţă renala moderată. Utilizarea Roswera la pacienţi cu insuficienţă renală severă este contraindicată la orice doză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţi cu insuficienţă hepatică\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePentru pacienţii cu scoruri Child-Pugh de 7 sau mai mici nu s-a constatat creşterea expunerii sistemice la rosuvastatină. Totuşi, creşterea expunerii sistemice a fost observată la pacienţi cu scoruri ChildPugh de 8 şi 9. La aceşti pacienţi trebuie avută în vedere evaluarea funcţiei renale. Nu există experienţă clinică la pacienţi cu scoruri Child-Pugh peste 9. Roswera este contraindicat la pacienţii cu boală hepatică activă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eUtilizarea la copii trebuie recomandată de către medicii de specialitate. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi cu vârsta de 10 până la 17 ani (băieţi: stadiul Tanner II sau peste, iar fetele la cel puţin 1 an după menarhă)\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa copii şi adolescenţi cu hipercolesterolemie familială heterozigotă, doza uzuală iniţială este de 5 mg pe zi. Intervalul de dozare uzual este 5\u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e\u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e20 mg oral, o dată pe zi. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCreşterea dozelor trebuie efectuată în funcţie de răspunsul la tratament şi tolerabilitatea individuală a copiilor, conform recomandărilor ghidurilor de tratament pediatric. Copiii și adolescenții trebuie să efectueze tratament dietetic hipocolesterolemiant standard înainte de inițierea tratamentului cu rosuvastatină; regimul alimentar trebuie continuat pe toată durata tratamentului cu rosuvastatină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSiguranţa şi eficacitatea tratamentului cu doze mai mari de 20 mg nu au fost încă stabilite la aceste grupe de populaţie. Comprimatele de 30 şi 40 mg nu sunt recomandate la copii. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii cu vârsta sub 10 ani\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eExperienţa clinică este limitată la un număr mic de copii (cu vârste de 8 ani şi până la 10 ani) cu hipercolesterolemie familială - forma homozigotă. De aceea, Roswera nu este recomandat la copii cu vârsta sub 10 ani.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRasă\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa subiecţii asiatici a fost observată creşterea expunerii sistemice. La pacienţii de origine asiatică, se recomandă o doză iniţială de 5 mg. Dozele de 30 şi 40 mg sunt contraindicate la aceşti pacienţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePolimorfism genetic\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSe ştie că prezenţa anumitor tipuri de polimorfism genetic poate duce la creşterea concentraţiilor plasmatice ale rosuvastatinei (vezi pct. 5.2). La pacienţii cu astfel de tipuri cunoscute de polimorfism, se recomandă administrarea unor doze mai mici de rosuvastatină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDoze la pacienţi cu factori de risc de miopatie\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţi cu factori de risc de miopatie doza inţială recomandată este de 5 mg. Dozele de 30 şi 40 mg sunt contraindicate la unii dintre aceşti pacienţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eTratament concomitent\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina reprezintă substrat al unor proteine de transport (de exemplu, OATP1B1 şi BCRP). Riscul de miopatie (incluzând rabdomioliză) este crescut în cazul administrării concomitente a rosuvastatinei cu anumite medicamente ce pot creşte concentraţiile plasmatice ale rosuvastatinei, din cauza interacţiunilor cu aceste proteine transportoare (de exemplu, ciclosporina şi anumiţi inhibitopri ai proteazelor, inclusiv combinaţi de ritonavir cu atazanavir, lopinavir şi\/sau tipranavir. Atunci când este posibil, se recomandă luarea în consideraţie a unui tratament alternativ şi, dacă este necesar, terapia cu rosuvastatină poate fi întreruptă. În situaţiile în care administrarea concomitentă a acestor medicamnte şi rosuvastatină nu poate fi evitată, trebuie evaluat raportul beneficiu\/risc al tratamentului concomitent şi ajustarea cu atenţie a dozelor de rosuvastatin.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eContraindicaţii\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera este contraindicată:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e - la pacienţii cu hipersensibilitate la substanţa activă sau la oricare dintre excipienţii enumeraţi\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi cu boală hepatică activă, incluzând creşterea inexplicabilă, persistentă, a transaminazelor plasmatice şi orice creştere a transaminazelor plasmatice care depăşeşte de 3 ori limita superioară a normalului (ULN)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi cu insuficienţă renală severă (clearance al creatininei \u0026lt;30 ml\/min).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi cu miopatie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi care primesc tratament concomitent cu ciclosporină\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- în timpul sarcinii şi alăptării şi la femei aflate în perioada fertilă care nu utilizează măsuri contraceptive corespunzătoare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDozele de 30 şi 40 mg sunt contraindicate la pacienţi cu factori de risc de miopatie\/rabdomioliză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAstfel de factori de risc sunt:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- insuficienţa renală moderată (clearance-ul creatininei \u0026lt;60 ml\/min)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- hipotiroidie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- antecedente personale sau familiale de afecţiuni ereditare musculare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- istoric de toxicitate musculară la un alt inhibitor al HMG-CoA reductază sau fibraţi\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- consum exagerat de alcool etilic\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- situaţii în care nivelele plasmatice ale medicamentului pot creşte\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- pacienţi cu origine asiatică - utilizare concomitentă de fibraţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e \u003cstrong\u003eAtenţionări şi precauţii speciale pentru utilizare\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte renale\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eProteinuria, evidenţiată prin teste de tip \"dipstick\" şi de cele mai multe ori de origine tubulară, a fost observată la pacienţii trataţi cu doze mai mari de rosuvastatină în particular 40 mg, şi în cele mai multe cazuri a fost tranzitorie sau intermitentă. Proteinuria nu s-a demonstrat a fi un factor predictiv al unei boli renale acute sau progresive. Incidenţa raportărilor de reacţii adverse severe renale la utilizarea dozei de 40 mg, în perioada de după punerea pe piaţă a medicamentului, este mai mare. În cazul pacienţilor trataţi cu doze de 30 mg sau 40 mg, la efectuarea controlului de rutină trebuie avută în vedere şi evaluarea funcţiei renale.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte la nivelul musculaturii scheletice\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii trataţi cu rosuvastatină au fost raportate efecte asupra muşchilor scheletici, ca mialgie, miopatie şi, rareori, rabdomioliză la toate dozele şi în special la doze de peste 20 mg. În foarte rare cazuri, a fost raportată rabdomioliza la asocierea de ezetimib şi inhibitori ai HMG-CoA reductazei. Interacţiunea farmacodinamică nu poate fi exclusă şi la utilizarea acestei asocieri, este necesară precauţie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei, incidenţa rabdomiolizei asociate cu utilizarea Rowsera este mai mare la utilizarea dozei de 40 mg, în perioada de după punerea pe piaţă a medicamentului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDeterminarea valorilor creatinkinazei\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCreatinkinaza (CK) nu trebuie măsurată după efectuarea unor exerciţii fizice intense sau în prezenţa unei cauze evidente care ar putea să ducă la creşterea valorilor CK şi care ar putea modifica interpretarea rezultatului. În cazul în care concentraţiile plasmatice iniţiale ale CK sunt crescute în mod semnificativ (\u0026gt;5 x ULN), trebuie efectuat un test de confirmare în următoarele 5-7 zile. Dacă repetarea testului confirmă o valoare iniţială de \u0026gt;5 x ULN, atunci tratamentul nu trebuie început.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎnainte de tratament\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSimilar altor inhibitori ai HMG-CoA reductazei, Roswera trebuie recomandat cu prudenţă la pacienţii care prezintă factori predispozanţi pentru miopatie\/rabdomioliză:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- insuficienţă renală\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- hipotiroidie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- antecedente personale sau heredocolaterale de afecţiuni musculare ereditare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- antecedente de toxicitate musculară la administrarea altor inhibitori ai HMG-CoA reductazei sau a fibraţilor\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- consum exagerat de alcool etilic\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- vârstă \u0026gt;70 ani - situaţii în care poate apare o creştere a concentraţiilor plasmatice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- utilizarea concomitentă a fibraţilor.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa asemenea pacienţi, riscul trebuie evaluat în funcţie de posibilele beneficii ale tratamentului şi este recomandată monitorizarea clinică. Dacă nivelele CK sunt semnificativ crescute faţă de valorile bazale (\u0026gt;5 x ULN) tratamentul nu trebuie iniţiat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn timpul tratamentului\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţilor trebuie să li se recomande să raporteze imediat durerile musculare inexplicabile, hipotonia musculară sau crampele, mai ales dacă acestea se asociază cu stare de rău general sau febră. La aceşti pacienţi trebuie măsurate concentraţiile plasmatice ale CK. Tratamentul trebuie întrerupt dacă: concentraţiile plasmatice ale CK sunt mult crescute (\u0026gt;5 x ULN) sau dacă simptomele musculare sunt severe şi determină un disconfort zilnic (chiar şi în cazul în care concentraţiile plasmatice ale CK sunt ≤5 ori limita superioară a normalului). Dacă simptomele se remit şi concentraţiile plasmatice ale CK revin la normal, atunci trebuie avută în vedere reluarea tratamentului cu Roswera sau cu un alt inhibitor de HMG-CoA reductază, în cea mai mică doză şi sub o monitorizare atentă. Monitorizarea de rutină a concentraţiilor plasmatice ale CK la pacienţii asimptomatici nu este justificată. Au fost raportate cazuri foarte rare de miopatie necrozantă prin mecanism imunitar (IMNM) în timpul sau după tratamentul cu statine, incusiv rosuvastatină. IMNM este caracterizat clinic prin astenie musculară proximală şi creşterea concentraţiilor plasmatice ale CK, care persistă, chiar dacă tratamentul cu statine este întrerupt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiile clinice, la numărul mic de pacienţi trataţi cu rosuvastatină şi un alt tratament concomitent, nu s-a înregistrat o incidenţă mai mare a efectelor asupra musculaturii scheletice. Cu toate acestea, la pacienţii trataţi cu alţi inhibitori ai HMG-CoA reductazei, concomitent cu fibraţi cum este gemfibrozilul, ciclosporină, acid nicotinic, antifungice azolice, inhibitori ai proteazelor şi antibiotice macrolidice s-a constatat o incidenţă crescută a miozitei şi miopatiei. Gemfibrozilul creşte riscul de miopatie atunci când este administrat concomitent cu unii inhibitori ai HMG-CoA reductazei. De aceea, asocierea Roswera şi gemfibrozil nu este recomandată. Beneficiul privind scăderea suplimentară a concentraţiilor plasmatice de lipide prin administrarea asociată de Roswera şi fibraţi sau niacină trebuie atent evaluat faţă de potenţialele riscuri ale acestei asocieri. Dozele de 30 mg şi 40 mg sunt contraindicate la utilizare concomitentă cu fibraţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera nu trebuie utilizat la nici un pacient care prezintă o afecţiune acută, severă, sugestivă pentru miopatie sau cu predispoziţie de a dezvolta insuficienţă renală secundară rabdomiolizei (de exemplu sepsis, hipotensiune arterială, intervenţie chirurgicală majoră, traumatisme, tulburări severe metabolice, endocrine şi electrolitice; crize convulsive necontrolate).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte hepatice\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei, Roswera trebuie utilizat cu prudenţă la pacienţii care consumă cantităţi excesive de alcool etilic şi\/sau au antecedente de boală hepatică.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSe recomandă efectuarea de teste funcţionale hepatice înainte de începerea tratamentului şi la 3 luni după începerea tratamentului. În cazul în care concentraţia plasmatică a transaminazelor este de 3 ori mai mare decât limita superioară a normalului, tratamentul cu Roswera trebuie întrerupt sau doza trebuie redusă. Incidenţa reacţiilor hepatice severe (în principal constând în creşterea transaminazelor hepatice) este mai mare în perioada de după punerea pe piaţă a medicamentului, pentru doza de 40 mg. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii cu hipercolesterolemie secundară determinate de hipotiroidism sau sindrom nefrotic, afecţiunea de bază trebuie tratată înaintea începerii tratamentului cu Roswera.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRasa Rezultatele studiilor de farmacocinetică arată o creştere a expunerii la pacienţii de rasă asiatică, comparativ cu cei de rasă albă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInhibitorii de proteaze\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii la care s-au administrat concomitent rosuvastatină şi diverşi inhibitori ai proteazelor în asociere cu ritonavir, a fost observată creşterea concentraţiilor plasmatice ale rosuvastatinei. La iniţierea şi creşterea dozelor de rosuvastatină la pacienţii cu HIV trataţi concomitent cu inhibitori ai proteazelor, trebuie luat în considerare atât beneficiul scăderii lipidemiei de către rosuvastatină, cât şi creşterea potenţială a concentraţiilor plasmatice ale rosuvastatinei. Utilizarea concomitentă a rosuvastatinei şi inhibitorilor proteazelor nu este recomandată, decât cu.Utilizarea concomitentă cu inhibitorii de proteaze se poate face numai cu scăderea dozelor de rosuvastatină. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePneumonie interstiţială\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa utilizarea unor statine, în special la utilizare îndelungată, au fost raportate cazuri excepţional de rare de pneumonie interstiţială (vezi pct. 4.8). Tabloul clinic poate include dispnee, tuse neproductivă şi deteriorarea stării generale (fatigabilitate, pierdere în greutate şi hipertermie). Dacă se suspectează că un pacient dezvoltă o pneumonie interstiţială, tratamentul cu statine trebuie întrerupt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDiabet zaharat\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eExistă dovezi care sugerează că statinele cresc glicemia şi, la unii pacienţi cu risc crescut de apariţie a diabetului zaharat, pot produce hiperglicemie cu valori care să necesite măsuri considerate de rutină la pacienţii cu diabet zaharat diagnosticat. Totuşi, riscul de apariţie a diabetului zaharat este depăşit de beneficiul reducerii riscului cardiovascular şi, prin urmare, nu există un motiv pentru întreruperea tratamentului cu statine. Pacienţii cu risc crescut (valori ale glicemiei în condiţii de repus alimentar între 5,6 şi 6,9 mmol\/l, IMC\u0026gt;30 kg\/m2, valori crescute ale trigliceridemiei, hipertensiune arterială) trebuie monitorizaţi clinic şi paraclinic în acord cu ghidurile naţionale. În studiul clinic JUPITER, frecvenţa globală raportată de apariţie a diabetului zaharat a fost de 2,8% la rosuvastatină şi de 2,3% la placebo, mai ales la pacienţii cu valori ale glicemiei între 5,6 şi 6,9 mmol\/l în condiţii de repaus alimentar.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEvaluarea înalţimii, greutăţii corporale, indexului masei corporale şi a caracteristicilor sexuale secundare conform scalei Tanner la pacienţii copii cu vârsta de 10 până la 17 ani în tratament cu rosuvastatină este limitată la perioada de 1 an. După un studiu de 52 săptămâni, nu au fost observate efecte asupra creşterii, greutăţii corporale, IMC sau maturizării sexuale. Datele clinice la copii şi adolescenţi sunt limitate, iar efectele rosuvastatinei pe perioade îndelungate (\u0026gt;1 an) asupra pubertăţii sunt necunoscute.  Într-un studiu clinic la copii şi adolescenţi în tratament cu rosuvastatină timp de 52 săptămâni, creşterile CK peste ULN x 10 şi simptomele musculare apărute după exerciţii fizice sau activitate fizică crescută, au apărut mai frecvent, comparativ cu studiile clinice la adulţi. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera comprimate filmate conţine lactoză. Pacienţii cu afecţiuni ereditare rare de intoleranţă la galactoză, deficit de lactază (Lapp) sau sindrom de malabsorbţie la glucoză-galactoză nu trebuie să utilizeze acest medicament.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInteracţiuni cu alte medicamente şi alte forme de interacţiune\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfectele altor medicamente asupra rosuvastatinei\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInhibitorii proteinelor de transport\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este substrat al anumitor proteine de transport, incuzând transportorul hepatic de captare OATP1B1 şi a transportorului hepatic de eflux BCRP. Administrarea concomitentă a rosuvastatinei împreună cu medicamente care inhibă activitatea proteinelor de transport poate duce la creşterea concentraţiilor plasmatice ale rosuvastatinei şi la creşterea riscului de miopatie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCiclosporină\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn timpul tratamentului concomitent cu rosuvastatină şi ciclosporină, valorile ariei de sub curba concentraţiei plasmatice în funcţie de timp (ASC) ale rosuvastatinei au fost în medie de 7 ori mai mari decât cele observate la voluntarii sănătoşi (vezi tabelul 1). Rosuvastatina este contraindicată la pacienţii la care se administrează concomitent ciclosporină.  Administrarea concomitentă nu a afectat concentraţiile plasmatice ale ciclosporinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInhibitorii proteazelor \u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCu toate că nu se cunoaşte exact mecanismul interacţiunii, utilizarea concomitentă a unui inhibitor de protează poate determina o creştere puternică a concentraţiilor plasmatice ale rosuvastatinei.  De exemplu, într-un studiu de farmacocinetică, administrarea concomitentă la voluntari tineri de rosuvastatină 10 mg şi o combinaţie de doi inhibitori ai proteazelor (atazanavir 300 mg şi ritonavir100 mg), a fost asociată cu o creştere de aproximativ trei ori, respectiv şapte ori, a ASC şi, respectiv, Cmax a rosuvastatinei la starea de echilibru. Utilizarea concomitentă de rosuvastatină şi unele combinaţii de inhibitori ai proteazelor poate fi luată în considerare numai după ajustarea atentă a dozelor de rosuvastatină, în funcţie de creşterea aşteptată a concentraţiilor plasmatice ale rosuvastatinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eGemfibrozil şi alte hipolipemiante\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eUtilizarea concomitentă de rosuvastatină şi gemfibrozil a determinat creşterea de 2 ori a Cmax şi ASC pentru rosuvastatină. Pe baza datelor obţinute din studiile de interacţiune specifică nu sunt de aşteptat interacţiuni clinic semnificative în cazul administrării concomitente de fenofibrat, totuşi poate apărea o interacţiune farmacodinamică. Gemfibrozilul, fenofibratul, alţi fibraţi şi doze hipolipemiante (≥ 1g\/zi) de niacină (acid nicotinic) cresc riscul de miopatie atunci când sunt administrate concomitent cu inhibitori ai HMG-CoA reductazei, probabil datorită faptului că aceştia pot produce miopatie şi în monoterapie. Dozele de 30 mg şi 40 mg sunt contraindicate la utilizarea concomitentă a fibraţilor. De asemenea, aceşti pacienţi trebuie să utilizeze doza iniţială de 5 mg. \u003cem\u003eEzetimib\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eUtilizarea concomitentă de rosuvastatină 10 mg şi ezetimib 10 mg a determinat o creştere de 1,2 ori a ASC pentru rosuvastatină la pacienţii cu hipercolesterolemie. Totuşi, nu poate fi exclusă o interacţiune farmacodinamică, privitor la reacţiile adverse, între Roswera şi ezetimib.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAntiacide\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdministrarea simultană de rosuvastatină şi o suspensie conţinând un antiacid cu hidroxid de aluminiu şi magneziu a determinat scăderea concentraţiei plasmatice a rosuvastatinei de aproximativ 50%. Acest efect a fost mai mic atunci când antiacidul a fost administrat la 2 ore după Rowsera. Nu a fost studiată importanţa clinică a acestei interacţiuni.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEritromicină\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdministrarea simultană de rosuvastatină şi eritromicină a dus la scăderea cu 20% a ASC şi scăderea cu 30% a Cmax a rosuvastatinei. Această interacţiune poate fi determinată de creşterea motilităţii intestinale de către eritromicină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEnzimele citocromului P450\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRezultatele din studiile in vitro şi in vivo arată că rosuvastatina nu este nici inhibitor şi nici inductor al izoenzimelor citocromului P450. În plus, rosuvastatina este un substrat slab pentru aceste enzime.  De aceea, nu sunt aşteptate interacţiuni medicamentoase depinzând de metabolizarea mediată de citocromul P450. Nu s-au observat interacţiuni clinic semnificative nici între rosuvastatină şi fluconazol (un inhibitor al CYP2C9 şi CYP3A4) sau rosuvastatină şi ketoconazol (un inhibitor al CYP2A6 şi CYP3A4).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInteracţiuni care necesită ajustarea dozei de rosuvastatină\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAtunci când este necesară administrarea concomitentă de rosuvastatină şi alte medicamente care determină creşterea cunoscută a concentraţiilor plasmatice ale rosuvastatinei, dozele de rosuvastatină trebuie scăzute. În cazul în care creşterea aşteptată a ASC este de aproximativ 2 ori sau mai mare, tratamentul trebuie iniţiat cu doza zilnică unică de 5 mg rosuvastatină. Doza zilnică maximă de rosuvastatină trebuie ajustată astfel încât concentraţiile plasmatice de rosuvastatină aşteptate să nu depăşească pe cele care apar după administrarea de rosuvastatină 40 mg pe zi, în monoterapie; de exemplu, la administrarea concomitentă cu gemfibrozil, trebuie administrată o doză zilnică de 20 mg rosuvastatină (creştere de 1,9 ori a ASC) şi de 10 mg rosuvastatină, în cazul administrării concomitente cu asocierea atazanavir\/ritonavir (creştere de 3,1 ori a ASC).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfectul rosuvastatinei asupra unor medicamente administrare concomitent\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAntagonişti de vitamină K\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei, iniţierea tratamentului sau creşterea dozei de Roswera la pacienţi trataţi concomitent cu antagonişti de vitamină K (de exemplu warfarină sau alt anticoagulant cumarinic) pot duce la creşterea International Normalised Ratio (INR). Întreruperea tratamentului sau scăderea dozelor de Roswera poate duce la scăderea INR-ului. În astfel de situaţii, se impune monitorizarea valorilor INR.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eContraceptive orale\/tratament de substituţie hormonală (HRT-hormone replacement therapy)\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdministrarea concomitentă de rosuvastatină şi un contraceptiv oral a determinat creşterea ASC pentru etinilestradiol şi norgestrel cu 26% şi, respectiv, 34%. Această creştere a concentraţiilor plasmatice trebuie avută în vedere când se aleg dozele de contraceptive orale. Nu sunt disponibile date de farmacocinetică pentru subiecţii care utilizează concomitent rosuvastatină şi HRT şi, de aceea, un efect similar nu poate fi exclus. Cu toate acestea, în studiile clinice, asocierea a fost frecvent utilizată la femei şi a fost bine tolerată.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAlte produse medicamentoase\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePe baza datelor obţinute din studiile de interacţiune specifică, nu sunt de aşteptat interacţiuni clinic semnificative în cazul administrării concomitente de digoxină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAu fost efectuate studii de interacţiune medicamentoasă numai la adulţi. Nivelul interacţiunilor medicamentoase la copii şi adolescenţi nu este cunoscut.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFertilitatea, sarcina şi alăptarea\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera este contraindicat în sarcină şi alăptare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSarcina\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFemeile cu potenţial fertil trebuie să utilizeze metode contraceptive corespunzătoare. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDeoarece colesterolul şi alţi produşi ai biosintezei colesterolului sunt esenţiali pentru dezvoltarea fătului, riscul potenţial al inhibării HMG-CoA reductazei depăşeşte avantajul tratamentului în timpul sarcinii. Studiile efectuate la animale aduc informaţii limitate despre toxicitatea asupra funcţiei de reproducere. Dacă o pacientă rămâne însărcinată în timpul utilizării acestui produs, tratamentului trebuie întrerupt imediat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAlăptarea\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina se excretă în lapte, la şobolan. Nu există date privind excreţia în lapte, la om.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte asupra capacităţii de a conduce vehicule şi de a folosi utilaje\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu s-au efectuat studii care să determine efectul administrării rosuvastatinei asupra capacităţii de a conduce vehicule sau de a folosi utilaje. Cu toate acestea, pe baza proprietăţilor sale farmacodinamice, este puţin probabil ca rosuvastatina să afecteze aceste abilităţi. La conducerea vehiculelor sau la folosirea utilajelor, trebuie avut în vedere că în timpul tratamentului pot să apară ameţeli.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eReacţii adverse\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSumar al profilului de siguranţă\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eReacţiile adverse care apar la administrarea rosuvastatinei sunt, în general, uşoare şi tranzitorii. În studiile clinice controlate, mai puţin de 4% dintre pacienţii trataţi cu rosuvastatină au fost excluşi din cauza reacţiilor adverse.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLista tabelară a reacţiilor adverse\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePe baza datelor din studiile clinice şi experienţa vastă după punerea pe piaţă, următorul tabel prezintă profilul reacţiilor adverse pentru rosuvastatină. Reacţiile adverse enumerate mai jos sunt clasificate în funcţie de frecvenţă şi sisteme de organe (SO). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Foarte frecvente (\u0026gt;1\/10) \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Frecvente (\u0026gt;1\/100 la \u0026lt;1\/10) \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Mai puţin frecvente (\u0026gt;1\/1000 la \u0026lt;1\/100) \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Rare (\u0026gt;1\/10000 la \u0026lt;1\/1000)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Foarte rare (\u0026lt;1\/10000),\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Cu frecvenţă necunoscută (nu poate fi estimată din datele disponibile)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eReacţiile adverse pe baza datelor din studiile clinice\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e -Tulburări hematologice şi limfatice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e -Trombocitopenie  \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări ale sistemului imunitar\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Reacţii de hipersenbilitate, inclusiv angioedem\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări endocrine\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Diabet zaharat\u003csup style=\"position: relative; font-size: 9px; line-height: 0; vertical-align: baseline; top: -0.5em;\"\u003e1\u003c\/sup\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări psihice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Depresie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări ale sistemului nervos\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Cefalee Ameţeli\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Polineuropatie Pierderea memoriei\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Neuropatie periferică Tulburări ale somnului  (inclusiv insomnie şi coşmaruri)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări respiratorii, toracice şi mediastinale\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tuse Dispnee\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări gastrointestinale\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Constipaţie,Greaţă,Durere abdominală\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Pancreatită,Diaree\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări hepatobiliare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Creşterea concentraţiilor transaminazelor hepatice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Icter Hepatită\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Afecţiuni cutanate şi ale ţesutului subcutanat\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Prurit Erupţie cutanată tranzitorie Urticarie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- StevensJohnson syndrome\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări musculoscheletice şi ale ţesutului conjunctiv\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Mialgie Miopatie (inclusiv miozită) Rabdomioliză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Artralgie Miopatie necrozantă mediată imunitar\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări tendinoase, uneori complicate prin ruptură de tendon\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări renale şi ale căilor urinare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Hematurie \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări ale aparatului genital şi sânului\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Ginecomastie \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări generale şi la nivelul locului de administrare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Astenie   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Edeme\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCreşterea creatinkinazei de peste 10 x ULN şi simptomele musculare după efort fizic sau creşterea activităţii fizice au fost observate mai frecvent într-un studiu clinic de 52 săptămâni, în care s-au facut comparaţii între copii şi adulţi (vezi pct. 4.4). Din alt punct d evedere, profilul siguranţei rosuvastatinei a fost similar la copii şi adolescenţi, comparativ cu adulţii. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRaportarea reacţiilor adverse suspectate \u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRaportarea reacţiilor adverse suspectate după autorizarea medicamentului este importantă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSupradozaj\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu există tratament specific în caz de supradozaj. În caz de supradozaj, pacientul trebuie tratat simptomatic şi trebuie instituite măsurile de susţinere adecvate. Se recomandă monitorizarea funcţiei hepatice şi a concentraţiilor plasmatice de CK. Este puţin probabil ca hemodializa să aducă vreun beneficiu.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePROPRIETĂŢI FARMACOLOGICE\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eProprietăţi farmacodinamice\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eGrupa farmacoterapeutică: hipocolesterolemiante şi hipotrigliceridemiante; inhibitori ai HMG-CoA reductazei, codul ATC: C10AA07.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eMecanism de acţiune\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este un inhibitor selectiv şi competitiv al HMG-CoA reductazei, enzima cheie în procesul de transformare a 3-hidroxil-3-metilglutaril coenzima A la mevalonat, un precursor al colesterolului. Locul principal de acţiune al rosuvastatinei este ficatul, organul ţintă pentru scăderea olesterolului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina creşte numărul receptorilor LDL de pe suprafaţa celulelor hepatice, crescând captarea şi catabolismul LDL şi inhibă sinteza hepatică de VLDL, reducând în acest mod numărul total al particulelor de VLDL şi LDL\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte farmacodinamice\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina scade concentraţiilor crescute de LDL-colesterol, colesterol total şi trigliceride şi creşte HDL-colesterolul. De asemenea, rosuvastatina scade Apo-B, non HDL-C, VLDL-C, VLDL-TG, rapoartele LDL-C\/HDL-C, C total\/HDL-C, non HDL-C\/HDL-C, Apo-B\/ApoA-I.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfectul terapeutic se obţine într-o săptămână de la începerea tratamentului şi 90% din răspunsul maxim este atins după 2 săptămâni. Răspunsul maxim este atins de obicei după 4 săptămâni şi se menţine ulterior.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEficacitate şi siguranţă clinică\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este eficace la adulţii cu hipercolesterolemie, cu şi fără hipertrigliceridemie, indiferent de rasă, sex sau vârstă şi la anumite populaţii cum sunt diabeticii, sau pacienţii cu hipercolesterolemie familială.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrin analiza datelor cumulate din studiile de fază III, rosuvastatina s-a demonstrat a fi eficace la majoritatea pacienţilor cu hipercolesterolemie de tip IIa şi IIb (valoarea iniţială medie a LDL-C de aproximativ 4,8 mmol\/l) atunci când tratamentul a urmărit atingerea valorilor ţintă recomandate de către Societatea Europeană de Ateroscleroză (EAS; 1998); aproximativ 80% din pacienţii trataţi cu 10 mg au atins nivelele ţintă recomandate de EAS pentru LDL-C (\u0026lt;3 mmol\/l).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu mare care a inclus 435 pacienţi cu hipercolesterolemie familială - forma heterozigotă au fost trataţi cu rosuvastatina în doze între 20 mg şi 80 mg cu proiect de tatonare a dozelor. Toate dozele s-au demonstrat a avea efecte favorabile asupra parametrilor lipidici şi asupra valorilor ţintă terapeutice. După creşterea treptată până la o doză zilnică de 40 mg (la 12 săptămâni de tratament), concentraţia LDL-C s-a redus cu 53%. 33% din pacienţi au atins valorile recomandate pentru LDL-C de către EAS (\u0026lt;3 mmol\/l). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu deschis, cu proiect de tatonare a dozelor, 42 pacienţi cu hipercolesterolemie familială - forma homozigotă au fost evaluaţi privind răspunsul lor la tratamentul cu doze de 20-40 mg rosuvastatina. În toată populaţia, scăderea medie a valorilor LDL-C a fost de 22%.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiile clinice cu un număr limitat de pacienţi, rosuvastatina a demonstrat o eficacitate suplimentară în ceea ce priveşte scăderea concentraţiei plasmatice a trigliceridelor atunci când a fost administrată în asociere cu fenofibrat şi în ceea ce priveşte creşterea concentraţiei plasmatice a HDLC atunci când a fost administrat în asociere cu niacina.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu clinic multi-centric, dublu-orb, placebo-controlat (METEOR) la 984 pacienţi cu vârsta cuprinsă între 45 şi 70 ani, cu risc scăzut de boală coronariană (definis ca risc Framingham \u0026lt;10% pe o perioadă de 10 ani), cu valori medii ale LDL-colesterolului de 4,0 mmol\/l (154.5 mg\/dl), dar cu ateroscleroză subclinică (detectată prin testul CIMT - Carotid Intima Media Thickness) au fost repartizaţi randomizat la tratament cu rosuvastatină 40 mg o dată pe zi sau placebo, timp de 2 ani. Rosuvastatina a încetinit semnificativ rata de evoluţie a grosimii intimei arterei carotidiene (CIMT) comparativ cu placebo cu -0,0145 mm\/an [IÎ 95% -0.0196, -0.0093; p\u0026lt;0,0001]. Modificarea faţă de valorile bazale a fost de -0,0014 mm\/an (-0.12%\/an (fără semnificaţie statistică)) pentru rosuvastatină, comparativ cu evoluţia de +0,0131 mm\/an (1,12%\/an (p\u0026lt;0,0001)) pentru cei din grupul placebo. Nu a fost încă demonstrată relaţia directă între scăderea CIMT şi reducerea riscului evenimentelor cardiovasculare. Grupele de populaţie studiate în METEOR prezintă risc scăzut pentru boală coronariană şi nu reprezintă populaţia ţintă pentru doza de rosuvastatină de 40 mg. Această doză trebuie prescrisă numai la pacienţii cu hipercolesterolemie severă şi risc cardiovascular înalt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePentru justificarea utilizării statinelor în prevenţia primară, a fost efectuat un studiu de evaluare intervenţională cu rosuvastatină (JUPITER), asupra efectelor rosuvastatinei asupra incidenţei evenimentelor majore cardiovasculare aterosclerotice la 17802 bărbaţi (\u0026gt;50 ani) şi femei (\u0026gt;60 ani). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eParticipanţii la studiu au fost repartizaţi randomizat la tratament cu placebo (n=8901) sau rosuvastatină 20 mg o dată pe zi (n=8901) şi au fost urmăriţi, în medie, timp de 2 ani. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eConcentraţia de LDL-colesterol a fost redusă cu 45% (p\u0026lt;0,001) în grupul tratat cu rosuvastatină, comparativ cu grupul tratat cu placebo. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-o analiză post-hoc a unor sub-grupe de pacienţi cu risc crescut cu scor de risc Framingham de bază de \u0026gt;20% (1558 subiecţi), s-a observat o reducere semnificativă a obiectivului combinat de mortalitate cardiovasculară, accident vascular cerebral şi infarct de miocard (p=0,028) la tratamentul cu rosuvastatină versus placebo. Reducerea absolută a ratei riscului de eveniment per 1000 pacient-ani a fost de 8,8. În cadrul acestui grup de risc înalt, mortalitatea totală a rămas nemodificată (p=0,193). Într-o analiză post-hoc a unor sub-grupe de pacienţi cu risc crescut (9302 subiecţi) cu un scor de risc de bază de \u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e\u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e 5% (extrapolat pentru a include subiecţi cu vârsta de peste 65 ani), s-a observat o reducere semnificativă a obiectivului combinat final de mortalitate cardiovasculară, accident vascular cerebral şi infarct de miocard (p=0,0003) la grupul tratat cu rosuvastatină, faţă de cel tratat cu placebo. Reducerea absolută a ratei riscului de eveniment per 1000 pacient-ani a fost de 5,1. În cadrul acestui grup de risc înalt, mortalitatea totală a rămas nemodificată (p=0,076). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiul JUPITER, 6,6% dintre pacienţii trataţi cu rosuvastatină şi 6,2% dintre subiecţii trataţi cu placebo au întrerupt studiul din cauza unui eveniment advers. Cele mai frecvente reacţii adverse care au determinat întreruperea tratamentului au fost: mialgie (0,3% la rosuvastatină, 0,2% la placebo), durere abdominală (0,03% la rosuvastatină, 0,02% la placebo) şi erupţie cutanată tranzitorie (0,02% la rosuvastatină, 0,03% la placebo). Cele mai frecvente reacţii adverse cu proporţie mai mare sau egală cu grupul placebo au fost: infecţie urinară (8,7% la rosuvastatină, 8,6% la placebo), nazofaringită (7,6% la rosuvastatină, 7,2% la placebo), durere dorsală (7,6% la rosuvastatină, 6,9% la placebo) şi mialgie (7,6% la rosuvastatină, 6,6% la placebo).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu dublu-orb, randomizat, multi-centric, placebo-controlat, de 12 săptămâni (n=176,97 de sex masculin şi 79 de sex feminin) urmat de o fază deschisa de încă 40 săptămâni (n=173,96 de sex masculin şi 77 de sex feminin), au participat pacienţi cu vârsta de 10 până la 17 ani (în stadiu Tanner II-V, iar fetele la cel puţin 1 an după menarhă) cu hipercolesterolemie familială heterozigotă, care au primit rosuvastatină 5, 10 sau 20 mg pe zi sau placebo, timp de 12 săptămâni, după care toţi au primit rosuvastatină o dată pe zi, timp de 40 săptămâni. La intrarea în studiu, aproximativ 30% dintre pacienţi aveau vârsta între 10\u0026gt;13 ani şi aproximativ 17%, 18%, 40%, şi 25% au fost în stadii Tanner II, III, IV, şi V.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eConcentraţia LDL-colesterolului a fost redusă cu 38,3%, 44,6% şi 50,0% în urma tratamentului cu rosuvastatină în doză de 5, 10 şi, respectiv, 20 mg, comparativ cu 0,7% pentru cei din grupul placebo.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa sfârşitul celor 40 săptămâni de fază deschisă, cu creşterea dozei de până la maxim 20 mg o dată pe zi, 70 din cei 173 pacienţi (40,5%) au atins nivelul ţintă al concentraţiei LDL-colesterolului de sub 2,8 mmol\/l.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDupă cele 52 săptămâni de tratament ale studiului, nu au fost observate efecte asupra creşterii, greutăţii corporale, indexului masei corporale sau a maturizării sexuale (vezi pct. 4.4). Datele din studii clinice la copii şi adolescenţi sunt limitate, iar efectele pe termen lung ale rosuvastatinei (\u0026gt;1 an) asupra pubertăţii sunt necunoscute. Acest studiu (n=176) nu a fost conceput pentru comparaţii ale reacţiilor adverse rare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eProprietăţi farmacocinetice\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAbsorbţie\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eConcentraţiile plasmatice maxime de rosuvastatină se ating după 5 ore de la administrarea orală. Biodisponibilitatea absolută este de aproximativ 20%.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDistribuţie\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este captată extensiv de ficat, care este principalul loc de sinteză a colesterolului şi al clearance-ului LDL-C. Volumul aparent de distribuţie al rosuvastatinei este de aproximativ 134 l. Aproximativ 90% din rosuvastatină se leagă de proteinele plasmatice, în principal de albumină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eMetabolizare\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este metabolizată limitat (de aproximativ 10%). Studiile in vitro asupra metabolismului, în care s-au folosit hepatocite umane au arătat că rosuvastatina este un substrat slab pentru metabolizarea dependentă de citocromul P450. Principala izoenzimă implicată a fost CYP2C9 iar izoenzimă 2C19, 3A4 şi 2D6 au fost implicate într-o măsură mai mică. Principalii metaboliţi identificaţi sunt N-desmetil- şi lacton-metaboliţii. Metabolitul N-desmetil este cu aproximativ 50% mai puţin activ decât rosuvastatina, în timp ce metabolitul lactonă este considerat inactiv clinic.Rosuvastatina este responsabilă de inhibarea activităţii a mai mult de 90% din HMG-CoA reductaza circulantă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEliminare\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAproximativ 90% din doza de rosuvastatină se excretă nemodificată în materiile fecale (constând în substanţă activă absorbită şi neabsorbită), iar restul este excretată prin urină. Aproximativ 5% este excretată nemodificat prin urină. Timpul de înjumătăţire plasmatică prin eliminare este de aproximativ 20 ore. Timpul de înjumătăţire plasmatică prin eliminare nu creşte la administrarea unor doze mai mari. Media geometrică a clearance-ului plasmatic este de aproximativ 50 litri\/oră (coeficient de variaţie 21,7%). Ca şi în cazul altor inhibitori de HMG-CoA reductază, captarea hepatică a rosuvastatinei implică transportorul membranar OATP-C. Acest sistem de transport este important pentru eliminarea hepatică a rosuvastatinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLiniaritate\/nonliniaritate\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eExpunerea sistemică la rosuvastatină creşte proporţional cu doza administrată. Administrarea mai multor doze zilnice nu este urmată de modificări ale parametrilor farmacocinetici.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eGrupe speciale de populaţie\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eVârstă şi sex\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu s-a constatat nici o modificare semnificativă clinic, legată de vârstă sau de sex, în ceea ce priveşte farmacocinetica rosuvastatinei la adulţi. Farmacocinetica rosuvastatinei la copii şi adolescenţi cu hipercolesterolemie familială heterozigotă a fost similară celei a voluntarilor tineri.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRasă\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eStudii de farmacocinetică au aratat o creştere de aproximativ 2 ori a valorilor medii ale ASC şi Cmax la pacienţii asiatici (Japonia, China, Filipine, Vietnam şi Coreea) comparativ cu pacienţii de rasa albă; populaţiile asiatice-indiene prezintă o creştere de aproximativ 1,3 ori a valorilor medii ale ASC şi Cmax. O analiză populaţională de farmacocinetică la pacienţii de rasă albă şi neagră nu a arătat diferenţe clinic relevante ale parametrilor farmacocinetici.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInsuficienţă renală\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu efectuat la pacienţi în diferite grade ale insuficienţei renale, insuficienţa renală uşoară până la moderată nu influenţează concentraţia plasmatică a rosuvastatinei sau a metabolitului său Ndesmetil. Pacienţii cu insuficienţă renală severă (clearance-ul la creatinină \u0026lt; 30 ml\/min) au prezentat o concentraţie plasmatică de rosuvastatină de 3 ori mai mare şi o concentraţie plasmatică a metabolitului N-desmetil de 9 ori mai mare, comparativ cu voluntarii sănătoşi. Concentraţiile plasmatice ale rosuvastatinei, la starea de echilibru, la pacienţii care efectuează hemodializă au fost cu aproximativ 50% mai mari comparativ cu voluntarii sănătoşi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInsuficienţă hepatică\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu efectuat la pacienţi cu diferite grade de afectare hepatică, nu s-a evidenţiat creşterea expunerii la rosuvastatină la pacienţii cu un scor Child-Pugh de 7 sau mai mic. Cu toate acestea, 2 pacienţi cu scoruri Child-Pugh de 8 şi 9 au prezentat o creştere a expunerii sistemice la rosuvastatină de cel puţin de 2 ori mai mare comparativ cu pacienţii care prezentau scoruri Child-Pugh mai mici. Nu au fost studiaţi pacienţi cu scoruri Child-Pugh mai mari de 9.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eParametrii farmacologici la copii şi adolescenţi cu hipercolesterolemie familială heterozigotă cu vârsta între 10 şi 17 ani nu au avut caracteristici deosebite. Un stdiu farmacocinetic de mici dimensiuni cu rosuvastatină (administrată sub formă de comprimate) la 18 copii a demonstrat că nivelul concentraţiei plasmatice la copii pare similar adulţilor. În plus, rezultatele arată că nu se aşteaptă modificări ale proporţionalităţii dozei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDate preclinice de siguranţă\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDatele preclinice din studiile convenţionale de siguranţă farmacologică,de toxicitate după doze repetate, de genotoxicitate şi potenţial carcinogen nu au arătat nici un risc deosebit pentru om.  Nu au fost evaluate testele specifice asupra hERG. Reacţiile adverse care nu au apărut în studiile clinice, însă au fost prezente la animale la administrarea unor doze similare celor recomandate au fost următoarele: în studiile de toxicitate la doze repetate, s-au produs modificări histopatologice hepatice probabil datorate acţiunii farmacologice a rosuvastatinei, la şoarece, şobolan şi, în mai mică măsură, la nivelul veziculei biliare la câini, dar nu şi la maimuţe. În plus, la maimuţe şi câini, la doze crescute, a fost observată toxicitate testiculară. Într-un studiu efectuat la şobolan, pre- şi postnatal, toxicitatea asupra funcţiei de reproducere a fost evidentă, ţinând cont de dimensiunile, greutatea feţilor şi supravieţuirea puilor reduse. Aceste efecte au fost observate la doze toxice pentru mame la o expunere sistemică de câteva ori mai mare decât nivelul terapeutic de expunere sistemică. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePROPRIETĂŢI FARMACEUTICE\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLista excipienţilor\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNucleu\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLactoză anhidră\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCeluloză microcristalină\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCrospovidonă\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eStearat de magneziu\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDioxid de siliciu coloidal anhidru.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFilm\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLactoză monohidrat\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDioxid de titan (E171)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eMacrogol 6000\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopolimer butyl-metacrilat\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eIncompatibilităţi\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu este cazul.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePerioada de valabilitate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e3 ani.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrecauţii speciale pentru păstrare\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAcest medicament nu necesită precauţii speciale de păstrare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eA se păstra în ambalajul original, pentru a fi protejat de lumină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNatura şi conţinutul ambalajului\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eBlistere perforate din OPA-Al-PVC-Al): cutie cu 10, 14, 20, 28, 30, 56, 60, 84, 90, 98 şi 100 comprimate filmate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEste posibil ca nu toate mărimile de ambalaj să fie comercializate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDEŢINĂTORUL AUTORIZAŢIEI DE PUNERE PE PIAŢĂ\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"KRKA d.d., Novo mesto","offers":[{"title":"Default Title","offer_id":43907941990540,"sku":"40350","price":72.54,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/40350.jpg?v=1732807305"},{"product_id":"roswera-20mg-compfilm","title":"Roswera 20mg comp.film.","description":"\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 13.91px;\"\u003eRoswera 5 mg comprimate filmate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 10 mg comprimate filmate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 15 mg comprimate filmate\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 20 mg comprimate filmate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 30 mg comprimate filmate\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 40 mg comprimate filmate\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 13.91px;\"\u003eCOMPOZIŢIA CALITATIVĂ ŞI CANTITATIVĂ\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine rosuvastatină 5 mg (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 10 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 15 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 20 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 30 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 40 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 13.91px;\"\u003eExcipient(ţi) cu efect cunoscut: \u003c\/span\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 5 mg conţine lactoză anhidră 41,9 mg.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 10 mg conţine lactoză anhidră 41,9 mg.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 15 mg conţine lactoză anhidră 62,9 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 20 mg conţine lactoză anhidră 83,8 mg.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 30 mg conţine lactoză anhidră 125,7 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 40 mg conţine lactoză anhidră 167,6 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFORMA FARMACEUTICĂ\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eComprimat filmat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e5 mg: comprimate filmate de culoare albă, rotunde (diametrul de 7 mm), uşor biconvexe, cu margini teşite, marcate cu numărul 5 pe una dintre feţe.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e10 mg: comprimate filmate de culoare albă, rotunde (diametrul de 7,5 mm), uşor biconvexe, cu margini teşite, marcate cu numărul 10 pe una dintre feţe.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e15 mg: comprimate filmate de culoare albă, rotunde (diametrul de 9 mm), uşor biconvexe, cu margini teşite, marcate cu numărul 15 pe una dintre feţe.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e20 mg: comprimate filmate de culoare albă, rotunde (diametrul de 10 mm), cu margini teşite.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e30 mg: comprimate filmate de culoare albă, biconvexe, alungite, marcate pe ambele feţe (dimensiuni:15 mm x 8 mm). Linia mediană are numai rolul de a uşura ruperea comprimatului pentru a fi înghiţit uşor şi nu de divizare în doze egale.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e40 mg: comprimate filmate de culoare albă, biconvexe, alungite (dimensiuni: 16 mm x 8,5 mm).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDATE CLINICE\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eIndicaţii terapeutice\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eTratamentul hipercolesterolemiei\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdulţi, adolescenţi şi copii cu vârsta de 10 ani sau peste, cu hipercolesterolemie primară (tip IIa, inclusiv hipercolesterolemia familială - forma heterozigotă) sau dislipidemie mixtă (tip IIb), ca adjuvant al dietei la pacienţii care nu răspund adecvat numai la dietă şi la alte metode de tratament non-farmacologic (cum sunt exerciţiile fizice, scăderea în greutate).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eHipercolesterolemie familială - forma homozigotă, ca tratament adjuvant al dietei şi al altor metode de scădere a lipidemiei (de exemplu afereza LDL) sau în cazurile în care aceste tratamente nu sunt adecvate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrevenţia evenimentelor cardiovasculare Prevenţia evenimentelor cardiovasculare majore la pacienţii cu risc major pentru un prim eveniment cardiovascular (vezi pct. 5.1), ca tratament adjuvant în controlul altor factori de risc. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e \u003cstrong\u003eDoze şi mod de administrare\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e Doze\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎnainte de începerea tratamentului, pacientul trebuie să urmeze un regim hipocolesterolemiant standard care trebuie continuat şi în timpul tratamentului. Doza trebuie adaptată pentru fiecare pacient, în funcţie de obiectivul tratamentului şi de răspunsul pacientului, respectând recomandările din ghidurile actuale de tratament.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera poate fi administrat în orice moment al zilei, cu sau fără alimente.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEste posibil să nu fie disponibile toate concentraţiile de Roswera.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eTratamentul hipercolesterolemiei\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDoza iniţială recomandată este de 5 sau 10 mg administrată oral, o dată pe zi, atât la pacienţii care iau pentru prima dată statine, cât şi la pacienţii care trec de pe un tratament cu alt inhibitor de HMG CoA reductază. Alegerea dozei iniţiale se face în funcţie de nivelul individual al colesterolemiei şi aprecierea riscului cardiovascular, precum şi de riscul potenţial al reacţiilor adverse. Dacă este necesar, doza poate fi crescută după 4 săptămâni la 20 mg. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDatorită creşterii incidenţei reacţiilor adverse la utilizarea dozei de 40 mg, comparativ cu dozele mai scăzute, creşterea dozei de la 20 mg la 30 mg sau până la doza maximă de 40 mg trebuie luată în considerare numai la pacienţii cu hipercolesterolemie severă şi risc cardiovascular crescut (în particular la pacienţii cu hipercolesterolemie familială), care nu ating valoarea stabilită ca obiectiv al tratamentului cu doza de 20 mg, aceştia urmând a fi monitorizaţi prin teste periodice. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa iniţierea tratamentului cu dozele de 30 mg saur 40 mg este necesară monitorizare de specialitate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrevenţia evenimentelor cardiovasculare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiul clinic al reducerii riscului de evenimente cardiovasculare, doza utilizată a fost de 20 mg pe zi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţi vârstnici\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii cu vârsta \u0026gt;70 ani se recomandă o doză iniţială de 5 mg. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţi cu insuficienţă renală\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu este necesară ajustarea dozelor la pacienţi cu insuficienţă renală uşoară sau moderată. Doza iniţială recomandată la pacienţi cu insuficienţă renala moderată (clearance-ul creatininei \u0026lt;60 ml\/min) este de 5 mg. Utilizarea dozelor de 30 mg şi 40 mg este contraindicată la pacienţii cu insuficienţă renala moderată. Utilizarea Roswera la pacienţi cu insuficienţă renală severă este contraindicată la orice doză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţi cu insuficienţă hepatică\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePentru pacienţii cu scoruri Child-Pugh de 7 sau mai mici nu s-a constatat creşterea expunerii sistemice la rosuvastatină. Totuşi, creşterea expunerii sistemice a fost observată la pacienţi cu scoruri ChildPugh de 8 şi 9. La aceşti pacienţi trebuie avută în vedere evaluarea funcţiei renale. Nu există experienţă clinică la pacienţi cu scoruri Child-Pugh peste 9. Roswera este contraindicat la pacienţii cu boală hepatică activă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eUtilizarea la copii trebuie recomandată de către medicii de specialitate. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi cu vârsta de 10 până la 17 ani (băieţi: stadiul Tanner II sau peste, iar fetele la cel puţin 1 an după menarhă)\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa copii şi adolescenţi cu hipercolesterolemie familială heterozigotă, doza uzuală iniţială este de 5 mg pe zi. Intervalul de dozare uzual este 5\u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e\u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e20 mg oral, o dată pe zi. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCreşterea dozelor trebuie efectuată în funcţie de răspunsul la tratament şi tolerabilitatea individuală a copiilor, conform recomandărilor ghidurilor de tratament pediatric. Copiii și adolescenții trebuie să efectueze tratament dietetic hipocolesterolemiant standard înainte de inițierea tratamentului cu rosuvastatină; regimul alimentar trebuie continuat pe toată durata tratamentului cu rosuvastatină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSiguranţa şi eficacitatea tratamentului cu doze mai mari de 20 mg nu au fost încă stabilite la aceste grupe de populaţie. Comprimatele de 30 şi 40 mg nu sunt recomandate la copii. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii cu vârsta sub 10 ani\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eExperienţa clinică este limitată la un număr mic de copii (cu vârste de 8 ani şi până la 10 ani) cu hipercolesterolemie familială - forma homozigotă. De aceea, Roswera nu este recomandat la copii cu vârsta sub 10 ani.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRasă\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa subiecţii asiatici a fost observată creşterea expunerii sistemice. La pacienţii de origine asiatică, se recomandă o doză iniţială de 5 mg. Dozele de 30 şi 40 mg sunt contraindicate la aceşti pacienţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePolimorfism genetic\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSe ştie că prezenţa anumitor tipuri de polimorfism genetic poate duce la creşterea concentraţiilor plasmatice ale rosuvastatinei (vezi pct. 5.2). La pacienţii cu astfel de tipuri cunoscute de polimorfism, se recomandă administrarea unor doze mai mici de rosuvastatină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDoze la pacienţi cu factori de risc de miopatie\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţi cu factori de risc de miopatie doza inţială recomandată este de 5 mg. Dozele de 30 şi 40 mg sunt contraindicate la unii dintre aceşti pacienţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eTratament concomitent\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina reprezintă substrat al unor proteine de transport (de exemplu, OATP1B1 şi BCRP). Riscul de miopatie (incluzând rabdomioliză) este crescut în cazul administrării concomitente a rosuvastatinei cu anumite medicamente ce pot creşte concentraţiile plasmatice ale rosuvastatinei, din cauza interacţiunilor cu aceste proteine transportoare (de exemplu, ciclosporina şi anumiţi inhibitopri ai proteazelor, inclusiv combinaţi de ritonavir cu atazanavir, lopinavir şi\/sau tipranavir. Atunci când este posibil, se recomandă luarea în consideraţie a unui tratament alternativ şi, dacă este necesar, terapia cu rosuvastatină poate fi întreruptă. În situaţiile în care administrarea concomitentă a acestor medicamnte şi rosuvastatină nu poate fi evitată, trebuie evaluat raportul beneficiu\/risc al tratamentului concomitent şi ajustarea cu atenţie a dozelor de rosuvastatin.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eContraindicaţii\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera este contraindicată:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e - la pacienţii cu hipersensibilitate la substanţa activă sau la oricare dintre excipienţii enumeraţi\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi cu boală hepatică activă, incluzând creşterea inexplicabilă, persistentă, a transaminazelor plasmatice şi orice creştere a transaminazelor plasmatice care depăşeşte de 3 ori limita superioară a normalului (ULN)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi cu insuficienţă renală severă (clearance al creatininei \u0026lt;30 ml\/min).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi cu miopatie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi care primesc tratament concomitent cu ciclosporină\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- în timpul sarcinii şi alăptării şi la femei aflate în perioada fertilă care nu utilizează măsuri contraceptive corespunzătoare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDozele de 30 şi 40 mg sunt contraindicate la pacienţi cu factori de risc de miopatie\/rabdomioliză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAstfel de factori de risc sunt:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- insuficienţa renală moderată (clearance-ul creatininei \u0026lt;60 ml\/min)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- hipotiroidie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- antecedente personale sau familiale de afecţiuni ereditare musculare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- istoric de toxicitate musculară la un alt inhibitor al HMG-CoA reductază sau fibraţi\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- consum exagerat de alcool etilic\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- situaţii în care nivelele plasmatice ale medicamentului pot creşte\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- pacienţi cu origine asiatică - utilizare concomitentă de fibraţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e \u003cstrong\u003eAtenţionări şi precauţii speciale pentru utilizare\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte renale\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eProteinuria, evidenţiată prin teste de tip \"dipstick\" şi de cele mai multe ori de origine tubulară, a fost observată la pacienţii trataţi cu doze mai mari de rosuvastatină în particular 40 mg, şi în cele mai multe cazuri a fost tranzitorie sau intermitentă. Proteinuria nu s-a demonstrat a fi un factor predictiv al unei boli renale acute sau progresive. Incidenţa raportărilor de reacţii adverse severe renale la utilizarea dozei de 40 mg, în perioada de după punerea pe piaţă a medicamentului, este mai mare. În cazul pacienţilor trataţi cu doze de 30 mg sau 40 mg, la efectuarea controlului de rutină trebuie avută în vedere şi evaluarea funcţiei renale.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte la nivelul musculaturii scheletice\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii trataţi cu rosuvastatină au fost raportate efecte asupra muşchilor scheletici, ca mialgie, miopatie şi, rareori, rabdomioliză la toate dozele şi în special la doze de peste 20 mg. În foarte rare cazuri, a fost raportată rabdomioliza la asocierea de ezetimib şi inhibitori ai HMG-CoA reductazei. Interacţiunea farmacodinamică nu poate fi exclusă şi la utilizarea acestei asocieri, este necesară precauţie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei, incidenţa rabdomiolizei asociate cu utilizarea Rowsera este mai mare la utilizarea dozei de 40 mg, în perioada de după punerea pe piaţă a medicamentului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDeterminarea valorilor creatinkinazei\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCreatinkinaza (CK) nu trebuie măsurată după efectuarea unor exerciţii fizice intense sau în prezenţa unei cauze evidente care ar putea să ducă la creşterea valorilor CK şi care ar putea modifica interpretarea rezultatului. În cazul în care concentraţiile plasmatice iniţiale ale CK sunt crescute în mod semnificativ (\u0026gt;5 x ULN), trebuie efectuat un test de confirmare în următoarele 5-7 zile. Dacă repetarea testului confirmă o valoare iniţială de \u0026gt;5 x ULN, atunci tratamentul nu trebuie început.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎnainte de tratament\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSimilar altor inhibitori ai HMG-CoA reductazei, Roswera trebuie recomandat cu prudenţă la pacienţii care prezintă factori predispozanţi pentru miopatie\/rabdomioliză:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- insuficienţă renală\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- hipotiroidie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- antecedente personale sau heredocolaterale de afecţiuni musculare ereditare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- antecedente de toxicitate musculară la administrarea altor inhibitori ai HMG-CoA reductazei sau a fibraţilor\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- consum exagerat de alcool etilic\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- vârstă \u0026gt;70 ani - situaţii în care poate apare o creştere a concentraţiilor plasmatice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- utilizarea concomitentă a fibraţilor.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa asemenea pacienţi, riscul trebuie evaluat în funcţie de posibilele beneficii ale tratamentului şi este recomandată monitorizarea clinică. Dacă nivelele CK sunt semnificativ crescute faţă de valorile bazale (\u0026gt;5 x ULN) tratamentul nu trebuie iniţiat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn timpul tratamentului\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţilor trebuie să li se recomande să raporteze imediat durerile musculare inexplicabile, hipotonia musculară sau crampele, mai ales dacă acestea se asociază cu stare de rău general sau febră. La aceşti pacienţi trebuie măsurate concentraţiile plasmatice ale CK. Tratamentul trebuie întrerupt dacă: concentraţiile plasmatice ale CK sunt mult crescute (\u0026gt;5 x ULN) sau dacă simptomele musculare sunt severe şi determină un disconfort zilnic (chiar şi în cazul în care concentraţiile plasmatice ale CK sunt ≤5 ori limita superioară a normalului). Dacă simptomele se remit şi concentraţiile plasmatice ale CK revin la normal, atunci trebuie avută în vedere reluarea tratamentului cu Roswera sau cu un alt inhibitor de HMG-CoA reductază, în cea mai mică doză şi sub o monitorizare atentă. Monitorizarea de rutină a concentraţiilor plasmatice ale CK la pacienţii asimptomatici nu este justificată. Au fost raportate cazuri foarte rare de miopatie necrozantă prin mecanism imunitar (IMNM) în timpul sau după tratamentul cu statine, incusiv rosuvastatină. IMNM este caracterizat clinic prin astenie musculară proximală şi creşterea concentraţiilor plasmatice ale CK, care persistă, chiar dacă tratamentul cu statine este întrerupt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiile clinice, la numărul mic de pacienţi trataţi cu rosuvastatină şi un alt tratament concomitent, nu s-a înregistrat o incidenţă mai mare a efectelor asupra musculaturii scheletice. Cu toate acestea, la pacienţii trataţi cu alţi inhibitori ai HMG-CoA reductazei, concomitent cu fibraţi cum este gemfibrozilul, ciclosporină, acid nicotinic, antifungice azolice, inhibitori ai proteazelor şi antibiotice macrolidice s-a constatat o incidenţă crescută a miozitei şi miopatiei. Gemfibrozilul creşte riscul de miopatie atunci când este administrat concomitent cu unii inhibitori ai HMG-CoA reductazei. De aceea, asocierea Roswera şi gemfibrozil nu este recomandată. Beneficiul privind scăderea suplimentară a concentraţiilor plasmatice de lipide prin administrarea asociată de Roswera şi fibraţi sau niacină trebuie atent evaluat faţă de potenţialele riscuri ale acestei asocieri. Dozele de 30 mg şi 40 mg sunt contraindicate la utilizare concomitentă cu fibraţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera nu trebuie utilizat la nici un pacient care prezintă o afecţiune acută, severă, sugestivă pentru miopatie sau cu predispoziţie de a dezvolta insuficienţă renală secundară rabdomiolizei (de exemplu sepsis, hipotensiune arterială, intervenţie chirurgicală majoră, traumatisme, tulburări severe metabolice, endocrine şi electrolitice; crize convulsive necontrolate).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte hepatice\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei, Roswera trebuie utilizat cu prudenţă la pacienţii care consumă cantităţi excesive de alcool etilic şi\/sau au antecedente de boală hepatică.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSe recomandă efectuarea de teste funcţionale hepatice înainte de începerea tratamentului şi la 3 luni după începerea tratamentului. În cazul în care concentraţia plasmatică a transaminazelor este de 3 ori mai mare decât limita superioară a normalului, tratamentul cu Roswera trebuie întrerupt sau doza trebuie redusă. Incidenţa reacţiilor hepatice severe (în principal constând în creşterea transaminazelor hepatice) este mai mare în perioada de după punerea pe piaţă a medicamentului, pentru doza de 40 mg. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii cu hipercolesterolemie secundară determinate de hipotiroidism sau sindrom nefrotic, afecţiunea de bază trebuie tratată înaintea începerii tratamentului cu Roswera.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRasa Rezultatele studiilor de farmacocinetică arată o creştere a expunerii la pacienţii de rasă asiatică, comparativ cu cei de rasă albă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInhibitorii de proteaze\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii la care s-au administrat concomitent rosuvastatină şi diverşi inhibitori ai proteazelor în asociere cu ritonavir, a fost observată creşterea concentraţiilor plasmatice ale rosuvastatinei. La iniţierea şi creşterea dozelor de rosuvastatină la pacienţii cu HIV trataţi concomitent cu inhibitori ai proteazelor, trebuie luat în considerare atât beneficiul scăderii lipidemiei de către rosuvastatină, cât şi creşterea potenţială a concentraţiilor plasmatice ale rosuvastatinei. Utilizarea concomitentă a rosuvastatinei şi inhibitorilor proteazelor nu este recomandată, decât cu.Utilizarea concomitentă cu inhibitorii de proteaze se poate face numai cu scăderea dozelor de rosuvastatină. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePneumonie interstiţială\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa utilizarea unor statine, în special la utilizare îndelungată, au fost raportate cazuri excepţional de rare de pneumonie interstiţială (vezi pct. 4.8). Tabloul clinic poate include dispnee, tuse neproductivă şi deteriorarea stării generale (fatigabilitate, pierdere în greutate şi hipertermie). Dacă se suspectează că un pacient dezvoltă o pneumonie interstiţială, tratamentul cu statine trebuie întrerupt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDiabet zaharat\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eExistă dovezi care sugerează că statinele cresc glicemia şi, la unii pacienţi cu risc crescut de apariţie a diabetului zaharat, pot produce hiperglicemie cu valori care să necesite măsuri considerate de rutină la pacienţii cu diabet zaharat diagnosticat. Totuşi, riscul de apariţie a diabetului zaharat este depăşit de beneficiul reducerii riscului cardiovascular şi, prin urmare, nu există un motiv pentru întreruperea tratamentului cu statine. Pacienţii cu risc crescut (valori ale glicemiei în condiţii de repus alimentar între 5,6 şi 6,9 mmol\/l, IMC\u0026gt;30 kg\/m2, valori crescute ale trigliceridemiei, hipertensiune arterială) trebuie monitorizaţi clinic şi paraclinic în acord cu ghidurile naţionale. În studiul clinic JUPITER, frecvenţa globală raportată de apariţie a diabetului zaharat a fost de 2,8% la rosuvastatină şi de 2,3% la placebo, mai ales la pacienţii cu valori ale glicemiei între 5,6 şi 6,9 mmol\/l în condiţii de repaus alimentar.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEvaluarea înalţimii, greutăţii corporale, indexului masei corporale şi a caracteristicilor sexuale secundare conform scalei Tanner la pacienţii copii cu vârsta de 10 până la 17 ani în tratament cu rosuvastatină este limitată la perioada de 1 an. După un studiu de 52 săptămâni, nu au fost observate efecte asupra creşterii, greutăţii corporale, IMC sau maturizării sexuale. Datele clinice la copii şi adolescenţi sunt limitate, iar efectele rosuvastatinei pe perioade îndelungate (\u0026gt;1 an) asupra pubertăţii sunt necunoscute.  Într-un studiu clinic la copii şi adolescenţi în tratament cu rosuvastatină timp de 52 săptămâni, creşterile CK peste ULN x 10 şi simptomele musculare apărute după exerciţii fizice sau activitate fizică crescută, au apărut mai frecvent, comparativ cu studiile clinice la adulţi. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera comprimate filmate conţine lactoză. Pacienţii cu afecţiuni ereditare rare de intoleranţă la galactoză, deficit de lactază (Lapp) sau sindrom de malabsorbţie la glucoză-galactoză nu trebuie să utilizeze acest medicament.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInteracţiuni cu alte medicamente şi alte forme de interacţiune\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfectele altor medicamente asupra rosuvastatinei\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInhibitorii proteinelor de transport\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este substrat al anumitor proteine de transport, incuzând transportorul hepatic de captare OATP1B1 şi a transportorului hepatic de eflux BCRP. Administrarea concomitentă a rosuvastatinei împreună cu medicamente care inhibă activitatea proteinelor de transport poate duce la creşterea concentraţiilor plasmatice ale rosuvastatinei şi la creşterea riscului de miopatie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCiclosporină\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn timpul tratamentului concomitent cu rosuvastatină şi ciclosporină, valorile ariei de sub curba concentraţiei plasmatice în funcţie de timp (ASC) ale rosuvastatinei au fost în medie de 7 ori mai mari decât cele observate la voluntarii sănătoşi (vezi tabelul 1). Rosuvastatina este contraindicată la pacienţii la care se administrează concomitent ciclosporină.  Administrarea concomitentă nu a afectat concentraţiile plasmatice ale ciclosporinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInhibitorii proteazelor \u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCu toate că nu se cunoaşte exact mecanismul interacţiunii, utilizarea concomitentă a unui inhibitor de protează poate determina o creştere puternică a concentraţiilor plasmatice ale rosuvastatinei.  De exemplu, într-un studiu de farmacocinetică, administrarea concomitentă la voluntari tineri de rosuvastatină 10 mg şi o combinaţie de doi inhibitori ai proteazelor (atazanavir 300 mg şi ritonavir100 mg), a fost asociată cu o creştere de aproximativ trei ori, respectiv şapte ori, a ASC şi, respectiv, Cmax a rosuvastatinei la starea de echilibru. Utilizarea concomitentă de rosuvastatină şi unele combinaţii de inhibitori ai proteazelor poate fi luată în considerare numai după ajustarea atentă a dozelor de rosuvastatină, în funcţie de creşterea aşteptată a concentraţiilor plasmatice ale rosuvastatinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eGemfibrozil şi alte hipolipemiante\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eUtilizarea concomitentă de rosuvastatină şi gemfibrozil a determinat creşterea de 2 ori a Cmax şi ASC pentru rosuvastatină. Pe baza datelor obţinute din studiile de interacţiune specifică nu sunt de aşteptat interacţiuni clinic semnificative în cazul administrării concomitente de fenofibrat, totuşi poate apărea o interacţiune farmacodinamică. Gemfibrozilul, fenofibratul, alţi fibraţi şi doze hipolipemiante (≥ 1g\/zi) de niacină (acid nicotinic) cresc riscul de miopatie atunci când sunt administrate concomitent cu inhibitori ai HMG-CoA reductazei, probabil datorită faptului că aceştia pot produce miopatie şi în monoterapie. Dozele de 30 mg şi 40 mg sunt contraindicate la utilizarea concomitentă a fibraţilor. De asemenea, aceşti pacienţi trebuie să utilizeze doza iniţială de 5 mg. \u003cem\u003eEzetimib\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eUtilizarea concomitentă de rosuvastatină 10 mg şi ezetimib 10 mg a determinat o creştere de 1,2 ori a ASC pentru rosuvastatină la pacienţii cu hipercolesterolemie. Totuşi, nu poate fi exclusă o interacţiune farmacodinamică, privitor la reacţiile adverse, între Roswera şi ezetimib.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAntiacide\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdministrarea simultană de rosuvastatină şi o suspensie conţinând un antiacid cu hidroxid de aluminiu şi magneziu a determinat scăderea concentraţiei plasmatice a rosuvastatinei de aproximativ 50%. Acest efect a fost mai mic atunci când antiacidul a fost administrat la 2 ore după Rowsera. Nu a fost studiată importanţa clinică a acestei interacţiuni.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEritromicină\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdministrarea simultană de rosuvastatină şi eritromicină a dus la scăderea cu 20% a ASC şi scăderea cu 30% a Cmax a rosuvastatinei. Această interacţiune poate fi determinată de creşterea motilităţii intestinale de către eritromicină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEnzimele citocromului P450\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRezultatele din studiile in vitro şi in vivo arată că rosuvastatina nu este nici inhibitor şi nici inductor al izoenzimelor citocromului P450. În plus, rosuvastatina este un substrat slab pentru aceste enzime.  De aceea, nu sunt aşteptate interacţiuni medicamentoase depinzând de metabolizarea mediată de citocromul P450. Nu s-au observat interacţiuni clinic semnificative nici între rosuvastatină şi fluconazol (un inhibitor al CYP2C9 şi CYP3A4) sau rosuvastatină şi ketoconazol (un inhibitor al CYP2A6 şi CYP3A4).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInteracţiuni care necesită ajustarea dozei de rosuvastatină\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAtunci când este necesară administrarea concomitentă de rosuvastatină şi alte medicamente care determină creşterea cunoscută a concentraţiilor plasmatice ale rosuvastatinei, dozele de rosuvastatină trebuie scăzute. În cazul în care creşterea aşteptată a ASC este de aproximativ 2 ori sau mai mare, tratamentul trebuie iniţiat cu doza zilnică unică de 5 mg rosuvastatină. Doza zilnică maximă de rosuvastatină trebuie ajustată astfel încât concentraţiile plasmatice de rosuvastatină aşteptate să nu depăşească pe cele care apar după administrarea de rosuvastatină 40 mg pe zi, în monoterapie; de exemplu, la administrarea concomitentă cu gemfibrozil, trebuie administrată o doză zilnică de 20 mg rosuvastatină (creştere de 1,9 ori a ASC) şi de 10 mg rosuvastatină, în cazul administrării concomitente cu asocierea atazanavir\/ritonavir (creştere de 3,1 ori a ASC).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfectul rosuvastatinei asupra unor medicamente administrare concomitent\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAntagonişti de vitamină K\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei, iniţierea tratamentului sau creşterea dozei de Roswera la pacienţi trataţi concomitent cu antagonişti de vitamină K (de exemplu warfarină sau alt anticoagulant cumarinic) pot duce la creşterea International Normalised Ratio (INR). Întreruperea tratamentului sau scăderea dozelor de Roswera poate duce la scăderea INR-ului. În astfel de situaţii, se impune monitorizarea valorilor INR.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eContraceptive orale\/tratament de substituţie hormonală (HRT-hormone replacement therapy)\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdministrarea concomitentă de rosuvastatină şi un contraceptiv oral a determinat creşterea ASC pentru etinilestradiol şi norgestrel cu 26% şi, respectiv, 34%. Această creştere a concentraţiilor plasmatice trebuie avută în vedere când se aleg dozele de contraceptive orale. Nu sunt disponibile date de farmacocinetică pentru subiecţii care utilizează concomitent rosuvastatină şi HRT şi, de aceea, un efect similar nu poate fi exclus. Cu toate acestea, în studiile clinice, asocierea a fost frecvent utilizată la femei şi a fost bine tolerată.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAlte produse medicamentoase\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePe baza datelor obţinute din studiile de interacţiune specifică, nu sunt de aşteptat interacţiuni clinic semnificative în cazul administrării concomitente de digoxină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAu fost efectuate studii de interacţiune medicamentoasă numai la adulţi. Nivelul interacţiunilor medicamentoase la copii şi adolescenţi nu este cunoscut.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFertilitatea, sarcina şi alăptarea\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera este contraindicat în sarcină şi alăptare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSarcina\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFemeile cu potenţial fertil trebuie să utilizeze metode contraceptive corespunzătoare. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDeoarece colesterolul şi alţi produşi ai biosintezei colesterolului sunt esenţiali pentru dezvoltarea fătului, riscul potenţial al inhibării HMG-CoA reductazei depăşeşte avantajul tratamentului în timpul sarcinii. Studiile efectuate la animale aduc informaţii limitate despre toxicitatea asupra funcţiei de reproducere. Dacă o pacientă rămâne însărcinată în timpul utilizării acestui produs, tratamentului trebuie întrerupt imediat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAlăptarea\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina se excretă în lapte, la şobolan. Nu există date privind excreţia în lapte, la om.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte asupra capacităţii de a conduce vehicule şi de a folosi utilaje\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu s-au efectuat studii care să determine efectul administrării rosuvastatinei asupra capacităţii de a conduce vehicule sau de a folosi utilaje. Cu toate acestea, pe baza proprietăţilor sale farmacodinamice, este puţin probabil ca rosuvastatina să afecteze aceste abilităţi. La conducerea vehiculelor sau la folosirea utilajelor, trebuie avut în vedere că în timpul tratamentului pot să apară ameţeli.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eReacţii adverse\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSumar al profilului de siguranţă\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eReacţiile adverse care apar la administrarea rosuvastatinei sunt, în general, uşoare şi tranzitorii. În studiile clinice controlate, mai puţin de 4% dintre pacienţii trataţi cu rosuvastatină au fost excluşi din cauza reacţiilor adverse.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLista tabelară a reacţiilor adverse\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePe baza datelor din studiile clinice şi experienţa vastă după punerea pe piaţă, următorul tabel prezintă profilul reacţiilor adverse pentru rosuvastatină. Reacţiile adverse enumerate mai jos sunt clasificate în funcţie de frecvenţă şi sisteme de organe (SO). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Foarte frecvente (\u0026gt;1\/10) \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Frecvente (\u0026gt;1\/100 la \u0026lt;1\/10) \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Mai puţin frecvente (\u0026gt;1\/1000 la \u0026lt;1\/100) \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Rare (\u0026gt;1\/10000 la \u0026lt;1\/1000)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Foarte rare (\u0026lt;1\/10000),\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Cu frecvenţă necunoscută (nu poate fi estimată din datele disponibile)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eReacţiile adverse pe baza datelor din studiile clinice\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e -Tulburări hematologice şi limfatice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e -Trombocitopenie  \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări ale sistemului imunitar\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Reacţii de hipersenbilitate, inclusiv angioedem\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări endocrine\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Diabet zaharat\u003csup style=\"position: relative; font-size: 9px; line-height: 0; vertical-align: baseline; top: -0.5em;\"\u003e1\u003c\/sup\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări psihice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Depresie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări ale sistemului nervos\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Cefalee Ameţeli\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Polineuropatie Pierderea memoriei\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Neuropatie periferică Tulburări ale somnului  (inclusiv insomnie şi coşmaruri)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări respiratorii, toracice şi mediastinale\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tuse Dispnee\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări gastrointestinale\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Constipaţie,Greaţă,Durere abdominală\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Pancreatită,Diaree\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări hepatobiliare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Creşterea concentraţiilor transaminazelor hepatice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Icter Hepatită\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Afecţiuni cutanate şi ale ţesutului subcutanat\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Prurit Erupţie cutanată tranzitorie Urticarie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- StevensJohnson syndrome\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări musculoscheletice şi ale ţesutului conjunctiv\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Mialgie Miopatie (inclusiv miozită) Rabdomioliză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Artralgie Miopatie necrozantă mediată imunitar\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări tendinoase, uneori complicate prin ruptură de tendon\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări renale şi ale căilor urinare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Hematurie \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări ale aparatului genital şi sânului\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Ginecomastie \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări generale şi la nivelul locului de administrare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Astenie   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Edeme\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCreşterea creatinkinazei de peste 10 x ULN şi simptomele musculare după efort fizic sau creşterea activităţii fizice au fost observate mai frecvent într-un studiu clinic de 52 săptămâni, în care s-au facut comparaţii între copii şi adulţi (vezi pct. 4.4). Din alt punct d evedere, profilul siguranţei rosuvastatinei a fost similar la copii şi adolescenţi, comparativ cu adulţii. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRaportarea reacţiilor adverse suspectate \u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRaportarea reacţiilor adverse suspectate după autorizarea medicamentului este importantă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSupradozaj\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu există tratament specific în caz de supradozaj. În caz de supradozaj, pacientul trebuie tratat simptomatic şi trebuie instituite măsurile de susţinere adecvate. Se recomandă monitorizarea funcţiei hepatice şi a concentraţiilor plasmatice de CK. Este puţin probabil ca hemodializa să aducă vreun beneficiu.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePROPRIETĂŢI FARMACOLOGICE\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eProprietăţi farmacodinamice\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eGrupa farmacoterapeutică: hipocolesterolemiante şi hipotrigliceridemiante; inhibitori ai HMG-CoA reductazei, codul ATC: C10AA07.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eMecanism de acţiune\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este un inhibitor selectiv şi competitiv al HMG-CoA reductazei, enzima cheie în procesul de transformare a 3-hidroxil-3-metilglutaril coenzima A la mevalonat, un precursor al colesterolului. Locul principal de acţiune al rosuvastatinei este ficatul, organul ţintă pentru scăderea olesterolului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina creşte numărul receptorilor LDL de pe suprafaţa celulelor hepatice, crescând captarea şi catabolismul LDL şi inhibă sinteza hepatică de VLDL, reducând în acest mod numărul total al particulelor de VLDL şi LDL\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte farmacodinamice\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina scade concentraţiilor crescute de LDL-colesterol, colesterol total şi trigliceride şi creşte HDL-colesterolul. De asemenea, rosuvastatina scade Apo-B, non HDL-C, VLDL-C, VLDL-TG, rapoartele LDL-C\/HDL-C, C total\/HDL-C, non HDL-C\/HDL-C, Apo-B\/ApoA-I.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfectul terapeutic se obţine într-o săptămână de la începerea tratamentului şi 90% din răspunsul maxim este atins după 2 săptămâni. Răspunsul maxim este atins de obicei după 4 săptămâni şi se menţine ulterior.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEficacitate şi siguranţă clinică\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este eficace la adulţii cu hipercolesterolemie, cu şi fără hipertrigliceridemie, indiferent de rasă, sex sau vârstă şi la anumite populaţii cum sunt diabeticii, sau pacienţii cu hipercolesterolemie familială.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrin analiza datelor cumulate din studiile de fază III, rosuvastatina s-a demonstrat a fi eficace la majoritatea pacienţilor cu hipercolesterolemie de tip IIa şi IIb (valoarea iniţială medie a LDL-C de aproximativ 4,8 mmol\/l) atunci când tratamentul a urmărit atingerea valorilor ţintă recomandate de către Societatea Europeană de Ateroscleroză (EAS; 1998); aproximativ 80% din pacienţii trataţi cu 10 mg au atins nivelele ţintă recomandate de EAS pentru LDL-C (\u0026lt;3 mmol\/l).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu mare care a inclus 435 pacienţi cu hipercolesterolemie familială - forma heterozigotă au fost trataţi cu rosuvastatina în doze între 20 mg şi 80 mg cu proiect de tatonare a dozelor. Toate dozele s-au demonstrat a avea efecte favorabile asupra parametrilor lipidici şi asupra valorilor ţintă terapeutice. După creşterea treptată până la o doză zilnică de 40 mg (la 12 săptămâni de tratament), concentraţia LDL-C s-a redus cu 53%. 33% din pacienţi au atins valorile recomandate pentru LDL-C de către EAS (\u0026lt;3 mmol\/l). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu deschis, cu proiect de tatonare a dozelor, 42 pacienţi cu hipercolesterolemie familială - forma homozigotă au fost evaluaţi privind răspunsul lor la tratamentul cu doze de 20-40 mg rosuvastatina. În toată populaţia, scăderea medie a valorilor LDL-C a fost de 22%.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiile clinice cu un număr limitat de pacienţi, rosuvastatina a demonstrat o eficacitate suplimentară în ceea ce priveşte scăderea concentraţiei plasmatice a trigliceridelor atunci când a fost administrată în asociere cu fenofibrat şi în ceea ce priveşte creşterea concentraţiei plasmatice a HDLC atunci când a fost administrat în asociere cu niacina.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu clinic multi-centric, dublu-orb, placebo-controlat (METEOR) la 984 pacienţi cu vârsta cuprinsă între 45 şi 70 ani, cu risc scăzut de boală coronariană (definis ca risc Framingham \u0026lt;10% pe o perioadă de 10 ani), cu valori medii ale LDL-colesterolului de 4,0 mmol\/l (154.5 mg\/dl), dar cu ateroscleroză subclinică (detectată prin testul CIMT - Carotid Intima Media Thickness) au fost repartizaţi randomizat la tratament cu rosuvastatină 40 mg o dată pe zi sau placebo, timp de 2 ani. Rosuvastatina a încetinit semnificativ rata de evoluţie a grosimii intimei arterei carotidiene (CIMT) comparativ cu placebo cu -0,0145 mm\/an [IÎ 95% -0.0196, -0.0093; p\u0026lt;0,0001]. Modificarea faţă de valorile bazale a fost de -0,0014 mm\/an (-0.12%\/an (fără semnificaţie statistică)) pentru rosuvastatină, comparativ cu evoluţia de +0,0131 mm\/an (1,12%\/an (p\u0026lt;0,0001)) pentru cei din grupul placebo. Nu a fost încă demonstrată relaţia directă între scăderea CIMT şi reducerea riscului evenimentelor cardiovasculare. Grupele de populaţie studiate în METEOR prezintă risc scăzut pentru boală coronariană şi nu reprezintă populaţia ţintă pentru doza de rosuvastatină de 40 mg. Această doză trebuie prescrisă numai la pacienţii cu hipercolesterolemie severă şi risc cardiovascular înalt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePentru justificarea utilizării statinelor în prevenţia primară, a fost efectuat un studiu de evaluare intervenţională cu rosuvastatină (JUPITER), asupra efectelor rosuvastatinei asupra incidenţei evenimentelor majore cardiovasculare aterosclerotice la 17802 bărbaţi (\u0026gt;50 ani) şi femei (\u0026gt;60 ani). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eParticipanţii la studiu au fost repartizaţi randomizat la tratament cu placebo (n=8901) sau rosuvastatină 20 mg o dată pe zi (n=8901) şi au fost urmăriţi, în medie, timp de 2 ani. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eConcentraţia de LDL-colesterol a fost redusă cu 45% (p\u0026lt;0,001) în grupul tratat cu rosuvastatină, comparativ cu grupul tratat cu placebo. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-o analiză post-hoc a unor sub-grupe de pacienţi cu risc crescut cu scor de risc Framingham de bază de \u0026gt;20% (1558 subiecţi), s-a observat o reducere semnificativă a obiectivului combinat de mortalitate cardiovasculară, accident vascular cerebral şi infarct de miocard (p=0,028) la tratamentul cu rosuvastatină versus placebo. Reducerea absolută a ratei riscului de eveniment per 1000 pacient-ani a fost de 8,8. În cadrul acestui grup de risc înalt, mortalitatea totală a rămas nemodificată (p=0,193). Într-o analiză post-hoc a unor sub-grupe de pacienţi cu risc crescut (9302 subiecţi) cu un scor de risc de bază de \u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e\u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e 5% (extrapolat pentru a include subiecţi cu vârsta de peste 65 ani), s-a observat o reducere semnificativă a obiectivului combinat final de mortalitate cardiovasculară, accident vascular cerebral şi infarct de miocard (p=0,0003) la grupul tratat cu rosuvastatină, faţă de cel tratat cu placebo. Reducerea absolută a ratei riscului de eveniment per 1000 pacient-ani a fost de 5,1. În cadrul acestui grup de risc înalt, mortalitatea totală a rămas nemodificată (p=0,076). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiul JUPITER, 6,6% dintre pacienţii trataţi cu rosuvastatină şi 6,2% dintre subiecţii trataţi cu placebo au întrerupt studiul din cauza unui eveniment advers. Cele mai frecvente reacţii adverse care au determinat întreruperea tratamentului au fost: mialgie (0,3% la rosuvastatină, 0,2% la placebo), durere abdominală (0,03% la rosuvastatină, 0,02% la placebo) şi erupţie cutanată tranzitorie (0,02% la rosuvastatină, 0,03% la placebo). Cele mai frecvente reacţii adverse cu proporţie mai mare sau egală cu grupul placebo au fost: infecţie urinară (8,7% la rosuvastatină, 8,6% la placebo), nazofaringită (7,6% la rosuvastatină, 7,2% la placebo), durere dorsală (7,6% la rosuvastatină, 6,9% la placebo) şi mialgie (7,6% la rosuvastatină, 6,6% la placebo).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu dublu-orb, randomizat, multi-centric, placebo-controlat, de 12 săptămâni (n=176,97 de sex masculin şi 79 de sex feminin) urmat de o fază deschisa de încă 40 săptămâni (n=173,96 de sex masculin şi 77 de sex feminin), au participat pacienţi cu vârsta de 10 până la 17 ani (în stadiu Tanner II-V, iar fetele la cel puţin 1 an după menarhă) cu hipercolesterolemie familială heterozigotă, care au primit rosuvastatină 5, 10 sau 20 mg pe zi sau placebo, timp de 12 săptămâni, după care toţi au primit rosuvastatină o dată pe zi, timp de 40 săptămâni. La intrarea în studiu, aproximativ 30% dintre pacienţi aveau vârsta între 10\u0026gt;13 ani şi aproximativ 17%, 18%, 40%, şi 25% au fost în stadii Tanner II, III, IV, şi V.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eConcentraţia LDL-colesterolului a fost redusă cu 38,3%, 44,6% şi 50,0% în urma tratamentului cu rosuvastatină în doză de 5, 10 şi, respectiv, 20 mg, comparativ cu 0,7% pentru cei din grupul placebo.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa sfârşitul celor 40 săptămâni de fază deschisă, cu creşterea dozei de până la maxim 20 mg o dată pe zi, 70 din cei 173 pacienţi (40,5%) au atins nivelul ţintă al concentraţiei LDL-colesterolului de sub 2,8 mmol\/l.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDupă cele 52 săptămâni de tratament ale studiului, nu au fost observate efecte asupra creşterii, greutăţii corporale, indexului masei corporale sau a maturizării sexuale (vezi pct. 4.4). Datele din studii clinice la copii şi adolescenţi sunt limitate, iar efectele pe termen lung ale rosuvastatinei (\u0026gt;1 an) asupra pubertăţii sunt necunoscute. Acest studiu (n=176) nu a fost conceput pentru comparaţii ale reacţiilor adverse rare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eProprietăţi farmacocinetice\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAbsorbţie\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eConcentraţiile plasmatice maxime de rosuvastatină se ating după 5 ore de la administrarea orală. Biodisponibilitatea absolută este de aproximativ 20%.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDistribuţie\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este captată extensiv de ficat, care este principalul loc de sinteză a colesterolului şi al clearance-ului LDL-C. Volumul aparent de distribuţie al rosuvastatinei este de aproximativ 134 l. Aproximativ 90% din rosuvastatină se leagă de proteinele plasmatice, în principal de albumină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eMetabolizare\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este metabolizată limitat (de aproximativ 10%). Studiile in vitro asupra metabolismului, în care s-au folosit hepatocite umane au arătat că rosuvastatina este un substrat slab pentru metabolizarea dependentă de citocromul P450. Principala izoenzimă implicată a fost CYP2C9 iar izoenzimă 2C19, 3A4 şi 2D6 au fost implicate într-o măsură mai mică. Principalii metaboliţi identificaţi sunt N-desmetil- şi lacton-metaboliţii. Metabolitul N-desmetil este cu aproximativ 50% mai puţin activ decât rosuvastatina, în timp ce metabolitul lactonă este considerat inactiv clinic.Rosuvastatina este responsabilă de inhibarea activităţii a mai mult de 90% din HMG-CoA reductaza circulantă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEliminare\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAproximativ 90% din doza de rosuvastatină se excretă nemodificată în materiile fecale (constând în substanţă activă absorbită şi neabsorbită), iar restul este excretată prin urină. Aproximativ 5% este excretată nemodificat prin urină. Timpul de înjumătăţire plasmatică prin eliminare este de aproximativ 20 ore. Timpul de înjumătăţire plasmatică prin eliminare nu creşte la administrarea unor doze mai mari. Media geometrică a clearance-ului plasmatic este de aproximativ 50 litri\/oră (coeficient de variaţie 21,7%). Ca şi în cazul altor inhibitori de HMG-CoA reductază, captarea hepatică a rosuvastatinei implică transportorul membranar OATP-C. Acest sistem de transport este important pentru eliminarea hepatică a rosuvastatinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLiniaritate\/nonliniaritate\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eExpunerea sistemică la rosuvastatină creşte proporţional cu doza administrată. Administrarea mai multor doze zilnice nu este urmată de modificări ale parametrilor farmacocinetici.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eGrupe speciale de populaţie\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eVârstă şi sex\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu s-a constatat nici o modificare semnificativă clinic, legată de vârstă sau de sex, în ceea ce priveşte farmacocinetica rosuvastatinei la adulţi. Farmacocinetica rosuvastatinei la copii şi adolescenţi cu hipercolesterolemie familială heterozigotă a fost similară celei a voluntarilor tineri.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRasă\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eStudii de farmacocinetică au aratat o creştere de aproximativ 2 ori a valorilor medii ale ASC şi Cmax la pacienţii asiatici (Japonia, China, Filipine, Vietnam şi Coreea) comparativ cu pacienţii de rasa albă; populaţiile asiatice-indiene prezintă o creştere de aproximativ 1,3 ori a valorilor medii ale ASC şi Cmax. O analiză populaţională de farmacocinetică la pacienţii de rasă albă şi neagră nu a arătat diferenţe clinic relevante ale parametrilor farmacocinetici.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInsuficienţă renală\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu efectuat la pacienţi în diferite grade ale insuficienţei renale, insuficienţa renală uşoară până la moderată nu influenţează concentraţia plasmatică a rosuvastatinei sau a metabolitului său Ndesmetil. Pacienţii cu insuficienţă renală severă (clearance-ul la creatinină \u0026lt; 30 ml\/min) au prezentat o concentraţie plasmatică de rosuvastatină de 3 ori mai mare şi o concentraţie plasmatică a metabolitului N-desmetil de 9 ori mai mare, comparativ cu voluntarii sănătoşi. Concentraţiile plasmatice ale rosuvastatinei, la starea de echilibru, la pacienţii care efectuează hemodializă au fost cu aproximativ 50% mai mari comparativ cu voluntarii sănătoşi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInsuficienţă hepatică\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu efectuat la pacienţi cu diferite grade de afectare hepatică, nu s-a evidenţiat creşterea expunerii la rosuvastatină la pacienţii cu un scor Child-Pugh de 7 sau mai mic. Cu toate acestea, 2 pacienţi cu scoruri Child-Pugh de 8 şi 9 au prezentat o creştere a expunerii sistemice la rosuvastatină de cel puţin de 2 ori mai mare comparativ cu pacienţii care prezentau scoruri Child-Pugh mai mici. Nu au fost studiaţi pacienţi cu scoruri Child-Pugh mai mari de 9.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eParametrii farmacologici la copii şi adolescenţi cu hipercolesterolemie familială heterozigotă cu vârsta între 10 şi 17 ani nu au avut caracteristici deosebite. Un stdiu farmacocinetic de mici dimensiuni cu rosuvastatină (administrată sub formă de comprimate) la 18 copii a demonstrat că nivelul concentraţiei plasmatice la copii pare similar adulţilor. În plus, rezultatele arată că nu se aşteaptă modificări ale proporţionalităţii dozei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDate preclinice de siguranţă\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDatele preclinice din studiile convenţionale de siguranţă farmacologică,de toxicitate după doze repetate, de genotoxicitate şi potenţial carcinogen nu au arătat nici un risc deosebit pentru om.  Nu au fost evaluate testele specifice asupra hERG. Reacţiile adverse care nu au apărut în studiile clinice, însă au fost prezente la animale la administrarea unor doze similare celor recomandate au fost următoarele: în studiile de toxicitate la doze repetate, s-au produs modificări histopatologice hepatice probabil datorate acţiunii farmacologice a rosuvastatinei, la şoarece, şobolan şi, în mai mică măsură, la nivelul veziculei biliare la câini, dar nu şi la maimuţe. În plus, la maimuţe şi câini, la doze crescute, a fost observată toxicitate testiculară. Într-un studiu efectuat la şobolan, pre- şi postnatal, toxicitatea asupra funcţiei de reproducere a fost evidentă, ţinând cont de dimensiunile, greutatea feţilor şi supravieţuirea puilor reduse. Aceste efecte au fost observate la doze toxice pentru mame la o expunere sistemică de câteva ori mai mare decât nivelul terapeutic de expunere sistemică. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePROPRIETĂŢI FARMACEUTICE\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLista excipienţilor\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNucleu\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLactoză anhidră\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCeluloză microcristalină\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCrospovidonă\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eStearat de magneziu\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDioxid de siliciu coloidal anhidru.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFilm\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLactoză monohidrat\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDioxid de titan (E171)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eMacrogol 6000\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopolimer butyl-metacrilat\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eIncompatibilităţi\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu este cazul.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePerioada de valabilitate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e3 ani.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrecauţii speciale pentru păstrare\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAcest medicament nu necesită precauţii speciale de păstrare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eA se păstra în ambalajul original, pentru a fi protejat de lumină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNatura şi conţinutul ambalajului\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eBlistere perforate din OPA-Al-PVC-Al): cutie cu 10, 14, 20, 28, 30, 56, 60, 84, 90, 98 şi 100 comprimate filmate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEste posibil ca nu toate mărimile de ambalaj să fie comercializate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDEŢINĂTORUL AUTORIZAŢIEI DE PUNERE PE PIAŢĂ\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"KRKA d.d., Novo mesto","offers":[{"title":"Default Title","offer_id":43931136622732,"sku":"40351","price":94.23,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/40351.jpg?v=1732807188"},{"product_id":"roswera-5mg-compfilm","title":"Roswera 5mg comp.film.","description":"\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 13.91px;\"\u003eRoswera 5 mg comprimate filmate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 10 mg comprimate filmate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 15 mg comprimate filmate\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 20 mg comprimate filmate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 30 mg comprimate filmate\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera 40 mg comprimate filmate\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 13.91px;\"\u003eCOMPOZIŢIA CALITATIVĂ ŞI CANTITATIVĂ\u003c\/span\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine rosuvastatină 5 mg (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 10 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 15 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 20 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 30 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat conţine 40 mg rosuvastatină (sub formă de rosuvastatină calcică).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 13.91px;\"\u003eExcipient(ţi) cu efect cunoscut: \u003c\/span\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 5 mg conţine lactoză anhidră 41,9 mg.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 10 mg conţine lactoză anhidră 41,9 mg.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 15 mg conţine lactoză anhidră 62,9 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 20 mg conţine lactoză anhidră 83,8 mg.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 30 mg conţine lactoză anhidră 125,7 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFiecare comprimat filmat de 40 mg conţine lactoză anhidră 167,6 mg.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFORMA FARMACEUTICĂ\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eComprimat filmat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e5 mg: comprimate filmate de culoare albă, rotunde (diametrul de 7 mm), uşor biconvexe, cu margini teşite, marcate cu numărul 5 pe una dintre feţe.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e10 mg: comprimate filmate de culoare albă, rotunde (diametrul de 7,5 mm), uşor biconvexe, cu margini teşite, marcate cu numărul 10 pe una dintre feţe.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e15 mg: comprimate filmate de culoare albă, rotunde (diametrul de 9 mm), uşor biconvexe, cu margini teşite, marcate cu numărul 15 pe una dintre feţe.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e20 mg: comprimate filmate de culoare albă, rotunde (diametrul de 10 mm), cu margini teşite.\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e30 mg: comprimate filmate de culoare albă, biconvexe, alungite, marcate pe ambele feţe (dimensiuni:15 mm x 8 mm). Linia mediană are numai rolul de a uşura ruperea comprimatului pentru a fi înghiţit uşor şi nu de divizare în doze egale.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e40 mg: comprimate filmate de culoare albă, biconvexe, alungite (dimensiuni: 16 mm x 8,5 mm).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDATE CLINICE\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eIndicaţii terapeutice\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eTratamentul hipercolesterolemiei\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdulţi, adolescenţi şi copii cu vârsta de 10 ani sau peste, cu hipercolesterolemie primară (tip IIa, inclusiv hipercolesterolemia familială - forma heterozigotă) sau dislipidemie mixtă (tip IIb), ca adjuvant al dietei la pacienţii care nu răspund adecvat numai la dietă şi la alte metode de tratament non-farmacologic (cum sunt exerciţiile fizice, scăderea în greutate).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eHipercolesterolemie familială - forma homozigotă, ca tratament adjuvant al dietei şi al altor metode de scădere a lipidemiei (de exemplu afereza LDL) sau în cazurile în care aceste tratamente nu sunt adecvate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrevenţia evenimentelor cardiovasculare Prevenţia evenimentelor cardiovasculare majore la pacienţii cu risc major pentru un prim eveniment cardiovascular (vezi pct. 5.1), ca tratament adjuvant în controlul altor factori de risc. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e \u003cstrong\u003eDoze şi mod de administrare\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e Doze\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎnainte de începerea tratamentului, pacientul trebuie să urmeze un regim hipocolesterolemiant standard care trebuie continuat şi în timpul tratamentului. Doza trebuie adaptată pentru fiecare pacient, în funcţie de obiectivul tratamentului şi de răspunsul pacientului, respectând recomandările din ghidurile actuale de tratament.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera poate fi administrat în orice moment al zilei, cu sau fără alimente.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEste posibil să nu fie disponibile toate concentraţiile de Roswera.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eTratamentul hipercolesterolemiei\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDoza iniţială recomandată este de 5 sau 10 mg administrată oral, o dată pe zi, atât la pacienţii care iau pentru prima dată statine, cât şi la pacienţii care trec de pe un tratament cu alt inhibitor de HMG CoA reductază. Alegerea dozei iniţiale se face în funcţie de nivelul individual al colesterolemiei şi aprecierea riscului cardiovascular, precum şi de riscul potenţial al reacţiilor adverse. Dacă este necesar, doza poate fi crescută după 4 săptămâni la 20 mg. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDatorită creşterii incidenţei reacţiilor adverse la utilizarea dozei de 40 mg, comparativ cu dozele mai scăzute, creşterea dozei de la 20 mg la 30 mg sau până la doza maximă de 40 mg trebuie luată în considerare numai la pacienţii cu hipercolesterolemie severă şi risc cardiovascular crescut (în particular la pacienţii cu hipercolesterolemie familială), care nu ating valoarea stabilită ca obiectiv al tratamentului cu doza de 20 mg, aceştia urmând a fi monitorizaţi prin teste periodice. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa iniţierea tratamentului cu dozele de 30 mg saur 40 mg este necesară monitorizare de specialitate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrevenţia evenimentelor cardiovasculare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiul clinic al reducerii riscului de evenimente cardiovasculare, doza utilizată a fost de 20 mg pe zi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţi vârstnici\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii cu vârsta \u0026gt;70 ani se recomandă o doză iniţială de 5 mg. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţi cu insuficienţă renală\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu este necesară ajustarea dozelor la pacienţi cu insuficienţă renală uşoară sau moderată. Doza iniţială recomandată la pacienţi cu insuficienţă renala moderată (clearance-ul creatininei \u0026lt;60 ml\/min) este de 5 mg. Utilizarea dozelor de 30 mg şi 40 mg este contraindicată la pacienţii cu insuficienţă renala moderată. Utilizarea Roswera la pacienţi cu insuficienţă renală severă este contraindicată la orice doză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţi cu insuficienţă hepatică\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePentru pacienţii cu scoruri Child-Pugh de 7 sau mai mici nu s-a constatat creşterea expunerii sistemice la rosuvastatină. Totuşi, creşterea expunerii sistemice a fost observată la pacienţi cu scoruri ChildPugh de 8 şi 9. La aceşti pacienţi trebuie avută în vedere evaluarea funcţiei renale. Nu există experienţă clinică la pacienţi cu scoruri Child-Pugh peste 9. Roswera este contraindicat la pacienţii cu boală hepatică activă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eUtilizarea la copii trebuie recomandată de către medicii de specialitate. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi cu vârsta de 10 până la 17 ani (băieţi: stadiul Tanner II sau peste, iar fetele la cel puţin 1 an după menarhă)\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa copii şi adolescenţi cu hipercolesterolemie familială heterozigotă, doza uzuală iniţială este de 5 mg pe zi. Intervalul de dozare uzual este 5\u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e\u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e20 mg oral, o dată pe zi. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCreşterea dozelor trebuie efectuată în funcţie de răspunsul la tratament şi tolerabilitatea individuală a copiilor, conform recomandărilor ghidurilor de tratament pediatric. Copiii și adolescenții trebuie să efectueze tratament dietetic hipocolesterolemiant standard înainte de inițierea tratamentului cu rosuvastatină; regimul alimentar trebuie continuat pe toată durata tratamentului cu rosuvastatină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSiguranţa şi eficacitatea tratamentului cu doze mai mari de 20 mg nu au fost încă stabilite la aceste grupe de populaţie. Comprimatele de 30 şi 40 mg nu sunt recomandate la copii. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii cu vârsta sub 10 ani\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eExperienţa clinică este limitată la un număr mic de copii (cu vârste de 8 ani şi până la 10 ani) cu hipercolesterolemie familială - forma homozigotă. De aceea, Roswera nu este recomandat la copii cu vârsta sub 10 ani.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRasă\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa subiecţii asiatici a fost observată creşterea expunerii sistemice. La pacienţii de origine asiatică, se recomandă o doză iniţială de 5 mg. Dozele de 30 şi 40 mg sunt contraindicate la aceşti pacienţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePolimorfism genetic\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSe ştie că prezenţa anumitor tipuri de polimorfism genetic poate duce la creşterea concentraţiilor plasmatice ale rosuvastatinei (vezi pct. 5.2). La pacienţii cu astfel de tipuri cunoscute de polimorfism, se recomandă administrarea unor doze mai mici de rosuvastatină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDoze la pacienţi cu factori de risc de miopatie\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţi cu factori de risc de miopatie doza inţială recomandată este de 5 mg. Dozele de 30 şi 40 mg sunt contraindicate la unii dintre aceşti pacienţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eTratament concomitent\u003c\/span\u003e\u003c\/u\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina reprezintă substrat al unor proteine de transport (de exemplu, OATP1B1 şi BCRP). Riscul de miopatie (incluzând rabdomioliză) este crescut în cazul administrării concomitente a rosuvastatinei cu anumite medicamente ce pot creşte concentraţiile plasmatice ale rosuvastatinei, din cauza interacţiunilor cu aceste proteine transportoare (de exemplu, ciclosporina şi anumiţi inhibitopri ai proteazelor, inclusiv combinaţi de ritonavir cu atazanavir, lopinavir şi\/sau tipranavir. Atunci când este posibil, se recomandă luarea în consideraţie a unui tratament alternativ şi, dacă este necesar, terapia cu rosuvastatină poate fi întreruptă. În situaţiile în care administrarea concomitentă a acestor medicamnte şi rosuvastatină nu poate fi evitată, trebuie evaluat raportul beneficiu\/risc al tratamentului concomitent şi ajustarea cu atenţie a dozelor de rosuvastatin.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eContraindicaţii\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera este contraindicată:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e - la pacienţii cu hipersensibilitate la substanţa activă sau la oricare dintre excipienţii enumeraţi\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi cu boală hepatică activă, incluzând creşterea inexplicabilă, persistentă, a transaminazelor plasmatice şi orice creştere a transaminazelor plasmatice care depăşeşte de 3 ori limita superioară a normalului (ULN)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi cu insuficienţă renală severă (clearance al creatininei \u0026lt;30 ml\/min).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi cu miopatie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- la pacienţi care primesc tratament concomitent cu ciclosporină\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- în timpul sarcinii şi alăptării şi la femei aflate în perioada fertilă care nu utilizează măsuri contraceptive corespunzătoare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDozele de 30 şi 40 mg sunt contraindicate la pacienţi cu factori de risc de miopatie\/rabdomioliză.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAstfel de factori de risc sunt:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- insuficienţa renală moderată (clearance-ul creatininei \u0026lt;60 ml\/min)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- hipotiroidie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- antecedente personale sau familiale de afecţiuni ereditare musculare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- istoric de toxicitate musculară la un alt inhibitor al HMG-CoA reductază sau fibraţi\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- consum exagerat de alcool etilic\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- situaţii în care nivelele plasmatice ale medicamentului pot creşte\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- pacienţi cu origine asiatică - utilizare concomitentă de fibraţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e \u003cstrong\u003eAtenţionări şi precauţii speciale pentru utilizare\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte renale\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eProteinuria, evidenţiată prin teste de tip \"dipstick\" şi de cele mai multe ori de origine tubulară, a fost observată la pacienţii trataţi cu doze mai mari de rosuvastatină în particular 40 mg, şi în cele mai multe cazuri a fost tranzitorie sau intermitentă. Proteinuria nu s-a demonstrat a fi un factor predictiv al unei boli renale acute sau progresive. Incidenţa raportărilor de reacţii adverse severe renale la utilizarea dozei de 40 mg, în perioada de după punerea pe piaţă a medicamentului, este mai mare. În cazul pacienţilor trataţi cu doze de 30 mg sau 40 mg, la efectuarea controlului de rutină trebuie avută în vedere şi evaluarea funcţiei renale.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte la nivelul musculaturii scheletice\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii trataţi cu rosuvastatină au fost raportate efecte asupra muşchilor scheletici, ca mialgie, miopatie şi, rareori, rabdomioliză la toate dozele şi în special la doze de peste 20 mg. În foarte rare cazuri, a fost raportată rabdomioliza la asocierea de ezetimib şi inhibitori ai HMG-CoA reductazei. Interacţiunea farmacodinamică nu poate fi exclusă şi la utilizarea acestei asocieri, este necesară precauţie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei, incidenţa rabdomiolizei asociate cu utilizarea Rowsera este mai mare la utilizarea dozei de 40 mg, în perioada de după punerea pe piaţă a medicamentului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDeterminarea valorilor creatinkinazei\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCreatinkinaza (CK) nu trebuie măsurată după efectuarea unor exerciţii fizice intense sau în prezenţa unei cauze evidente care ar putea să ducă la creşterea valorilor CK şi care ar putea modifica interpretarea rezultatului. În cazul în care concentraţiile plasmatice iniţiale ale CK sunt crescute în mod semnificativ (\u0026gt;5 x ULN), trebuie efectuat un test de confirmare în următoarele 5-7 zile. Dacă repetarea testului confirmă o valoare iniţială de \u0026gt;5 x ULN, atunci tratamentul nu trebuie început.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎnainte de tratament\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSimilar altor inhibitori ai HMG-CoA reductazei, Roswera trebuie recomandat cu prudenţă la pacienţii care prezintă factori predispozanţi pentru miopatie\/rabdomioliză:\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- insuficienţă renală\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- hipotiroidie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- antecedente personale sau heredocolaterale de afecţiuni musculare ereditare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- antecedente de toxicitate musculară la administrarea altor inhibitori ai HMG-CoA reductazei sau a fibraţilor\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- consum exagerat de alcool etilic\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- vârstă \u0026gt;70 ani - situaţii în care poate apare o creştere a concentraţiilor plasmatice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- utilizarea concomitentă a fibraţilor.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa asemenea pacienţi, riscul trebuie evaluat în funcţie de posibilele beneficii ale tratamentului şi este recomandată monitorizarea clinică. Dacă nivelele CK sunt semnificativ crescute faţă de valorile bazale (\u0026gt;5 x ULN) tratamentul nu trebuie iniţiat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn timpul tratamentului\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePacienţilor trebuie să li se recomande să raporteze imediat durerile musculare inexplicabile, hipotonia musculară sau crampele, mai ales dacă acestea se asociază cu stare de rău general sau febră. La aceşti pacienţi trebuie măsurate concentraţiile plasmatice ale CK. Tratamentul trebuie întrerupt dacă: concentraţiile plasmatice ale CK sunt mult crescute (\u0026gt;5 x ULN) sau dacă simptomele musculare sunt severe şi determină un disconfort zilnic (chiar şi în cazul în care concentraţiile plasmatice ale CK sunt ≤5 ori limita superioară a normalului). Dacă simptomele se remit şi concentraţiile plasmatice ale CK revin la normal, atunci trebuie avută în vedere reluarea tratamentului cu Roswera sau cu un alt inhibitor de HMG-CoA reductază, în cea mai mică doză şi sub o monitorizare atentă. Monitorizarea de rutină a concentraţiilor plasmatice ale CK la pacienţii asimptomatici nu este justificată. Au fost raportate cazuri foarte rare de miopatie necrozantă prin mecanism imunitar (IMNM) în timpul sau după tratamentul cu statine, incusiv rosuvastatină. IMNM este caracterizat clinic prin astenie musculară proximală şi creşterea concentraţiilor plasmatice ale CK, care persistă, chiar dacă tratamentul cu statine este întrerupt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiile clinice, la numărul mic de pacienţi trataţi cu rosuvastatină şi un alt tratament concomitent, nu s-a înregistrat o incidenţă mai mare a efectelor asupra musculaturii scheletice. Cu toate acestea, la pacienţii trataţi cu alţi inhibitori ai HMG-CoA reductazei, concomitent cu fibraţi cum este gemfibrozilul, ciclosporină, acid nicotinic, antifungice azolice, inhibitori ai proteazelor şi antibiotice macrolidice s-a constatat o incidenţă crescută a miozitei şi miopatiei. Gemfibrozilul creşte riscul de miopatie atunci când este administrat concomitent cu unii inhibitori ai HMG-CoA reductazei. De aceea, asocierea Roswera şi gemfibrozil nu este recomandată. Beneficiul privind scăderea suplimentară a concentraţiilor plasmatice de lipide prin administrarea asociată de Roswera şi fibraţi sau niacină trebuie atent evaluat faţă de potenţialele riscuri ale acestei asocieri. Dozele de 30 mg şi 40 mg sunt contraindicate la utilizare concomitentă cu fibraţi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera nu trebuie utilizat la nici un pacient care prezintă o afecţiune acută, severă, sugestivă pentru miopatie sau cu predispoziţie de a dezvolta insuficienţă renală secundară rabdomiolizei (de exemplu sepsis, hipotensiune arterială, intervenţie chirurgicală majoră, traumatisme, tulburări severe metabolice, endocrine şi electrolitice; crize convulsive necontrolate).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte hepatice\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei, Roswera trebuie utilizat cu prudenţă la pacienţii care consumă cantităţi excesive de alcool etilic şi\/sau au antecedente de boală hepatică.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSe recomandă efectuarea de teste funcţionale hepatice înainte de începerea tratamentului şi la 3 luni după începerea tratamentului. În cazul în care concentraţia plasmatică a transaminazelor este de 3 ori mai mare decât limita superioară a normalului, tratamentul cu Roswera trebuie întrerupt sau doza trebuie redusă. Incidenţa reacţiilor hepatice severe (în principal constând în creşterea transaminazelor hepatice) este mai mare în perioada de după punerea pe piaţă a medicamentului, pentru doza de 40 mg. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii cu hipercolesterolemie secundară determinate de hipotiroidism sau sindrom nefrotic, afecţiunea de bază trebuie tratată înaintea începerii tratamentului cu Roswera.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRasa Rezultatele studiilor de farmacocinetică arată o creştere a expunerii la pacienţii de rasă asiatică, comparativ cu cei de rasă albă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInhibitorii de proteaze\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa pacienţii la care s-au administrat concomitent rosuvastatină şi diverşi inhibitori ai proteazelor în asociere cu ritonavir, a fost observată creşterea concentraţiilor plasmatice ale rosuvastatinei. La iniţierea şi creşterea dozelor de rosuvastatină la pacienţii cu HIV trataţi concomitent cu inhibitori ai proteazelor, trebuie luat în considerare atât beneficiul scăderii lipidemiei de către rosuvastatină, cât şi creşterea potenţială a concentraţiilor plasmatice ale rosuvastatinei. Utilizarea concomitentă a rosuvastatinei şi inhibitorilor proteazelor nu este recomandată, decât cu.Utilizarea concomitentă cu inhibitorii de proteaze se poate face numai cu scăderea dozelor de rosuvastatină. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePneumonie interstiţială\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa utilizarea unor statine, în special la utilizare îndelungată, au fost raportate cazuri excepţional de rare de pneumonie interstiţială (vezi pct. 4.8). Tabloul clinic poate include dispnee, tuse neproductivă şi deteriorarea stării generale (fatigabilitate, pierdere în greutate şi hipertermie). Dacă se suspectează că un pacient dezvoltă o pneumonie interstiţială, tratamentul cu statine trebuie întrerupt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDiabet zaharat\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eExistă dovezi care sugerează că statinele cresc glicemia şi, la unii pacienţi cu risc crescut de apariţie a diabetului zaharat, pot produce hiperglicemie cu valori care să necesite măsuri considerate de rutină la pacienţii cu diabet zaharat diagnosticat. Totuşi, riscul de apariţie a diabetului zaharat este depăşit de beneficiul reducerii riscului cardiovascular şi, prin urmare, nu există un motiv pentru întreruperea tratamentului cu statine. Pacienţii cu risc crescut (valori ale glicemiei în condiţii de repus alimentar între 5,6 şi 6,9 mmol\/l, IMC\u0026gt;30 kg\/m2, valori crescute ale trigliceridemiei, hipertensiune arterială) trebuie monitorizaţi clinic şi paraclinic în acord cu ghidurile naţionale. În studiul clinic JUPITER, frecvenţa globală raportată de apariţie a diabetului zaharat a fost de 2,8% la rosuvastatină şi de 2,3% la placebo, mai ales la pacienţii cu valori ale glicemiei între 5,6 şi 6,9 mmol\/l în condiţii de repaus alimentar.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEvaluarea înalţimii, greutăţii corporale, indexului masei corporale şi a caracteristicilor sexuale secundare conform scalei Tanner la pacienţii copii cu vârsta de 10 până la 17 ani în tratament cu rosuvastatină este limitată la perioada de 1 an. După un studiu de 52 săptămâni, nu au fost observate efecte asupra creşterii, greutăţii corporale, IMC sau maturizării sexuale. Datele clinice la copii şi adolescenţi sunt limitate, iar efectele rosuvastatinei pe perioade îndelungate (\u0026gt;1 an) asupra pubertăţii sunt necunoscute.  Într-un studiu clinic la copii şi adolescenţi în tratament cu rosuvastatină timp de 52 săptămâni, creşterile CK peste ULN x 10 şi simptomele musculare apărute după exerciţii fizice sau activitate fizică crescută, au apărut mai frecvent, comparativ cu studiile clinice la adulţi. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera comprimate filmate conţine lactoză. Pacienţii cu afecţiuni ereditare rare de intoleranţă la galactoză, deficit de lactază (Lapp) sau sindrom de malabsorbţie la glucoză-galactoză nu trebuie să utilizeze acest medicament.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInteracţiuni cu alte medicamente şi alte forme de interacţiune\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfectele altor medicamente asupra rosuvastatinei\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInhibitorii proteinelor de transport\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este substrat al anumitor proteine de transport, incuzând transportorul hepatic de captare OATP1B1 şi a transportorului hepatic de eflux BCRP. Administrarea concomitentă a rosuvastatinei împreună cu medicamente care inhibă activitatea proteinelor de transport poate duce la creşterea concentraţiilor plasmatice ale rosuvastatinei şi la creşterea riscului de miopatie.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCiclosporină\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn timpul tratamentului concomitent cu rosuvastatină şi ciclosporină, valorile ariei de sub curba concentraţiei plasmatice în funcţie de timp (ASC) ale rosuvastatinei au fost în medie de 7 ori mai mari decât cele observate la voluntarii sănătoşi (vezi tabelul 1). Rosuvastatina este contraindicată la pacienţii la care se administrează concomitent ciclosporină.  Administrarea concomitentă nu a afectat concentraţiile plasmatice ale ciclosporinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInhibitorii proteazelor \u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCu toate că nu se cunoaşte exact mecanismul interacţiunii, utilizarea concomitentă a unui inhibitor de protează poate determina o creştere puternică a concentraţiilor plasmatice ale rosuvastatinei.  De exemplu, într-un studiu de farmacocinetică, administrarea concomitentă la voluntari tineri de rosuvastatină 10 mg şi o combinaţie de doi inhibitori ai proteazelor (atazanavir 300 mg şi ritonavir100 mg), a fost asociată cu o creştere de aproximativ trei ori, respectiv şapte ori, a ASC şi, respectiv, Cmax a rosuvastatinei la starea de echilibru. Utilizarea concomitentă de rosuvastatină şi unele combinaţii de inhibitori ai proteazelor poate fi luată în considerare numai după ajustarea atentă a dozelor de rosuvastatină, în funcţie de creşterea aşteptată a concentraţiilor plasmatice ale rosuvastatinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eGemfibrozil şi alte hipolipemiante\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eUtilizarea concomitentă de rosuvastatină şi gemfibrozil a determinat creşterea de 2 ori a Cmax şi ASC pentru rosuvastatină. Pe baza datelor obţinute din studiile de interacţiune specifică nu sunt de aşteptat interacţiuni clinic semnificative în cazul administrării concomitente de fenofibrat, totuşi poate apărea o interacţiune farmacodinamică. Gemfibrozilul, fenofibratul, alţi fibraţi şi doze hipolipemiante (≥ 1g\/zi) de niacină (acid nicotinic) cresc riscul de miopatie atunci când sunt administrate concomitent cu inhibitori ai HMG-CoA reductazei, probabil datorită faptului că aceştia pot produce miopatie şi în monoterapie. Dozele de 30 mg şi 40 mg sunt contraindicate la utilizarea concomitentă a fibraţilor. De asemenea, aceşti pacienţi trebuie să utilizeze doza iniţială de 5 mg. \u003cem\u003eEzetimib\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eUtilizarea concomitentă de rosuvastatină 10 mg şi ezetimib 10 mg a determinat o creştere de 1,2 ori a ASC pentru rosuvastatină la pacienţii cu hipercolesterolemie. Totuşi, nu poate fi exclusă o interacţiune farmacodinamică, privitor la reacţiile adverse, între Roswera şi ezetimib.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAntiacide\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdministrarea simultană de rosuvastatină şi o suspensie conţinând un antiacid cu hidroxid de aluminiu şi magneziu a determinat scăderea concentraţiei plasmatice a rosuvastatinei de aproximativ 50%. Acest efect a fost mai mic atunci când antiacidul a fost administrat la 2 ore după Rowsera. Nu a fost studiată importanţa clinică a acestei interacţiuni.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEritromicină\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdministrarea simultană de rosuvastatină şi eritromicină a dus la scăderea cu 20% a ASC şi scăderea cu 30% a Cmax a rosuvastatinei. Această interacţiune poate fi determinată de creşterea motilităţii intestinale de către eritromicină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEnzimele citocromului P450\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRezultatele din studiile in vitro şi in vivo arată că rosuvastatina nu este nici inhibitor şi nici inductor al izoenzimelor citocromului P450. În plus, rosuvastatina este un substrat slab pentru aceste enzime.  De aceea, nu sunt aşteptate interacţiuni medicamentoase depinzând de metabolizarea mediată de citocromul P450. Nu s-au observat interacţiuni clinic semnificative nici între rosuvastatină şi fluconazol (un inhibitor al CYP2C9 şi CYP3A4) sau rosuvastatină şi ketoconazol (un inhibitor al CYP2A6 şi CYP3A4).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInteracţiuni care necesită ajustarea dozei de rosuvastatină\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAtunci când este necesară administrarea concomitentă de rosuvastatină şi alte medicamente care determină creşterea cunoscută a concentraţiilor plasmatice ale rosuvastatinei, dozele de rosuvastatină trebuie scăzute. În cazul în care creşterea aşteptată a ASC este de aproximativ 2 ori sau mai mare, tratamentul trebuie iniţiat cu doza zilnică unică de 5 mg rosuvastatină. Doza zilnică maximă de rosuvastatină trebuie ajustată astfel încât concentraţiile plasmatice de rosuvastatină aşteptate să nu depăşească pe cele care apar după administrarea de rosuvastatină 40 mg pe zi, în monoterapie; de exemplu, la administrarea concomitentă cu gemfibrozil, trebuie administrată o doză zilnică de 20 mg rosuvastatină (creştere de 1,9 ori a ASC) şi de 10 mg rosuvastatină, în cazul administrării concomitente cu asocierea atazanavir\/ritonavir (creştere de 3,1 ori a ASC).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfectul rosuvastatinei asupra unor medicamente administrare concomitent\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAntagonişti de vitamină K\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCa şi în cazul altor inhibitori ai HMG-CoA reductazei, iniţierea tratamentului sau creşterea dozei de Roswera la pacienţi trataţi concomitent cu antagonişti de vitamină K (de exemplu warfarină sau alt anticoagulant cumarinic) pot duce la creşterea International Normalised Ratio (INR). Întreruperea tratamentului sau scăderea dozelor de Roswera poate duce la scăderea INR-ului. În astfel de situaţii, se impune monitorizarea valorilor INR.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eContraceptive orale\/tratament de substituţie hormonală (HRT-hormone replacement therapy)\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAdministrarea concomitentă de rosuvastatină şi un contraceptiv oral a determinat creşterea ASC pentru etinilestradiol şi norgestrel cu 26% şi, respectiv, 34%. Această creştere a concentraţiilor plasmatice trebuie avută în vedere când se aleg dozele de contraceptive orale. Nu sunt disponibile date de farmacocinetică pentru subiecţii care utilizează concomitent rosuvastatină şi HRT şi, de aceea, un efect similar nu poate fi exclus. Cu toate acestea, în studiile clinice, asocierea a fost frecvent utilizată la femei şi a fost bine tolerată.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAlte produse medicamentoase\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePe baza datelor obţinute din studiile de interacţiune specifică, nu sunt de aşteptat interacţiuni clinic semnificative în cazul administrării concomitente de digoxină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAu fost efectuate studii de interacţiune medicamentoasă numai la adulţi. Nivelul interacţiunilor medicamentoase la copii şi adolescenţi nu este cunoscut.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFertilitatea, sarcina şi alăptarea\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRoswera este contraindicat în sarcină şi alăptare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSarcina\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFemeile cu potenţial fertil trebuie să utilizeze metode contraceptive corespunzătoare. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDeoarece colesterolul şi alţi produşi ai biosintezei colesterolului sunt esenţiali pentru dezvoltarea fătului, riscul potenţial al inhibării HMG-CoA reductazei depăşeşte avantajul tratamentului în timpul sarcinii. Studiile efectuate la animale aduc informaţii limitate despre toxicitatea asupra funcţiei de reproducere. Dacă o pacientă rămâne însărcinată în timpul utilizării acestui produs, tratamentului trebuie întrerupt imediat.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAlăptarea\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina se excretă în lapte, la şobolan. Nu există date privind excreţia în lapte, la om.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte asupra capacităţii de a conduce vehicule şi de a folosi utilaje\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu s-au efectuat studii care să determine efectul administrării rosuvastatinei asupra capacităţii de a conduce vehicule sau de a folosi utilaje. Cu toate acestea, pe baza proprietăţilor sale farmacodinamice, este puţin probabil ca rosuvastatina să afecteze aceste abilităţi. La conducerea vehiculelor sau la folosirea utilajelor, trebuie avut în vedere că în timpul tratamentului pot să apară ameţeli.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eReacţii adverse\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSumar al profilului de siguranţă\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eReacţiile adverse care apar la administrarea rosuvastatinei sunt, în general, uşoare şi tranzitorii. În studiile clinice controlate, mai puţin de 4% dintre pacienţii trataţi cu rosuvastatină au fost excluşi din cauza reacţiilor adverse.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLista tabelară a reacţiilor adverse\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePe baza datelor din studiile clinice şi experienţa vastă după punerea pe piaţă, următorul tabel prezintă profilul reacţiilor adverse pentru rosuvastatină. Reacţiile adverse enumerate mai jos sunt clasificate în funcţie de frecvenţă şi sisteme de organe (SO). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Foarte frecvente (\u0026gt;1\/10) \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Frecvente (\u0026gt;1\/100 la \u0026lt;1\/10) \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Mai puţin frecvente (\u0026gt;1\/1000 la \u0026lt;1\/100) \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Rare (\u0026gt;1\/10000 la \u0026lt;1\/1000)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Foarte rare (\u0026lt;1\/10000),\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- Cu frecvenţă necunoscută (nu poate fi estimată din datele disponibile)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eReacţiile adverse pe baza datelor din studiile clinice\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e -Tulburări hematologice şi limfatice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e -Trombocitopenie  \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări ale sistemului imunitar\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Reacţii de hipersenbilitate, inclusiv angioedem\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări endocrine\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Diabet zaharat\u003csup style=\"position: relative; font-size: 9px; line-height: 0; vertical-align: baseline; top: -0.5em;\"\u003e1\u003c\/sup\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări psihice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Depresie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări ale sistemului nervos\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Cefalee Ameţeli\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Polineuropatie Pierderea memoriei\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Neuropatie periferică Tulburări ale somnului  (inclusiv insomnie şi coşmaruri)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări respiratorii, toracice şi mediastinale\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tuse Dispnee\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări gastrointestinale\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Constipaţie,Greaţă,Durere abdominală\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Pancreatită,Diaree\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări hepatobiliare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Creşterea concentraţiilor transaminazelor hepatice\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Icter Hepatită\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Afecţiuni cutanate şi ale ţesutului subcutanat\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Prurit Erupţie cutanată tranzitorie Urticarie\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e- StevensJohnson syndrome\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări musculoscheletice şi ale ţesutului conjunctiv\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Mialgie Miopatie (inclusiv miozită) Rabdomioliză\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Artralgie Miopatie necrozantă mediată imunitar\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări tendinoase, uneori complicate prin ruptură de tendon\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări renale şi ale căilor urinare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Hematurie \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări ale aparatului genital şi sânului\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Ginecomastie \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Tulburări generale şi la nivelul locului de administrare\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Astenie   \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e-Edeme\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCreşterea creatinkinazei de peste 10 x ULN şi simptomele musculare după efort fizic sau creşterea activităţii fizice au fost observate mai frecvent într-un studiu clinic de 52 săptămâni, în care s-au facut comparaţii între copii şi adulţi (vezi pct. 4.4). Din alt punct d evedere, profilul siguranţei rosuvastatinei a fost similar la copii şi adolescenţi, comparativ cu adulţii. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRaportarea reacţiilor adverse suspectate \u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRaportarea reacţiilor adverse suspectate după autorizarea medicamentului este importantă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eSupradozaj\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu există tratament specific în caz de supradozaj. În caz de supradozaj, pacientul trebuie tratat simptomatic şi trebuie instituite măsurile de susţinere adecvate. Se recomandă monitorizarea funcţiei hepatice şi a concentraţiilor plasmatice de CK. Este puţin probabil ca hemodializa să aducă vreun beneficiu.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePROPRIETĂŢI FARMACOLOGICE\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eProprietăţi farmacodinamice\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eGrupa farmacoterapeutică: hipocolesterolemiante şi hipotrigliceridemiante; inhibitori ai HMG-CoA reductazei, codul ATC: C10AA07.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eMecanism de acţiune\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este un inhibitor selectiv şi competitiv al HMG-CoA reductazei, enzima cheie în procesul de transformare a 3-hidroxil-3-metilglutaril coenzima A la mevalonat, un precursor al colesterolului. Locul principal de acţiune al rosuvastatinei este ficatul, organul ţintă pentru scăderea olesterolului.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina creşte numărul receptorilor LDL de pe suprafaţa celulelor hepatice, crescând captarea şi catabolismul LDL şi inhibă sinteza hepatică de VLDL, reducând în acest mod numărul total al particulelor de VLDL şi LDL\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfecte farmacodinamice\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina scade concentraţiilor crescute de LDL-colesterol, colesterol total şi trigliceride şi creşte HDL-colesterolul. De asemenea, rosuvastatina scade Apo-B, non HDL-C, VLDL-C, VLDL-TG, rapoartele LDL-C\/HDL-C, C total\/HDL-C, non HDL-C\/HDL-C, Apo-B\/ApoA-I.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEfectul terapeutic se obţine într-o săptămână de la începerea tratamentului şi 90% din răspunsul maxim este atins după 2 săptămâni. Răspunsul maxim este atins de obicei după 4 săptămâni şi se menţine ulterior.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEficacitate şi siguranţă clinică\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este eficace la adulţii cu hipercolesterolemie, cu şi fără hipertrigliceridemie, indiferent de rasă, sex sau vârstă şi la anumite populaţii cum sunt diabeticii, sau pacienţii cu hipercolesterolemie familială.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrin analiza datelor cumulate din studiile de fază III, rosuvastatina s-a demonstrat a fi eficace la majoritatea pacienţilor cu hipercolesterolemie de tip IIa şi IIb (valoarea iniţială medie a LDL-C de aproximativ 4,8 mmol\/l) atunci când tratamentul a urmărit atingerea valorilor ţintă recomandate de către Societatea Europeană de Ateroscleroză (EAS; 1998); aproximativ 80% din pacienţii trataţi cu 10 mg au atins nivelele ţintă recomandate de EAS pentru LDL-C (\u0026lt;3 mmol\/l).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu mare care a inclus 435 pacienţi cu hipercolesterolemie familială - forma heterozigotă au fost trataţi cu rosuvastatina în doze între 20 mg şi 80 mg cu proiect de tatonare a dozelor. Toate dozele s-au demonstrat a avea efecte favorabile asupra parametrilor lipidici şi asupra valorilor ţintă terapeutice. După creşterea treptată până la o doză zilnică de 40 mg (la 12 săptămâni de tratament), concentraţia LDL-C s-a redus cu 53%. 33% din pacienţi au atins valorile recomandate pentru LDL-C de către EAS (\u0026lt;3 mmol\/l). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu deschis, cu proiect de tatonare a dozelor, 42 pacienţi cu hipercolesterolemie familială - forma homozigotă au fost evaluaţi privind răspunsul lor la tratamentul cu doze de 20-40 mg rosuvastatina. În toată populaţia, scăderea medie a valorilor LDL-C a fost de 22%.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiile clinice cu un număr limitat de pacienţi, rosuvastatina a demonstrat o eficacitate suplimentară în ceea ce priveşte scăderea concentraţiei plasmatice a trigliceridelor atunci când a fost administrată în asociere cu fenofibrat şi în ceea ce priveşte creşterea concentraţiei plasmatice a HDLC atunci când a fost administrat în asociere cu niacina.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu clinic multi-centric, dublu-orb, placebo-controlat (METEOR) la 984 pacienţi cu vârsta cuprinsă între 45 şi 70 ani, cu risc scăzut de boală coronariană (definis ca risc Framingham \u0026lt;10% pe o perioadă de 10 ani), cu valori medii ale LDL-colesterolului de 4,0 mmol\/l (154.5 mg\/dl), dar cu ateroscleroză subclinică (detectată prin testul CIMT - Carotid Intima Media Thickness) au fost repartizaţi randomizat la tratament cu rosuvastatină 40 mg o dată pe zi sau placebo, timp de 2 ani. Rosuvastatina a încetinit semnificativ rata de evoluţie a grosimii intimei arterei carotidiene (CIMT) comparativ cu placebo cu -0,0145 mm\/an [IÎ 95% -0.0196, -0.0093; p\u0026lt;0,0001]. Modificarea faţă de valorile bazale a fost de -0,0014 mm\/an (-0.12%\/an (fără semnificaţie statistică)) pentru rosuvastatină, comparativ cu evoluţia de +0,0131 mm\/an (1,12%\/an (p\u0026lt;0,0001)) pentru cei din grupul placebo. Nu a fost încă demonstrată relaţia directă între scăderea CIMT şi reducerea riscului evenimentelor cardiovasculare. Grupele de populaţie studiate în METEOR prezintă risc scăzut pentru boală coronariană şi nu reprezintă populaţia ţintă pentru doza de rosuvastatină de 40 mg. Această doză trebuie prescrisă numai la pacienţii cu hipercolesterolemie severă şi risc cardiovascular înalt.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePentru justificarea utilizării statinelor în prevenţia primară, a fost efectuat un studiu de evaluare intervenţională cu rosuvastatină (JUPITER), asupra efectelor rosuvastatinei asupra incidenţei evenimentelor majore cardiovasculare aterosclerotice la 17802 bărbaţi (\u0026gt;50 ani) şi femei (\u0026gt;60 ani). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eParticipanţii la studiu au fost repartizaţi randomizat la tratament cu placebo (n=8901) sau rosuvastatină 20 mg o dată pe zi (n=8901) şi au fost urmăriţi, în medie, timp de 2 ani. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eConcentraţia de LDL-colesterol a fost redusă cu 45% (p\u0026lt;0,001) în grupul tratat cu rosuvastatină, comparativ cu grupul tratat cu placebo. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-o analiză post-hoc a unor sub-grupe de pacienţi cu risc crescut cu scor de risc Framingham de bază de \u0026gt;20% (1558 subiecţi), s-a observat o reducere semnificativă a obiectivului combinat de mortalitate cardiovasculară, accident vascular cerebral şi infarct de miocard (p=0,028) la tratamentul cu rosuvastatină versus placebo. Reducerea absolută a ratei riscului de eveniment per 1000 pacient-ani a fost de 8,8. În cadrul acestui grup de risc înalt, mortalitatea totală a rămas nemodificată (p=0,193). Într-o analiză post-hoc a unor sub-grupe de pacienţi cu risc crescut (9302 subiecţi) cu un scor de risc de bază de \u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e\u003c\/span\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e 5% (extrapolat pentru a include subiecţi cu vârsta de peste 65 ani), s-a observat o reducere semnificativă a obiectivului combinat final de mortalitate cardiovasculară, accident vascular cerebral şi infarct de miocard (p=0,0003) la grupul tratat cu rosuvastatină, faţă de cel tratat cu placebo. Reducerea absolută a ratei riscului de eveniment per 1000 pacient-ani a fost de 5,1. În cadrul acestui grup de risc înalt, mortalitatea totală a rămas nemodificată (p=0,076). \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎn studiul JUPITER, 6,6% dintre pacienţii trataţi cu rosuvastatină şi 6,2% dintre subiecţii trataţi cu placebo au întrerupt studiul din cauza unui eveniment advers. Cele mai frecvente reacţii adverse care au determinat întreruperea tratamentului au fost: mialgie (0,3% la rosuvastatină, 0,2% la placebo), durere abdominală (0,03% la rosuvastatină, 0,02% la placebo) şi erupţie cutanată tranzitorie (0,02% la rosuvastatină, 0,03% la placebo). Cele mai frecvente reacţii adverse cu proporţie mai mare sau egală cu grupul placebo au fost: infecţie urinară (8,7% la rosuvastatină, 8,6% la placebo), nazofaringită (7,6% la rosuvastatină, 7,2% la placebo), durere dorsală (7,6% la rosuvastatină, 6,9% la placebo) şi mialgie (7,6% la rosuvastatină, 6,6% la placebo).\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cu\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/u\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu dublu-orb, randomizat, multi-centric, placebo-controlat, de 12 săptămâni (n=176,97 de sex masculin şi 79 de sex feminin) urmat de o fază deschisa de încă 40 săptămâni (n=173,96 de sex masculin şi 77 de sex feminin), au participat pacienţi cu vârsta de 10 până la 17 ani (în stadiu Tanner II-V, iar fetele la cel puţin 1 an după menarhă) cu hipercolesterolemie familială heterozigotă, care au primit rosuvastatină 5, 10 sau 20 mg pe zi sau placebo, timp de 12 săptămâni, după care toţi au primit rosuvastatină o dată pe zi, timp de 40 săptămâni. La intrarea în studiu, aproximativ 30% dintre pacienţi aveau vârsta între 10\u0026gt;13 ani şi aproximativ 17%, 18%, 40%, şi 25% au fost în stadii Tanner II, III, IV, şi V.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eConcentraţia LDL-colesterolului a fost redusă cu 38,3%, 44,6% şi 50,0% în urma tratamentului cu rosuvastatină în doză de 5, 10 şi, respectiv, 20 mg, comparativ cu 0,7% pentru cei din grupul placebo.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLa sfârşitul celor 40 săptămâni de fază deschisă, cu creşterea dozei de până la maxim 20 mg o dată pe zi, 70 din cei 173 pacienţi (40,5%) au atins nivelul ţintă al concentraţiei LDL-colesterolului de sub 2,8 mmol\/l.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDupă cele 52 săptămâni de tratament ale studiului, nu au fost observate efecte asupra creşterii, greutăţii corporale, indexului masei corporale sau a maturizării sexuale (vezi pct. 4.4). Datele din studii clinice la copii şi adolescenţi sunt limitate, iar efectele pe termen lung ale rosuvastatinei (\u0026gt;1 an) asupra pubertăţii sunt necunoscute. Acest studiu (n=176) nu a fost conceput pentru comparaţii ale reacţiilor adverse rare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eProprietăţi farmacocinetice\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAbsorbţie\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eConcentraţiile plasmatice maxime de rosuvastatină se ating după 5 ore de la administrarea orală. Biodisponibilitatea absolută este de aproximativ 20%.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDistribuţie\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este captată extensiv de ficat, care este principalul loc de sinteză a colesterolului şi al clearance-ului LDL-C. Volumul aparent de distribuţie al rosuvastatinei este de aproximativ 134 l. Aproximativ 90% din rosuvastatină se leagă de proteinele plasmatice, în principal de albumină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eMetabolizare\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRosuvastatina este metabolizată limitat (de aproximativ 10%). Studiile in vitro asupra metabolismului, în care s-au folosit hepatocite umane au arătat că rosuvastatina este un substrat slab pentru metabolizarea dependentă de citocromul P450. Principala izoenzimă implicată a fost CYP2C9 iar izoenzimă 2C19, 3A4 şi 2D6 au fost implicate într-o măsură mai mică. Principalii metaboliţi identificaţi sunt N-desmetil- şi lacton-metaboliţii. Metabolitul N-desmetil este cu aproximativ 50% mai puţin activ decât rosuvastatina, în timp ce metabolitul lactonă este considerat inactiv clinic.Rosuvastatina este responsabilă de inhibarea activităţii a mai mult de 90% din HMG-CoA reductaza circulantă.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEliminare\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAproximativ 90% din doza de rosuvastatină se excretă nemodificată în materiile fecale (constând în substanţă activă absorbită şi neabsorbită), iar restul este excretată prin urină. Aproximativ 5% este excretată nemodificat prin urină. Timpul de înjumătăţire plasmatică prin eliminare este de aproximativ 20 ore. Timpul de înjumătăţire plasmatică prin eliminare nu creşte la administrarea unor doze mai mari. Media geometrică a clearance-ului plasmatic este de aproximativ 50 litri\/oră (coeficient de variaţie 21,7%). Ca şi în cazul altor inhibitori de HMG-CoA reductază, captarea hepatică a rosuvastatinei implică transportorul membranar OATP-C. Acest sistem de transport este important pentru eliminarea hepatică a rosuvastatinei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLiniaritate\/nonliniaritate\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eExpunerea sistemică la rosuvastatină creşte proporţional cu doza administrată. Administrarea mai multor doze zilnice nu este urmată de modificări ale parametrilor farmacocinetici.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eGrupe speciale de populaţie\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eVârstă şi sex\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu s-a constatat nici o modificare semnificativă clinic, legată de vârstă sau de sex, în ceea ce priveşte farmacocinetica rosuvastatinei la adulţi. Farmacocinetica rosuvastatinei la copii şi adolescenţi cu hipercolesterolemie familială heterozigotă a fost similară celei a voluntarilor tineri.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eRasă\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eStudii de farmacocinetică au aratat o creştere de aproximativ 2 ori a valorilor medii ale ASC şi Cmax la pacienţii asiatici (Japonia, China, Filipine, Vietnam şi Coreea) comparativ cu pacienţii de rasa albă; populaţiile asiatice-indiene prezintă o creştere de aproximativ 1,3 ori a valorilor medii ale ASC şi Cmax. O analiză populaţională de farmacocinetică la pacienţii de rasă albă şi neagră nu a arătat diferenţe clinic relevante ale parametrilor farmacocinetici.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInsuficienţă renală\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu efectuat la pacienţi în diferite grade ale insuficienţei renale, insuficienţa renală uşoară până la moderată nu influenţează concentraţia plasmatică a rosuvastatinei sau a metabolitului său Ndesmetil. Pacienţii cu insuficienţă renală severă (clearance-ul la creatinină \u0026lt; 30 ml\/min) au prezentat o concentraţie plasmatică de rosuvastatină de 3 ori mai mare şi o concentraţie plasmatică a metabolitului N-desmetil de 9 ori mai mare, comparativ cu voluntarii sănătoşi. Concentraţiile plasmatice ale rosuvastatinei, la starea de echilibru, la pacienţii care efectuează hemodializă au fost cu aproximativ 50% mai mari comparativ cu voluntarii sănătoşi.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eInsuficienţă hepatică\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eÎntr-un studiu efectuat la pacienţi cu diferite grade de afectare hepatică, nu s-a evidenţiat creşterea expunerii la rosuvastatină la pacienţii cu un scor Child-Pugh de 7 sau mai mic. Cu toate acestea, 2 pacienţi cu scoruri Child-Pugh de 8 şi 9 au prezentat o creştere a expunerii sistemice la rosuvastatină de cel puţin de 2 ori mai mare comparativ cu pacienţii care prezentau scoruri Child-Pugh mai mici. Nu au fost studiaţi pacienţi cu scoruri Child-Pugh mai mari de 9.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopii şi adolescenţi\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eParametrii farmacologici la copii şi adolescenţi cu hipercolesterolemie familială heterozigotă cu vârsta între 10 şi 17 ani nu au avut caracteristici deosebite. Un stdiu farmacocinetic de mici dimensiuni cu rosuvastatină (administrată sub formă de comprimate) la 18 copii a demonstrat că nivelul concentraţiei plasmatice la copii pare similar adulţilor. În plus, rezultatele arată că nu se aşteaptă modificări ale proporţionalităţii dozei.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDate preclinice de siguranţă\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDatele preclinice din studiile convenţionale de siguranţă farmacologică,de toxicitate după doze repetate, de genotoxicitate şi potenţial carcinogen nu au arătat nici un risc deosebit pentru om.  Nu au fost evaluate testele specifice asupra hERG. Reacţiile adverse care nu au apărut în studiile clinice, însă au fost prezente la animale la administrarea unor doze similare celor recomandate au fost următoarele: în studiile de toxicitate la doze repetate, s-au produs modificări histopatologice hepatice probabil datorate acţiunii farmacologice a rosuvastatinei, la şoarece, şobolan şi, în mai mică măsură, la nivelul veziculei biliare la câini, dar nu şi la maimuţe. În plus, la maimuţe şi câini, la doze crescute, a fost observată toxicitate testiculară. Într-un studiu efectuat la şobolan, pre- şi postnatal, toxicitatea asupra funcţiei de reproducere a fost evidentă, ţinând cont de dimensiunile, greutatea feţilor şi supravieţuirea puilor reduse. Aceste efecte au fost observate la doze toxice pentru mame la o expunere sistemică de câteva ori mai mare decât nivelul terapeutic de expunere sistemică. \u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePROPRIETĂŢI FARMACEUTICE\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLista excipienţilor\u003c\/span\u003e\u003c\/em\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNucleu\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLactoză anhidră\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCeluloză microcristalină\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCrospovidonă\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eStearat de magneziu\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDioxid de siliciu coloidal anhidru.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cem\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eFilm\u003c\/span\u003e\u003c\/em\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eLactoză monohidrat\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDioxid de titan (E171)\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eMacrogol 6000\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eCopolimer butyl-metacrilat\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eIncompatibilităţi\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNu este cazul.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePerioada de valabilitate\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e3 ani.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003ePrecauţii speciale pentru păstrare\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eAcest medicament nu necesită precauţii speciale de păstrare.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eA se păstra în ambalajul original, pentru a fi protejat de lumină.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eNatura şi conţinutul ambalajului\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eBlistere perforate din OPA-Al-PVC-Al): cutie cu 10, 14, 20, 28, 30, 56, 60, 84, 90, 98 şi 100 comprimate filmate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eEste posibil ca nu toate mărimile de ambalaj să fie comercializate.\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cstrong\u003e\u003cspan style=\"line-height: 12.84px;\"\u003eDEŢINĂTORUL AUTORIZAŢIEI DE PUNERE PE PIAŢĂ\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"color: #222222; font-family: Arial, Helvetica, sans-serif; font-size: 13px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: #fcfdfd; text-decoration-style: initial; text-decoration-color: initial;\"\u003e\u003cspan style=\"font-size: 12px;\"\u003e\u003cspan style=\"font-family: arial, helvetica, sans-serif;\"\u003e\u003cspan style=\"line-height: 12.84px;\"\u003e KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia\u003c\/span\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e","brand":"KRKA d.d., Novo mesto","offers":[{"title":"Default Title","offer_id":43907942219916,"sku":"40352","price":46.18,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/40352.jpg?v=1732807086"},{"product_id":"atoris-10mg-compfilm","title":"Atoris 10mg comp.film.","description":"\u003cp\u003e1. CE ESTE ATORIS SI PENTRU CE SE UTILIZEAZA \u003cbr\u003eAtoris face parte dintr-o clasa de medicamente cunoscute sub denumirea de statine, care sunt medicamente pentru reglarea valorii lipidelor (grasimii).\u003c\/p\u003e\r\n\u003cp\u003eAtoris este utilizat pentru scaderea lipidelor din singe, cunoscute sub numele de colesterol si trigliceride, atunci cand o dieta cu cantitati scazute de grasimi si modificarea stilului de viata nu au fost eficace. Daca prezentati risc crescut de boala de inima, Atoris poate, de asemenea, sa fie utilizat pentru scaderea riscului chiar daca valorile colesterolului dumneavoastra sunt normale. In timpul tratamentului trebuie sa continuati dieta standard de scadere a colesterolului.\u003c\/p\u003e\r\n\u003cp\u003e2. INAINTE SA UTILIZATI ATORIS \u003cbr\u003eNu utilizati Atoris \u003cbr\u003e- daca sunteti hipersensibil (alergic) la Atoris, la oricare medicament asemănător utilizat pentru scaderea nivelului lipidelor in sange sau la oricare dintre celelalte componente ale Atoris - pentru detalii, vezi punctul 6; \u003cbr\u003e- daca aveti sau ati avut vreodata o afectiune a ficatului; \u003cbr\u003e- daca ati avut valori anormale, inexplicabile, ale testelor functiei hepatice; \u003cbr\u003e- daca sunteti femeie care poate sa aiba copii si nu utilizati o metoda de contraceptie eficace; \u003cbr\u003e- daca sunteti gravida, incercati sa deveniti gravida \u003cbr\u003e- daca alaptati.\u003c\/p\u003e\r\n\u003cp\u003eAveti grija deosebita cand utilizati Atoris \u003cbr\u003eUrmatoarele constituie motive pentru care Atoris poate sa nu fie adecvat pentru dumneavoastra: \u003cbr\u003e- daca ati avut accident vascular cerebral cu sangerare la nivelul creierului sau daca aveti mici pungi de lichid la nivelul creierului din cauza unor atacuri cerebrale vasculare precedente \u003cbr\u003e- daca aveti probleme ale rinichilor; \u003cbr\u003e- daca aveti o reducere a functiei glandei tiroide (hipotiroidism); \u003cbr\u003e- daca aveti sau ati avut vreodata dureri musculare repetate sau neexplicate, istoric personal sau familial de afectiuni musculare; \u003cbr\u003e- daca ati avut in trecut afectiuni musculare in timpul tratamentului cu alte medicamente pentru scaderea valorii lipidelor (de exemplu alte \"statine\" sau \"fibrati\"); \u003cbr\u003e- daca consumati cu regularitate o cantitate mare de alcool etilic ; \u003cbr\u003e- daca ati avut afectiuni ale ficatului; \u003cbr\u003e- daca aveti varsta peste 70 de ani. \u003cbr\u003eInaintea inceperii tratamentului cu Atoris, adresati-va medicului dumneavoastra sau farmacistului \u003cbr\u003e- daca aveti insuficienta respiratorie grava. \u003cbr\u003eDaca vreuna dintre atentionarile de mai sus este valabila in cazul dumneavoastra, este posibil ca medicul dumneavoastra sa doreasca sa vi se efectueze analize ale sangelui inainte si in timpul tratamentului cu Atoris, pentru a evalua riscul dumneavoastra de a face reactii adverse musculare. Se stie ca riscul reactiilor adverse musculare, cum ar fi rabdomioliza, este mai mare la utilizarea concomitenta, in acelasi timp, a mai multor medicamente (vezi punctul 2 “Utilizarea altor medicamente”).\u003c\/p\u003e\r\n\u003cp\u003eUtilizarea altor medicamente \u003cbr\u003eSunt unele medicamente care pot modifica efectul Atoris sau efectul acestora poate fi modificat de catre Atoris. Acest tip de interactiune poate duce la scaderea eficacitatii unuia sau ambelor medicamente. In plus, aceasta interactiune ar putea creste riscul sau severitatea reactiilor adverse, incluzand afectarea importanta a muschilor, cunoscuta sub numele de rabdomioliza, descrisa la punctul 4. \u003cbr\u003e• Medicamente utilizate pentru a modifica modul in care actioneaza sistemul dumneavoastra imunitar, de exemplu ciclosporina; \u003cbr\u003e• Anumite medicamente antibiotice sau antifungice, de exemplu eritromicina, claritromicina, telitromicina, ketoconazol, itraconazol,voriconazol, fluconazol, posaconazol, rifampicina, acid fusidic; \u003cbr\u003e• Alte medicamente care rregleaza valorile lipidelor, de exemplu, gemfibrozil, alti fibrati, colestipol; \u003cbr\u003e• Anumite blocante ale canalelor de calciu, utilizate in tratamentul anginei pectorale sau al tensiunii arterial mari, de exemplu amlodipina, diltiazem; medicamente care va regleaza ritmul inimii, de exemplu digoxina, verapamil, amiodarona; \u003cbr\u003e• Medicamente utilizate utilizate in tratamentul HIV, de exemplu, ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.; \u003cbr\u003e• Alte medicamente cunoscute ca interactioneaza cu Atoris, incluzand ezetimib (care reduce nivelul colesterolului in sange), contraceptivele orale, stiripentol (un anticonvulsivant pentru tratamentul epilepsiei), cimetidina (utilizata in arsuri gastrice si ulcere gastroduodenale), fenazona (un calmant al durerii) si antiacidele (medicamente pentru indigestie, care contin aluminiu sau magneziu). \u003cbr\u003e• Medicamente eliberate fara prescriptie medicala: sunatoare. \u003cbr\u003eVa rugam sa spuneti medicului dumneavoastra sau farmacistului daca luati sau ati luat recent orice alte medicamente, inclusiv dintre cele eliberate fara prescriptie medicala. \u003cbr\u003eUtilizarea Atoris cu alimente si bauturi \u003cbr\u003ePentru instructiuni privind utilizarea Atoris vezi punctul 3. Va rugam luati in considerare urmatoarele: \u003cbr\u003eSuc de grapefrut \u003cbr\u003eNu beti mai mult de unul sau doua pahare mici de suc de grapefrut pe zi, deoarece cantitatile mari de suc de grapefrut pot modifica efectele Atoris. \u003cbr\u003eAlcool etilic \u003cbr\u003eEvitati consumul in cantitate mare de alcool etilic in timpul tratamentului cu acest medicament. Pentru detalii, vezi punctul 2 “Aveti grija deosebita cand utilizati Atoris”.\u003c\/p\u003e\r\n\u003cp\u003eSarcina si alaptarea \u003cbr\u003eNu luati Atoris daca sunteti gravida sau incercati sa deveniti gravida. \u003cbr\u003eNu luati Atoris daca sunteti la varsta cand puteti face copii, decat daca folositi metode contraceptive adecvate. \u003cbr\u003eNu luati Atoris daca alaptati. \u003cbr\u003eSiguranta utilizarii Atoris in timpul sarcinii si alaptarii nu a fost inca dovedita. \u003cbr\u003eAdresati-va medicului dumneavoastra sau farmacistului pentru recomandari inainte de a lua orice medicament. \u003cbr\u003eConducerea vehiculelor si folosirea utilajelor \u003cbr\u003eIn mod normal, acest medicament nu va afecteaza capacitatea de a conduce vehicule sau de a folosi utilaje. Cu toate acestea, nu conduceti vehicule, daca acest medicament va influenteaza aceasta capacitate. Nu utilizati instrumente sau utilaje, daca capacitatea dumneavoastra de a le utiliza este afectata de acest medicament. \u003cbr\u003eInformatii importante privind unele componente ale Atoris \u003cbr\u003eAtoris contine lactoza. Daca medicul dumneavoastra v-a atentionat ca aveti intoleranta la unele categorii de glucide, va rugam sa-l intrebati inainte de a lua acest medicament.\u003c\/p\u003e\r\n\u003cp\u003e3. CUM SA UTILIZATI ATORIS \u003cbr\u003eInainte de inceperea tratamentului, medicul dumneavoastra va va recomanda o dieta cu continut scazut de colesterol, pe care trebuie sa o respectati, de asemenea, in timpul tratamentului cu Atoris. \u003cbr\u003eDoza initiala uzuala de Atoris este de 10 mg o data pe zi, la adulti si copii cu varsta de 10 ani sau mai peste. Aceasta doza poate fi crescuta de catre medicul dumneavoastra, daca este cazul, pana cand se ajunge la doza care va este necesara. Medicul dumneavoastra va adapta dozele la intervale de cate 4 saptamani sau mai mult. Doza maxima de Atoris este 80 mg o data pe zi la adulti si de 20 mg o data pe zi la copii. \u003cbr\u003eComprimatele de Atoris trebuie inghitite intregi, cu apa si pot fi administrate in orice moment al zilei, cu sau fara alimente. Cu toate acestea, incercati sa luati comprimatul in orice moment al zilei, in fiecare zi. \u003cbr\u003eUtilizati intotdeauna Atoris exact asa cum v-a spus medicul dumneavoastra. Trebuie sa discutati cu medicul dumneavoastra sau cu farmacistul daca nu sunteti sigur. \u003cbr\u003eDurata tratamentului cu Atoris este determinata de catre medicul dumneavoastra. \u003cbr\u003eAdresati-va medicului daca observati ca efectul Atoris este prea puternic sau prea slab.\u003c\/p\u003e\r\n\u003cp\u003e4. CUM SE PASTREAZA ATORIS \u003cbr\u003eA nu se lasa la vederea si indemana copiilor. \u003cbr\u003eA se pastra in ambalajul original, pentru a fi protejat de lumina si umiditate. \u003cbr\u003eNu utilizati Atoris dupa data de expirare inscrisa pe ambalaj. Data de expirare se refera la ultima zi a lunii respective. \u003cbr\u003eMedicamentele nu trebuie aruncate pe calea apei sau a reziduurilor menajere. Intrebati farmacistul cum sa eliminati medicamentele care nu va mai sunt necesare. Aceste masuri vor ajuta la protejarea mediului.\u003c\/p\u003e\r\n\u003cp\u003e5. INFORMATII SUPLIMENTARE \u003cbr\u003eCe contine Atoris \u003cbr\u003e- Substanta activa este atorvastatina. \u003cbr\u003e- Fiecare comprimat filmat de Atoris de 10 mg contine atorvastatina 10 mg, sub forma de atorvastatina calcica. \u003cbr\u003e- Celelalte componente sunt: nucleu-hidroxid de sodiu, laurilsulfat de sodiu, hidroxipropilceluloza, lactoza monohidrat, celuloza microcristalina, croscarmeloza sodica, \u003cbr\u003ecrospovidona, stearat de magneziu si film-alcool polivinil, dioxid de titan (E 171), macrogol 3000 si talc.\u003c\/p\u003e\r\n\u003cp\u003e \u003c\/p\u003e","brand":"KRKA d.d., Novo mesto","offers":[{"title":"Default Title","offer_id":43915791270028,"sku":"2752","price":49.59,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/2752.jpg?v=1750856740"},{"product_id":"atoris-20mg-compfilm","title":"Atoris 20mg comp.film.","description":"\u003cp\u003e1. CE ESTE ATORIS SI PENTRU CE SE UTILIZEAZA \u003cbr\u003eAtoris face parte dintr-o clasa de medicamente cunoscute sub denumirea de statine, care sunt medicamente pentru reglarea valorii lipidelor (grasimii).\u003c\/p\u003e\r\n\u003cp\u003eAtoris este utilizat pentru scaderea lipidelor din singe, cunoscute sub numele de colesterol si trigliceride, atunci cand o dieta cu cantitati scazute de grasimi si modificarea stilului de viata nu au fost eficace. Daca prezentati risc crescut de boala de inima, Atoris poate, de asemenea, sa fie utilizat pentru scaderea riscului chiar daca valorile colesterolului dumneavoastra sunt normale. In timpul tratamentului trebuie sa continuati dieta standard de scadere a colesterolului.\u003c\/p\u003e\r\n\u003cp\u003e2. INAINTE SA UTILIZATI ATORIS \u003cbr\u003eNu utilizati Atoris \u003cbr\u003e- daca sunteti hipersensibil (alergic) la Atoris, la oricare medicament asemănător utilizat pentru scaderea nivelului lipidelor in sange sau la oricare dintre celelalte componente ale Atoris - pentru detalii, vezi punctul 6; \u003cbr\u003e- daca aveti sau ati avut vreodata o afectiune a ficatului; \u003cbr\u003e- daca ati avut valori anormale, inexplicabile, ale testelor functiei hepatice; \u003cbr\u003e- daca sunteti femeie care poate sa aiba copii si nu utilizati o metoda de contraceptie eficace; \u003cbr\u003e- daca sunteti gravida, incercati sa deveniti gravida \u003cbr\u003e- daca alaptati.\u003c\/p\u003e\r\n\u003cp\u003eAveti grija deosebita cand utilizati Atoris \u003cbr\u003eUrmatoarele constituie motive pentru care Atoris poate sa nu fie adecvat pentru dumneavoastra: \u003cbr\u003e- daca ati avut accident vascular cerebral cu sangerare la nivelul creierului sau daca aveti mici pungi de lichid la nivelul creierului din cauza unor atacuri cerebrale vasculare precedente \u003cbr\u003e- daca aveti probleme ale rinichilor; \u003cbr\u003e- daca aveti o reducere a functiei glandei tiroide (hipotiroidism); \u003cbr\u003e- daca aveti sau ati avut vreodata dureri musculare repetate sau neexplicate, istoric personal sau familial de afectiuni musculare; \u003cbr\u003e- daca ati avut in trecut afectiuni musculare in timpul tratamentului cu alte medicamente pentru scaderea valorii lipidelor (de exemplu alte \"statine\" sau \"fibrati\"); \u003cbr\u003e- daca consumati cu regularitate o cantitate mare de alcool etilic ; \u003cbr\u003e- daca ati avut afectiuni ale ficatului; \u003cbr\u003e- daca aveti varsta peste 70 de ani. \u003cbr\u003eInaintea inceperii tratamentului cu Atoris, adresati-va medicului dumneavoastra sau farmacistului \u003cbr\u003e- daca aveti insuficienta respiratorie grava. \u003cbr\u003eDaca vreuna dintre atentionarile de mai sus este valabila in cazul dumneavoastra, este posibil ca medicul dumneavoastra sa doreasca sa vi se efectueze analize ale sangelui inainte si in timpul tratamentului cu Atoris, pentru a evalua riscul dumneavoastra de a face reactii adverse musculare. Se stie ca riscul reactiilor adverse musculare, cum ar fi rabdomioliza, este mai mare la utilizarea concomitenta, in acelasi timp, a mai multor medicamente (vezi punctul 2 “Utilizarea altor medicamente”).\u003c\/p\u003e\r\n\u003cp\u003eUtilizarea altor medicamente \u003cbr\u003eSunt unele medicamente care pot modifica efectul Atoris sau efectul acestora poate fi modificat de catre Atoris. Acest tip de interactiune poate duce la scaderea eficacitatii unuia sau ambelor medicamente. In plus, aceasta interactiune ar putea creste riscul sau severitatea reactiilor adverse, incluzand afectarea importanta a muschilor, cunoscuta sub numele de rabdomioliza, descrisa la punctul 4. \u003cbr\u003e• Medicamente utilizate pentru a modifica modul in care actioneaza sistemul dumneavoastra imunitar, de exemplu ciclosporina; \u003cbr\u003e• Anumite medicamente antibiotice sau antifungice, de exemplu eritromicina, claritromicina, telitromicina, ketoconazol, itraconazol,voriconazol, fluconazol, posaconazol, rifampicina, acid fusidic; \u003cbr\u003e• Alte medicamente care rregleaza valorile lipidelor, de exemplu, gemfibrozil, alti fibrati, colestipol; \u003cbr\u003e• Anumite blocante ale canalelor de calciu, utilizate in tratamentul anginei pectorale sau al tensiunii arterial mari, de exemplu amlodipina, diltiazem; medicamente care va regleaza ritmul inimii, de exemplu digoxina, verapamil, amiodarona; \u003cbr\u003e• Medicamente utilizate utilizate in tratamentul HIV, de exemplu, ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.; \u003cbr\u003e• Alte medicamente cunoscute ca interactioneaza cu Atoris, incluzand ezetimib (care reduce nivelul colesterolului in sange), contraceptivele orale, stiripentol (un anticonvulsivant pentru tratamentul epilepsiei), cimetidina (utilizata in arsuri gastrice si ulcere gastroduodenale), fenazona (un calmant al durerii) si antiacidele (medicamente pentru indigestie, care contin aluminiu sau magneziu). \u003cbr\u003e• Medicamente eliberate fara prescriptie medicala: sunatoare. \u003cbr\u003eVa rugam sa spuneti medicului dumneavoastra sau farmacistului daca luati sau ati luat recent orice alte medicamente, inclusiv dintre cele eliberate fara prescriptie medicala. \u003cbr\u003eUtilizarea Atoris cu alimente si bauturi \u003cbr\u003ePentru instructiuni privind utilizarea Atoris vezi punctul 3. Va rugam luati in considerare urmatoarele: \u003cbr\u003eSuc de grapefrut \u003cbr\u003eNu beti mai mult de unul sau doua pahare mici de suc de grapefrut pe zi, deoarece cantitatile mari de suc de grapefrut pot modifica efectele Atoris. \u003cbr\u003eAlcool etilic \u003cbr\u003eEvitati consumul in cantitate mare de alcool etilic in timpul tratamentului cu acest medicament. Pentru detalii, vezi punctul 2 “Aveti grija deosebita cand utilizati Atoris”.\u003c\/p\u003e\r\n\u003cp\u003eSarcina si alaptarea \u003cbr\u003eNu luati Atoris daca sunteti gravida sau incercati sa deveniti gravida. \u003cbr\u003eNu luati Atoris daca sunteti la varsta cand puteti face copii, decat daca folositi metode contraceptive adecvate. \u003cbr\u003eNu luati Atoris daca alaptati. \u003cbr\u003eSiguranta utilizarii Atoris in timpul sarcinii si alaptarii nu a fost inca dovedita. \u003cbr\u003eAdresati-va medicului dumneavoastra sau farmacistului pentru recomandari inainte de a lua orice medicament. \u003cbr\u003eConducerea vehiculelor si folosirea utilajelor \u003cbr\u003eIn mod normal, acest medicament nu va afecteaza capacitatea de a conduce vehicule sau de a folosi utilaje. Cu toate acestea, nu conduceti vehicule, daca acest medicament va influenteaza aceasta capacitate. Nu utilizati instrumente sau utilaje, daca capacitatea dumneavoastra de a le utiliza este afectata de acest medicament. \u003cbr\u003eInformatii importante privind unele componente ale Atoris \u003cbr\u003eAtoris contine lactoza. Daca medicul dumneavoastra v-a atentionat ca aveti intoleranta la unele categorii de glucide, va rugam sa-l intrebati inainte de a lua acest medicament.\u003c\/p\u003e\r\n\u003cp\u003e3. CUM SA UTILIZATI ATORIS \u003cbr\u003eInainte de inceperea tratamentului, medicul dumneavoastra va va recomanda o dieta cu continut scazut de colesterol, pe care trebuie sa o respectati, de asemenea, in timpul tratamentului cu Atoris. \u003cbr\u003eDoza initiala uzuala de Atoris este de 10 mg o data pe zi, la adulti si copii cu varsta de 10 ani sau mai peste. Aceasta doza poate fi crescuta de catre medicul dumneavoastra, daca este cazul, pana cand se ajunge la doza care va este necesara. Medicul dumneavoastra va adapta dozele la intervale de cate 4 saptamani sau mai mult. Doza maxima de Atoris este 80 mg o data pe zi la adulti si de 20 mg o data pe zi la copii. \u003cbr\u003eComprimatele de Atoris trebuie inghitite intregi, cu apa si pot fi administrate in orice moment al zilei, cu sau fara alimente. Cu toate acestea, incercati sa luati comprimatul in orice moment al zilei, in fiecare zi. \u003cbr\u003eUtilizati intotdeauna Atoris exact asa cum v-a spus medicul dumneavoastra. Trebuie sa discutati cu medicul dumneavoastra sau cu farmacistul daca nu sunteti sigur. \u003cbr\u003eDurata tratamentului cu Atoris este determinata de catre medicul dumneavoastra. \u003cbr\u003eAdresati-va medicului daca observati ca efectul Atoris este prea puternic sau prea slab.\u003c\/p\u003e\r\n\u003cp\u003e4. CUM SE PASTREAZA ATORIS \u003cbr\u003eA nu se lasa la vederea si indemana copiilor. \u003cbr\u003eA se pastra in ambalajul original, pentru a fi protejat de lumina si umiditate. \u003cbr\u003eNu utilizati Atoris dupa data de expirare inscrisa pe ambalaj. Data de expirare se refera la ultima zi a lunii respective. \u003cbr\u003eMedicamentele nu trebuie aruncate pe calea apei sau a reziduurilor menajere. Intrebati farmacistul cum sa eliminati medicamentele care nu va mai sunt necesare. Aceste masuri vor ajuta la protejarea mediului.\u003c\/p\u003e\r\n\u003cp\u003e5. INFORMATII SUPLIMENTARE \u003cbr\u003eCe contine Atoris \u003cbr\u003e- Substanta activa este atorvastatina. \u003cbr\u003e- Fiecare comprimat filmat de Atoris de 10 mg contine atorvastatina 10 mg, sub forma de atorvastatina calcica. \u003cbr\u003e- Celelalte componente sunt: nucleu-hidroxid de sodiu, laurilsulfat de sodiu, hidroxipropilceluloza, lactoza monohidrat, celuloza microcristalina, croscarmeloza sodica, \u003cbr\u003ecrospovidona, stearat de magneziu si film-alcool polivinil, dioxid de titan (E 171), macrogol 3000 si talc.\u003c\/p\u003e\r\n\u003cp\u003e \u003c\/p\u003e","brand":"KRKA d.d., Novo mesto","offers":[{"title":"Default Title","offer_id":43915535319180,"sku":"2753","price":57.95,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/2753.jpg?v=1750849799"},{"product_id":"hof-lipomin-comp","title":"Hof Lipomin comp.","description":"\u003cp\u003ePrezentare\u003cbr\u003e1 comprimat acoperit contine 305,00 mg extract de topinambur (Helianthi tuberosi tuber), 150,00 mg seminte de in (Lini semen), 80,00 mg carbonat de calciu echivalent la 32 mg Ca2+, 75,00 mg oxid de magneziu echivalent la 45 mg Mg2+, 60,00 mg ulei de in, 40,00 mg extract concentrat de usturoi (Allii sativi bulbus), 40 mg suc de praz (Allii porri), 15,00 mg carbonat de potasiu echivalent la 8,5 mg K+ si excipienti (polivinilpirolidona K30, stearat de magneziu, aerosil, hidroxipropilmetilceluloza, guma arabica, glucon delta lactone, dovlecel – Cucurbita pepo -, talc) pana la 820 mg.\u003cbr\u003e\u003cbr\u003eTopinamburul contine fitocomplexe de substante cu rol antioxidant, iar inulina din topinambur are efect in refacerea florei intestinale, reglarea tranzitului digestiv si detoxifierea colonului.\u003cbr\u003e\u003cbr\u003eUleiul de in contine o cantitate mare de mucilagii cu efect reglator al tranzitului intestinal. Contine acizi nesaturati de tip Omega 3 si Omega 6, cu rol binecunoscut in activitatea sistemului nervos central; contine acid oleic, cu rol protector si antioxidant pentru secretia normala de testosteron, cu efect in buna \u003cbr\u003ePrazul are in compozitia sa fibre si mucilagii cu rol in mentinerea unui tranzit intestinal normal, iar alliina si allicina pe care le contine au efect antihelmintic si antibiotic; este sursa deosebita de microelemente.\u003cbr\u003e\u003cbr\u003eINDICATII\u003cbr\u003eProdusul este un supliment alimentar si nu inlocuieste un regim alimentar variat si echilibrat. \u003cbr\u003eSe poate asocia ca supliment in regimul igieno – dietetic in tratamentele alopate hipocolesterolemiante, antihipertensive.\u003cbr\u003e\u003cbr\u003eACTIUNI\u003cbr\u003ehipolipemianta, hipocolesterolemianta, de scadere a trigliceridelor serice; regleaza raportul intre colesterolul „bun” si „rau” (HDL\/LDL).\u003cbr\u003e- asigura aportul de nutrienti si substante bioactive necesare echilibrarii dietei in prevenirea si combaterea aterosclerozei (inhiba ingrosarea si indurarea peretelui arterial, impiedicand reducerea progresiva a lumenului si pierderea elasticitatii vaselor arteriale); \u003cbr\u003e- reechilibrarea starilor de dislipidemie de diferite etiologii;\u003cbr\u003e- optimizarea nivelului colesterolului din organism; \u003cbr\u003e- neutralizarea si captarea de radicali liberi superoxidici;\u003cbr\u003e- inhiba reactiile de formare a grasimilor in organism si depunerea acestora.\u003cbr\u003e\u003cbr\u003eCONDITII DE PASTRARE\u003cbr\u003eA se pastra la temperaturi sub 25°C, ferit de umiditate si lumina, in ambalajul original!\u003cbr\u003eA nu se depasi doza zilnica recomandata!\u003cbr\u003eA se citi recomandarile inainte de utilizare!\u003cbr\u003eA se nu se utiliza dupa data de expirare inscrisa pe ambalaj!\u003cbr\u003eA nu se lasa la indemana copiilor mici!\u003cbr\u003eProdusul NU contine lactoza!\u003cbr\u003e\u003cbr\u003eADMINISTRARE\u003cbr\u003e1 – 2 comprimate de 2 – 3 ori pe zi dupa mesele principale sau dupa recomandarea medicului. Produsul se administreaza in cure prelungite (3 – 6 luni) sau chiar permanent.\u003cbr\u003e\u003cbr\u003e\u003cbr\u003e\u003c\/p\u003e","brand":"Hofigal","offers":[{"title":"Default Title","offer_id":43908139024524,"sku":"30430","price":184.39,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/products\/30430_e658085b-15cf-48dc-8e52-a6cd5fae7aa7.jpg?v=1625140229"},{"product_id":"romazic-10mg-compfilm","title":"Romazic 10mg comp.film.","description":"\u003cp\u003eRomazic 5 mg comprimate filmate\u003cbr\u003eRomazic 10 mg comprimate filmate\u003cbr\u003eRomazic 20 mg comprimate filmate\u003cbr\u003eRomazic 40 mg comprimate filmate\u003cbr\u003e\u003cbr\u003eRosuvastatină\u003cbr\u003e\u003cbr\u003eCitiţi cu atenţie şi în întregime acest prospect înainte de a începe să utilizaţi acest medicament deoarece conţine informaţii importante pentru dumneavoastră.\u003cbr\u003e- Păstraţi acest prospect. S-ar putea să fie necesar să-l recitiţi.\u003cbr\u003e- Dacă aveţi orice întrebări suplimentare, adresaţi-vă medicului dumneavoastră sau farmacistului .\u003cbr\u003e- Acest medicament a fost prescris numai pentru dumneavoastră. Nu trebuie să-l daţi altor persoane. Le poate face rău, chiar dacă au aceleaşi semne de boală ca dumneavoastră.\u003cbr\u003e- Dacă manifestaţi orice reacţii adverse adresaţi-vă medicului dumneavoastră sau farmacistului\u003cbr\u003e\u003cbr\u003eAcestea includ orice posibile reacţii adverse nemenţionate în acest prospect.Vezi punctul 4\u003cbr\u003e\u003cbr\u003eCe găsiţi în acest prospect:\u003cbr\u003e1. Ce este Romazic şi pentru ce se utilizează\u003cbr\u003e2. Ce trebuie să ştiţi înainte să utilizaţi Romazic\u003cbr\u003e3. Cum să utilizaţi Romazic\u003cbr\u003e4. Reacţii adverse posibile\u003cbr\u003e5. Cum se păstrează Romazic\u003cbr\u003e6. Conţinutul ambalajului şi alte informaţii\u003cbr\u003e\u003cbr\u003e1. Ce este Romazic şi pentru ce se utilizează\u003cbr\u003eRomazic aparţine unui grup de medicamente numite statine.\u003cbr\u003e\u003cbr\u003eVi s-a prescris Romazic deoarece:\u003cbr\u003e• aveţi concentraţie mare de colesterol în sânge. Aceasta înseamnă că prezentaţi risc pentru atac de cord sau accident vascular cerebral. Aţi fost sfătuit să utilizaţi o statină, deoarece schimbarea dietei dumneavoastră şi efectuarea de mai multe exerciţii fizice nu au fost măsuri suficiente pentru a vă corecta concentraţia de colesterol din sânge. Trebuie să continuaţi utilizarea dietei pentru reducerea colesterolului dumneavoastră şi exerciţiile fizice în perioada în\u003cbr\u003ecare luaţi Romazic, sau\u003cbr\u003e• aveţi alţi factori care vă cresc riscul de a avea atac de cord sau cerebrovascular sau probleme de sănătate înrudite.\u003cbr\u003eAtacul de cord sau cerebrovascular sau problemele de sănătate înrudite pot fi determinate de o afecţiune numită ateroscleroză.\u003cbr\u003eAteroscleroza se datorează depunerilor de depozite de grăsimi în arterele dumneavoastră.\u003cbr\u003eDe ce este important să luaţi în continuare Romazic?\u003c\/p\u003e\r\n\u003cp\u003eRomazic este utilizat pentru a corecta concentraţia substanţelor grase din sânge numite lipide, din care cea mai comună este constituită de colesterol.\u003cbr\u003e\u003cbr\u003eExistă în sânge diferite tipuri de colesterol- colesterol ‚rău’ (LDL-C) şi colesterol ‚bun’ (HDL-C).\u003cbr\u003eRomazic poate să scadă colesterolul ‚rău’ şi-l poate creşte pe cel ‚bun’.\u003cbr\u003eAcesta acţionează ajutând la blocarea producerii de colesterol rău de către organismul dumneavoastră.\u003cbr\u003eDe asemenea acesta îmbunătăţeşte capacitatea organismului dumneavoastră de a-l elimina din sângele dumneavoastră.\u003cbr\u003ePentru cei mai mulţi oameni, concentraţia mare de colesterol nu afectează felul în care se simt deoarece nu determină niciun simptom. Cu toate acestea, dacă nu se face tratament, depozitele de grăsimi se pot lipi în pereţii vaselor dumneavoastră de sânge determinând îngustarea acestora.\u003cbr\u003eUneori aceste vase de sânge îngustate se pot bloca ceea ce poate opri aprovizionarea cu sânge a inimii sau creierului ducând astfel la atac de cord sau cerebrovascular. Prin scăderea concentraţiei dumneavoastră de colesterol, puteţi să vă reduceţi riscul de accident cardiac, accident cerebrovascular sau probleme de sănătate înrudite.\u003cbr\u003e\u003cbr\u003eTrebuie să menţineţi utilizarea de Romazic chiar dacă aţi ajuns la concentraţia normală de colesterol în sânge, deoarece aceasta previne reluarea creşterii concentraţiei de colesterol şi determinarea depunerilor de depozite de grăsimi. Cu toate acestea, trebuie să opriţi utilizarea acestuia dacă medicul dumneavoastră vă recomandă aceasta sau dacă rămâneţi gravidă.\u003cbr\u003e\u003cbr\u003e2. Ce trebuie să ştiţi înainte să utilizaţi Romazic\u003cbr\u003eNu utilizaţi Romazic\u003cbr\u003e• dacă sunteţi alergic la rosuvastatină sau la oricare dintre celelalte componente ale acestui medicament (enumerate la punctul 6).\u003cbr\u003e• dacă sunteţi gravidă sau alăptaţi\u003cbr\u003eDacă rămâneţi gravidă în cursul tratamentului cu Romazic, întrerupeţi imediat tratamentul şi spuneţi medicului dumneavoastră. Femeile trebuie să evite să rămână gravide în perioada în care utilizează Romazic prin folosirea de măsuri contraceptive corespunzătoare.\u003cbr\u003e• dacă aveţi afecţiuni hepatice\u003cbr\u003e• dacă aveţi probleme renale severe\u003cbr\u003e• dacă aveţi dureri musculare repetate sau inexplicabile\u003cbr\u003e• dacă utilizaţi un medicament numit ciclosporină (utilizat de exemplu, după transplantul de organ).\u003cbr\u003eDacă vă aflaţi în oricare din aceste situaţii, vă rugăm să vă întoarceţi să discutaţi cu medicul dumneavoastră.\u003cbr\u003e\u003cbr\u003eÎn plus, nu utilizaţi Romazic 40 mg (doza cea mai mare):\u003cbr\u003e• dacă aveţi probleme moderate cu rinichii (dacă aveţi îndoieli, vă rugăm să întrebaţi medicul dumneavoastră)\u003cbr\u003e• dacă glanda dumneavoastră tiroidă nu funcţionează corespunzător\u003cbr\u003e• dacă aţi avut orice fel de durere musculară repetată sau inexplicabilă, probleme cu muşchii dumneavoastră sau în istoricul familiei sau probleme cu muşchii în trecut când aţi utilizat alte medicamente care scad concentraţia de colesterol din sânge\u003cbr\u003e• dacă obişnuiţi să consumaţi cu regularitate cantităţi mari de alcool etilic\u003cbr\u003e• dacă sunteţi de origine asiatică (japonez, chinez, filipinez, vietnamez, corean sau indian)\u003cbr\u003e• dacă utilizaţi alte medicamente pentru scăderea colesterolului din sânge numite fibraţi.\u003cbr\u003e\u003cbr\u003eDacă vă aflaţi în oricare din situaţiile menţionate (sau aveţi îndoieli), vă rugăm să vă întoarceţi şi să discutaţi cu medicul dumneavoastră.\u003cbr\u003e\u003cbr\u003eAtenţionări şi precauţii\u003cbr\u003eÎnainte să utilizaţi Romazic, adresaţi-vă medicului dumneavoastră sau farmacistului\u003cbr\u003e• dacă a aveţi probleme cu rinichii\u003cbr\u003e• dacă a aveţi probleme cu ficatul \u003cbr\u003e• dacă aţi avut orice dureri repetate sau inexplicabile la nivelul muşchilor, probleme musculare în trecutul dumneavoastră sau al familiei, sau probleme musculare în trecut în cazul utilizării altor medicamente pentru reducerea concentraţiei de colesterol din sânge. dumneavoastră personal sau o persoană din familia dumneavoastră, sau probleme musculare în trecut când aţi utilizat alte medicamente care reduc colesterolul din sânge.\u003c\/p\u003e\r\n\u003cp\u003eSpuneţi imediat medicului dumneavoastră dacă aveţi dureri musculare inexplicabile în special dacă nu vă simţiţi bine sau aveţi febră. De asemenea spuneţi-i medicului dumneavoastră dacă aveţi constant stare de slabiciune a muşchilor.\u003cbr\u003e• dacă obişnuiţi să consumaţi cu regularitate cantităţi mari de alcool etilic.\u003cbr\u003e• dacă glanda dumneavoastră tiroidă nu funcţionează corespunzător\u003cbr\u003e• dacă utilizaţi alte medicamente numite fibraţi pentru a scădea colesterolul din sânge\u003cbr\u003e\u003cbr\u003eVă rugăm să citiţi cu atenţie acest prospect, chiar dacă aţi utilizat alte medicamente pentru scăderea concentraţiilor mari de colesterol din sânge\u003cbr\u003e• dacă utilizaţi medicamente utilizate pentru tratamenul infecţiilor cu HIV cum sunt ritornavir cu lopinavir şi\/sau atazanavir, vă rugăm să vedeţi punctul „Romazic împreună cu alte medicamente”\u003cbr\u003e• dacă pacientul are vârsta sub 18 ani: Romazic nu este potrivit pentru administrare la copii şi adolescenţi cu vârsta sub 18 ani\u003cbr\u003e• dacă aveţi vârsta peste 70 ani (deoarece medicul dumneavoastră trebuie să decidă doza corectă pentru începutul tratamentului dumneavoastră cu Romazic)\u003cbr\u003e• dacă aveţi insuficienţă respiratorie severă\u003cbr\u003e• dacă sunteţi de origine asiatică ceea ce înseamnă japonez, chinez, filipinez, vietnamez, coreean şi indian. Medicul dumneavoastră trebuie să decidă doza corectă pentru începerea tratamentului dumneavoastră cu Romazic\u003cbr\u003e\u003cbr\u003eDacă vă aflaţi în oricare din situaţiile menţionate (sau aveţi îndoieli), nu utilizaţi Romazic 40 mg (doza cea mai mare) şi verificaţi împreună cu medicul sau farmacistul dumneavoastră înainte de a începe să utilizaţi orice doză de Romazic.\u003cbr\u003eLa un număr mic de persoane, statinele pot afecta ficatul. Această afectare este identificată printr-un test simplu pentru creşterea valorilor transaminazelor hepatice din sânge. Din acest motiv, de obicei, medicul dumneavoastră continuă efectuarea acestor analize de sânge (teste funcţionale hepatice) înainte şi în cursul tratamentului cu Romazic.\u003c\/p\u003e\r\n\u003cp\u003eÎn perioada tratamentului cu acest medicament, medicul dumneavoastră vă va monitoriza cu atenţie dacă aveţi diabet zaharat sau prezentaţi risc de apariţie a diabetului zaharat. Vă aflaţi în categoria cu risc de apariţie a diabetului zaharat dacă aveţi valori crescute de glucide şi grăsimi în sânge, edacă sunteţi supraponderal sau dacă aveţi hipertensiune arterială crescută.\u003cbr\u003e\u003cbr\u003eRomazic împreună cu alte medicamente\u003cbr\u003eSpuneţi medicului dumneavoastră sau farmacistului dacă utilizaţi, aţi utilizat recent sau s-ar putea să utilizaţi orice alte medicamente, inclusiv dintre cele eliberate fără prescripţie medicală.\u003cbr\u003e• ciclosporină (utilizată, de exemplu, după transplantul de organ),\u003cbr\u003e• warfarină (sau oricare alt medicament utilizat pentru subţierea sângelui).\u003cbr\u003e• fibraţi (cum ar fi gemfibrozil, fenofibrat) sau oricare medicament utilizat pentru scăderea colesterolului (cum este ezetimiba)\u003cbr\u003e• medicamente pentru tratamenul indigestiei (utilizate pentru neutralizarea acidităţii din stomacul dumneavoastră)\u003cbr\u003e• eritromicină (un antibiotic)\u003cbr\u003e• un contraceptiv oral (pilula)\u003cbr\u003e• terapie de substituţie hormonală sau ritornavir cu lopinavir şi\/sau atazanavir (utilizate pentru tratamenul infecţiilor cu HIV) vă rugăm să vedeţi punctul „Atenţionări şi precauţii”.\u003cbr\u003eEfectele acestor medicamente pot fi modificate de Romazic sau acestea pot modifica efectele Romazic.\u003cbr\u003e\u003cbr\u003eRomazic împreună cu alimente şi băuturi\u003cbr\u003ePuteţi să utilizaţi Romazic cu sau fără alimente.\u003c\/p\u003e\r\n\u003cp\u003eSarcina, alăptarea şi fertilitatea\u003cbr\u003eDacă sunteţi gravidă sau alăptaţi, credeţi că aţi putea fi gravidă sau intenţionaţi să rămâneţi gravidă, adresaţi-vă medicului dumneavoastră sau farmacistului pentru recomandări înainte de a lua acest medicament.\u003cbr\u003e\u003cbr\u003eNu utilizaţi Romazic dacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în perioada în care utilizaţi Romazic încetaţi imediat să-l utilizaţi şi anunţaţi-vă medicul. Femeile trebuie să evite să rămînă gravide în perioada în care utilizeaza Romazic folosind metode contraceptive corespunzătoare.\u003cbr\u003e\u003cbr\u003eConducerea vehiculelor şi folosirea utilajelor\u003cbr\u003eCele mai multe persoane pot să conducă vehicule şi să folosească utilaje în perioada în care utilizează\u003cbr\u003eRomazic - acesta nu afectează capacitatea lor pentru astfel de activităţi.\u003cbr\u003eCu toate acestea, unele persoane pot avea ameţeli în cursul tratamentului cu Romazic. Dacă vă simţiţi ameţit, adresaţi-vă medicului dumneavoastră înainte de a încerca să conduceţi vehicule sau să folosiţi utilaje.\u003cbr\u003e\u003cbr\u003eRomazic conţine lactoză\u003cbr\u003eRomazic conţine lactoză . Dacă medicul dumneavoastră v-a spus că aveţi intoleranţă la anumite zaharuri, discutaţi cu medicul dumneavoastră înainte de a lua Romazic.\u003cbr\u003e\u003cbr\u003e3. Cum să utilizaţi Romazic\u003cbr\u003eUtilizaţi întotdeauna acest medicament exact aşa cum v-a spus medicul sau farmacistul Discutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur. Doza corespunzătoare şi durata tratamentului vor fi estimate de către medicul dumneavoastră.\u003c\/p\u003e\r\n\u003cp\u003eDoze recomandate la adulţi\u003cbr\u003eDacă utilizaţi Romazic pentru valori mari ale colesterolului\u003cbr\u003eDoza de început\u003cbr\u003eTratamentul dumneavoastră cu Romazic trebuie să înceapă cu doze de 5 mg sau 10 mg, chiar dacă aţi utilizat anterior doze mai mari din alte statine. Alegerea dozei pentru începerea tratamentului va depinde de:\u003cbr\u003e• concentraţia de colesterol din sângele dumneavoastră\u003cbr\u003e• gradul dumneavoastră de risc pe care-l aveţi de a suferi un accident cardiac sau accident vascular cerebral\u003cbr\u003e• dacă aveţi un factor care vă poate face mai sensibil la posibilele reacţii adverse.\u003cbr\u003e\u003cbr\u003eVă rugăm să verificaţi cu medicul dumneavoastră sau farmacistul care este pentru dumneavoastră doza cea mai bună de început din Romazic .\u003cbr\u003eMedicul dumneavoastră poate decide să vă dea doza cea mai mică (5 mg) dacă:\u003cbr\u003e• dacă sunteţi de origine asiatică (japonez, chinez, filipinez, vietnamez, coreean şi indian).\u003cbr\u003e• dacă aveţi vârsta peste 70 ani\u003cbr\u003e• dacă aveţi probleme moderate cu rinichii\u003cbr\u003e• aveţi risc de dureri musculare (miopatii).\u003cbr\u003e\u003cbr\u003eCreşterea dozei şi doza zilnică maximă\u003cbr\u003eMedicul dumneavoastră poate decide creşterea dozei dumneavoastră. Aceasta este selectată astfel încât să utilizaţi cantitatea de Romazic care este corectă pentru dumneavoastră. Dacă începeţi cu doza de 5 mg, medicul dumneavoastră poate decide dublarea acesteia la 10 mg, apoi 20 mg şi apoi 40 mg dacă este necesar. Dacă începeţi cu 10 mg, medicul dumneavoastră poate decide să dubleze doza la 20 mg şi apoi 40 mg dacă este necesar. Va fi o pauză de 4 săptămâni între fiecare modificare a dozei.\u003cbr\u003e\u003cbr\u003eDoza zilnică maximă de Romazic este de 40 mg.\u003cbr\u003eAceasta este numai pentru pacienţi cu o concentraţie mare de colesterol şi un risc crescut de atac de cord sau accident vascular cerebral al căror colesterol nu scade suficient cu 20 mg.\u003cbr\u003eDacă utilizaţi Romazic pentru a reduce riscul dumneavoastră de a avea atac de cord, accident cerebrovascular sau probleme înrudite:\u003cbr\u003eDoza zilnică recomandată este de 20 mg. Cu toate acestea, medicul dumneavoastră poate decide utilizarea unei doze mai mici dacă sunteţi în una din situaţiile prezentate mai sus.\u003c\/p\u003e\r\n\u003cp\u003eUtilizarea comprimatelor dumneavoastră\u003cbr\u003e• Înghiţiţi fiecare comprimat întreg cu un pahar de apă.\u003cbr\u003e• Utilizaţi Romazic o dată pe zi. Puteţi să-l utilizaţi în orice moment al zilei.\u003cbr\u003e• Încercaţi să utilizaţi comprimatul la acelaşi moment al zilei pentru a vă ajuta să vă reamintiţi de el.\u003cbr\u003e\u003cbr\u003eVerificarea valorilor colesterolului cu regularitate\u003cbr\u003eEste important să mergeţi la medicul dumneavoastră pentru verificarea valorilor colesterolului cu regularitate, pentru a fi sigur că valoarea colesterolului a fost atinsă şi este menţinută la concentraţia corectă.\u003cbr\u003eMedicul dumneavoastră poate decide creşterea dozei astfel încât să utilizaţi cantitatea de Romazic corectă pentru dumneavoastră.\u003c\/p\u003e\r\n\u003cp\u003eDacă utilizaţi Romazic mai mult decât trebuie\u003cbr\u003eAdresaţi-vă pentru recomandări medicului dumneavoastră sau celui mai apropiat spital.\u003cbr\u003eDacă uitaţi să utilizaţi Romazic\u003cbr\u003eNu vă faceţi griji, doar utilizaţi doza următoare la momentul corect conform schemei de tratament\u003cbr\u003eNu luaţi o doză dublă pentru a compensa doza uitată.\u003cbr\u003eDacă încetaţi să utilizaţi Romazic\u003cbr\u003eDiscutaţi cu medicul dumneavoastră dacă doriţi să opriţi utilizarea de Romazic. Concentraţia dumneavoastră de colesterol poate creşte din nou dacă opriţi utilizarea de Romazic.\u003cbr\u003eDacă aveţi orice întrebări suplimentare cu privire la acest medicament, adresaţi-vă medicului dumneavoastră, farmacistului sau asistentei medicale.\u003cbr\u003e\u003cbr\u003e4. Reacţii adverse posibile\u003cbr\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele. Dacă apar reacţii adverse, aveţi nevoie de consult medical.\u003cbr\u003eOpriţi utilizarea de Romazic şi solicitaţi ajutor medical imediat dacă manifestaţi una din următoarele reacţii alergice:\u003cbr\u003e• dificultate în respiraţie însoţită sau nu de umflarea feţei, buzelor şi\/sau gâtului.\u003cbr\u003e• umflarea feţei, a buzelor şi\/sau a gâtului care pot determina dificultăţi la înghiţire.\u003cbr\u003e• mâncărimi severe la nivelul pielii (cu apariţia de umflături).\u003cbr\u003e\u003cbr\u003eDe asemenea, opriţi utilizarea de Romazic şi discutaţi imediat cu medicul dumneavoastră dacă aveţi orice fel de dureri neobişnuite în muşchii dumneavoastră, care durează mai mult decât v-aţi aştepta. Ca şi în cazul altor statine, un număr foarte mic de persoane au manifestat efecte neplăcute la nivelul muşchilor şi rar acestea au evoluat către începutul unei afectări musculare care pune viaţa în pericol, cunoscută ca rabdomioliză.\u003cbr\u003e\u003cbr\u003ePosibile reacţii adverse frecvente (afectează 1 până la 10 utilizatori din 100):\u003cbr\u003e• dureri de cap\u003cbr\u003e• dureri în capul pieptului\u003cbr\u003e• constipaţie\u003cbr\u003e• stare de rău\u003cbr\u003e• dureri musculare\u003cbr\u003e• stare de slăbiciune\u003cbr\u003e• ameţeli\u003cbr\u003e• o creştere a cantităţii de proteine în urină – în general aceasta revine la normal de la sine fără a opri tratamentul dumneavoastră cu comprimatele de Romazic (numai Romazic 40 mg).\u003cbr\u003e• diabet zaharat. Apariţia acestuia este mai probabilă dacă aveţi valori crescute ale glucidelor şi grăsimilor în sânge, dacă aveţi greutatea mai mare decât cea normală şi aveţi tensiune arterială mare. Medicul dumneavoastră vă va monitoriza cu atenţie în perioada în care urmaţi acest tratament.\u003c\/p\u003e\r\n\u003cp\u003ePosibile reacţii adverse mai puţin frecvente (afectează 1 până la 10 utilizatori din 1000):\u003cbr\u003e• înroşirea difuză şi trecătoare a pielii, mâncărimi sau alte reacţii la nivelul pielii\u003cbr\u003e• o creştere a cantităţii de proteine în urină – în general aceasta revine la normal de la sine fără a opri tratamentul dumneavoastră cu comprimatele de Romazic (numai Romazic 5 mg, 10 mg şi 20 mg).\u003cbr\u003e\u003cbr\u003ePosibile reacţii adverse rare (afectează 1 până la 10 utilizatori din 10000):\u003cbr\u003e• reacţii alergice severe - semnele includ umflarea feţei, a buzelor, a limbii şi\/sau gâtului, dificultăţi la înghiţire şi la respiraţie, mâncărimi severe la nivelul pielii (cu apariţia de umflături). Dacă dumneavoastră credeţi că aveţi o reacţie alergică, atunci opriţi administrarea de Romazic şi solicitaţi ajutor medical imediat.\u003cbr\u003e• afectare musculară- ca precauţie, opriţi utilizarea de Romazic şi spuneţi medicului dumneavoastră imediat dacă aveţi oricare durere musculară neobişnuită care durează mai mult decât v-aţi aşteptat\u003cbr\u003e• durere severă în capul pieptului (inflamarea pancreasului)\u003cbr\u003e• creşterea valorilor enzimelor hepatice în sânge\u003cbr\u003e• scăderea numărului de trombocite, care poate afecta coagularea sângelui. Dacă observaţi vânătăi inexplicabile sau pete roşii\/vinete pe piele trebuie să vă anunţaţi medicul.\u003cbr\u003e\u003cbr\u003ePosibile reacţii adverse foarte rare (afectează mai puţin de 1 utilizator din 10000):\u003cbr\u003e• icter (îngălbenirea pielii şi a ochilor)\u003cbr\u003e• hepatită (inflamarea ficatului)\u003cbr\u003e• urme de sânge în urină\u003cbr\u003e• afectarea nervilor picioarelor şi mâinilor dumneavoastră (cum ar fi amorţeli)\u003cbr\u003e• dureri articulare\u003cbr\u003e• pierderi de memorie\u003cbr\u003e• mărirea sânilor la bărbaţi (ginecomastie)\u003cbr\u003e\u003cbr\u003eEfecte adverse cu frecvenţă necunoscută (frecvenţa nu poate fi estimată din datele disponibile) care pot include:\u003cbr\u003e• diaree (scaune moi)\u003cbr\u003e• sindrom Stevens-Johnson (afectare cu vezicule la nivelul pielii, a gurii, a ochilor şi a zonei genitale)\u003cbr\u003e• tuse\u003cbr\u003e• scurtarea respiraţiei (dispnee)\u003cbr\u003e• edeme (umflături)\u003cbr\u003e• tulburări de somn, incluzând insomnie şi coşmaruri\u003cbr\u003e• dificultăţi sexuale\u003cbr\u003e• stare de depresie\u003cbr\u003e• tulburări respiratorii, incluzând tuse persistentă şi\/sau scurtarea respiraţiei sau febră\u003cbr\u003e• leziuni ale tendoanelor\u003cbr\u003e• slăbiciune musculară persistentă.\u003cbr\u003e\u003cbr\u003e5. Cum se păstrează Romazic\u003cbr\u003eNu lăsaţi acest medicament la vederea şi îndemâna copiilor.\u003cbr\u003eNu utilizaţi acest medicament după data de expirare înscrisă pe cutie şi blister după EXP. Data de expirare se referă la ultima zi a lunii respective.\u003cbr\u003eNu aruncaţi niciun medicament pe calea apei sau a reziduurilor menajere. Întrebaţi farmacistul cum să aruncaţi medicamentele pe care nu. le mai folosiţi. Aceste măsuri vor ajuta la protejarea mediului.\u003cbr\u003e\u003cbr\u003e6. Conţinutul ambalajului şi alte informaţii\u003cbr\u003eCe conţine Romazic\u003cbr\u003e• Substanţa activă este rosuvastatina (sub formă de rosuvastatină calcică).\u003cbr\u003e\u003cbr\u003eFiecare comprimat conţine 5 mg, 10 mg, 20 mg sau 40 mg de rosuvastatină.\u003cbr\u003e• Celelalte componente sunt:\u003cbr\u003eNucleul: lactoză monohidrat, celuloză microcristalină, citrat de sodiu, crospovidonă, siliciu coloidal anhidru, stearat de magneziu.\u003cbr\u003eFilmul: hipromeloză, lactoză monohidrat, macrogol, triacetin, dioxid de titan (E171).\u003cbr\u003e\u003cbr\u003eCum arată Romazic şi conţinutul ambalajului\u003cbr\u003eRomazic 5 mg sunt comprimate filmate rotunde, biconvexe de culoare albă sau aproape albă, marcate cu “5” pe o faţă.\u003cbr\u003eRomazic 10 mg sunt comprimate filmate rotunde, biconvexe de culoare albă sau aproape albă, marcate cu “10” pe o faţă\u003cbr\u003eRomazic 20 mg comprimate filmate: comprimate filmate rotunde, biconvexe de culoare albă sau aproape albă, marcate cu “20” pe o faţă.\u003cbr\u003eRomazic 40 mg sunt comprimate filmate oblongi, biconvexe de culoare albă sau aproape albă.\u003cbr\u003eMărimea ambalajului: cutie cu 30 comprimate.\u003cbr\u003e\u003cbr\u003eDeţinătorul autorizaţiei de punere pe piaţă şi fabricantul\u003cbr\u003ePharmaceutical Works POLPHARMA SA\u003cbr\u003e19 Pelplińska Street\u003cbr\u003e83-200 Starogard Gdański\u003cbr\u003ePolonia\u003c\/p\u003e","brand":"Polpharma SA","offers":[{"title":"Default Title","offer_id":43907973808268,"sku":"63735","price":80.77,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/63735.jpg?v=1721041661"},{"product_id":"romazic-20mg-compfilm","title":"Romazic 20mg comp.film.","description":"\u003cp\u003eRomazic 5 mg comprimate filmate\u003cbr\u003eRomazic 10 mg comprimate filmate\u003cbr\u003eRomazic 20 mg comprimate filmate\u003cbr\u003eRomazic 40 mg comprimate filmate\u003cbr\u003e\u003cbr\u003eRosuvastatină\u003cbr\u003e\u003cbr\u003eCitiţi cu atenţie şi în întregime acest prospect înainte de a începe să utilizaţi acest medicament deoarece conţine informaţii importante pentru dumneavoastră.\u003cbr\u003e- Păstraţi acest prospect. S-ar putea să fie necesar să-l recitiţi.\u003cbr\u003e- Dacă aveţi orice întrebări suplimentare, adresaţi-vă medicului dumneavoastră sau farmacistului .\u003cbr\u003e- Acest medicament a fost prescris numai pentru dumneavoastră. Nu trebuie să-l daţi altor persoane. Le poate face rău, chiar dacă au aceleaşi semne de boală ca dumneavoastră.\u003cbr\u003e- Dacă manifestaţi orice reacţii adverse adresaţi-vă medicului dumneavoastră sau farmacistului\u003cbr\u003e\u003cbr\u003eAcestea includ orice posibile reacţii adverse nemenţionate în acest prospect.Vezi punctul 4\u003cbr\u003e\u003cbr\u003eCe găsiţi în acest prospect:\u003cbr\u003e1. Ce este Romazic şi pentru ce se utilizează\u003cbr\u003e2. Ce trebuie să ştiţi înainte să utilizaţi Romazic\u003cbr\u003e3. Cum să utilizaţi Romazic\u003cbr\u003e4. Reacţii adverse posibile\u003cbr\u003e5. Cum se păstrează Romazic\u003cbr\u003e6. Conţinutul ambalajului şi alte informaţii\u003cbr\u003e\u003cbr\u003e1. Ce este Romazic şi pentru ce se utilizează\u003cbr\u003eRomazic aparţine unui grup de medicamente numite statine.\u003cbr\u003e\u003cbr\u003eVi s-a prescris Romazic deoarece:\u003cbr\u003e• aveţi concentraţie mare de colesterol în sânge. Aceasta înseamnă că prezentaţi risc pentru atac de cord sau accident vascular cerebral. Aţi fost sfătuit să utilizaţi o statină, deoarece schimbarea dietei dumneavoastră şi efectuarea de mai multe exerciţii fizice nu au fost măsuri suficiente pentru a vă corecta concentraţia de colesterol din sânge. Trebuie să continuaţi utilizarea dietei pentru reducerea colesterolului dumneavoastră şi exerciţiile fizice în perioada în\u003cbr\u003ecare luaţi Romazic, sau\u003cbr\u003e• aveţi alţi factori care vă cresc riscul de a avea atac de cord sau cerebrovascular sau probleme de sănătate înrudite.\u003cbr\u003eAtacul de cord sau cerebrovascular sau problemele de sănătate înrudite pot fi determinate de o afecţiune numită ateroscleroză.\u003cbr\u003eAteroscleroza se datorează depunerilor de depozite de grăsimi în arterele dumneavoastră.\u003cbr\u003eDe ce este important să luaţi în continuare Romazic?\u003c\/p\u003e\r\n\u003cp\u003eRomazic este utilizat pentru a corecta concentraţia substanţelor grase din sânge numite lipide, din care cea mai comună este constituită de colesterol.\u003cbr\u003e\u003cbr\u003eExistă în sânge diferite tipuri de colesterol- colesterol ‚rău’ (LDL-C) şi colesterol ‚bun’ (HDL-C).\u003cbr\u003eRomazic poate să scadă colesterolul ‚rău’ şi-l poate creşte pe cel ‚bun’.\u003cbr\u003eAcesta acţionează ajutând la blocarea producerii de colesterol rău de către organismul dumneavoastră.\u003cbr\u003eDe asemenea acesta îmbunătăţeşte capacitatea organismului dumneavoastră de a-l elimina din sângele dumneavoastră.\u003cbr\u003ePentru cei mai mulţi oameni, concentraţia mare de colesterol nu afectează felul în care se simt deoarece nu determină niciun simptom. Cu toate acestea, dacă nu se face tratament, depozitele de grăsimi se pot lipi în pereţii vaselor dumneavoastră de sânge determinând îngustarea acestora.\u003cbr\u003eUneori aceste vase de sânge îngustate se pot bloca ceea ce poate opri aprovizionarea cu sânge a inimii sau creierului ducând astfel la atac de cord sau cerebrovascular. Prin scăderea concentraţiei dumneavoastră de colesterol, puteţi să vă reduceţi riscul de accident cardiac, accident cerebrovascular sau probleme de sănătate înrudite.\u003cbr\u003e\u003cbr\u003eTrebuie să menţineţi utilizarea de Romazic chiar dacă aţi ajuns la concentraţia normală de colesterol în sânge, deoarece aceasta previne reluarea creşterii concentraţiei de colesterol şi determinarea depunerilor de depozite de grăsimi. Cu toate acestea, trebuie să opriţi utilizarea acestuia dacă medicul dumneavoastră vă recomandă aceasta sau dacă rămâneţi gravidă.\u003cbr\u003e\u003cbr\u003e2. Ce trebuie să ştiţi înainte să utilizaţi Romazic\u003cbr\u003eNu utilizaţi Romazic\u003cbr\u003e• dacă sunteţi alergic la rosuvastatină sau la oricare dintre celelalte componente ale acestui medicament (enumerate la punctul 6).\u003cbr\u003e• dacă sunteţi gravidă sau alăptaţi\u003cbr\u003eDacă rămâneţi gravidă în cursul tratamentului cu Romazic, întrerupeţi imediat tratamentul şi spuneţi medicului dumneavoastră. Femeile trebuie să evite să rămână gravide în perioada în care utilizează Romazic prin folosirea de măsuri contraceptive corespunzătoare.\u003cbr\u003e• dacă aveţi afecţiuni hepatice\u003cbr\u003e• dacă aveţi probleme renale severe\u003cbr\u003e• dacă aveţi dureri musculare repetate sau inexplicabile\u003cbr\u003e• dacă utilizaţi un medicament numit ciclosporină (utilizat de exemplu, după transplantul de organ).\u003cbr\u003eDacă vă aflaţi în oricare din aceste situaţii, vă rugăm să vă întoarceţi să discutaţi cu medicul dumneavoastră.\u003cbr\u003e\u003cbr\u003eÎn plus, nu utilizaţi Romazic 40 mg (doza cea mai mare):\u003cbr\u003e• dacă aveţi probleme moderate cu rinichii (dacă aveţi îndoieli, vă rugăm să întrebaţi medicul dumneavoastră)\u003cbr\u003e• dacă glanda dumneavoastră tiroidă nu funcţionează corespunzător\u003cbr\u003e• dacă aţi avut orice fel de durere musculară repetată sau inexplicabilă, probleme cu muşchii dumneavoastră sau în istoricul familiei sau probleme cu muşchii în trecut când aţi utilizat alte medicamente care scad concentraţia de colesterol din sânge\u003cbr\u003e• dacă obişnuiţi să consumaţi cu regularitate cantităţi mari de alcool etilic\u003cbr\u003e• dacă sunteţi de origine asiatică (japonez, chinez, filipinez, vietnamez, corean sau indian)\u003cbr\u003e• dacă utilizaţi alte medicamente pentru scăderea colesterolului din sânge numite fibraţi.\u003cbr\u003e\u003cbr\u003eDacă vă aflaţi în oricare din situaţiile menţionate (sau aveţi îndoieli), vă rugăm să vă întoarceţi şi să discutaţi cu medicul dumneavoastră.\u003cbr\u003e\u003cbr\u003eAtenţionări şi precauţii\u003cbr\u003eÎnainte să utilizaţi Romazic, adresaţi-vă medicului dumneavoastră sau farmacistului\u003cbr\u003e• dacă a aveţi probleme cu rinichii\u003cbr\u003e• dacă a aveţi probleme cu ficatul \u003cbr\u003e• dacă aţi avut orice dureri repetate sau inexplicabile la nivelul muşchilor, probleme musculare în trecutul dumneavoastră sau al familiei, sau probleme musculare în trecut în cazul utilizării altor medicamente pentru reducerea concentraţiei de colesterol din sânge. dumneavoastră personal sau o persoană din familia dumneavoastră, sau probleme musculare în trecut când aţi utilizat alte medicamente care reduc colesterolul din sânge.\u003c\/p\u003e\r\n\u003cp\u003eSpuneţi imediat medicului dumneavoastră dacă aveţi dureri musculare inexplicabile în special dacă nu vă simţiţi bine sau aveţi febră. De asemenea spuneţi-i medicului dumneavoastră dacă aveţi constant stare de slabiciune a muşchilor.\u003cbr\u003e• dacă obişnuiţi să consumaţi cu regularitate cantităţi mari de alcool etilic.\u003cbr\u003e• dacă glanda dumneavoastră tiroidă nu funcţionează corespunzător\u003cbr\u003e• dacă utilizaţi alte medicamente numite fibraţi pentru a scădea colesterolul din sânge\u003cbr\u003e\u003cbr\u003eVă rugăm să citiţi cu atenţie acest prospect, chiar dacă aţi utilizat alte medicamente pentru scăderea concentraţiilor mari de colesterol din sânge\u003cbr\u003e• dacă utilizaţi medicamente utilizate pentru tratamenul infecţiilor cu HIV cum sunt ritornavir cu lopinavir şi\/sau atazanavir, vă rugăm să vedeţi punctul „Romazic împreună cu alte medicamente”\u003cbr\u003e• dacă pacientul are vârsta sub 18 ani: Romazic nu este potrivit pentru administrare la copii şi adolescenţi cu vârsta sub 18 ani\u003cbr\u003e• dacă aveţi vârsta peste 70 ani (deoarece medicul dumneavoastră trebuie să decidă doza corectă pentru începutul tratamentului dumneavoastră cu Romazic)\u003cbr\u003e• dacă aveţi insuficienţă respiratorie severă\u003cbr\u003e• dacă sunteţi de origine asiatică ceea ce înseamnă japonez, chinez, filipinez, vietnamez, coreean şi indian. Medicul dumneavoastră trebuie să decidă doza corectă pentru începerea tratamentului dumneavoastră cu Romazic\u003cbr\u003e\u003cbr\u003eDacă vă aflaţi în oricare din situaţiile menţionate (sau aveţi îndoieli), nu utilizaţi Romazic 40 mg (doza cea mai mare) şi verificaţi împreună cu medicul sau farmacistul dumneavoastră înainte de a începe să utilizaţi orice doză de Romazic.\u003cbr\u003eLa un număr mic de persoane, statinele pot afecta ficatul. Această afectare este identificată printr-un test simplu pentru creşterea valorilor transaminazelor hepatice din sânge. Din acest motiv, de obicei, medicul dumneavoastră continuă efectuarea acestor analize de sânge (teste funcţionale hepatice) înainte şi în cursul tratamentului cu Romazic.\u003c\/p\u003e\r\n\u003cp\u003eÎn perioada tratamentului cu acest medicament, medicul dumneavoastră vă va monitoriza cu atenţie dacă aveţi diabet zaharat sau prezentaţi risc de apariţie a diabetului zaharat. Vă aflaţi în categoria cu risc de apariţie a diabetului zaharat dacă aveţi valori crescute de glucide şi grăsimi în sânge, edacă sunteţi supraponderal sau dacă aveţi hipertensiune arterială crescută.\u003cbr\u003e\u003cbr\u003eRomazic împreună cu alte medicamente\u003cbr\u003eSpuneţi medicului dumneavoastră sau farmacistului dacă utilizaţi, aţi utilizat recent sau s-ar putea să utilizaţi orice alte medicamente, inclusiv dintre cele eliberate fără prescripţie medicală.\u003cbr\u003e• ciclosporină (utilizată, de exemplu, după transplantul de organ),\u003cbr\u003e• warfarină (sau oricare alt medicament utilizat pentru subţierea sângelui).\u003cbr\u003e• fibraţi (cum ar fi gemfibrozil, fenofibrat) sau oricare medicament utilizat pentru scăderea colesterolului (cum este ezetimiba)\u003cbr\u003e• medicamente pentru tratamenul indigestiei (utilizate pentru neutralizarea acidităţii din stomacul dumneavoastră)\u003cbr\u003e• eritromicină (un antibiotic)\u003cbr\u003e• un contraceptiv oral (pilula)\u003cbr\u003e• terapie de substituţie hormonală sau ritornavir cu lopinavir şi\/sau atazanavir (utilizate pentru tratamenul infecţiilor cu HIV) vă rugăm să vedeţi punctul „Atenţionări şi precauţii”.\u003cbr\u003eEfectele acestor medicamente pot fi modificate de Romazic sau acestea pot modifica efectele Romazic.\u003cbr\u003e\u003cbr\u003eRomazic împreună cu alimente şi băuturi\u003cbr\u003ePuteţi să utilizaţi Romazic cu sau fără alimente.\u003c\/p\u003e\r\n\u003cp\u003eSarcina, alăptarea şi fertilitatea\u003cbr\u003eDacă sunteţi gravidă sau alăptaţi, credeţi că aţi putea fi gravidă sau intenţionaţi să rămâneţi gravidă, adresaţi-vă medicului dumneavoastră sau farmacistului pentru recomandări înainte de a lua acest medicament.\u003cbr\u003e\u003cbr\u003eNu utilizaţi Romazic dacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în perioada în care utilizaţi Romazic încetaţi imediat să-l utilizaţi şi anunţaţi-vă medicul. Femeile trebuie să evite să rămînă gravide în perioada în care utilizeaza Romazic folosind metode contraceptive corespunzătoare.\u003cbr\u003e\u003cbr\u003eConducerea vehiculelor şi folosirea utilajelor\u003cbr\u003eCele mai multe persoane pot să conducă vehicule şi să folosească utilaje în perioada în care utilizează\u003cbr\u003eRomazic - acesta nu afectează capacitatea lor pentru astfel de activităţi.\u003cbr\u003eCu toate acestea, unele persoane pot avea ameţeli în cursul tratamentului cu Romazic. Dacă vă simţiţi ameţit, adresaţi-vă medicului dumneavoastră înainte de a încerca să conduceţi vehicule sau să folosiţi utilaje.\u003cbr\u003e\u003cbr\u003eRomazic conţine lactoză\u003cbr\u003eRomazic conţine lactoză . Dacă medicul dumneavoastră v-a spus că aveţi intoleranţă la anumite zaharuri, discutaţi cu medicul dumneavoastră înainte de a lua Romazic.\u003cbr\u003e\u003cbr\u003e3. Cum să utilizaţi Romazic\u003cbr\u003eUtilizaţi întotdeauna acest medicament exact aşa cum v-a spus medicul sau farmacistul Discutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur. Doza corespunzătoare şi durata tratamentului vor fi estimate de către medicul dumneavoastră.\u003c\/p\u003e\r\n\u003cp\u003eDoze recomandate la adulţi\u003cbr\u003eDacă utilizaţi Romazic pentru valori mari ale colesterolului\u003cbr\u003eDoza de început\u003cbr\u003eTratamentul dumneavoastră cu Romazic trebuie să înceapă cu doze de 5 mg sau 10 mg, chiar dacă aţi utilizat anterior doze mai mari din alte statine. Alegerea dozei pentru începerea tratamentului va depinde de:\u003cbr\u003e• concentraţia de colesterol din sângele dumneavoastră\u003cbr\u003e• gradul dumneavoastră de risc pe care-l aveţi de a suferi un accident cardiac sau accident vascular cerebral\u003cbr\u003e• dacă aveţi un factor care vă poate face mai sensibil la posibilele reacţii adverse.\u003cbr\u003e\u003cbr\u003eVă rugăm să verificaţi cu medicul dumneavoastră sau farmacistul care este pentru dumneavoastră doza cea mai bună de început din Romazic .\u003cbr\u003eMedicul dumneavoastră poate decide să vă dea doza cea mai mică (5 mg) dacă:\u003cbr\u003e• dacă sunteţi de origine asiatică (japonez, chinez, filipinez, vietnamez, coreean şi indian).\u003cbr\u003e• dacă aveţi vârsta peste 70 ani\u003cbr\u003e• dacă aveţi probleme moderate cu rinichii\u003cbr\u003e• aveţi risc de dureri musculare (miopatii).\u003cbr\u003e\u003cbr\u003eCreşterea dozei şi doza zilnică maximă\u003cbr\u003eMedicul dumneavoastră poate decide creşterea dozei dumneavoastră. Aceasta este selectată astfel încât să utilizaţi cantitatea de Romazic care este corectă pentru dumneavoastră. Dacă începeţi cu doza de 5 mg, medicul dumneavoastră poate decide dublarea acesteia la 10 mg, apoi 20 mg şi apoi 40 mg dacă este necesar. Dacă începeţi cu 10 mg, medicul dumneavoastră poate decide să dubleze doza la 20 mg şi apoi 40 mg dacă este necesar. Va fi o pauză de 4 săptămâni între fiecare modificare a dozei.\u003cbr\u003e\u003cbr\u003eDoza zilnică maximă de Romazic este de 40 mg.\u003cbr\u003eAceasta este numai pentru pacienţi cu o concentraţie mare de colesterol şi un risc crescut de atac de cord sau accident vascular cerebral al căror colesterol nu scade suficient cu 20 mg.\u003cbr\u003eDacă utilizaţi Romazic pentru a reduce riscul dumneavoastră de a avea atac de cord, accident cerebrovascular sau probleme înrudite:\u003cbr\u003eDoza zilnică recomandată este de 20 mg. Cu toate acestea, medicul dumneavoastră poate decide utilizarea unei doze mai mici dacă sunteţi în una din situaţiile prezentate mai sus.\u003c\/p\u003e\r\n\u003cp\u003eUtilizarea comprimatelor dumneavoastră\u003cbr\u003e• Înghiţiţi fiecare comprimat întreg cu un pahar de apă.\u003cbr\u003e• Utilizaţi Romazic o dată pe zi. Puteţi să-l utilizaţi în orice moment al zilei.\u003cbr\u003e• Încercaţi să utilizaţi comprimatul la acelaşi moment al zilei pentru a vă ajuta să vă reamintiţi de el.\u003cbr\u003e\u003cbr\u003eVerificarea valorilor colesterolului cu regularitate\u003cbr\u003eEste important să mergeţi la medicul dumneavoastră pentru verificarea valorilor colesterolului cu regularitate, pentru a fi sigur că valoarea colesterolului a fost atinsă şi este menţinută la concentraţia corectă.\u003cbr\u003eMedicul dumneavoastră poate decide creşterea dozei astfel încât să utilizaţi cantitatea de Romazic corectă pentru dumneavoastră.\u003c\/p\u003e\r\n\u003cp\u003eDacă utilizaţi Romazic mai mult decât trebuie\u003cbr\u003eAdresaţi-vă pentru recomandări medicului dumneavoastră sau celui mai apropiat spital.\u003cbr\u003eDacă uitaţi să utilizaţi Romazic\u003cbr\u003eNu vă faceţi griji, doar utilizaţi doza următoare la momentul corect conform schemei de tratament\u003cbr\u003eNu luaţi o doză dublă pentru a compensa doza uitată.\u003cbr\u003eDacă încetaţi să utilizaţi Romazic\u003cbr\u003eDiscutaţi cu medicul dumneavoastră dacă doriţi să opriţi utilizarea de Romazic. Concentraţia dumneavoastră de colesterol poate creşte din nou dacă opriţi utilizarea de Romazic.\u003cbr\u003eDacă aveţi orice întrebări suplimentare cu privire la acest medicament, adresaţi-vă medicului dumneavoastră, farmacistului sau asistentei medicale.\u003cbr\u003e\u003cbr\u003e4. Reacţii adverse posibile\u003cbr\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele. Dacă apar reacţii adverse, aveţi nevoie de consult medical.\u003cbr\u003eOpriţi utilizarea de Romazic şi solicitaţi ajutor medical imediat dacă manifestaţi una din următoarele reacţii alergice:\u003cbr\u003e• dificultate în respiraţie însoţită sau nu de umflarea feţei, buzelor şi\/sau gâtului.\u003cbr\u003e• umflarea feţei, a buzelor şi\/sau a gâtului care pot determina dificultăţi la înghiţire.\u003cbr\u003e• mâncărimi severe la nivelul pielii (cu apariţia de umflături).\u003cbr\u003e\u003cbr\u003eDe asemenea, opriţi utilizarea de Romazic şi discutaţi imediat cu medicul dumneavoastră dacă aveţi orice fel de dureri neobişnuite în muşchii dumneavoastră, care durează mai mult decât v-aţi aştepta. Ca şi în cazul altor statine, un număr foarte mic de persoane au manifestat efecte neplăcute la nivelul muşchilor şi rar acestea au evoluat către începutul unei afectări musculare care pune viaţa în pericol, cunoscută ca rabdomioliză.\u003cbr\u003e\u003cbr\u003ePosibile reacţii adverse frecvente (afectează 1 până la 10 utilizatori din 100):\u003cbr\u003e• dureri de cap\u003cbr\u003e• dureri în capul pieptului\u003cbr\u003e• constipaţie\u003cbr\u003e• stare de rău\u003cbr\u003e• dureri musculare\u003cbr\u003e• stare de slăbiciune\u003cbr\u003e• ameţeli\u003cbr\u003e• o creştere a cantităţii de proteine în urină – în general aceasta revine la normal de la sine fără a opri tratamentul dumneavoastră cu comprimatele de Romazic (numai Romazic 40 mg).\u003cbr\u003e• diabet zaharat. Apariţia acestuia este mai probabilă dacă aveţi valori crescute ale glucidelor şi grăsimilor în sânge, dacă aveţi greutatea mai mare decât cea normală şi aveţi tensiune arterială mare. Medicul dumneavoastră vă va monitoriza cu atenţie în perioada în care urmaţi acest tratament.\u003c\/p\u003e\r\n\u003cp\u003ePosibile reacţii adverse mai puţin frecvente (afectează 1 până la 10 utilizatori din 1000):\u003cbr\u003e• înroşirea difuză şi trecătoare a pielii, mâncărimi sau alte reacţii la nivelul pielii\u003cbr\u003e• o creştere a cantităţii de proteine în urină – în general aceasta revine la normal de la sine fără a opri tratamentul dumneavoastră cu comprimatele de Romazic (numai Romazic 5 mg, 10 mg şi 20 mg).\u003cbr\u003e\u003cbr\u003ePosibile reacţii adverse rare (afectează 1 până la 10 utilizatori din 10000):\u003cbr\u003e• reacţii alergice severe - semnele includ umflarea feţei, a buzelor, a limbii şi\/sau gâtului, dificultăţi la înghiţire şi la respiraţie, mâncărimi severe la nivelul pielii (cu apariţia de umflături). Dacă dumneavoastră credeţi că aveţi o reacţie alergică, atunci opriţi administrarea de Romazic şi solicitaţi ajutor medical imediat.\u003cbr\u003e• afectare musculară- ca precauţie, opriţi utilizarea de Romazic şi spuneţi medicului dumneavoastră imediat dacă aveţi oricare durere musculară neobişnuită care durează mai mult decât v-aţi aşteptat\u003cbr\u003e• durere severă în capul pieptului (inflamarea pancreasului)\u003cbr\u003e• creşterea valorilor enzimelor hepatice în sânge\u003cbr\u003e• scăderea numărului de trombocite, care poate afecta coagularea sângelui. Dacă observaţi vânătăi inexplicabile sau pete roşii\/vinete pe piele trebuie să vă anunţaţi medicul.\u003cbr\u003e\u003cbr\u003ePosibile reacţii adverse foarte rare (afectează mai puţin de 1 utilizator din 10000):\u003cbr\u003e• icter (îngălbenirea pielii şi a ochilor)\u003cbr\u003e• hepatită (inflamarea ficatului)\u003cbr\u003e• urme de sânge în urină\u003cbr\u003e• afectarea nervilor picioarelor şi mâinilor dumneavoastră (cum ar fi amorţeli)\u003cbr\u003e• dureri articulare\u003cbr\u003e• pierderi de memorie\u003cbr\u003e• mărirea sânilor la bărbaţi (ginecomastie)\u003cbr\u003e\u003cbr\u003eEfecte adverse cu frecvenţă necunoscută (frecvenţa nu poate fi estimată din datele disponibile) care pot include:\u003cbr\u003e• diaree (scaune moi)\u003cbr\u003e• sindrom Stevens-Johnson (afectare cu vezicule la nivelul pielii, a gurii, a ochilor şi a zonei genitale)\u003cbr\u003e• tuse\u003cbr\u003e• scurtarea respiraţiei (dispnee)\u003cbr\u003e• edeme (umflături)\u003cbr\u003e• tulburări de somn, incluzând insomnie şi coşmaruri\u003cbr\u003e• dificultăţi sexuale\u003cbr\u003e• stare de depresie\u003cbr\u003e• tulburări respiratorii, incluzând tuse persistentă şi\/sau scurtarea respiraţiei sau febră\u003cbr\u003e• leziuni ale tendoanelor\u003cbr\u003e• slăbiciune musculară persistentă.\u003cbr\u003e\u003cbr\u003e5. Cum se păstrează Romazic\u003cbr\u003eNu lăsaţi acest medicament la vederea şi îndemâna copiilor.\u003cbr\u003eNu utilizaţi acest medicament după data de expirare înscrisă pe cutie şi blister după EXP. Data de expirare se referă la ultima zi a lunii respective.\u003cbr\u003eNu aruncaţi niciun medicament pe calea apei sau a reziduurilor menajere. Întrebaţi farmacistul cum să aruncaţi medicamentele pe care nu. le mai folosiţi. Aceste măsuri vor ajuta la protejarea mediului.\u003cbr\u003e\u003cbr\u003e6. Conţinutul ambalajului şi alte informaţii\u003cbr\u003eCe conţine Romazic\u003cbr\u003e• Substanţa activă este rosuvastatina (sub formă de rosuvastatină calcică).\u003cbr\u003e\u003cbr\u003eFiecare comprimat conţine 5 mg, 10 mg, 20 mg sau 40 mg de rosuvastatină.\u003cbr\u003e• Celelalte componente sunt:\u003cbr\u003eNucleul: lactoză monohidrat, celuloză microcristalină, citrat de sodiu, crospovidonă, siliciu coloidal anhidru, stearat de magneziu.\u003cbr\u003eFilmul: hipromeloză, lactoză monohidrat, macrogol, triacetin, dioxid de titan (E171).\u003cbr\u003e\u003cbr\u003eCum arată Romazic şi conţinutul ambalajului\u003cbr\u003eRomazic 5 mg sunt comprimate filmate rotunde, biconvexe de culoare albă sau aproape albă, marcate cu “5” pe o faţă.\u003cbr\u003eRomazic 10 mg sunt comprimate filmate rotunde, biconvexe de culoare albă sau aproape albă, marcate cu “10” pe o faţă\u003cbr\u003eRomazic 20 mg comprimate filmate: comprimate filmate rotunde, biconvexe de culoare albă sau aproape albă, marcate cu “20” pe o faţă.\u003cbr\u003eRomazic 40 mg sunt comprimate filmate oblongi, biconvexe de culoare albă sau aproape albă.\u003cbr\u003eMărimea ambalajului: cutie cu 30 comprimate.\u003cbr\u003e\u003cbr\u003eDeţinătorul autorizaţiei de punere pe piaţă şi fabricantul\u003cbr\u003ePharmaceutical Works POLPHARMA SA\u003cbr\u003e19 Pelplińska Street\u003cbr\u003e83-200 Starogard Gdański\u003cbr\u003ePolonia\u003c\/p\u003e","brand":"Polpharma SA","offers":[{"title":"Default Title","offer_id":43930824540300,"sku":"63739","price":95.71,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/63739.jpg?v=1721041749"},{"product_id":"pitabel-4mg-compfilm","title":"Pitabel 4mg comp.film.","description":"\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel 2 mg comprimate filmate\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel 4 mg comprimate filmate\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitavastatină\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCe este Pitabel şi pentru ce se utilizează\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel conține o substanță activă numită pitavastatină. Acesta aparține unui grup de medicamente numite „statine”. Pitabel este utilizat pentru corectarea nivelului de grăsime (lipide) din sânge și poate fi administrat atât de copii de la vârsta de 6 ani, cât și de adulți. Un dezechilibru al grăsimilor, în special al colesterolului, poate duce uneori la infarct sau accident vascular cerebral.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVi s-a prescris Pitabel deoarece aveți un dezechilibru al grăsimilor și schimbarea dietei și modificarea stilului de viață nu au fost suficiente pentru a corecta acest lucru. Ar trebui să continuați dieta de scădere a colesterolului și modificările stilului de viață în timp ce luați Pitabel.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"2\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCe trebuie să ştiţi înainte să luaţi Pitabel\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu luaţi Pitabel dacă:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- sunteţi alergic (hipersensibil) la pitavastatină, la alte statine sau la oricare dintre celelalte componente ale acestui medicament (enumerate la pct. 6);\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- dacă sunteți însărcinată sau alăptați;\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- dacă sunteți o femeie capabilă să aveți copii și nu utilizați o metodă contraceptivă fiabilă (vezi „Sarcina, alăptarea și fertilitatea”);\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- dacă aveți în prezent probleme cu ficatul;\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- dacă luați ciclosporină – medicament utilizat după un transplant de organe.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- dacă aveți dureri musculare repetate sau inexplicabile. Dacă nu sunteți sigur, discutați cu medicul sau farmacistul înainte de a lua Pitabel.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAtenţionări şi precauţii\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDiscutați cu medicul dumneavoastră sau farmacistul înainte de a administra Pitabel dacă:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eaveți insuficiență respiratorie severă (probleme respiratorii severe).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eați avut vreodată probleme cu rinichii.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eați avut anterior probleme cu ficatul. „Statinele” pot afecta ficatul la un număr mic de persoane. De obicei, medicul dumneavoastră va efectua un test de sânge (testul funcției hepatice) înainte și în timpul tratamentului cu Pitabel.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eați avut vreodată probleme cu glanda tiroidă.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edumneavoastră sau orice membru al familiei dumneavoastră aveți antecedente de probleme musculare.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eați avut antecedente de probleme musculare atunci când luați alte medicamente care scad colesterolul (de exemplu, statine sau fibrați).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003econsumați alcool în exces.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eluați sau ați luat în ultimele 7 zile un medicament numit acid fusidic (un medicament pentru tratamentul unor infecții bacteriene) pe cale orală sau prin injecție. Combinația de acid fusidic și Pitabel poate duce la probleme musculare grave (rabdomioliză).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre situațiile de mai sus vi se aplică (sau nu sunteți sigur), discutați cu medical dumneavoastră sau cu farmacistul înainte de a lua Pitabel. De asemenea, spuneți medicului dumneavoastră sau farmacistului dacă aveți o slăbiciune musculară constantă. Este posibil să fie necesare teste și medicamente suplimentare pentru a diagnostica și trata acest lucru.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎn timp ce utilizați acest medicament, medicul dumneavoastră vă va monitoriza îndeaproape dacă aveți diabet sau dacă sunteți expus riscului de a dezvolta diabet. Este posibil să aveți riscul de a dezvolta diabet dacă aveți un nivel ridicat de zaharuri și grăsimi în sânge, dacă sunteți supraponderal și aveți tensiune arterială crescută.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCopii și adolescenți\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel nu trebuie administrat copiilor cu vârsta sub 6 ani.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎnainte de a lua Pitabel, adolescentele ar trebui să primească îndrumări și consiliere cu privire la metodele de contracepție.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel împreună cu alte medicamente\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSpuneți medicului dumneavoastră sau farmacistului dacă luați, ați luat recent sau s-ar putea să luați orice alte medicamente. Aceasta include orice medicamente obținute fără prescripție medicală și remedii pe bază de plante. Unele medicamente administrate concomitent pot afecta reciproc funcționarea lor corectă.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSpuneți în special medicului dumneavoastră sau farmacistului dacă luați oricare dintre următoarele:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ealte medicamente numite „fibrați” - cum ar fi gemfibrozil și fenofibrat;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eeritromicină sau rifampicină - tipuri de antibiotice utilizate pentru tratamentul unor infecții;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ewarfarină sau orice alt medicament utilizat pentru subțierea sângelui;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emedicamente pentru tratamentul HIV numite „inhibitori de protează” (de exemplu, ritonavir, lopinavir, darunavir, atazanavir) și „inhibitori non-nucleozidici ai revers transcriptazei” (de exemplu efavirenz);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eniacină (vitamina B3);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă trebuie să luați acid fusidic pe cale orală pentru a trata o infecție bacteriană, va trebui să întrerupeți temporar utilizarea Pitabel. Medicul dumneavoastră vă va spune când este sigur să reporniți utilizarea Pitabel. Administrarea Pitabel cu acid fusidic poate duce rar la slăbiciune musculară, sensibilitate sau durere (rabdomioliză). Vedeți mai multe informații despre rabdomioliză în secțiunea 4.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre cele de mai sus vi se aplică (sau nu sunteți sigur), discutați cu medicul dumneavoastră sau cu farmacistul înainte de a lua Pitabel.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel împreună cu alimente sau băuturi\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel poate fi administrat cu sau fără alimente.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSarcina, alăptarea și fertilitatea\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu luați Pitabel dacă sunteți gravidă sau alăptați. Dacă intenționați să rămâneți gravidă, discutați cu medicul dumneavoastră înainte de a lua Pitabel. Dacă sunteți femeie care poate avea copii, trebuie să utilizați o metodă contraceptivă fiabilă, în timp ce luați Pitabel. Încetați să luați Pitabel și consultați imediat un medic dacă rămâneți gravidă în timp ce luați Pitabel. Adresați-vă medicului dumneavoastră sau farmacistului pentru recomandări înainte de a lua orice medicament, dacă sunteți gravidă sau alăptați.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eConducerea vehiculelor şi folosirea utilajelor\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel nu este de așteptat să interfereze cu capacitatea dumneavoastră de a conduce vehicule sau de a folosi utilaje. Cu toate acestea, dacă vă simțiți amețit sau somnoros în timp ce luați Pitabel, nu conduceți vehicule, nu utilizați utilaje sau instrumente.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel conţine lactoză\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel conține lactoză (un tip de zahăr). Dacă medicul dumneavoastră v-a spus că nu puteți tolera sau digera unele zaharuri, discutați cu medicul dumneavoastră înainte de a lua acest medicament.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"3\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCum să luaţi Pitabel\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLuaţi întotdeauna acest medicament exact aşa cum v-a spus medicul dumneavoastră. Discutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCum se administrează acest medicament\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎnghițiți comprimatul întreg cu o cantitate de apă, cu sau fără alimente. Puteți lua medicamentul în orice moment al zilei. Cu toate acestea, încercați să luați comprimatul în același timp în fiecare zi.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCât de mult de administrat\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDoza inițială uzuală este de 1 mg o dată pe zi. După câteva săptămâni, medicul dumneavoastră poate decide să vă mărească doza. Doza maximă pentru adulți și copii cu vârsta peste 10 ani este de 4 mg în fiecare zi.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă aveți probleme cu ficatul, nu trebuie să luați mai mult de 2 mg pe zi.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eUtilizare la copii și adolescenți\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDoza maximă la copiii cu vârsta sub 10 ani este de 2 mg în fiecare zi.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă este necesar, comprimatele pot fi dispersate într-un pahar cu apă imediat înainte de administrare, apoi clătiți paharul cu un volum adițional de apă și beți din nou imediat. Nu folosiți sucuri de fructe sau lapte pentru a dispersa comprimatele.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ePitabel nu este recomandat pentru utilizare la copii cu vârsta sub 6 ani.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAlte lucruri pe care trebuie să le cunoașteți în timp ce luați Pitabel\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă sunteți internați în spital sau primiți tratament pentru o altă problemă, spuneți personalului medical că luați Pitabel.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eMedicul dumneavoastră poate efectua controale regulate ale colesterolului.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eNu încetați să luați Pitabel fără să discutați mai întâi cu medicul dumneavoastră. Nivelul de colesterol poate crește.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luaţi mai mult Pitabel\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luați mai mult Pitabel decât trebuie, discutați cu un medic sau mergeți imediat la spital. Luați ambalajul medicamentului cu dvs.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă uitaţi să luaţi Pitabel\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu vă faceți griji, luați următoarea doză la momentul corect. Nu luați o doză dublă pentru a compensa cea pe care ați uitat-o.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă aveţi orice întrebări suplimentare cu privire la acest medicament, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"4\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eReacţii adverse posibile\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele. Următoarele reacții adverse pot apărea la administrarea acestui medicament:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eOpriți administrarea Pitabel și consultați imediat un medic, dacă observați oricare dintre următoarele reacții adverse grave - este posibil să aveți nevoie de tratament medical urgent:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ereacție alergică - semnele pot include: dificultăți de respirație, umflarea feței, buzelor, limbii sau gâtului, probleme de înghițire, mâncărime severă a pielii (cu noduli umflați).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edurere musculară inexplicabilă sau slăbiciune, mai ales dacă vă simțiți rău, aveți febră sau aveți urină maro-roșiatică. Pitavastatina poate provoca rareori (mai puțin de 1 din 1000 de persoane) efecte musculare neplăcute. Dacă nu sunt investigate, pot duce la probleme grave, cum ar fi defectarea musculară anormală (rabdomioliză), care poate duce la probleme cu rinichii.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eprobleme respiratorii, inclusiv tuse persistentă și \/ sau dificultăți de respirație sau febră.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eprobleme hepatice care pot provoca îngălbenirea pielii și a ochilor (icter).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003epancreatită (dureri severe la nivelul abdomenului și spatelui).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAlte reacții adverse includ:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cem\u003eFrecvente\u003c\/em\u003e (afectează mai puțin de 1 din 10 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri articulare, dureri musculare.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003econstipație, diaree, indigestie, senzație de rău.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edurere de cap.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cem\u003eMai puțin frecvente\u003c\/em\u003e (afectează mai puțin de 1 din 100 de persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003espasme musculare.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esenzație de slăbiciune, oboseală sau stare de rău.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eumflarea gleznelor, picioarelor sau degetelor.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri de stomac, gură uscată, stare de rău, pierderea poftei de mâncare, gust modificat.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003epiele palidă și senzație de slăbiciune sau respirație (anemie).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emâncărime sau erupții cutanate.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ețiuituri în urechi.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esenzație de amețeală sau somnolență, insomnie (alte tulburări de somn, inclusiv coșmaruri).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003enevoie crescută de a merge la toaletă (frecvență urinară).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esenzație de amorțeală și sensibilitate redusă la degetele mâinilor, degetele de la picioare, picioare și față.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cem\u003eRare\u003c\/em\u003e (afectează mai puțin de 1 din 1000 de persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eroșeață a pielii, înroșire și mâncărime a pielii.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edeteriorarea vederii.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edurere în limbă.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esenzație neplăcută sau disconfort în stomac.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edezvoltare excesivă a sânului la bărbat.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eEfecte secundare cu frecvență necunoscută\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eSlăbiciune musculară constantă.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eumflarea feței sau a extremităților (angioedem)\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eSindrom de tip Lupus (care include iritație, tulburări ale articulațiilor, efecte asupra celulelor sanguine).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAlte reacții adverse posibile\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ePierderea memoriei.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDificultăți sexuale.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDepresie.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDiabet. Această reacție este mai probabilă dacă aveți niveluri ridicate de zahăr și grăsimi în sânge, sunteți supraponderal și aveți tensiune arterială crescută. Medicul dumneavoastră vă poate monitoriza în timp ce luați acest medicament.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRaportarea reacţiilor adverse\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă manifestaţi orice reacţii adverse, adresaţi-vă medicului dumneavoastră sau farmacistului. Acestea includ orice posibile reacţii adverse nemenţionate în acest prospect.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"5\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCum se păstrează Pitabel\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eA se păstra la temperaturi sub 25 oC, în ambalajul original.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu lăsaţi acest medicament la vederea şi îndemâna copiilor.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu utilizaţi acest medicament după data de expirare înscrisă pe cutie și blister, după „EXP”. Data de expirare se referă la ultima zi a lunii respective.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu aruncaţi niciun medicament pe calea apei sau a reziduurilor menajere. Întrebaţi farmacistul cum să aruncaţi medicamentele pe care nu le mai folosiţi. Aceste măsuri vor ajuta la protejarea mediului.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"6\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eConţinutul ambalajului şi alte informaţii\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCe conţine Pitabel\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Substanţa activă este pitavastatină.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat Pitabel 2 mg conţine pitavastatină 2 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat Pitabel 4 mg conţine pitavastatină 4 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Celelalte componente sunt:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Nucleu: lactoză monohidrat, L-hidroxipropilceluloză LH-11, aluminometasilicat de magneziu de tip 1B, hidroxipropilmetilceluloză 603w, stearat de magneziu.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Film (Pitabel 2 mg): Opadry 03O580007 White care conţine: hidroxipropilmetilceluloză 2910, hipromeloză (E464), dioxid de titan (E171), trietil citrat, siliciu coloidal anhidru.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Film (Pitabel 4 mg): Opadry 03O580007 White care conţine: hidroxipropilmetilceluloză 2910, hipromeloză (E464), dioxid de titan (E171), trietil citrat, siliciu coloidal anhidru.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCum arată Pitabel şi conţinutul ambalajului\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel 2 mg comprimate filmate\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eComprimate filmate rotunde, biconvexe, de culoare albă.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCutie cu 2 blistere din PVC-PE-PVDC\/Al care conţin a câte 15 comprimate filmate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel 4 mg comprimate filmate\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eComprimate filmate rotunde, biconvexe, de culoare albă.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCutie cu 2 blistere din PVC-PE-PVDC\/Al care conţin a câte 15 comprimate filmate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDeţinătorul certificatului de înregistrare\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNobel Ilaç Sanayii ve Ticaret A.Ş.,\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003esec. Saray, str. Dr. Adnan Buyukdeniz 14, 34768\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eUmraniye, Istanbul, Turcia.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFabricantul\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNOBEL İLAÇ SANAYİİ ve TİCARET A.Ş.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSancaklar Mah. Eski Akçakoca Cad. No: 299\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e81100 DÜZCE \/ TÜRKİYE\u003c\/p\u003e","brand":"Nobel Ilac","offers":[{"title":"Default Title","offer_id":43908060184716,"sku":"99219","price":294.08,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/99219.jpg?v=1750847069"},{"product_id":"equilibra-colest-ok-caps-1","title":"Equilibra Colest-ok caps.","description":"\u003cp style=\"text-align: justify;\" data-start=\"12\" data-end=\"50\"\u003eEquilibra Colest OK\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\" data-start=\"52\" data-end=\"229\"\u003eSupliment alimentar formulat cu extract de bergamotă, orez roșu fermentat și pulbere de amarant, destinat susținerii menținerii nivelurilor normale ale colesterolului din sânge.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\" data-start=\"231\" data-end=\"245\"\u003eBeneficii:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"246\" data-end=\"602\"\u003e\r\n\u003cli data-section-id=\"1qj5wsl\" data-start=\"246\" data-end=\"376\"\u003eConține monacolină K din orez roșu fermentat, care contribuie la menținerea concentrațiilor normale ale colesterolului în sânge.\u003c\/li\u003e\r\n\u003cli data-section-id=\"c508xc\" data-start=\"377\" data-end=\"449\"\u003eFormula este îmbogățită cu extract de bergamotă și pulbere de amarant.\u003c\/li\u003e\r\n\u003cli data-section-id=\"1l25x79\" data-start=\"450\" data-end=\"552\"\u003eConține 2,6 mg de monacolină K per comprimat, conform limitei maxime admise de legislația europeană.\u003c\/li\u003e\r\n\u003cli data-section-id=\"134suqy\" data-start=\"553\" data-end=\"602\"\u003eAdministrare simplă: un singur comprimat pe zi.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\" data-start=\"604\" data-end=\"643\"\u003eIngrediente active (per comprimat):\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"644\" data-end=\"802\"\u003e\r\n\u003cli data-section-id=\"3fp23y\" data-start=\"644\" data-end=\"675\"\u003eExtract de bergamotă – 500 mg\u003c\/li\u003e\r\n\u003cli data-section-id=\"1d3jyz\" data-start=\"676\" data-end=\"773\"\u003eOrez roșu fermentat – 58 mg\r\n\u003cul data-start=\"708\" data-end=\"773\"\u003e\r\n\u003cli data-section-id=\"alsl4f\" data-start=\"708\" data-end=\"738\"\u003edin care monacoline – 2,9 mg\u003c\/li\u003e\r\n\u003cli data-section-id=\"1h0zm7h\" data-start=\"741\" data-end=\"773\"\u003edin care monacolină K – 2,6 mg\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n\u003cli data-section-id=\"1tn8ag8\" data-start=\"774\" data-end=\"802\"\u003ePulbere de amarant – 50 mg\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\" data-start=\"804\" data-end=\"1081\"\u003eIngrediente inactive:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\" data-start=\"804\" data-end=\"1081\"\u003eAgenți de încărcare (celuloză, fosfat dicalcic, hidroxipropilceluloză, carboximetilceluloză sodică reticulată), stabilizatori (mono- și digliceride ale acizilor grași), agenți antiaglomeranți (săruri de magneziu ale acizilor grași, dioxid de siliciu).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\" data-start=\"1083\" data-end=\"1298\"\u003eMod de administrare:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\" data-start=\"1083\" data-end=\"1298\"\u003eSe recomandă administrarea a 1 comprimat pe zi, după masa principală, cu un pahar de apă. Pentru o înghițire mai ușoară, comprimatul poate fi divizat în două părți datorită liniei de rupere.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\" data-start=\"1300\" data-end=\"1316\"\u003eAtenționări:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"1317\" data-end=\"1719\"\u003e\r\n\u003cli data-section-id=\"ox9upe\" data-start=\"1317\" data-end=\"1378\"\u003eNu este recomandat femeilor însărcinate sau care alăptează.\u003c\/li\u003e\r\n\u003cli data-section-id=\"11d48jm\" data-start=\"1379\" data-end=\"1506\"\u003eNu se recomandă utilizarea concomitentă cu medicamente hipolipemiante sau cu alte suplimente care conțin orez roșu fermentat.\u003c\/li\u003e\r\n\u003cli data-section-id=\"ds9z0p\" data-start=\"1507\" data-end=\"1576\"\u003eNu este recomandat persoanelor sub 18 ani și celor peste 70 de ani.\u003c\/li\u003e\r\n\u003cli data-section-id=\"1t4dsnw\" data-start=\"1577\" data-end=\"1676\"\u003eSuplimentele alimentare nu înlocuiesc o dietă variată și echilibrată și un stil de viață sănătos.\u003c\/li\u003e\r\n\u003cli data-section-id=\"14hau0b\" data-start=\"1677\" data-end=\"1719\"\u003eA nu se depăși doza zilnică recomandată.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\" data-start=\"1721\" data-end=\"1822\"\u003eCondiții de păstrare:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\" data-start=\"1721\" data-end=\"1822\"\u003eA se păstra într-un loc uscat, ferit de surse de căldură și lumină directă.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\" data-start=\"1824\" data-end=\"1839\"\u003ePrezentare:\u003c\/p\u003e\r\n\u003cul data-start=\"1840\" data-end=\"1855\"\u003e\r\n\u003cli style=\"text-align: justify;\" data-section-id=\"2tsqf1\" data-start=\"1840\" data-end=\"1855\"\u003e20 comprimate\u003c\/li\u003e\r\n\u003c\/ul\u003e","brand":"Equilibra","offers":[{"title":"Default Title","offer_id":43908226941068,"sku":"99446","price":184.14,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/jVChhrcETDvnH1qJyEkcYEIh2gGL4ZMXDVcbbgEo.jpg?v=1789633692"},{"product_id":"rosuvastatina-stada-5mg-comp-film","title":"Rosuvastatina STADA 5mg comp. film.","description":"\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STA DA 5 mg comprimate lilimite\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 10 mg comprimate lllmatc\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatimi STADA 20 mg comprimate Minate\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCe este Rosuvastatina STADA şl pentru ce se utilizează\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina aparţine unui grup de medicamente numite statine.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVi s-a prescris Rosuvastatina STA DA deoarece:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eAveţi un nivel ridicat de colesterol în sânge. Aceasta înseamnă că prezentaţi risc de a face un atac do eoni sau un accident vascular cerebral. Rosuvastatina STADA este utilizată la adulţi, adolescenţi şi copii cu vârsta de 6 ani şi peste pentru a trata colesterolul crescut.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVi s-a recomandat să utilizaţi o slatină, deoarece modificarea regimului alimentar şi efectuarea mai multor exerciţii fizice nu au fost suficiente pentru a vă corecta nivelul colesterolului din sângele dumneavoastră. în timpul tratamentului cu Rosuvastatina STADA trebuie să continuaţi regimul dumneavoastră alimentar de scădere a colesterolului şi exerciţiile fizice, sau\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eAveţi alţi factori care vă cresc riscul de a avea un atac de cord, un accident vascular cerebral sau alte probleme asemănătoare de sănătate.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAtacul de cord, accidentul vascular cerebral şi alte probleme de sănătate pot fi determinate de o boală, denumită ateroscleroză. Ateroseleroza este cauzată de acumularea de depozite de grăsimi în arterele dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDe ce este important să continuaţi utilizarea Rosuvastatina STADA?\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA este utilizată pentru a corecta nivelurile de substanţe grase din sânge numite lipide, cea mai cunoscută dintre acestea fiind colesterolul. In sânge sunt prezente diferite tipuri dc colesterol, colesterolul „rău” (LDL-C) şi colesterolul „bun” (HDL-C).\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eRosuvastatina STADA scade cantitatea de colesterol „rău” şi creşte colesterolu 1 „bun”.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eMedicamentul acţionează prin blocarea producerii de colesterol „rău” şi îmbunătăţeşte capacitatea organismului de a-1 elimina din sânge.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLa majoritatea persoanelor, valorile mari ale colesterolului nu influenţează starea generală, deoarece nu produc niciun simptom. Cu toate acestea, în absenţa tratamentului, în pereţii vaselor de sânge se pot dezvolta depozite de grăsimi care determină îngustarea lor.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eUneori, aceste vase de sânge îngustate se pot bloca şi pot împiedica alimentarea cu sânge a inimii sau a creierului, provocând un atac de cord sau un accident vascular cerebral. Prin scăderea nivelului do colesterol din sânge puteţi reduce riscul de a face atac de cord, accident vascular cerebral sau probleme asemănătoare dc sănătate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eTrebuio să continuaţi să luaţi Rosuvastatina STADA, chiar dacă colesterolul dumneavoastră a revenit la o valoare normală, deoarece previne creşterea ulterioară a valorilor colesterolului din sângele dumneavoastră şi acumularea de depozite de grăsimi. Cu toate acestea, dacă medicul dumneavoastră vă slătuieşte astfel sau dacă rămâneţi gravidă, trebuie să întrerupeţi utilizarea.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"2\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCe trebuie să ştiţi înainte să luaţi Rosuvastatina STADA\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNU luaţi Kosuvastatina STADA:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi alergie la rosuvastatină sau la oricare dintre celelalte componente ale acestui medicament (enumerate la pct. 6);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în timp ce administraţi rosuvastatina, opriţi imediat tratamentul şi informaţi medicului dumneavoastră, femeile trebuie să evite să rămână gravide în timpul tratamentului cu rosuvastatină, utilizând o metodă de contracepţie adecvată;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi o boală hepatică;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme severe cu rinichii;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi dureri şi crampe musculare repetate sau inexplicabile;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă luaţi un medicament combinat de solbsbuvir\/velpatasvir\/voxilaprevir (utilizat pentru o infecţie virală a ficatului, numită hepatită C);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă luaţi un medicament numit ciclosporină (utilizat, de exemplu, după un transplant de organ).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre situaţiile de mai sus se aplică în cazul dumneavoastră (sau dacă nu sunteţi sigur), vă rugăm să vă adresaţi din nou medicului dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDe asemenea, nu luaţi Kosuvastatina STADA 40 mg (doza maximă):\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme moderate cu rinichii (dacă nu sunteţi sigur, adresaţi-vă medicului dumneavoastră);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă glanda tiroidă nu vă funcţionează corect;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aţi avut orice dureri şi crampe musculare repetate sau inexplicabile, antecedente personale sau familiale de probleme musculare sau antecedente personale dc probleme musculare în timpul tratamentului cu alte medicamente care scad colesterolul;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă consumaţi în mod regulat cantităţi mari de alcool;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi de origine asiatică (japoneză, chineză, filipineză, vietnameză, coreeană sau indiană);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă luaţi alte medicamente numite librnţi pentru a reduce colesterolul.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre situaţiile de mai sus se aplică în cazul dumneavoastră (sau nu sunteţi sigur), vă rugăm să vă adresaţi din nou medicul dumneavoastră. Atenţionări şi precauţii\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎnainte să utilizaţi Rosuvastatina STADA, adresaţi-vă medicului dumneavoastră sau farmacistului:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme cu rinichii;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme cu ficatul;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi dureri şi crampe musculare repetate sau inexplicabile, antecedente personale sau familiale de probleme musculare sau antecedente deprobleme musculare în timpul tratamentului cu alte medicamente care scad colesterolul. Informaţi imediat medicul dumneavoastră dacă aveţi dureri sau crampe musculare inexplicabile, în special dacă vă simţiţi rău sau aveţi febră. De asemenea, spuneţi medicului dumneavoastră sau farmacistului dacă aveţi o slăbiciune musculară constantă;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă consumaţi în mod regulat cantităţi mari de alcool;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă glanda dumneavoastră tiroidă nu funcţionează corect;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă utilizaţi alte medicamente numite fibraţi pentru a vă reduce colesterolul din sânge. Vă rugăm să citiţi cu atenţie acest prospect, chiar dacă aţi mai utilizat înainte alte medicamente pentru valori mari ale colesterolului;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă utilizaţi medicamente pentru tratarea infecţiei cu HIV, cum ar fi ritonavir cu lopinavir şi\/sau atazanavir, vezi „Rosuvastatina STADA împreună cu alte medicamente”;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă utilizaţi sau aţi utilizat în ultimele 7 zile un medicament numit acid fusidic (un medicament utilizat în tratamentul infecţiilor bacteriene) administrat oral sau injectabil.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCombinaţia de acid fusidic şi rosuvastatină poate provoca probleme musculare grave (rabdomioliză), vezi „Rosuvastatina STADA împreună cu alte medicamente”;\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi vârsta peste 70 ani (deoarece medicul dumneavoastră trebuie să stabilească doza iniţială de Rosuvastatina STADA adecvată pentru dumneavoastră);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi insuficienţă respiratorie severă;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi de origine asiatică (de exemplu, japoneză, chineză, filipineză, vietnameză, coreeană sau indiană). Medicul dumneavoastră trebuie să stabilească o doză iniţială adecvată de rosuvastatină pentru dumneavoastră;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aţi avut vreodată o erupţie cutanată severă sau descuamare a pielii, vezicule şi\/sau afte la nivelul gurii după ce aţi luat rosuvastatină sau alte medicamente care conţin rosuvastatină.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎn asociere cu tratamentul cu rosuvastatină, au fost raportate reacţii cutanate grave, inclusiv sindromul Stevens-Johnson şi reacţie la medicament cu eozinofilie şi simptome sistemice (DRESS).\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eOpriţi utilizarea rosuvastatinci şi solicitaţi imediat asistenţă medicală dacă observaţi oricare dintre simptomele enumerate la pct. 4.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre cele de mai sus este valabilă în cazul dumneavoastră (sau dacă nu sunteţi sigur):\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eNu utilizaţi Rosuvastatină STADA 40 mg (doza maximă) şi adresaţi-vă medicului dumneavoastră sau farmacistului înainte de a începe să luaţi orice doză de Rosuvastatina STADA.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLa un număr mic de persoane statinele pot afecta ficatul. Aceasta se identifică printr-un test simplu care detectează niveluri crescute de enzime hepatice (transaminaze) în sânge. Din acest motiv, medicul dumneavoastră va efectua, de obicei, aceste analize de sânge (teste ale funcţiei hepatice) înainte şi în timpul tratamentul cu rosuvastatină.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eîn timp ce luaţi acest medicament, medicul dumneavoastră vă va monitoriza cu atenţie dacă aveţi diabet zaharat sau aveţi risc de a dezvolta diabet zaharat. Sunteţi susceptibil pentru riscul de a dezvolta diabet zaharat, dacă aveţi o valoare ridicată de zaharuri şi grăsimi în sânge, sunteţi supraponderal şi aveţi tensiune arterială crescută.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCopii şi adolescenţi\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă pacientul are vârsta sub 6 ani:Rosuvastatina STADA nu trebuie administrată copiilor cu vârsta sub 6 ani.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă pacientul are vârsta sub 18 ani:Rosuvastatina STADA40 mg nu trebuie administrată copiilor şi adolescenţilor cu vârsta sub 18 ani.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatină STADA împreună cu alte medicamente\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSpuneţi medicului dumneavoastră sau farmacistului dacă utilizaţi, aţi utilizat recent sau s-ar putea să utilizaţi orice alte medicamente.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eInformaţi-1 pe medicul dumneavoastră dacă luaţi oricare dintre următoarele medicamente:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eciclosporină (utilizată după un transplant de organe);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ewar farină, ticagrelor sau clopidogrel (sau orice alt medicament pentru subţierea sângelui);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003efibraţi (cum ar fi gemfibrozil, fenofibrat) sau orice alt medicament utilizat pentru scăderea colesterolului (cum ar fi ezetimib);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emedicamente pentru indigestie (folosite pentru a neutraliza acidul din stomac);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eeritromicină (un antibiotic), acid fusidic (un antibiotic - vedeţi mai sus „Atenţionări şi precauţii”);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003econtraceptive orale (pilula);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eregorafenib (utilizat pentru tratarea cancerului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edarolutamidă (utilizată pentru tratarea cancerului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eterapie de substituţie hormonală;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eoricare dintre următoarele medicamente utilizate pentru tratamentul infecţiilor virale, inclusiv infecţia cu HIV sau hepatita C, singur sau în combinaţie (vezi „Atenţionări şi precauţii”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eEfectele acestor medicamente pot fi modificate de rosuvastatină sau pot modifica efectul rosuvastatinei.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă trebuie să utilizaţi acid fusidic pe cale orală pentru a trata o infecţie bacteriană, va trebui să încetaţi temporar administrarea acestui medicament. Medicul dumneavoastră vă va spune când este sigur să reîncepeţi tratamentul cu rosuvastatină. Administrarea de rosuvastatină cu acid fusidic poate provoca ocazional slăbiciune musculară, sensibilitate musculară sau dureri musculare (rabdomioliză). Pentru mai multe informaţii privind rabdomioliza vezi pct. 4.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSarcina şi alăptarea\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă sunteţi gravidă sau alăptaţi, credeţi că aţi putea fi gravidă sau intenţionaţi să rămâneţi gravidă, adresaţi-vă medicului dumneavoastră sau farmacistului înainte de a utiliza acest medicament.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu luaţi Rosuvastatina STADA dacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în timpul tratamentului cu Rosuvastatină STADA, opriţi imediat să o administraţi şi spuneţi medicului dumneavoastră. Femeile trebuie să evite să rămână gravide în timpul tratamentului cu Rosuvastatină STADA, utilizând o metodă contraceptivă adecvată.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eConducerea şi folosirea vehiculelor\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMajoritatea pacienţilor pot conduce vehicule şi pot folosi utilaje în timpul tratamentului cu Rosuvastatină STADA, deoarece nu le va influenţa capacitatea de a desfăşura aceste activităţi. Cu toate acestea, unele persoane pot prezenta ameţeli în timpul tratamentului cu Rosuvastatină STADA. Dacă vă simţiţi ameţit, adresaţi-vă medicului dumneavoastră înainte de a încerca să conduceţi vehicule sau să folosiţi utilaje.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA conţine lactoză\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă medicul dumneavoastră v-a atenţionat că aveţi intoleranţă la unele categorii de glucide, vă rugăm să-l întrebaţi înainte de a lua acest medicament.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePentru lista tuturor excipienţilor, vezi pct. 6. Conţinutul ambalajului şi alte informaţii.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"3\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCum să luaţi Rosuvastatina STADA\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLuaţi întotdeauna acest medicament exact aşa cum v-a spus medicul sau farmacistul. Discutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza uzuală la adulţi\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luaţi Rosuvastatină STADApentru valori mari ale colesterolului:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza iniţială\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eTratamentul dumneavoastră cu Rosuvastatina STADA trebuie înceaput cu doza de 5 mg sau 10 mg, chiar dacă înainte aţi luat o doză mai mare dintr-o altă statină. Alegerea dozei iniţiale va depinde de:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003econcentraţia de colesterol din sflngcle dumneavoastră;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003egradul de risc pe care îl aveţi dc a avea un atac dc cord sau un accident vascular cerebral;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eprezenţa unui factor care v-ar putea face mai susceptibil la posibilele reacţii adverse.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVă rugăm să vă adresaţi medicului dumneavoastră sau farmacistului pentru a vedea care doză iniţială ele Rosuvastatina STADAeste cea mai potrivită pentru dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMedicul dumneavoastră poate decide să înceapă tratamentul cu doza minimă (5 mg):\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi de origine asiatică (de exemplu, japoneză, chineză, filipineză, vietnameză, coreeană sau indiană);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi vârsta peste 70 ani;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme renale moderate;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi expus unui risc de dureri şi crampe musculare (miopatie).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCreşterea dozei şi doza zilnică maximă\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMedicul dumneavoastră poate decide dacă să vă mărească doza, pentru a ajunge să luaţi doza de Rosuvastatina STADA care este potrivită pentru dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă aţi început tratamentul cu doza dc 5 mg, medicul dumneavoastră poate decide să vă dubleze doza la 10 mg, ulterior la 20 mg şi apoi, dacă este necesar, la 40 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă aţi început tratamentul cu doza de 10 mg, medicul dumneavoastră poate decide să vă dubleze doza la 20 mg şi apoi, dacă este necesar, la 40 mg. Va exista un interval de patru săptămâni între fiecare creştere a dozei.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza zilnică maximă de Rosuvastatina STADAeste de 40 mg. Această doză este doar pentru pacienţii eu niveluri mari de colesterol şi cu risc crescut de a avea un atac de cord sau un accident vascular cerebral, ale căror niveluri de colesterol nu scad suficient cu doza de 20 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luaţi Rosuvastatina STADA pentru a reduce riscul dc a face atac dc cord, accident vascular cerebral sau probleme asemănătoare dc sănătate:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza recomandată este de 20 mg pe zi. Cu toate acestea, medicul dumneavoastră poate decide să utilizaţi o doză mai mică dacă aveţi oricare dintre factorii menţionaţi mai sus.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAdministrarea la copii şi adolescenţi cu vârsta cuprinsă între 6 şi 17 ani\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eIntervalul de doze la copii şi adolescenţi cu vârsta cuprinsă între 6 şi 17 ani este de 5 mg până la 20 mg o dată pe zi. Doza uzuală pentru începerea tratamentului este de 5 mg pe zi, iar medicul dumneavoastră vă poate creşte treptat doza până când ajungeţi la o doză de rosuvastatină potrivită pentru dumneavoastră. Doza zilnică maximă de rosuvastatină este de 10 sau 20 mg pentru copiii cu vârsta cuprinsă între 6 şi 17 ani, în funcţie de boala de bază tratată. Luaţi doza o dală pe zi.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 40 mg comprimate nu trebuie administrată la copii.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCum să luaţi comprimatele\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eînghiţiţi fiecare comprimat întreg, cu o cantitate suficientă de apă.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLuaţi Rosuvastatina STADA o dată pe zi. îl puteţi lua în orice moment al zilei cu sau fără alimente. încercaţi să luaţi comprimatul la aceeaşi oră în fiecare zi. Acest lucru vă va ajuta să vă amintiţi să le luaţi.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVerificări regulate ale nivelului colesterolului\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eEste important să vă prezentaţi la medicul dumneavoastră pentru a vi sc efectua controale regulate ale valorilor colesterolului din sânge; în acest mod, vă asiguraţi că valoarea concentraţiei colesterolului a ajuns şi se menţine în limite normale.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMedicul dumneavoastră poate decide să vă mărească doza, astfel încât să administraţi doza dc Rosuvastatina STADA potrivită pentru dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luaţi mai mult Rosuvastatina STADA decât trebuie\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eContactaţi medicul dumneavoastră sau cel mai apropiat spital pentru consult medical.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă sunteţi internat în spital sau sunteţi tratat pentru o altă afecţiune, spuneţi personalului medical că luaţi Rosuvastatina STADA.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă uitaţi să luaţi Rosuvastatina STADA\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu vă faceţi grij i, luaţi următoarea doză la ora programată. Nu luaţi o doză dublă pentru a compensa doza uitată.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă încetaţi să administraţi Rosuvastatina STADA\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDiscutaţi cu medicul dumneavoastră dacă doriţi să încetaţi să administraţi Rosuvastatina STADA.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNivelul colesterolului dumneavoastră poate creşte din nou dacă încetaţi să luaţi Rosuvastatina STADA.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă aveţi orice întrebări suplimentare cu privire la utilizarea acestui medicament, adresaţi-vă medicului dumneavoastră, sau farmacistului.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"4\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eReacţii adverse posibile\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eEste important să cunoaşteţi care pot fi aceste reacţii adverse. Ele sunt de obicei uşoare şi dispar într-un interval scurt de timp.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eOpriţi tratamentul cu Rosuvastatina STADA şi solicitaţi imediat asistenţă medicală dacă prezentaţi oricare dintre următoarele simptome:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003erespiraţie dificilă, cu sau fără umflarea feţei, buzelor, limbii şi\/sau gâtului;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eumflarea feţei, buzelor, limbii şi\/sau gâtului, care poate provoca dificultăţi la înghiţire;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emâncărimi intense ale pielii (cu urticarie);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003epete dc culoare roşie, care nu sunt în relief, în formă de ţintă sau circulare, apărute pe torace, adesea însoţite de vezicule în mijloc, descuamare a pielii, ulceraţii la nivelul gurii, gâtului, nasului, organelor genitale şi ochilor. Aceste erupţii cutanate severe pot fi precedate de febră şi simptome asemănătoare gripei (sindrom Stevens-Johnson);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eerupţie cutanată extinsă, temperatură crescută a corpului şi ganglioni limfal ici măriţi (sindrom DRESS sau sindrom de hipersensibilitate la medicamente). Dc asemenea, opriţi tratamentul cu Rosuvastatina STADAşi consultaţi imediat medicul dumneavoastră:\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi dureri şi crampe musculare inexplicabile, care durează mai mult decât vă aşteptaţi. Simptomele musculare sunt mai frecvente la copii şi adolescenţi decât la adulţi. Similar altor statine, un număr foarte mic de persoane au prezentat efecte musculare neplăcute care, foarte rar, au dus la leziuni musculare care pun viaţa în pericol, cunoscute sub denumirea de rabdomioliză;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă prezentaţi o ruptură musculară;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi un sindrom asemănător celui din lupus (inclusiv urticarie, afecţiuni ale articulaţiilor şi efecte asupra celulelor sanguine).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse frecvente (pot afecta până la 1 din 10 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri de cap;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri de stomac, constipaţie, greaţă;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri musculare;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eslăbiciune, ameţeli;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ecreşterea cantităţii de proteine din urină aceasta revine, de obicei, la normal de la sine, fără a fi necesară întreruperea tratamentului cu Rosuvastatina STADA comprimate (valabil numai pentru doza de 40 mg Rosuvastatină STADA);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ediabet zaharat. Acest lucru este mai probabil dacă aveţi niveluri ridicate dc zahăr şi grăsimi din sânge, sunteţi supraponderal şi aveţi tensiune arterială ridicată. Medicul dumneavoastră vă va monitoriza îndeaproape în timp ce luaţi acest medicament.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse mai puţin frecvente (pot afecta până la 1 din 100 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eerupţii cutanate, mâncărimc şi alte reacţii ale pielii;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ecreşterea cantităţii de proteine din urină - aceasta revine, de obicei, la normal de la sine, fără a fi necesară întreruperea tratamentului cu Rosuvastatina STADA comprimate (numai pentru Rosuvastatina STADA 5 mg, 10 mg şi 20 mg).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse rare (pot afecta până la 1 din 1000 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ereacţii alergice severe - simptomele includ umflarea feţei, buzelor, limbii şi\/sau gâtului, dificultăţi la înghiţire şi respiraţie, mâncărimi severe ale pielii (cu urticarie). Dacă credeţi că aveţi o reacţie alergică, încetaţi să luaţi Rosuvastatina STADA şi solicitaţi imediat asistenţă medicală;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eleziuni musculare la adulţi - ca măsură de precauţie, încetaţi să luaţi Rosuvastatina STADA şi consultaţi imediat medicul dumneavoastră dacă aveţi dureri sau crampe musculare neobişnuite, care durează mai mult decât v-aţi aştepta;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri severe de stomac (semn posibil de inflamare a pancreasului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ecreşterea valorilor enzimel or hepatice (transaminaze) în sânge;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esângerarea sau vânătăile apar mai uşor decât în mod normal datorită nivelului scăzut de trombocite în sânge;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esindrom cu simptome asemănătoare celor din lupus (inclusiv urticarie, afecţiuni ale articulaţiilor şi efecte asupra celulelor sanguine).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse foarte rare (pot afecta până la 1 din 10.000 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eicter (îngălbenirea pielii şi a albului ochilor), hepatită (inflamaţia ficatului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eurme de sânge în urină;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eleziuni ale nervilor de la nivelul picioarelor şi mâinilor (cum ar fi amorţeală);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri articulare;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003epierderi de memorie;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emărirea sânilor la bărbaţi (ginecomastie).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse cu frecvenţă necunoscută (frecvenţa nu poate fi estimată din datele disponibile)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ediaree (scaune moi);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003etuse, dificultăţi de respiraţie;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eedem (umflare);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003etulburări de somn, inclusiv insomnie şi coşmaruri;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edisfuncţii sexuale;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edepresie;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eprobleme respiratorii, inclusiv tuse persistentă şi\/sau scurtarea respiraţiei sau febră;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eleziuni ale tendoanelor, slăbiciune musculară constantă.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRaportarea reacţiilor adverse\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă manifestaţi orice reacţii adverse, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAcestea includ orice posibile reacţii adverse nemenţionate în acest prospect.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"5\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCum se păstrează Rosuvastatina STADA\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu lăsaţi acest medicament la vederea şi îndemâna copiilor.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eA se păstra în ambalaj original pentru a fi protejat de umiditate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu utilizaţi acest medicament după data de expirare înscrisă pe ambalaj după EXR\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eData dc expirare se referă la ultima zi a lunii respective Nu aruncaţi niciun medicament pe calea apei sau a reziduurilor menajere. întrebaţi farmacistul cum să aruncaţi medicamentele pe care nu le mai folosiţi. Aceste măsuri vor ajuta la protejarea mediului.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"6\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eConţinutul ambalajului şi alte informaţii\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCe conţine Rosuvastatina STADA\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Substanţa activă este rosuvastatina.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cu\u003eRosuvastatina STADA 5 mg:\u003c\/u\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat filmat conţine rosuvastatină (sub formă de rosuvastatină calcică) - 5 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cu\u003eRosuvastatina STADA 10 mg:\u003c\/u\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat filmat conţine rosuvastatină (sub formă de rosuvastatină calcică) -10 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cu\u003eRosuvastatina STADA 20 mg:\u003c\/u\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat filmat conţine rosuvastatină (sub formă de rosuvastatină calcică) - 20 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Celelalte componente sunt: nucleu: lactoză monohidrat, povidonă K 30, crospovidonă tip A, celuloză pulbere, copovidonă, siliciu coloidal anhidru, stearat de magneziu;\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003efilm: alcool polivinilic, macrogol (MW 3350), dioxid de titan (E171), talc.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCum arată Rosuvastatina STADAşi conţinutul ambalajului\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 5 mg se prezintă sub formă de comprimate filmate albe, rotunde, biconvexe, cu diametrul de 5 mm.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 10 mg se prezintă sub formă de comprimate filmate albe, rotunde, biconvexe, cu diametrul de 7 mm.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 20 mg se prezintă sub formă de comprimate filmate albe, rotunde, biconvexe, cu diametrul de 9 mm.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA este disponibil în cutii cu 4 blistere a câte 7 comprimate filmate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDeţinătorul certificatului de înregistrare\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLaboratorio STADA, S.L.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFrederic Mompou, 5\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e08960 Sânt Just Desvern (Barcelona),\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSpania\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFabricantul\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSTADA Arzneimittel AG\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eStadastrasse,2-18\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eD-61118 Bad Vilbel, Germania\u003c\/p\u003e","brand":"Stada Arzneimittel AG","offers":[{"title":"Default Title","offer_id":43908073422988,"sku":"103647","price":42.85,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/103647.jpg?v=1750847668"},{"product_id":"rosuvastatina-stada-20mg-comp-film","title":"Rosuvastatina STADA 20mg comp. film.","description":"\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STA DA 5 mg comprimate lilimite\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 10 mg comprimate lllmatc\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatimi STADA 20 mg comprimate Minate\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCe este Rosuvastatina STADA şl pentru ce se utilizează\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina aparţine unui grup de medicamente numite statine.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVi s-a prescris Rosuvastatina STA DA deoarece:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eAveţi un nivel ridicat de colesterol în sânge. Aceasta înseamnă că prezentaţi risc de a face un atac do eoni sau un accident vascular cerebral. Rosuvastatina STADA este utilizată la adulţi, adolescenţi şi copii cu vârsta de 6 ani şi peste pentru a trata colesterolul crescut.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVi s-a recomandat să utilizaţi o slatină, deoarece modificarea regimului alimentar şi efectuarea mai multor exerciţii fizice nu au fost suficiente pentru a vă corecta nivelul colesterolului din sângele dumneavoastră. în timpul tratamentului cu Rosuvastatina STADA trebuie să continuaţi regimul dumneavoastră alimentar de scădere a colesterolului şi exerciţiile fizice, sau\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eAveţi alţi factori care vă cresc riscul de a avea un atac de cord, un accident vascular cerebral sau alte probleme asemănătoare de sănătate.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAtacul de cord, accidentul vascular cerebral şi alte probleme de sănătate pot fi determinate de o boală, denumită ateroscleroză. Ateroseleroza este cauzată de acumularea de depozite de grăsimi în arterele dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDe ce este important să continuaţi utilizarea Rosuvastatina STADA?\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA este utilizată pentru a corecta nivelurile de substanţe grase din sânge numite lipide, cea mai cunoscută dintre acestea fiind colesterolul. In sânge sunt prezente diferite tipuri dc colesterol, colesterolul „rău” (LDL-C) şi colesterolul „bun” (HDL-C).\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eRosuvastatina STADA scade cantitatea de colesterol „rău” şi creşte colesterolu 1 „bun”.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eMedicamentul acţionează prin blocarea producerii de colesterol „rău” şi îmbunătăţeşte capacitatea organismului de a-1 elimina din sânge.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLa majoritatea persoanelor, valorile mari ale colesterolului nu influenţează starea generală, deoarece nu produc niciun simptom. Cu toate acestea, în absenţa tratamentului, în pereţii vaselor de sânge se pot dezvolta depozite de grăsimi care determină îngustarea lor.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eUneori, aceste vase de sânge îngustate se pot bloca şi pot împiedica alimentarea cu sânge a inimii sau a creierului, provocând un atac de cord sau un accident vascular cerebral. Prin scăderea nivelului do colesterol din sânge puteţi reduce riscul de a face atac de cord, accident vascular cerebral sau probleme asemănătoare dc sănătate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eTrebuio să continuaţi să luaţi Rosuvastatina STADA, chiar dacă colesterolul dumneavoastră a revenit la o valoare normală, deoarece previne creşterea ulterioară a valorilor colesterolului din sângele dumneavoastră şi acumularea de depozite de grăsimi. Cu toate acestea, dacă medicul dumneavoastră vă slătuieşte astfel sau dacă rămâneţi gravidă, trebuie să întrerupeţi utilizarea.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"2\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCe trebuie să ştiţi înainte să luaţi Rosuvastatina STADA\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNU luaţi Kosuvastatina STADA:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi alergie la rosuvastatină sau la oricare dintre celelalte componente ale acestui medicament (enumerate la pct. 6);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în timp ce administraţi rosuvastatina, opriţi imediat tratamentul şi informaţi medicului dumneavoastră, femeile trebuie să evite să rămână gravide în timpul tratamentului cu rosuvastatină, utilizând o metodă de contracepţie adecvată;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi o boală hepatică;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme severe cu rinichii;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi dureri şi crampe musculare repetate sau inexplicabile;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă luaţi un medicament combinat de solbsbuvir\/velpatasvir\/voxilaprevir (utilizat pentru o infecţie virală a ficatului, numită hepatită C);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă luaţi un medicament numit ciclosporină (utilizat, de exemplu, după un transplant de organ).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre situaţiile de mai sus se aplică în cazul dumneavoastră (sau dacă nu sunteţi sigur), vă rugăm să vă adresaţi din nou medicului dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDe asemenea, nu luaţi Kosuvastatina STADA 40 mg (doza maximă):\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme moderate cu rinichii (dacă nu sunteţi sigur, adresaţi-vă medicului dumneavoastră);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă glanda tiroidă nu vă funcţionează corect;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aţi avut orice dureri şi crampe musculare repetate sau inexplicabile, antecedente personale sau familiale de probleme musculare sau antecedente personale dc probleme musculare în timpul tratamentului cu alte medicamente care scad colesterolul;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă consumaţi în mod regulat cantităţi mari de alcool;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi de origine asiatică (japoneză, chineză, filipineză, vietnameză, coreeană sau indiană);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă luaţi alte medicamente numite librnţi pentru a reduce colesterolul.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre situaţiile de mai sus se aplică în cazul dumneavoastră (sau nu sunteţi sigur), vă rugăm să vă adresaţi din nou medicul dumneavoastră. Atenţionări şi precauţii\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎnainte să utilizaţi Rosuvastatina STADA, adresaţi-vă medicului dumneavoastră sau farmacistului:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme cu rinichii;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme cu ficatul;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi dureri şi crampe musculare repetate sau inexplicabile, antecedente personale sau familiale de probleme musculare sau antecedente deprobleme musculare în timpul tratamentului cu alte medicamente care scad colesterolul. Informaţi imediat medicul dumneavoastră dacă aveţi dureri sau crampe musculare inexplicabile, în special dacă vă simţiţi rău sau aveţi febră. De asemenea, spuneţi medicului dumneavoastră sau farmacistului dacă aveţi o slăbiciune musculară constantă;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă consumaţi în mod regulat cantităţi mari de alcool;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă glanda dumneavoastră tiroidă nu funcţionează corect;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă utilizaţi alte medicamente numite fibraţi pentru a vă reduce colesterolul din sânge. Vă rugăm să citiţi cu atenţie acest prospect, chiar dacă aţi mai utilizat înainte alte medicamente pentru valori mari ale colesterolului;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă utilizaţi medicamente pentru tratarea infecţiei cu HIV, cum ar fi ritonavir cu lopinavir şi\/sau atazanavir, vezi „Rosuvastatina STADA împreună cu alte medicamente”;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă utilizaţi sau aţi utilizat în ultimele 7 zile un medicament numit acid fusidic (un medicament utilizat în tratamentul infecţiilor bacteriene) administrat oral sau injectabil.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCombinaţia de acid fusidic şi rosuvastatină poate provoca probleme musculare grave (rabdomioliză), vezi „Rosuvastatina STADA împreună cu alte medicamente”;\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi vârsta peste 70 ani (deoarece medicul dumneavoastră trebuie să stabilească doza iniţială de Rosuvastatina STADA adecvată pentru dumneavoastră);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi insuficienţă respiratorie severă;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi de origine asiatică (de exemplu, japoneză, chineză, filipineză, vietnameză, coreeană sau indiană). Medicul dumneavoastră trebuie să stabilească o doză iniţială adecvată de rosuvastatină pentru dumneavoastră;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aţi avut vreodată o erupţie cutanată severă sau descuamare a pielii, vezicule şi\/sau afte la nivelul gurii după ce aţi luat rosuvastatină sau alte medicamente care conţin rosuvastatină.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎn asociere cu tratamentul cu rosuvastatină, au fost raportate reacţii cutanate grave, inclusiv sindromul Stevens-Johnson şi reacţie la medicament cu eozinofilie şi simptome sistemice (DRESS).\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eOpriţi utilizarea rosuvastatinci şi solicitaţi imediat asistenţă medicală dacă observaţi oricare dintre simptomele enumerate la pct. 4.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre cele de mai sus este valabilă în cazul dumneavoastră (sau dacă nu sunteţi sigur):\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eNu utilizaţi Rosuvastatină STADA 40 mg (doza maximă) şi adresaţi-vă medicului dumneavoastră sau farmacistului înainte de a începe să luaţi orice doză de Rosuvastatina STADA.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLa un număr mic de persoane statinele pot afecta ficatul. Aceasta se identifică printr-un test simplu care detectează niveluri crescute de enzime hepatice (transaminaze) în sânge. Din acest motiv, medicul dumneavoastră va efectua, de obicei, aceste analize de sânge (teste ale funcţiei hepatice) înainte şi în timpul tratamentul cu rosuvastatină.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eîn timp ce luaţi acest medicament, medicul dumneavoastră vă va monitoriza cu atenţie dacă aveţi diabet zaharat sau aveţi risc de a dezvolta diabet zaharat. Sunteţi susceptibil pentru riscul de a dezvolta diabet zaharat, dacă aveţi o valoare ridicată de zaharuri şi grăsimi în sânge, sunteţi supraponderal şi aveţi tensiune arterială crescută.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCopii şi adolescenţi\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă pacientul are vârsta sub 6 ani:Rosuvastatina STADA nu trebuie administrată copiilor cu vârsta sub 6 ani.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă pacientul are vârsta sub 18 ani:Rosuvastatina STADA40 mg nu trebuie administrată copiilor şi adolescenţilor cu vârsta sub 18 ani.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatină STADA împreună cu alte medicamente\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSpuneţi medicului dumneavoastră sau farmacistului dacă utilizaţi, aţi utilizat recent sau s-ar putea să utilizaţi orice alte medicamente.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eInformaţi-1 pe medicul dumneavoastră dacă luaţi oricare dintre următoarele medicamente:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eciclosporină (utilizată după un transplant de organe);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ewar farină, ticagrelor sau clopidogrel (sau orice alt medicament pentru subţierea sângelui);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003efibraţi (cum ar fi gemfibrozil, fenofibrat) sau orice alt medicament utilizat pentru scăderea colesterolului (cum ar fi ezetimib);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emedicamente pentru indigestie (folosite pentru a neutraliza acidul din stomac);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eeritromicină (un antibiotic), acid fusidic (un antibiotic - vedeţi mai sus „Atenţionări şi precauţii”);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003econtraceptive orale (pilula);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eregorafenib (utilizat pentru tratarea cancerului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edarolutamidă (utilizată pentru tratarea cancerului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eterapie de substituţie hormonală;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eoricare dintre următoarele medicamente utilizate pentru tratamentul infecţiilor virale, inclusiv infecţia cu HIV sau hepatita C, singur sau în combinaţie (vezi „Atenţionări şi precauţii”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eEfectele acestor medicamente pot fi modificate de rosuvastatină sau pot modifica efectul rosuvastatinei.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă trebuie să utilizaţi acid fusidic pe cale orală pentru a trata o infecţie bacteriană, va trebui să încetaţi temporar administrarea acestui medicament. Medicul dumneavoastră vă va spune când este sigur să reîncepeţi tratamentul cu rosuvastatină. Administrarea de rosuvastatină cu acid fusidic poate provoca ocazional slăbiciune musculară, sensibilitate musculară sau dureri musculare (rabdomioliză). Pentru mai multe informaţii privind rabdomioliza vezi pct. 4.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSarcina şi alăptarea\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă sunteţi gravidă sau alăptaţi, credeţi că aţi putea fi gravidă sau intenţionaţi să rămâneţi gravidă, adresaţi-vă medicului dumneavoastră sau farmacistului înainte de a utiliza acest medicament.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu luaţi Rosuvastatina STADA dacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în timpul tratamentului cu Rosuvastatină STADA, opriţi imediat să o administraţi şi spuneţi medicului dumneavoastră. Femeile trebuie să evite să rămână gravide în timpul tratamentului cu Rosuvastatină STADA, utilizând o metodă contraceptivă adecvată.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eConducerea şi folosirea vehiculelor\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMajoritatea pacienţilor pot conduce vehicule şi pot folosi utilaje în timpul tratamentului cu Rosuvastatină STADA, deoarece nu le va influenţa capacitatea de a desfăşura aceste activităţi. Cu toate acestea, unele persoane pot prezenta ameţeli în timpul tratamentului cu Rosuvastatină STADA. Dacă vă simţiţi ameţit, adresaţi-vă medicului dumneavoastră înainte de a încerca să conduceţi vehicule sau să folosiţi utilaje.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA conţine lactoză\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă medicul dumneavoastră v-a atenţionat că aveţi intoleranţă la unele categorii de glucide, vă rugăm să-l întrebaţi înainte de a lua acest medicament.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePentru lista tuturor excipienţilor, vezi pct. 6. Conţinutul ambalajului şi alte informaţii.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"3\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCum să luaţi Rosuvastatina STADA\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLuaţi întotdeauna acest medicament exact aşa cum v-a spus medicul sau farmacistul. Discutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza uzuală la adulţi\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luaţi Rosuvastatină STADApentru valori mari ale colesterolului:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza iniţială\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eTratamentul dumneavoastră cu Rosuvastatina STADA trebuie înceaput cu doza de 5 mg sau 10 mg, chiar dacă înainte aţi luat o doză mai mare dintr-o altă statină. Alegerea dozei iniţiale va depinde de:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003econcentraţia de colesterol din sflngcle dumneavoastră;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003egradul de risc pe care îl aveţi dc a avea un atac dc cord sau un accident vascular cerebral;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eprezenţa unui factor care v-ar putea face mai susceptibil la posibilele reacţii adverse.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVă rugăm să vă adresaţi medicului dumneavoastră sau farmacistului pentru a vedea care doză iniţială ele Rosuvastatina STADAeste cea mai potrivită pentru dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMedicul dumneavoastră poate decide să înceapă tratamentul cu doza minimă (5 mg):\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi de origine asiatică (de exemplu, japoneză, chineză, filipineză, vietnameză, coreeană sau indiană);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi vârsta peste 70 ani;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme renale moderate;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi expus unui risc de dureri şi crampe musculare (miopatie).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCreşterea dozei şi doza zilnică maximă\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMedicul dumneavoastră poate decide dacă să vă mărească doza, pentru a ajunge să luaţi doza de Rosuvastatina STADA care este potrivită pentru dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă aţi început tratamentul cu doza dc 5 mg, medicul dumneavoastră poate decide să vă dubleze doza la 10 mg, ulterior la 20 mg şi apoi, dacă este necesar, la 40 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă aţi început tratamentul cu doza de 10 mg, medicul dumneavoastră poate decide să vă dubleze doza la 20 mg şi apoi, dacă este necesar, la 40 mg. Va exista un interval de patru săptămâni între fiecare creştere a dozei.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza zilnică maximă de Rosuvastatina STADAeste de 40 mg. Această doză este doar pentru pacienţii eu niveluri mari de colesterol şi cu risc crescut de a avea un atac de cord sau un accident vascular cerebral, ale căror niveluri de colesterol nu scad suficient cu doza de 20 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luaţi Rosuvastatina STADA pentru a reduce riscul dc a face atac dc cord, accident vascular cerebral sau probleme asemănătoare dc sănătate:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza recomandată este de 20 mg pe zi. Cu toate acestea, medicul dumneavoastră poate decide să utilizaţi o doză mai mică dacă aveţi oricare dintre factorii menţionaţi mai sus.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAdministrarea la copii şi adolescenţi cu vârsta cuprinsă între 6 şi 17 ani\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eIntervalul de doze la copii şi adolescenţi cu vârsta cuprinsă între 6 şi 17 ani este de 5 mg până la 20 mg o dată pe zi. Doza uzuală pentru începerea tratamentului este de 5 mg pe zi, iar medicul dumneavoastră vă poate creşte treptat doza până când ajungeţi la o doză de rosuvastatină potrivită pentru dumneavoastră. Doza zilnică maximă de rosuvastatină este de 10 sau 20 mg pentru copiii cu vârsta cuprinsă între 6 şi 17 ani, în funcţie de boala de bază tratată. Luaţi doza o dală pe zi.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 40 mg comprimate nu trebuie administrată la copii.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCum să luaţi comprimatele\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eînghiţiţi fiecare comprimat întreg, cu o cantitate suficientă de apă.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLuaţi Rosuvastatina STADA o dată pe zi. îl puteţi lua în orice moment al zilei cu sau fără alimente. încercaţi să luaţi comprimatul la aceeaşi oră în fiecare zi. Acest lucru vă va ajuta să vă amintiţi să le luaţi.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVerificări regulate ale nivelului colesterolului\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eEste important să vă prezentaţi la medicul dumneavoastră pentru a vi sc efectua controale regulate ale valorilor colesterolului din sânge; în acest mod, vă asiguraţi că valoarea concentraţiei colesterolului a ajuns şi se menţine în limite normale.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMedicul dumneavoastră poate decide să vă mărească doza, astfel încât să administraţi doza dc Rosuvastatina STADA potrivită pentru dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luaţi mai mult Rosuvastatina STADA decât trebuie\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eContactaţi medicul dumneavoastră sau cel mai apropiat spital pentru consult medical.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă sunteţi internat în spital sau sunteţi tratat pentru o altă afecţiune, spuneţi personalului medical că luaţi Rosuvastatina STADA.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă uitaţi să luaţi Rosuvastatina STADA\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu vă faceţi grij i, luaţi următoarea doză la ora programată. Nu luaţi o doză dublă pentru a compensa doza uitată.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă încetaţi să administraţi Rosuvastatina STADA\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDiscutaţi cu medicul dumneavoastră dacă doriţi să încetaţi să administraţi Rosuvastatina STADA.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNivelul colesterolului dumneavoastră poate creşte din nou dacă încetaţi să luaţi Rosuvastatina STADA.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă aveţi orice întrebări suplimentare cu privire la utilizarea acestui medicament, adresaţi-vă medicului dumneavoastră, sau farmacistului.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"4\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eReacţii adverse posibile\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eEste important să cunoaşteţi care pot fi aceste reacţii adverse. Ele sunt de obicei uşoare şi dispar într-un interval scurt de timp.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eOpriţi tratamentul cu Rosuvastatina STADA şi solicitaţi imediat asistenţă medicală dacă prezentaţi oricare dintre următoarele simptome:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003erespiraţie dificilă, cu sau fără umflarea feţei, buzelor, limbii şi\/sau gâtului;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eumflarea feţei, buzelor, limbii şi\/sau gâtului, care poate provoca dificultăţi la înghiţire;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emâncărimi intense ale pielii (cu urticarie);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003epete dc culoare roşie, care nu sunt în relief, în formă de ţintă sau circulare, apărute pe torace, adesea însoţite de vezicule în mijloc, descuamare a pielii, ulceraţii la nivelul gurii, gâtului, nasului, organelor genitale şi ochilor. Aceste erupţii cutanate severe pot fi precedate de febră şi simptome asemănătoare gripei (sindrom Stevens-Johnson);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eerupţie cutanată extinsă, temperatură crescută a corpului şi ganglioni limfal ici măriţi (sindrom DRESS sau sindrom de hipersensibilitate la medicamente). Dc asemenea, opriţi tratamentul cu Rosuvastatina STADAşi consultaţi imediat medicul dumneavoastră:\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi dureri şi crampe musculare inexplicabile, care durează mai mult decât vă aşteptaţi. Simptomele musculare sunt mai frecvente la copii şi adolescenţi decât la adulţi. Similar altor statine, un număr foarte mic de persoane au prezentat efecte musculare neplăcute care, foarte rar, au dus la leziuni musculare care pun viaţa în pericol, cunoscute sub denumirea de rabdomioliză;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă prezentaţi o ruptură musculară;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi un sindrom asemănător celui din lupus (inclusiv urticarie, afecţiuni ale articulaţiilor şi efecte asupra celulelor sanguine).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse frecvente (pot afecta până la 1 din 10 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri de cap;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri de stomac, constipaţie, greaţă;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri musculare;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eslăbiciune, ameţeli;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ecreşterea cantităţii de proteine din urină aceasta revine, de obicei, la normal de la sine, fără a fi necesară întreruperea tratamentului cu Rosuvastatina STADA comprimate (valabil numai pentru doza de 40 mg Rosuvastatină STADA);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ediabet zaharat. Acest lucru este mai probabil dacă aveţi niveluri ridicate dc zahăr şi grăsimi din sânge, sunteţi supraponderal şi aveţi tensiune arterială ridicată. Medicul dumneavoastră vă va monitoriza îndeaproape în timp ce luaţi acest medicament.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse mai puţin frecvente (pot afecta până la 1 din 100 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eerupţii cutanate, mâncărimc şi alte reacţii ale pielii;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ecreşterea cantităţii de proteine din urină - aceasta revine, de obicei, la normal de la sine, fără a fi necesară întreruperea tratamentului cu Rosuvastatina STADA comprimate (numai pentru Rosuvastatina STADA 5 mg, 10 mg şi 20 mg).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse rare (pot afecta până la 1 din 1000 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ereacţii alergice severe - simptomele includ umflarea feţei, buzelor, limbii şi\/sau gâtului, dificultăţi la înghiţire şi respiraţie, mâncărimi severe ale pielii (cu urticarie). Dacă credeţi că aveţi o reacţie alergică, încetaţi să luaţi Rosuvastatina STADA şi solicitaţi imediat asistenţă medicală;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eleziuni musculare la adulţi - ca măsură de precauţie, încetaţi să luaţi Rosuvastatina STADA şi consultaţi imediat medicul dumneavoastră dacă aveţi dureri sau crampe musculare neobişnuite, care durează mai mult decât v-aţi aştepta;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri severe de stomac (semn posibil de inflamare a pancreasului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ecreşterea valorilor enzimel or hepatice (transaminaze) în sânge;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esângerarea sau vânătăile apar mai uşor decât în mod normal datorită nivelului scăzut de trombocite în sânge;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esindrom cu simptome asemănătoare celor din lupus (inclusiv urticarie, afecţiuni ale articulaţiilor şi efecte asupra celulelor sanguine).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse foarte rare (pot afecta până la 1 din 10.000 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eicter (îngălbenirea pielii şi a albului ochilor), hepatită (inflamaţia ficatului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eurme de sânge în urină;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eleziuni ale nervilor de la nivelul picioarelor şi mâinilor (cum ar fi amorţeală);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri articulare;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003epierderi de memorie;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emărirea sânilor la bărbaţi (ginecomastie).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse cu frecvenţă necunoscută (frecvenţa nu poate fi estimată din datele disponibile)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ediaree (scaune moi);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003etuse, dificultăţi de respiraţie;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eedem (umflare);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003etulburări de somn, inclusiv insomnie şi coşmaruri;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edisfuncţii sexuale;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edepresie;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eprobleme respiratorii, inclusiv tuse persistentă şi\/sau scurtarea respiraţiei sau febră;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eleziuni ale tendoanelor, slăbiciune musculară constantă.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRaportarea reacţiilor adverse\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă manifestaţi orice reacţii adverse, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAcestea includ orice posibile reacţii adverse nemenţionate în acest prospect.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"5\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCum se păstrează Rosuvastatina STADA\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu lăsaţi acest medicament la vederea şi îndemâna copiilor.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eA se păstra în ambalaj original pentru a fi protejat de umiditate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu utilizaţi acest medicament după data de expirare înscrisă pe ambalaj după EXR\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eData dc expirare se referă la ultima zi a lunii respective Nu aruncaţi niciun medicament pe calea apei sau a reziduurilor menajere. întrebaţi farmacistul cum să aruncaţi medicamentele pe care nu le mai folosiţi. Aceste măsuri vor ajuta la protejarea mediului.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"6\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eConţinutul ambalajului şi alte informaţii\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCe conţine Rosuvastatina STADA\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Substanţa activă este rosuvastatina.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cu\u003eRosuvastatina STADA 5 mg:\u003c\/u\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat filmat conţine rosuvastatină (sub formă de rosuvastatină calcică) - 5 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cu\u003eRosuvastatina STADA 10 mg:\u003c\/u\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat filmat conţine rosuvastatină (sub formă de rosuvastatină calcică) -10 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cu\u003eRosuvastatina STADA 20 mg:\u003c\/u\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat filmat conţine rosuvastatină (sub formă de rosuvastatină calcică) - 20 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Celelalte componente sunt: nucleu: lactoză monohidrat, povidonă K 30, crospovidonă tip A, celuloză pulbere, copovidonă, siliciu coloidal anhidru, stearat de magneziu;\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003efilm: alcool polivinilic, macrogol (MW 3350), dioxid de titan (E171), talc.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCum arată Rosuvastatina STADAşi conţinutul ambalajului\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 5 mg se prezintă sub formă de comprimate filmate albe, rotunde, biconvexe, cu diametrul de 5 mm.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 10 mg se prezintă sub formă de comprimate filmate albe, rotunde, biconvexe, cu diametrul de 7 mm.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 20 mg se prezintă sub formă de comprimate filmate albe, rotunde, biconvexe, cu diametrul de 9 mm.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA este disponibil în cutii cu 4 blistere a câte 7 comprimate filmate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDeţinătorul certificatului de înregistrare\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLaboratorio STADA, S.L.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFrederic Mompou, 5\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e08960 Sânt Just Desvern (Barcelona),\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSpania\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFabricantul\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSTADA Arzneimittel AG\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eStadastrasse,2-18\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eD-61118 Bad Vilbel, Germania\u003c\/p\u003e","brand":"Stada Arzneimittel AG","offers":[{"title":"Default Title","offer_id":43921365237900,"sku":"103648","price":93.18,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/103648.jpg?v=1750847668"},{"product_id":"policol-one-plameca-caps","title":"Policol One Plameca  caps.","description":"\u003cp style=\"text-align: justify;\"\u003e\u003cspan lang=\"RO\"\u003ePolicol One\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eConține Guggul - ajută la menținerea nivelului normal al colesterolului din sânge.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSaccharomices cerevisiae, Drojdie de orez roșu, Niacină (vitamina B3), extracte de plante și coenzima Q10.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eConține Anghinare (Artichoke) care ajută la menținerea sănătății ficatului și păpădie care contribuie la funcționarea normală a ficatului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eMOD DE UTILIZARE\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eLuați 1 capsulă în zi, cu un pahar cu apă de preferat odată cu cina.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eGrupuri de populație expuse riscului: solicitați consiliere profesională.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu se permite utilizarea de către femeile gravide și în perioada de alăptare, persoanele sub 18 ani și adulții de peste 70 de ani.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSolicitați sfatul medicului cu privire la utilizarea acestui produs dacă aveți probleme de sănătate. Nu trebuie consumat dacă luați medicamente care scad colesterolul.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu trebuie consumat dacă consumați deja alte produse care conțin drojdie de orez roșu.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu trebuie să depășiți cantitatea zilnică de 3 mg de menacolină K.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eConsumul excesiv poate provoca disconfort intestinal.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eEvitati consumul impreuna cu medicamente si alte suplimente alimentare pe baza de fibre. Suplimentele alimentare nu trebuie folosite ca înlocuitori pentru o alimentație variată și echilibrată. Este important de urmat o dietă variată și echilibrată și un stil de viață sănătos.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu depășiți doza zilnică recomandată.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eA nu se lăsa la îndemâna copiilor mai mici.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eA se pastra intr-un loc racoros si uscat.\u003c\/p\u003e","brand":"Plantas Medicinalies","offers":[{"title":"Default Title","offer_id":43908244308108,"sku":"106332","price":191.64,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/106332.jpg?v=1750847941"},{"product_id":"ultrox-20mg-compfilm","title":"Ultrox 20mg comp.film.","description":"\u003cp style=\"text-align: justify;\"\u003eIndicaţii terapeutice\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eTratamentul hipercolesterolemiei\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAdulţi, adolescenţi şi copii cu vârsta de 6 ani şi peste cu hipercolesterolemie primară (tipul IIa, inclusiv hipercolesterolemia familială heterozigotă) sau dislipidemie mixtă (tipul IIb) ca adjuvant la dietă, atunci când răspunsul la dietă şi la alte tratamente non-farmacologice (de exemplu exerciţiu fizic, scădere ponderală) nu este adecvat.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAdulţi, adolescenţi și copii cu vârsta de 6 ani și peste cu hipercolesterolemie familială homozigotă ca adjuvant la dietă şi la alte tratamente hipolipemiante (de exemplu LDL-afereză) sau în cazul în care astfel de tratamente nu sunt adecvate.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePrevenţia evenimentelor cardiovasculare\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePrevenţia evenimentelor cardiovasculare majore la pacienţii la care se estimează că prezintă risc crescut pentru apariţia unui prim eveniment cardiovascular, ca adjuvant la măsurile corectoare a altor factori de risc.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDoze şi mod de administrare\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eÎnainte de iniţierea tratamentului pacientul trebuie instruit să urmeze o dietă standard de reducere a colesterolemiei care trebuie să continue pe durata tratamentului. Doza trebuie individualizată în funcţie de obiectivul tratamentului şi răspunsul pacientului, utilizând ghidurile curente.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eUltrox poate fi administrat în orice moment al zilei cu sau fără alimente.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eTratamentul hipercolesterolemiei\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDoza de iniţiere recomandată este 5 mg sau 10 mg administrate pe cale orală o dată pe zi, atât la pacienţii care nu au mai urmat niciodată tratament cu statine, cât şi la pacienţii care sunt trecuţi de la un tratament cu un alt inhibitor al HMG-CoA reductazei. Alegerea dozei de iniţiere trebuie să ia în considerare colesterolemia fiecărui pacient şi riscul cardiovascular, cât şi riscul potenţial de reacţii adverse. Ajustarea dozei poate fi făcută după 4 săptămâni, dacă este necesar. Având în vedere creşterea frecvenţei raportării de reacţii adverse în cazul utilizării dozei de 40 mg, comparativ cu dozele mai mici , o creştere treptată finală la doza maximă de 40 mg trebuie luată în considerare numai în cazul pacienţilor cu hipercolesterolemie severă şi risc cardiovascular crescut (în special pacienţii cu hipercolesterolemie familială), care nu ating valorile ţintă ale tratamentului cu doza de 20 mg şi în cazul cărora se va efectua o monitorizare de rutină . La iniţierea dozei de 40 mg se recomandă monitorizare specializată.\u003c\/p\u003e","brand":"Nobel Ilac","offers":[{"title":"Default Title","offer_id":43930607845516,"sku":"108302","price":81.39,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/108302.jpg?v=1750848225"},{"product_id":"ultrox-10mg-compfilm","title":"Ultrox 10mg comp.film.","description":"\u003cp style=\"text-align: justify;\"\u003eIndicaţii terapeutice\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eTratamentul hipercolesterolemiei\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAdulţi, adolescenţi şi copii cu vârsta de 6 ani şi peste cu hipercolesterolemie primară (tipul IIa, inclusiv hipercolesterolemia familială heterozigotă) sau dislipidemie mixtă (tipul IIb) ca adjuvant la dietă, atunci când răspunsul la dietă şi la alte tratamente non-farmacologice (de exemplu exerciţiu fizic, scădere ponderală) nu este adecvat.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAdulţi, adolescenţi și copii cu vârsta de 6 ani și peste cu hipercolesterolemie familială homozigotă ca adjuvant la dietă şi la alte tratamente hipolipemiante (de exemplu LDL-afereză) sau în cazul în care astfel de tratamente nu sunt adecvate.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePrevenţia evenimentelor cardiovasculare\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePrevenţia evenimentelor cardiovasculare majore la pacienţii la care se estimează că prezintă risc crescut pentru apariţia unui prim eveniment cardiovascular, ca adjuvant la măsurile corectoare a altor factori de risc.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDoze şi mod de administrare\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eÎnainte de iniţierea tratamentului pacientul trebuie instruit să urmeze o dietă standard de reducere a colesterolemiei care trebuie să continue pe durata tratamentului. Doza trebuie individualizată în funcţie de obiectivul tratamentului şi răspunsul pacientului, utilizând ghidurile curente.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eUltrox poate fi administrat în orice moment al zilei cu sau fără alimente.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eTratamentul hipercolesterolemiei\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDoza de iniţiere recomandată este 5 mg sau 10 mg administrate pe cale orală o dată pe zi, atât la pacienţii care nu au mai urmat niciodată tratament cu statine, cât şi la pacienţii care sunt trecuţi de la un tratament cu un alt inhibitor al HMG-CoA reductazei. Alegerea dozei de iniţiere trebuie să ia în considerare colesterolemia fiecărui pacient şi riscul cardiovascular, cât şi riscul potenţial de reacţii adverse. Ajustarea dozei poate fi făcută după 4 săptămâni, dacă este necesar. Având în vedere creşterea frecvenţei raportării de reacţii adverse în cazul utilizării dozei de 40 mg, comparativ cu dozele mai mici , o creştere treptată finală la doza maximă de 40 mg trebuie luată în considerare numai în cazul pacienţilor cu hipercolesterolemie severă şi risc cardiovascular crescut (în special pacienţii cu hipercolesterolemie familială), care nu ating valorile ţintă ale tratamentului cu doza de 20 mg şi în cazul cărora se va efectua o monitorizare de rutină . La iniţierea dozei de 40 mg se recomandă monitorizare specializată.\u003c\/p\u003e","brand":"Nobel Ilac","offers":[{"title":"Default Title","offer_id":43930471006348,"sku":"108301","price":62.16,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/108301.jpg?v=1750848224"},{"product_id":"ultrox-5mg-compfilm","title":"Ultrox 5mg comp.film.","description":"\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cstrong style=\"font-weight: 600;\"\u003eIndicaţii terapeutice\u003c\/strong\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cem\u003eTratamentul hipercolesterolemiei\u003c\/em\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAdulţi, adolescenţi şi copii cu vârsta de 6 ani şi peste cu hipercolesterolemie primară (tipul IIa, inclusiv hipercolesterolemia familială heterozigotă) sau dislipidemie mixtă (tipul IIb) ca adjuvant la dietă, atunci când răspunsul la dietă şi la alte tratamente non-farmacologice (de exemplu exerciţiu fizic, scădere ponderală) nu este adecvat.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAdulţi, adolescenţi și copii cu vârsta de 6 ani și peste cu hipercolesterolemie familială homozigotă ca adjuvant la dietă şi la alte tratamente hipolipemiante (de exemplu LDL-afereză) sau în cazul în care astfel de tratamente nu sunt adecvate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cem\u003ePrevenţia evenimentelor cardiovasculare\u003c\/em\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePrevenţia evenimentelor cardiovasculare majore la pacienţii la care se estimează că prezintă risc crescut pentru apariţia unui prim eveniment cardiovascular, ca adjuvant la măsurile corectoare a altor factori de risc.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cstrong style=\"font-weight: 600;\"\u003eDoze şi mod de administrare\u003c\/strong\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎnainte de iniţierea tratamentului pacientul trebuie instruit să urmeze o dietă standard de reducere a colesterolemiei care trebuie să continue pe durata tratamentului. Doza trebuie individualizată în funcţie de obiectivul tratamentului şi răspunsul pacientului, utilizând ghidurile curente.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eUltrox poate fi administrat în orice moment al zilei cu sau fără alimente.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cstrong style=\"font-weight: 600;\"\u003eTratamentul hipercolesterolemiei\u003c\/strong\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza de iniţiere recomandată este 5 mg sau 10 mg administrate pe cale orală o dată pe zi, atât la pacienţii care nu au mai urmat niciodată tratament cu statine, cât şi la pacienţii care sunt trecuţi de la un tratament cu un alt inhibitor al HMG-CoA reductazei. Alegerea dozei de iniţiere trebuie să ia în considerare colesterolemia fiecărui pacient şi riscul cardiovascular, cât şi riscul potenţial de reacţii adverse. Ajustarea dozei poate fi făcută după 4 săptămâni, dacă este necesar. Având în vedere creşterea frecvenţei raportării de reacţii adverse în cazul utilizării dozei de 40 mg, comparativ cu dozele mai mici , o creştere treptată finală la doza maximă de 40 mg trebuie luată în considerare numai în cazul pacienţilor cu hipercolesterolemie severă şi risc cardiovascular crescut (în special pacienţii cu hipercolesterolemie familială), care nu ating valorile ţintă ale tratamentului cu doza de 20 mg şi în cazul cărora se va efectua o monitorizare de rutină . La iniţierea dozei de 40 mg se recomandă monitorizare specializată.\u003c\/p\u003e","brand":"Nobel Ilac","offers":[{"title":"Default Title","offer_id":43908084760716,"sku":"109554","price":39.57,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/aNhpdVCTwk2kW2H38kv7KaQazdq38s7CmkXAImSG.jpg?v=1752046034"},{"product_id":"arterin-colesterol-comp","title":"Arterin Colesterol comp.","description":"\u003cp style=\"text-align: justify;\"\u003eIndicatii:\u003cbr\u003eArterin este recomandat pentru persoanele care doresc sa-si mentina concentratiile normale ale colesterolului din sange, utilizand o substanta activa din sursa naturala.\u003cbr\u003e\u003cbr\u003eArterin este o solutie eficienta si bine tolerata pentru mentinera concentratie normale ale colesterolului, Contine Monacolin K din drojdie rosie de orez, care contribuie la mentinera nivelului normal de colesterol.\u003cbr\u003e\u003cbr\u003eAdministrare:\u003cbr\u003e1 comprimat pe zi, in timpul meselor, preferabil seara\u003c\/p\u003e","brand":"Omega Hipocrate","offers":[{"title":"Default Title","offer_id":43908264460428,"sku":"111486","price":492.14,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/111486.jpg?v=1750848700"},{"product_id":"aterolip-caps-1","title":"Aterolip caps.","description":null,"brand":"SIA AD Smart,Riga","offers":[{"title":"Default Title","offer_id":43908200824972,"sku":"91149","price":182.51,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/91149.jpg?v=1750846165"},{"product_id":"bitonic-inulinoprim-pulbere-250g","title":"Bitonic InulinoPrim pulbere 250g","description":"\u003cp style=\"text-align: justify;\"\u003eSupliment natural cu Bio Inulină din Cicoare pentru funcționarea normală a florei intestinale, digestie, imunitate și slăbire.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eBIo Inulin din Cicoare (Cichorium intybus) 250 g într-un borcan antiseptic.\u003cbr\u003e Rădăcina de cicoare conține minim 88% inulină, sub formă de pudră naturală de culoare albă spre galben cu gust ușor dulceag.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eIngrediente: cant. 1 linguriță.\u003cbr\u003e Pudră de cicoare 8,33g din care:\u003cbr\u003e Fibre de Inulină 7,33g\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDigestie: \u003cbr\u003e- Normalizează și diversifică flora intestinală \u003cbr\u003e- Modifică pH-ul colonului \u003cbr\u003e- Sporește absorbția mineralelor, în special Calciului și Magneziului\u003cbr\u003e- Indigestie, constipație, balonare \u003cbr\u003e- Disbacterioză\u003cbr\u003e- Reglarea greutății (slăbire) – mîrește senzația de sațietate\u003cbr\u003e- Managementul diabetului de tip 2\u003cbr\u003e- Reglarea aportului de zahăr în sânge\u003cbr\u003e- Controlul colesterolului (indiferent de vârstă) – sănătatea cardio-vasculară\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eImunitate:\u003cbr\u003e- Întărește sistemului imunitar\u003cbr\u003e- Îmbunătățește absorbția nutrienților\u003cbr\u003e- Prevenirea alergiilor, rinoconjunctivitelor, eczemelor\u003cbr\u003e\u003cbr\u003eModul de administrare:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e1linguriță care trebuie dizolvate total în apă (în total 8,33 g). Poate fi utilizat alternativ la gătit sau dizolvat în produse lactate (iaurt, chefir), sucuri naturale, smoothie-uri, sosuri de salată sau supe. Se recomandă consumul zilnic de 2 litri de lichid în timpul consumului de Inulină.\u003c\/p\u003e\r\n\u003cp\u003e\u003cbr\u003e\u003cbr\u003e\u003c\/p\u003e","brand":"Lifecare Essentials","offers":[{"title":"Default Title","offer_id":43908268392588,"sku":"112536","price":413.73,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/egFJSMpR50nDsQo3Oq3mztBHuBlmEKdb7o5gPMwf.jpg?v=1753339267"},{"product_id":"co-roswera-10mg-compfilm","title":"Co-Roswera 10mg\/10mg comp.film.","description":"\u003cp style=\"text-align: justify;\"\u003eCe este Co-Roswera şi pentru ce se utilizează\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera conține două substanțe active diferite. Una dintre substanțele active este rosuvastatina, care face parte dintr-o clasă de medicamente numite statine, cealalaltă substanță activă este ezetimibul.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera reduce valorile din sânge ale colesterolului total, ale colesterolului „rău” (LDL colesterol) şi ale substanţelor grase numite trigliceride. În plus, creşte valorile colesterolului „bun” (HDL colesterol). Colesterolul HDL este adesea denumit colesterol „bun”, deoarece ajută la evitarea depozitării colesterolului rău în artere și protejează împotriva bolilor de inimă.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera acționează pentru a reduce valorile colesterolului dumneavoastră din sânge în două moduri: reduce colesterolul absorbit din tractul digestiv, precum și colesterolul produs de organismul dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera este utilizat la pacienţii la care nu se poate obţine un control al valorilor colesterolului numai prin regim alimentar. Pe perioada utilizării acestui medicament, trebuie să continuaţi regimul dumneavoastră alimentar de scădere a colesterolului. Medicul dumneavoastră vă poate prescrie Co-Roswera dacă utilizați deja rosuvastatină și ezetimib, în aceleași concentrații.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDacă aveți o afecțiune a inimii, Co-Roswera scade riscul de infarct miocardic, accident vascular cerebral, intervenție chirurgicală pentru îmbunătățirea circulației sângelui sau riscul spitalizării pentru dureri în piept.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera nu vă ajută să scădeți în greutate.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eTrebuie să continuați să luați Co-Roswera, chiar dacă aveți colesterolul în concentrații normale, deoarece împiedică creșterea nivelului de colesterol și acumularea de depozite grase. Cu toate acestea, trebuie să opriți tratamentul dacă medicul dumneavoastră vă spune să faceți acest lucru sau ați rămas gravidă.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCe trebuie să ştiţi înainte să luaţi Co-Roswera\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu luaţi Co-Roswera\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- dacă sunteţi alergic la rosuvastatină, ezetimib sau la oricare dintre celelalte componente ale acestui medicament.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- dacă sunteți gravidă sau alăptați. Dacă rămâneți gravidă în timpul tratamentului cu Co-Roswera, întrerupeți imediat administrarea medicamentului și spuneți-i medicului dumneavoastră. Femeile trebuie să evite să rămână gravide în timpul tratamentului cu Co-Roswera, utilizând metode de contracepţie adecvate.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- dacă aveți afecțiuni ale ficatului. - dacă aveți insuficienţă severă a rinichilor.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- dacă aveți dureri musculare repetate sau inexplicabile (miopatie).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- dacă luați o combinație de medicamente formată din sofosbuvir\/velpatasvir\/voxilaprevir (utilizată pentru infecția virală a ficatului numită hepatită C).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- dacă utilizați un medicament numit ciclosporină (utilizat de exemplu, după transplantul de organe).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDacă oricare dintre cele de mai sus sunt valabile în cazul dumneavoastră (sau dacă nu sunteţi sigur), vă rugăm să vă adresaţi medicului dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCopii și adolescenți\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eUtilizarea Co-Roswera nu este recomandată la copii și adolescenți cu vârsta sub 18 ani.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSarcina şi alăptarea\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu luați Co-Roswera dacă sunteţi gravidă, intenționați să rămâneți gravidă sau credeți că ați putea fi gravidă. Dacă rămâneţi gravidă în timpul tratamentului cu Co-Roswera, întrerupeți imediat administrarea acestuia şi spuneți-i medicului dumneavoastră. În timpul tratamentului cu Co-Roswera, femeile trebuie să utilizeze metode contraceptive adecvate. Adresați-vă medicului dumneavoastră sau farmacistului pentru recomandări înainte de a lua orice medicament.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eConducerea vehiculelor şi folosirea utilajelor\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu este de aşteptat ca Co-Roswera să vă afecteze capacitatea de a conduce vehicule sau de a folosi utilaje. Cu toate acestea, trebuie luat în considerare faptul că unele persoane pot prezenta ameţeli după ce utilizează Co-Roswera. Dacă vă simţiţi ameţit, adresaţi-vă medicului dumneavoastră înainte de a conduce vehicule sau de a folosi utilaje.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera conține lactoză și sodiu\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDacă vi s-a spus de către medicul dumneavoastră că aveți intoleranță la unele zaharuri, adresați-vă medicului dumneavoastră înainte de a lua acest medicament. Acest medicament conține mai puțin de 1 mmol de sodiu (23 mg) per comprimat, adică practic „nu conține sodiu”.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCum să luaţi Co-Roswera\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eUtilizaţi întotdeauna acest medicament exact aşa cum v-a spus medicul sau farmacistul. Discutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Înainte de inițierea tratamentului cu Co-Roswera, trebuie să urmați un regim alimentar care să scadă nivelul colesterolului și să fiți tratat cu rosuvastatină și ezetimib în aceleași doze. Acest medicament nu este adecvat pentru a începe tratamentul.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Trebuie să continuați cu regimul alimentar de reducere a colesterolului în timp ce luați CoRoswera. Doza zilnică recomandată este de un comprimat Co-Roswera pe cale orală. Puteți lua comprimatul în orice moment al zilei, cu sau fără mâncare. Înghițiți fiecare comprimat întreg, cu un pahar cu apă. Luați medicamentul în aceeași perioadă a zilei.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDoza zilnică recomandată este de un comprimat Co-Roswera pe cale orală. Puteți lua comprimatul în orice moment al zilei, cu sau fără mâncare. Înghițiți fiecare comprimat întreg, cu un pahar cu apă. Luați medicamentul în aceeași perioadă a zilei.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eControale regulate ale valorilor colesterolului din sânge\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eEste important să vă prezentaţi la medicul dumneavoastră, pentru a vi se efectua controale regulate ale valorilor colesterolului din sânge; în acest mod, vă asiguraţi că valoarea concentraţiei colesterolului a ajuns şi se menţine în limite normale.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDacă utilizaţi mai mult Co-Roswera decât trebuie\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAdresați-vă medicului dumneavoastră sau unității de urgențe a celui mai apropiat spital. Dacă ajungeți la spital sau vi se recomandă tratament pentru o altă afecțiune, spuneți personalului medical că luați Co-Roswera.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDacă uitaţi să utilizaţi Co-Roswera\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu vă îngrijoraţi, luați doza următoare la momentul corespunzător. Nu luaţi o doză dublă pentru a compensa doza uitată.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDacă încetaţi să utilizaţi Co-Roswera\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDiscutaţi cu medicul dumneavoastră dacă doriţi să opriţi tratamentul cu Co-Roswera. Este posibil ca valoarea concentraţiei colesterolului din sângele dumneavoastră să înceapă să crească din nou, dacă încetaţi să utilizaţi Co-Roswera.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDacă aveţi orice întrebări suplimentare cu privire la acest medicament, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eReacţii adverse posibile\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele. Este important să cunoaşteţi care pot fi aceste reacţii adverse. Ele sunt, de obicei, ușoare și dispar după scurt timp.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eIncetați tratamentul cu Co-Roswera şi solicitaţi imediat asistenţă medicală, dacă prezentaţi oricare dintre următoarele reacţii alergice:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Dificultăți în respirație, cu sau fără umflarea feței, a buzelor, a limbii și \/ sau a gâtului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Umflare a feței, buzelor, limbii și\/sau a gâtului, care poate provoca dificultăți la înghițire.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Mâncărime severă a pielii (cu proeminențe ale pielii).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSau, dacă prezentați oricare dintre acestea:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Sindrom asemănător bolii lupice (incluzând erupții trecătoare pe piele, tulburări la nivelul articulațiilor și efecte asupra celulelor din sânge).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Ruptură a mușchilor.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Pete de culoare roșie, care nu sunt în relief, în formă de țintă sau circulare, apărute pe torace, adesea însoțite de vezicule în mijloc, descuamare a pielii, ulcerații la nivelul gurii, gâtului, nasului, organelor genitale și ochilor. Aceste erupții grave pe piele pot fi precedate de febră și simptome asemănătoare gripei (sindrom Stevens-Johnson).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Erupție extinsă pe piele, temperatură crescută a corpului și ganglioni limfatici măriți (sindrom DRESS sau sindrom de hipersensibilitate la medicamente).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDe asemenea, încetați să luați Co-Roswera și discutați imediat cu medicul dumneavoastră dacă aveți o sensibilitate crescută sau dureri la nivelul mușchilor, care durează mai mult decât v-ați aștepta. Ca și în cazul altor statine, un număr foarte mic de persoane au prezentat efecte neplăcute la nivelul mușchilor și, rareori, acestea au continuat până au ajuns să amenințe viața, prezentând leziuni ale mușchilor (o afecțiune cunoscută sub numele de rabdomioliză).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCum se păstrează Co-Roswera\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu lăsaţi acest medicament la vederea şi îndemâna copiilor.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu utilizaţi acest medicament după data de expirare înscrisă pe cutie și blister. Data de expirare se referă la ultima zi a lunii respective. A se păstra în ambalajul original, pentru a fi protejat de lumină și umiditate.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAcest medicament nu necesită condiții speciale de temperatură pentru păstrare. Nu aruncaţi niciun medicament pe calea apei sau a reziduurilor menajere. Întrebaţi farmacistul cum să aruncaţi medicamentele pe care nu le mai folosiţi. Aceste măsuri vor ajuta la protejarea mediului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e \u003c\/p\u003e","brand":"KRKA d.d., Novo mesto","offers":[{"title":"Default Title","offer_id":43908099276940,"sku":"118484","price":134.87,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/118484.jpg?v=1750849303"},{"product_id":"co-roswera-20mg10mg-compfilm","title":"Co-Roswera 20mg\/10mg comp.film.","description":"\u003cp style=\"text-align: justify;\"\u003eCo-Roswera 20 mg \/ 10 mg \u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera este un medicament care conține două substanțe active:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"396\" data-end=\"570\"\u003e\r\n\u003cli data-start=\"396\" data-end=\"500\"\u003eRosuvastatină – aparține clasei statinelor, medicamente care reduc colesterolul produs de organism\u003c\/li\u003e\r\n\u003cli data-start=\"501\" data-end=\"570\"\u003eEzetimib – reduce absorbția colesterolului din tractul digestiv\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePrin acțiunea combinată a celor două substanțe, Co-Roswera ajută la controlul eficient al nivelului de colesterol din sânge.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eIndicații:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera este utilizat pentru:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"745\" data-end=\"973\"\u003e\r\n\u003cli data-start=\"745\" data-end=\"781\"\u003ereducerea colesterolului total\u003c\/li\u003e\r\n\u003cli data-start=\"782\" data-end=\"824\"\u003ereducerea colesterolului „rău” (LDL)\u003c\/li\u003e\r\n\u003cli data-start=\"825\" data-end=\"856\"\u003ereducerea trigliceridelor\u003c\/li\u003e\r\n\u003cli data-start=\"857\" data-end=\"973\"\u003ecreșterea colesterolului „bun” (HDL), care protejează vasele de sânge și reduce riscul de boli cardiovasculare\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eEste indicat la pacienții la care regimul alimentar și modificările stilului de viață nu sunt suficiente pentru controlul colesterolului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eMedicul poate prescrie Co-Roswera pacienților care utilizau deja rosuvastatină și ezetimib în aceleași doze, ca tratament combinat într-un singur comprimat.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eBeneficii:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"1363\" data-end=\"1597\"\u003e\r\n\u003cli data-start=\"1363\" data-end=\"1413\"\u003ereduce colesterolul prin două mecanisme diferite\u003c\/li\u003e\r\n\u003cli data-start=\"1414\" data-end=\"1477\"\u003eajută la prevenirea depunerilor de grăsimi pe vasele de sânge\u003c\/li\u003e\r\n\u003cli data-start=\"1478\" data-end=\"1541\"\u003econtribuie la protecția inimii și a sistemului cardiovascular\u003c\/li\u003e\r\n\u003cli data-start=\"1542\" data-end=\"1597\"\u003emenține colesterolul în limite normale pe termen lung\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eMod de administrare:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"1623\" data-end=\"1834\"\u003e\r\n\u003cli data-start=\"1623\" data-end=\"1664\"\u003eDoza recomandată: 1 comprimat pe zi\u003c\/li\u003e\r\n\u003cli data-start=\"1665\" data-end=\"1722\"\u003eSe administrează oral, cu apă, cu sau fără alimente\u003c\/li\u003e\r\n\u003cli data-start=\"1723\" data-end=\"1780\"\u003eSe recomandă administrarea la aceeași oră în fiecare zi\u003c\/li\u003e\r\n\u003cli data-start=\"1781\" data-end=\"1834\"\u003eComprimatele se înghit întregi, fără a fi mestecate\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eTratamentul trebuie asociat cu dietă hipocolesterolemiantă, care trebuie continuată pe toată durata administrării.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eContraindicații:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu utilizați Co-Roswera:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2001\" data-end=\"2118\"\u003e\r\n\u003cli data-start=\"2001\" data-end=\"2083\"\u003edacă sunteți alergic la rosuvastatină, ezetimib sau la oricare dintre excipienți\u003c\/li\u003e\r\n\u003cli data-start=\"2084\" data-end=\"2118\"\u003eîn timpul sarcinii sau alăptării\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSarcina și alăptarea:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2145\" data-end=\"2386\"\u003e\r\n\u003cli data-start=\"2145\" data-end=\"2191\"\u003eCo-Roswera este contraindicat în sarcină\u003c\/li\u003e\r\n\u003cli data-start=\"2192\" data-end=\"2299\"\u003eDacă rămâneți gravidă în timpul tratamentului, întrerupeți imediat administrarea și adresați-vă medicului\u003c\/li\u003e\r\n\u003cli data-start=\"2300\" data-end=\"2386\"\u003eFemeile aflate la vârstă fertilă trebuie să utilizeze metode contraceptive eficiente\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eConducerea vehiculelor:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2415\" data-end=\"2546\"\u003e\r\n\u003cli data-start=\"2415\" data-end=\"2470\"\u003eNu afectează, în mod normal, capacitatea de a conduce\u003c\/li\u003e\r\n\u003cli data-start=\"2471\" data-end=\"2546\"\u003eDacă apar amețeli, evitați conducerea vehiculelor și folosirea utilajelor\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eMonitorizare:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSe recomandă controale regulate ale colesterolului pentru a verifica eficiența tratamentului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCompoziție:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2679\" data-end=\"2802\"\u003e\r\n\u003cli data-start=\"2679\" data-end=\"2802\"\u003eFiecare comprimat filmat conține:\r\n\u003cul data-start=\"2717\" data-end=\"2802\"\u003e\r\n\u003cli data-start=\"2717\" data-end=\"2779\"\u003erosuvastatină 20 mg (sub formă de rosuvastatină calcică)\u003c\/li\u003e\r\n\u003cli data-start=\"2782\" data-end=\"2802\"\u003eezetimib 10 mg\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eForma de prezentare:\u003c\/p\u003e\r\n\u003cul data-start=\"2828\" data-end=\"2864\"\u003e\r\n\u003cli style=\"text-align: justify;\" data-start=\"2828\" data-end=\"2864\"\u003eCutie cu 30 comprimate filmate\u003c\/li\u003e\r\n\u003c\/ul\u003e","brand":"KRKA d.d., Novo mesto","offers":[{"title":"Default Title","offer_id":43908100325516,"sku":"119160","price":167.64,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/dUkjuLbVZYSHAaLPDbwRdrerEwyGwEZBqdmwaa6x.jpg?v=1769410752"},{"product_id":"kirrano-holestop-hsp35-caps","title":"KIRRANO HOLESTOP HSP35+ caps.","description":"\u003cp style=\"text-align: justify;\"\u003eHOLESTOP HSP 35+\u003cbr\u003eMetabolismul normal al macronutrienților cu Quenzima Q10, Niveluri Normale ale Colesterolului și Glicemiei.\u003cbr\u003eSupliment alimentar\u003cbr\u003eBogat în: L-leucină, Vitamina B3, Vitamina B9, Coenzima Q10, Biotină.\u003cbr\u003eCu extract din: spirulina, usturoi, grâu, semințe de in, chlorella.\u003cbr\u003e • DIFERENȚA ALICINA. Alicina este componenta activă din usturoi (benefică pentru sistemul imunitar și sistemul circulator) care este eliberată dintr-un cățel proaspăt zdrobit, formulă care contribuie la formarea energiei intracelulare, fiind prezentă în toate celulele corpului, în special în mitocondrii, participă la producția energiei și stimulează reacțiile biochimice;\u003cbr\u003e • Extract din usturoi– Usturoiul și preparatele sale au fost recunoscute pe scară largă ca având efecte benefice în gestionarea bolilor cardiovasculare. Consumul de usturoi are efecte semnificative asupra scăderii tensiunii arteriale, prevenirea aterosclerozei, reducerea colesterolului seric și a trigliceridelor, inhibarea agregării trombocitelor;\u003cbr\u003e • BENEFICII PENTRU SĂNĂTATEA INIMII. Beneficiile usturoiului sunt cunoscute pe scară largă de secole, iar tehnologia modernă a făcut posibilă valorificarea celor mai utile componente pentru a ajuta la menținerea nivelurilor sănătoase ale tensiunii arteriale și a sănătății generale a inimii;\u003cbr\u003e • SPRIJIN SISTEMULUI IMUN. Păstrează-ți sistemul imunitar cu o doză zilnică de alicină. Usturoiul conține antioxidanți care protejează împotriva daunelor celulare, poate stimula funcția celulelor imunitare și poate ajuta la protejarea împotriva daunelor oxidative cauzate de radicalii liberi.\u003cbr\u003eBeneficii:\u003cbr\u003e • Spirulina:\u003cbr\u003e • Este considerată un superaliment – o sursă completă de nutrienți care ajută la funcționarea optimă a organismului. Spirulina poate reduce absorbția de colesterol de către organism, scăzând nivelul colesterolului. Acest lucru vă ajută să vă mențineți arterele curate, reducând tensiunea asupra inimii, care poate duce la boli de inimă și la cheaguri de sânge care cauzează accident vascular cerebral.\u003cbr\u003e • Biotina contribuie la:\u003cbr\u003e • Metabolismul energetic normal și la metabolismul normal al macronutrienților;\u003cbr\u003e • Menținerea sănătății psihice;\u003cbr\u003e • Menținerea sănătății părului;\u003cbr\u003e • Funcționarea normală a sistemului nervos.\u003cbr\u003e • Quenzima Q10\u003cbr\u003e • Contribuie la formarea energiei intracelulare, fiind prezentă în toate celulele corpului, în special în mitocondrii, participă la producția energiei și stimulează reacțiile biochimice;\u003cbr\u003e • Poate ajuta la menținerea funcției sănătoase a creierului;\u003cbr\u003e • Menține valoarea normală a presiunii arteriale, dar și nivelurile normale ale colesterolului și glicemiei;\u003cbr\u003e • Crește rezistență la efort și reduce frecvența și intensitatea durerelor cardiace.\u003cbr\u003e • Extractul din grâu\u003cbr\u003e • Poate elimina toxinele stocate în organism.\u003cbr\u003e • Prin nivelul ridicat de enzime care se conțin în grâu ajută la digestie, ajutându-vă corpul să descompună alimentele și să absoarbă nutrienții.\u003cbr\u003e • Îmbunătățește funcția sistemului imunitar.\u003cbr\u003e • Nivelurile tale de energie pot fi mai mari decât de obicei din hrana pe care o primești. Odată ce corpul tău a eliminat substanțele nocive, energia ta poate fi direcționată către îndeplinirea sarcinilor zilnice și exerciții fizice. S-ar putea să vă simțiți întineriți și împrospătați.\u003cbr\u003e • Poate îmbunătăți funcția cognitivă.\u003cbr\u003e • Extractul din semințe de in\u003cbr\u003e • Semințele de in sunt bogate în ALA, un tip de acid gras omega-3 care poate oferi numeroase beneficii pentru sănătatea inimii.\u003cbr\u003e • Semințele de in pot ajuta la promovarea mișcărilor intestinale regulate și la îmbunătățirea sănătății digestive.\u003cbr\u003e • Conținutul ridicat de fibre al semințelor de in poate ajuta la scăderea nivelului de colesterol și la îmbunătățirea sănătății inimii.\u003cbr\u003e • Semințele de in pot fi deosebit de utile pentru cei cu hipertensiune arterială, deoarece pot ajuta la scăderea acestui marker al sănătății inimii.\u003cbr\u003e • Semințele de in vă pot ajuta să vă simțiți plini pentru mai mult timp, ceea ce poate sprijini gestionarea greutății.\u003cbr\u003e • Extractul din chlorella\u003cbr\u003e • Îndepărtează toxinele dăunătoare.\u003cbr\u003e • Suport pentru inima. Acizii grași și mineralele din Chlorella, reduc, de asemenea, rigiditatea vaselor de sânge. Acest lucru îmbunătățește funcția vaselor de sânge și scade tensiunea arterială. Menținerea colesterolului bun, a tensiunii arteriale și a vaselor de sânge reduce riscul de a dezvolta boli de inimă.\u003cbr\u003e • Suport pentru sistemul imunitar. Antioxidanții și alți nutrienți din chlorella au demonstrat proprietăți antibacteriene, antivirale și antitumorale, ceea ce vă poate stimula sistemul imunitar și ajuta la combaterea infecțiilor.\u003cbr\u003e • Vitamina B3\u003cbr\u003e • Contribuie la metabolismul energetic normal, la funcționarea normală a sistemului nervos, la menținerea sănătății pielii , la reducerea oboselii și extenuării.\u003cbr\u003e • Vitamina B9\u003cbr\u003e • Contribuie la metabolismul normal al homocisteinei, la menținerea sănătății psihice, la funcționarea normală a sistemului imunitar, la reducerea oboselii și extenuării, la buna funcționare a hematopoeziei, la procesul de diviziune celulară.\u003cbr\u003eMod de administrare\u003cbr\u003e • Oral, în timpul mesei sau după masă, cu o cantitate suficientă de apă.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePrecauții\u003cbr\u003e • Suplimentele alimentare  nu trebuie să înlocuiască  o dietă variată și echilibrată și un stil de viață sănătos;\u003cbr\u003e • A nu se depăși doza recomandată pentru consumul zilnic;\u003cbr\u003e • A nu se lăsf la îndemâna și la vederea copiilor mici;\u003cbr\u003e • Nu este recomandat femeilor însărcinate și care alăptează.\u003c\/p\u003e","brand":"Portavita SRL","offers":[{"title":"Default Title","offer_id":44779657625740,"sku":"111089","price":278.87,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/111089.jpg?v=1763031909"},{"product_id":"zetor-comp-film-20mg","title":"Zetor 20mg comp.film.","description":"\u003cp style=\"text-align: justify;\"\u003eZetor \u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCompoziție:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eFiecare comprimat filmat conține:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"184\" data-end=\"437\"\u003e\r\n\u003cli data-start=\"184\" data-end=\"276\"\u003eSubstanță activă: rosuvastatină (sub formă de sare de calciu) 20 mg\u003c\/li\u003e\r\n\u003cli data-start=\"277\" data-end=\"437\"\u003eExcipienți: celuloză microcristalină, lactoză, fosfat de calciu dibazic, glicolat de amidon sodic, Kollidon CL, stearat de magneziu, amestec pentru film\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eIndicații terapeutice:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eTratamentul hipercolesterolemiei:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"578\" data-end=\"956\"\u003e\r\n\u003cli data-start=\"578\" data-end=\"802\"\u003eHipercolesterolemie primară (tip IIa, inclusiv forma familială heterozigotă) sau dislipidemie mixtă (tip IIb) la adulți, adolescenți și copii ≥6 ani, ca adjuvant la dietă când măsurile nemedicamentoase sunt insuficiente.\u003c\/li\u003e\r\n\u003cli data-start=\"803\" data-end=\"956\"\u003eHipercolesterolemie familială homozigotă la adulți, adolescenți și copii ≥6 ani, ca adjuvant la dietă și alte terapii hipolipemiante (ex. LDL-afereză).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePrevenția complicațiilor cardiovasculare:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"1003\" data-end=\"1139\"\u003e\r\n\u003cli data-start=\"1003\" data-end=\"1139\"\u003ePrevenția primară a evenimentelor cardiovasculare majore la pacienți cu risc crescut, ca adjuvant în corectarea altor factori de risc.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eContraindicații:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"1165\" data-end=\"1563\"\u003e\r\n\u003cli data-start=\"1165\" data-end=\"1230\"\u003eHipersensibilitate la rosuvastatină sau la oricare componentă\u003c\/li\u003e\r\n\u003cli data-start=\"1231\" data-end=\"1342\"\u003eAfecțiuni hepatice active sau creșteri persistente ale transaminazelor (\u0026gt;3× limita superioară a normalului)\u003c\/li\u003e\r\n\u003cli data-start=\"1343\" data-end=\"1391\"\u003eInsuficiență renală severă (ClCr \u0026lt;30 ml\/min)\u003c\/li\u003e\r\n\u003cli data-start=\"1392\" data-end=\"1404\"\u003eMiopatie\u003c\/li\u003e\r\n\u003cli data-start=\"1405\" data-end=\"1450\"\u003eAdministrare concomitentă cu ciclosporină\u003c\/li\u003e\r\n\u003cli data-start=\"1451\" data-end=\"1474\"\u003eSarcină și alăptare\u003c\/li\u003e\r\n\u003cli data-start=\"1475\" data-end=\"1536\"\u003eFemei aflate la vârstă fertilă fără contracepție adecvată\u003c\/li\u003e\r\n\u003cli data-start=\"1537\" data-end=\"1563\"\u003eIntoleranță la lactoză\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDoza de 40 mg este contraindicată la pacienți cu risc de miopatie\/rabdomioliză (hipotiroidism, insuficiență renală moderată, antecedente musculare, consum excesiv de alcool, origine asiatică, tratament concomitent cu fibrați etc.).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDoze și mod de administrare:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAdministrare orală, comprimatul se înghite întreg, cu apă, indiferent de mese.\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"1918\" data-end=\"2095\"\u003e\r\n\u003cli data-start=\"1918\" data-end=\"1969\"\u003eDoza inițială recomandată: 5–10 mg o dată pe zi\u003c\/li\u003e\r\n\u003cli data-start=\"1970\" data-end=\"2014\"\u003eAjustarea dozei se face după 4 săptămâni\u003c\/li\u003e\r\n\u003cli data-start=\"2015\" data-end=\"2095\"\u003eDoza maximă: 40 mg\/zi (numai la pacienți selectați, sub supraveghere medicală)\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eGrupe speciale:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2116\" data-end=\"2339\"\u003e\r\n\u003cli data-start=\"2116\" data-end=\"2155\"\u003eVârstnici: nu necesită ajustare\u003c\/li\u003e\r\n\u003cli data-start=\"2156\" data-end=\"2212\"\u003eInsuficiență renală moderată: doză inițială 5 mg\u003c\/li\u003e\r\n\u003cli data-start=\"2213\" data-end=\"2270\"\u003ePacienți asiatici: doză inițială recomandată 5 mg\u003c\/li\u003e\r\n\u003cli data-start=\"2271\" data-end=\"2339\"\u003eCopii și adolescenți \u0026lt;18 ani: utilizarea nu este recomandată\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eReacții adverse posibile:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDe obicei ușoare și tranzitorii.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eFrecvente:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2423\" data-end=\"2523\"\u003e\r\n\u003cli data-start=\"2423\" data-end=\"2443\"\u003eCefalee, amețeli\u003c\/li\u003e\r\n\u003cli data-start=\"2444\" data-end=\"2486\"\u003eConstipație, greață, dureri abdominale\u003c\/li\u003e\r\n\u003cli data-start=\"2487\" data-end=\"2498\"\u003eMialgie\u003c\/li\u003e\r\n\u003cli data-start=\"2499\" data-end=\"2523\"\u003eDiabet zaharat tip 2\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eRare:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2535\" data-end=\"2625\"\u003e\r\n\u003cli data-start=\"2535\" data-end=\"2561\"\u003eMiopatie, rabdomioliză\u003c\/li\u003e\r\n\u003cli data-start=\"2562\" data-end=\"2591\"\u003eCreșterea transaminazelor\u003c\/li\u003e\r\n\u003cli data-start=\"2592\" data-end=\"2625\"\u003eReacții de hipersensibilitate\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eFoarte rare:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2644\" data-end=\"2677\"\u003e\r\n\u003cli data-start=\"2644\" data-end=\"2663\"\u003eHepatită, icter\u003c\/li\u003e\r\n\u003cli data-start=\"2664\" data-end=\"2677\"\u003eHematurie\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDacă apar dureri musculare intense, slăbiciune sau febră, adresați-vă imediat medicului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eInteracțiuni medicamentoase importante:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2816\" data-end=\"3051\"\u003e\r\n\u003cli data-start=\"2816\" data-end=\"2852\"\u003eCiclosporină – contraindicat\u003c\/li\u003e\r\n\u003cli data-start=\"2853\" data-end=\"2905\"\u003eFibrați (gemfibrozil) – risc crescut de miopatie\u003c\/li\u003e\r\n\u003cli data-start=\"2906\" data-end=\"2936\"\u003eInhibitori de protează HIV\u003c\/li\u003e\r\n\u003cli data-start=\"2937\" data-end=\"2975\"\u003eAntagoniști vitamina K (warfarină)\u003c\/li\u003e\r\n\u003cli data-start=\"2976\" data-end=\"2999\"\u003eContraceptive orale\u003c\/li\u003e\r\n\u003cli data-start=\"3000\" data-end=\"3016\"\u003eEritromicină\u003c\/li\u003e\r\n\u003cli data-start=\"3017\" data-end=\"3051\"\u003eAntiacide cu aluminiu\/magneziu\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSarcina și alăptarea:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eContraindicat în sarcină și în perioada de alăptare.\u003cbr data-start=\"3134\" data-end=\"3137\"\u003e Femeile aflate la vârstă fertilă trebuie să utilizeze metode contraceptive eficiente.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSupradozaj:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu există antidot specific. Tratament simptomatic și monitorizarea funcțiilor hepatice și CPK.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePrezentare\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCutie cu 30 comprimate filmate.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCondiții de păstrare:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eA se păstra la temperaturi sub 30°C.\u003cbr data-start=\"3476\" data-end=\"3479\"\u003e A nu se lăsa la îndemâna copiilor.\u003c\/p\u003e","brand":"GM Pharmaceuticals Ltd.","offers":[{"title":"Default Title","offer_id":46449650139276,"sku":"127667","price":103.92,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/EKWbA0hqnKhGXYFV6rs5ZBopw8sKZm5GuYhBHypj.jpg?v=1772547273"},{"product_id":"zetor-comp-film-10mg","title":"Zetor 10mg comp.film.","description":"\u003cp style=\"text-align: justify;\"\u003eZetor \u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCompoziție:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eFiecare comprimat filmat conține:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"184\" data-end=\"437\"\u003e\r\n\u003cli data-start=\"184\" data-end=\"276\"\u003eSubstanță activă: rosuvastatină (sub formă de sare de calciu) 10 mg\u003c\/li\u003e\r\n\u003cli data-start=\"277\" data-end=\"437\"\u003eExcipienți: celuloză microcristalină, lactoză, fosfat de calciu dibazic, glicolat de amidon sodic, Kollidon CL, stearat de magneziu, amestec pentru film\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eIndicații terapeutice:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eTratamentul hipercolesterolemiei:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"578\" data-end=\"956\"\u003e\r\n\u003cli data-start=\"578\" data-end=\"802\"\u003eHipercolesterolemie primară (tip IIa, inclusiv forma familială heterozigotă) sau dislipidemie mixtă (tip IIb) la adulți, adolescenți și copii ≥6 ani, ca adjuvant la dietă când măsurile nemedicamentoase sunt insuficiente.\u003c\/li\u003e\r\n\u003cli data-start=\"803\" data-end=\"956\"\u003eHipercolesterolemie familială homozigotă la adulți, adolescenți și copii ≥6 ani, ca adjuvant la dietă și alte terapii hipolipemiante (ex. LDL-afereză).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePrevenția complicațiilor cardiovasculare:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"1003\" data-end=\"1139\"\u003e\r\n\u003cli data-start=\"1003\" data-end=\"1139\"\u003ePrevenția primară a evenimentelor cardiovasculare majore la pacienți cu risc crescut, ca adjuvant în corectarea altor factori de risc.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eContraindicații:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"1165\" data-end=\"1563\"\u003e\r\n\u003cli data-start=\"1165\" data-end=\"1230\"\u003eHipersensibilitate la rosuvastatină sau la oricare componentă\u003c\/li\u003e\r\n\u003cli data-start=\"1231\" data-end=\"1342\"\u003eAfecțiuni hepatice active sau creșteri persistente ale transaminazelor (\u0026gt;3× limita superioară a normalului)\u003c\/li\u003e\r\n\u003cli data-start=\"1343\" data-end=\"1391\"\u003eInsuficiență renală severă (ClCr \u0026lt;30 ml\/min)\u003c\/li\u003e\r\n\u003cli data-start=\"1392\" data-end=\"1404\"\u003eMiopatie\u003c\/li\u003e\r\n\u003cli data-start=\"1405\" data-end=\"1450\"\u003eAdministrare concomitentă cu ciclosporină\u003c\/li\u003e\r\n\u003cli data-start=\"1451\" data-end=\"1474\"\u003eSarcină și alăptare\u003c\/li\u003e\r\n\u003cli data-start=\"1475\" data-end=\"1536\"\u003eFemei aflate la vârstă fertilă fără contracepție adecvată\u003c\/li\u003e\r\n\u003cli data-start=\"1537\" data-end=\"1563\"\u003eIntoleranță la lactoză\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDoza de 40 mg este contraindicată la pacienți cu risc de miopatie\/rabdomioliză (hipotiroidism, insuficiență renală moderată, antecedente musculare, consum excesiv de alcool, origine asiatică, tratament concomitent cu fibrați etc.).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDoze și mod de administrare:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAdministrare orală, comprimatul se înghite întreg, cu apă, indiferent de mese.\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"1918\" data-end=\"2095\"\u003e\r\n\u003cli data-start=\"1918\" data-end=\"1969\"\u003eDoza inițială recomandată: 5–10 mg o dată pe zi\u003c\/li\u003e\r\n\u003cli data-start=\"1970\" data-end=\"2014\"\u003eAjustarea dozei se face după 4 săptămâni\u003c\/li\u003e\r\n\u003cli data-start=\"2015\" data-end=\"2095\"\u003eDoza maximă: 40 mg\/zi (numai la pacienți selectați, sub supraveghere medicală)\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eGrupe speciale:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2116\" data-end=\"2339\"\u003e\r\n\u003cli data-start=\"2116\" data-end=\"2155\"\u003eVârstnici: nu necesită ajustare\u003c\/li\u003e\r\n\u003cli data-start=\"2156\" data-end=\"2212\"\u003eInsuficiență renală moderată: doză inițială 5 mg\u003c\/li\u003e\r\n\u003cli data-start=\"2213\" data-end=\"2270\"\u003ePacienți asiatici: doză inițială recomandată 5 mg\u003c\/li\u003e\r\n\u003cli data-start=\"2271\" data-end=\"2339\"\u003eCopii și adolescenți \u0026lt;18 ani: utilizarea nu este recomandată\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eReacții adverse posibile:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDe obicei ușoare și tranzitorii.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eFrecvente:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2423\" data-end=\"2523\"\u003e\r\n\u003cli data-start=\"2423\" data-end=\"2443\"\u003eCefalee, amețeli\u003c\/li\u003e\r\n\u003cli data-start=\"2444\" data-end=\"2486\"\u003eConstipație, greață, dureri abdominale\u003c\/li\u003e\r\n\u003cli data-start=\"2487\" data-end=\"2498\"\u003eMialgie\u003c\/li\u003e\r\n\u003cli data-start=\"2499\" data-end=\"2523\"\u003eDiabet zaharat tip 2\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eRare:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2535\" data-end=\"2625\"\u003e\r\n\u003cli data-start=\"2535\" data-end=\"2561\"\u003eMiopatie, rabdomioliză\u003c\/li\u003e\r\n\u003cli data-start=\"2562\" data-end=\"2591\"\u003eCreșterea transaminazelor\u003c\/li\u003e\r\n\u003cli data-start=\"2592\" data-end=\"2625\"\u003eReacții de hipersensibilitate\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eFoarte rare:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2644\" data-end=\"2677\"\u003e\r\n\u003cli data-start=\"2644\" data-end=\"2663\"\u003eHepatită, icter\u003c\/li\u003e\r\n\u003cli data-start=\"2664\" data-end=\"2677\"\u003eHematurie\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDacă apar dureri musculare intense, slăbiciune sau febră, adresați-vă imediat medicului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eInteracțiuni medicamentoase importante:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\" data-start=\"2816\" data-end=\"3051\"\u003e\r\n\u003cli data-start=\"2816\" data-end=\"2852\"\u003eCiclosporină – contraindicat\u003c\/li\u003e\r\n\u003cli data-start=\"2853\" data-end=\"2905\"\u003eFibrați (gemfibrozil) – risc crescut de miopatie\u003c\/li\u003e\r\n\u003cli data-start=\"2906\" data-end=\"2936\"\u003eInhibitori de protează HIV\u003c\/li\u003e\r\n\u003cli data-start=\"2937\" data-end=\"2975\"\u003eAntagoniști vitamina K (warfarină)\u003c\/li\u003e\r\n\u003cli data-start=\"2976\" data-end=\"2999\"\u003eContraceptive orale\u003c\/li\u003e\r\n\u003cli data-start=\"3000\" data-end=\"3016\"\u003eEritromicină\u003c\/li\u003e\r\n\u003cli data-start=\"3017\" data-end=\"3051\"\u003eAntiacide cu aluminiu\/magneziu\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSarcina și alăptarea:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eContraindicat în sarcină și în perioada de alăptare.\u003cbr data-start=\"3134\" data-end=\"3137\"\u003e Femeile aflate la vârstă fertilă trebuie să utilizeze metode contraceptive eficiente.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSupradozaj:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu există antidot specific. Tratament simptomatic și monitorizarea funcțiilor hepatice și CPK.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePrezentare\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCutie cu 30 comprimate filmate.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCondiții de păstrare:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eA se păstra la temperaturi sub 30°C.\u003cbr data-start=\"3476\" data-end=\"3479\"\u003e A nu se lăsa la îndemâna copiilor.\u003c\/p\u003e","brand":"GM Pharmaceuticals Ltd.","offers":[{"title":"Default Title","offer_id":46449650172044,"sku":"127666","price":78.4,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/YTNn9aLu0K5uG3PodnbHtj6oEaOIkfVu1av8gaWS.jpg?v=1772547109"},{"product_id":"rosucard-20mg-comp-film","title":"Rosucard 20mg comp.film.","description":null,"brand":"Zentiva Labormed","offers":[{"title":"Default Title","offer_id":46756804067468,"sku":"127831","price":95.55,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/127831.png?v=1773806707"},{"product_id":"pitabel-2mg-comp-film","title":"Pitabel 2mg comp.film.","description":"\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel 2 mg comprimate filmate\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel 4 mg comprimate filmate\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitavastatină\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCe este Pitabel şi pentru ce se utilizează\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel conține o substanță activă numită pitavastatină. Acesta aparține unui grup de medicamente numite „statine”. Pitabel este utilizat pentru corectarea nivelului de grăsime (lipide) din sânge și poate fi administrat atât de copii de la vârsta de 6 ani, cât și de adulți. Un dezechilibru al grăsimilor, în special al colesterolului, poate duce uneori la infarct sau accident vascular cerebral.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVi s-a prescris Pitabel deoarece aveți un dezechilibru al grăsimilor și schimbarea dietei și modificarea stilului de viață nu au fost suficiente pentru a corecta acest lucru. Ar trebui să continuați dieta de scădere a colesterolului și modificările stilului de viață în timp ce luați Pitabel.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"2\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCe trebuie să ştiţi înainte să luaţi Pitabel\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu luaţi Pitabel dacă:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- sunteţi alergic (hipersensibil) la pitavastatină, la alte statine sau la oricare dintre celelalte componente ale acestui medicament (enumerate la pct. 6);\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- dacă sunteți însărcinată sau alăptați;\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- dacă sunteți o femeie capabilă să aveți copii și nu utilizați o metodă contraceptivă fiabilă (vezi „Sarcina, alăptarea și fertilitatea”);\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- dacă aveți în prezent probleme cu ficatul;\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- dacă luați ciclosporină – medicament utilizat după un transplant de organe.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- dacă aveți dureri musculare repetate sau inexplicabile. Dacă nu sunteți sigur, discutați cu medicul sau farmacistul înainte de a lua Pitabel.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAtenţionări şi precauţii\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDiscutați cu medicul dumneavoastră sau farmacistul înainte de a administra Pitabel dacă:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eaveți insuficiență respiratorie severă (probleme respiratorii severe).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eați avut vreodată probleme cu rinichii.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eați avut anterior probleme cu ficatul. „Statinele” pot afecta ficatul la un număr mic de persoane. De obicei, medicul dumneavoastră va efectua un test de sânge (testul funcției hepatice) înainte și în timpul tratamentului cu Pitabel.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eați avut vreodată probleme cu glanda tiroidă.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edumneavoastră sau orice membru al familiei dumneavoastră aveți antecedente de probleme musculare.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eați avut antecedente de probleme musculare atunci când luați alte medicamente care scad colesterolul (de exemplu, statine sau fibrați).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003econsumați alcool în exces.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eluați sau ați luat în ultimele 7 zile un medicament numit acid fusidic (un medicament pentru tratamentul unor infecții bacteriene) pe cale orală sau prin injecție. Combinația de acid fusidic și Pitabel poate duce la probleme musculare grave (rabdomioliză).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre situațiile de mai sus vi se aplică (sau nu sunteți sigur), discutați cu medical dumneavoastră sau cu farmacistul înainte de a lua Pitabel. De asemenea, spuneți medicului dumneavoastră sau farmacistului dacă aveți o slăbiciune musculară constantă. Este posibil să fie necesare teste și medicamente suplimentare pentru a diagnostica și trata acest lucru.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎn timp ce utilizați acest medicament, medicul dumneavoastră vă va monitoriza îndeaproape dacă aveți diabet sau dacă sunteți expus riscului de a dezvolta diabet. Este posibil să aveți riscul de a dezvolta diabet dacă aveți un nivel ridicat de zaharuri și grăsimi în sânge, dacă sunteți supraponderal și aveți tensiune arterială crescută.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCopii și adolescenți\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel nu trebuie administrat copiilor cu vârsta sub 6 ani.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎnainte de a lua Pitabel, adolescentele ar trebui să primească îndrumări și consiliere cu privire la metodele de contracepție.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel împreună cu alte medicamente\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSpuneți medicului dumneavoastră sau farmacistului dacă luați, ați luat recent sau s-ar putea să luați orice alte medicamente. Aceasta include orice medicamente obținute fără prescripție medicală și remedii pe bază de plante. Unele medicamente administrate concomitent pot afecta reciproc funcționarea lor corectă.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSpuneți în special medicului dumneavoastră sau farmacistului dacă luați oricare dintre următoarele:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ealte medicamente numite „fibrați” - cum ar fi gemfibrozil și fenofibrat;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eeritromicină sau rifampicină - tipuri de antibiotice utilizate pentru tratamentul unor infecții;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ewarfarină sau orice alt medicament utilizat pentru subțierea sângelui;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emedicamente pentru tratamentul HIV numite „inhibitori de protează” (de exemplu, ritonavir, lopinavir, darunavir, atazanavir) și „inhibitori non-nucleozidici ai revers transcriptazei” (de exemplu efavirenz);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eniacină (vitamina B3);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă trebuie să luați acid fusidic pe cale orală pentru a trata o infecție bacteriană, va trebui să întrerupeți temporar utilizarea Pitabel. Medicul dumneavoastră vă va spune când este sigur să reporniți utilizarea Pitabel. Administrarea Pitabel cu acid fusidic poate duce rar la slăbiciune musculară, sensibilitate sau durere (rabdomioliză). Vedeți mai multe informații despre rabdomioliză în secțiunea 4.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre cele de mai sus vi se aplică (sau nu sunteți sigur), discutați cu medicul dumneavoastră sau cu farmacistul înainte de a lua Pitabel.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel împreună cu alimente sau băuturi\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel poate fi administrat cu sau fără alimente.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSarcina, alăptarea și fertilitatea\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu luați Pitabel dacă sunteți gravidă sau alăptați. Dacă intenționați să rămâneți gravidă, discutați cu medicul dumneavoastră înainte de a lua Pitabel. Dacă sunteți femeie care poate avea copii, trebuie să utilizați o metodă contraceptivă fiabilă, în timp ce luați Pitabel. Încetați să luați Pitabel și consultați imediat un medic dacă rămâneți gravidă în timp ce luați Pitabel. Adresați-vă medicului dumneavoastră sau farmacistului pentru recomandări înainte de a lua orice medicament, dacă sunteți gravidă sau alăptați.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eConducerea vehiculelor şi folosirea utilajelor\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel nu este de așteptat să interfereze cu capacitatea dumneavoastră de a conduce vehicule sau de a folosi utilaje. Cu toate acestea, dacă vă simțiți amețit sau somnoros în timp ce luați Pitabel, nu conduceți vehicule, nu utilizați utilaje sau instrumente.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel conţine lactoză\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel conține lactoză (un tip de zahăr). Dacă medicul dumneavoastră v-a spus că nu puteți tolera sau digera unele zaharuri, discutați cu medicul dumneavoastră înainte de a lua acest medicament.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"3\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCum să luaţi Pitabel\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLuaţi întotdeauna acest medicament exact aşa cum v-a spus medicul dumneavoastră. Discutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCum se administrează acest medicament\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎnghițiți comprimatul întreg cu o cantitate de apă, cu sau fără alimente. Puteți lua medicamentul în orice moment al zilei. Cu toate acestea, încercați să luați comprimatul în același timp în fiecare zi.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCât de mult de administrat\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDoza inițială uzuală este de 1 mg o dată pe zi. După câteva săptămâni, medicul dumneavoastră poate decide să vă mărească doza. Doza maximă pentru adulți și copii cu vârsta peste 10 ani este de 4 mg în fiecare zi.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă aveți probleme cu ficatul, nu trebuie să luați mai mult de 2 mg pe zi.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eUtilizare la copii și adolescenți\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDoza maximă la copiii cu vârsta sub 10 ani este de 2 mg în fiecare zi.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă este necesar, comprimatele pot fi dispersate într-un pahar cu apă imediat înainte de administrare, apoi clătiți paharul cu un volum adițional de apă și beți din nou imediat. Nu folosiți sucuri de fructe sau lapte pentru a dispersa comprimatele.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ePitabel nu este recomandat pentru utilizare la copii cu vârsta sub 6 ani.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAlte lucruri pe care trebuie să le cunoașteți în timp ce luați Pitabel\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă sunteți internați în spital sau primiți tratament pentru o altă problemă, spuneți personalului medical că luați Pitabel.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eMedicul dumneavoastră poate efectua controale regulate ale colesterolului.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eNu încetați să luați Pitabel fără să discutați mai întâi cu medicul dumneavoastră. Nivelul de colesterol poate crește.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luaţi mai mult Pitabel\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luați mai mult Pitabel decât trebuie, discutați cu un medic sau mergeți imediat la spital. Luați ambalajul medicamentului cu dvs.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă uitaţi să luaţi Pitabel\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu vă faceți griji, luați următoarea doză la momentul corect. Nu luați o doză dublă pentru a compensa cea pe care ați uitat-o.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă aveţi orice întrebări suplimentare cu privire la acest medicament, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"4\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eReacţii adverse posibile\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele. Următoarele reacții adverse pot apărea la administrarea acestui medicament:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eOpriți administrarea Pitabel și consultați imediat un medic, dacă observați oricare dintre următoarele reacții adverse grave - este posibil să aveți nevoie de tratament medical urgent:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ereacție alergică - semnele pot include: dificultăți de respirație, umflarea feței, buzelor, limbii sau gâtului, probleme de înghițire, mâncărime severă a pielii (cu noduli umflați).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edurere musculară inexplicabilă sau slăbiciune, mai ales dacă vă simțiți rău, aveți febră sau aveți urină maro-roșiatică. Pitavastatina poate provoca rareori (mai puțin de 1 din 1000 de persoane) efecte musculare neplăcute. Dacă nu sunt investigate, pot duce la probleme grave, cum ar fi defectarea musculară anormală (rabdomioliză), care poate duce la probleme cu rinichii.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eprobleme respiratorii, inclusiv tuse persistentă și \/ sau dificultăți de respirație sau febră.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eprobleme hepatice care pot provoca îngălbenirea pielii și a ochilor (icter).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003epancreatită (dureri severe la nivelul abdomenului și spatelui).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAlte reacții adverse includ:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cem\u003eFrecvente\u003c\/em\u003e (afectează mai puțin de 1 din 10 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri articulare, dureri musculare.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003econstipație, diaree, indigestie, senzație de rău.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edurere de cap.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cem\u003eMai puțin frecvente\u003c\/em\u003e (afectează mai puțin de 1 din 100 de persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003espasme musculare.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esenzație de slăbiciune, oboseală sau stare de rău.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eumflarea gleznelor, picioarelor sau degetelor.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri de stomac, gură uscată, stare de rău, pierderea poftei de mâncare, gust modificat.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003epiele palidă și senzație de slăbiciune sau respirație (anemie).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emâncărime sau erupții cutanate.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ețiuituri în urechi.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esenzație de amețeală sau somnolență, insomnie (alte tulburări de somn, inclusiv coșmaruri).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003enevoie crescută de a merge la toaletă (frecvență urinară).\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esenzație de amorțeală și sensibilitate redusă la degetele mâinilor, degetele de la picioare, picioare și față.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cem\u003eRare\u003c\/em\u003e (afectează mai puțin de 1 din 1000 de persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eroșeață a pielii, înroșire și mâncărime a pielii.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edeteriorarea vederii.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edurere în limbă.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esenzație neplăcută sau disconfort în stomac.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edezvoltare excesivă a sânului la bărbat.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eEfecte secundare cu frecvență necunoscută\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eSlăbiciune musculară constantă.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eumflarea feței sau a extremităților (angioedem)\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eSindrom de tip Lupus (care include iritație, tulburări ale articulațiilor, efecte asupra celulelor sanguine).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAlte reacții adverse posibile\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ePierderea memoriei.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDificultăți sexuale.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDepresie.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDiabet. Această reacție este mai probabilă dacă aveți niveluri ridicate de zahăr și grăsimi în sânge, sunteți supraponderal și aveți tensiune arterială crescută. Medicul dumneavoastră vă poate monitoriza în timp ce luați acest medicament.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRaportarea reacţiilor adverse\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă manifestaţi orice reacţii adverse, adresaţi-vă medicului dumneavoastră sau farmacistului. Acestea includ orice posibile reacţii adverse nemenţionate în acest prospect.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"5\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCum se păstrează Pitabel\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eA se păstra la temperaturi sub 25 oC, în ambalajul original.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu lăsaţi acest medicament la vederea şi îndemâna copiilor.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu utilizaţi acest medicament după data de expirare înscrisă pe cutie și blister, după „EXP”. Data de expirare se referă la ultima zi a lunii respective.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu aruncaţi niciun medicament pe calea apei sau a reziduurilor menajere. Întrebaţi farmacistul cum să aruncaţi medicamentele pe care nu le mai folosiţi. Aceste măsuri vor ajuta la protejarea mediului.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"6\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eConţinutul ambalajului şi alte informaţii\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCe conţine Pitabel\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Substanţa activă este pitavastatină.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat Pitabel 2 mg conţine pitavastatină 2 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat Pitabel 4 mg conţine pitavastatină 4 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Celelalte componente sunt:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Nucleu: lactoză monohidrat, L-hidroxipropilceluloză LH-11, aluminometasilicat de magneziu de tip 1B, hidroxipropilmetilceluloză 603w, stearat de magneziu.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Film (Pitabel 2 mg): Opadry 03O580007 White care conţine: hidroxipropilmetilceluloză 2910, hipromeloză (E464), dioxid de titan (E171), trietil citrat, siliciu coloidal anhidru.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Film (Pitabel 4 mg): Opadry 03O580007 White care conţine: hidroxipropilmetilceluloză 2910, hipromeloză (E464), dioxid de titan (E171), trietil citrat, siliciu coloidal anhidru.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCum arată Pitabel şi conţinutul ambalajului\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel 2 mg comprimate filmate\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eComprimate filmate rotunde, biconvexe, de culoare albă.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCutie cu 2 blistere din PVC-PE-PVDC\/Al care conţin a câte 15 comprimate filmate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePitabel 4 mg comprimate filmate\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eComprimate filmate rotunde, biconvexe, de culoare albă.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCutie cu 2 blistere din PVC-PE-PVDC\/Al care conţin a câte 15 comprimate filmate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDeţinătorul certificatului de înregistrare\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNobel Ilaç Sanayii ve Ticaret A.Ş.,\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003esec. Saray, str. Dr. Adnan Buyukdeniz 14, 34768\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eUmraniye, Istanbul, Turcia.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFabricantul\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNOBEL İLAÇ SANAYİİ ve TİCARET A.Ş.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSancaklar Mah. Eski Akçakoca Cad. No: 299\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e81100 DÜZCE \/ TÜRKİYE\u003c\/p\u003e","brand":"Nobel Ilac","offers":[{"title":"Default Title","offer_id":49943600693388,"sku":"99220","price":214.05,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/99220.jpg?v=1779105872"},{"product_id":"rosuvastatin-lf-10mg-comp-film","title":"Rosuvastatin-LF 10mg comp. film.","description":"\u003cdiv\u003e\r\n\u003cdiv\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCe este Rosuvastatină şi pentru ce se utilizează\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eRosuvastatină face parte dintr-un grup de medicamente numite statine.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eVi s-a prescris Rosuvastatină deoarece:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAveţi o valoare mare a colesterolului în sânge. Aceasta înseamnă că prezentaţi risc de a face infarct miocardic sau accident vascular cerebral. Rosuvastatină este utilizat la adulţi, adolescenţi şi copii cu vârsta de 6 ani şi peste pentru tratamentul colesterolului mare.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eVi s-a recomandat să utilizaţi o statină, deoarece modificarea regimului alimentar şi efectuarea mai multor exerciţii fizice nu au fost suficiente pentru a corecta valoarea colesterolului din sângele dumneavoastră. În timpul tratamentului cu Rosuvastatină Atb trebuie să continuaţi regimul dumneavoastră alimentar de scădere a colesterolului şi exerciţiile fizice, sau\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAveţi alţi factori care vă cresc riscul de a prezenta un infarct miocardic, accident vascular cerebral sau probleme asemănătoare de sănătate.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eInfarctul miocardic, accidentul vascular cerebral şi alte probleme pot fi determinate de o afecţiune denumită ateroscleroză.Ateroscleroza este determinată de acumularea de depozite de grăsimi în arterele dumneavoastră.\u003c\/p\u003e\r\n\u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cdiv\u003eDe ce este important să continuaţi să luaţi Rosuvastatină?\u003c\/div\u003e\r\n\u003cdiv\u003eRosuvastatină este utilizată pentru a corecta valorile substanţelor grase din sânge denumite lipide, cea mai cunoscută dintre acestea fiind colesterolul.\u003c\/div\u003e\r\n\u003cdiv\u003eÎn sânge sunt prezente diferite tipuri de colesterol– colesterolul “rău” (LDL-C) şi colesterolul “bun” (HDL-C).\u003c\/div\u003e\r\n\u003cdiv\u003e-Rosuvastatină poate să scadă colesterolul “rău” şi să crească colesterolul “bun”.\u003c\/div\u003e\r\n\u003cdiv\u003e-Medicamentul acţionează ajutând organismul să blocheze producerea de colesterol “rău”. De asemenea, Rosuvastatină îmbunătăţeşte capacitatea organismului dumneavoastră de a-l elimina din sânge.\u003c\/div\u003e\r\n\u003cdiv\u003eLa majoritatea persoanelor, valorile mari ale colesterolului nu influenţează starea generală, deoarece nu produc niciun simptom. Cu toate acestea, în absenţa tratamentului, în pereţii vaselor de sânge se pot dezvolta depozite de grăsimi care determină îngustarea lor.\u003c\/div\u003e\r\n\u003cdiv\u003eUneori, aceste vase de sânge îngustate se pot bloca, ceea ce poate opri aportul de sânge la inimă sau creier, determinând infarct miocardic sau accident vascular cerebral.Prin scăderea valorilor\u003c\/div\u003e\r\n\u003cdiv\u003ecolesterolului din sânge, puteţi micşora riscul de a face infarct miocardic, accident vascular cerebral sau probleme asemănătoare de sănătate.\u003c\/div\u003e\r\n\u003cdiv\u003eTrebuie să continuaţi să utilizaţi Rosuvastatină, chiar dacă colesterolul dumneavoastră a revenit la o valoare normală, deoarece acesta previne creşterea ulterioară a valorilor colesterolului din sângele dumneavoastră şi acumularea de depozite de grăsimi.Cu toate acestea, dacă medicul dumneavoastră vă sfătuieşte altfel sau dacă rămâneţi gravidă, trebuie să întrerupeţi utilizarea.\u003c\/div\u003e\r\n\u003cdiv\u003eCe trebuie să ştiţi înainte să luaţi Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003eNu utilizaţi Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aţi avut vreodată o reacţie alergică la rosuvastatină sau la oricare dintre celelalt componente ale acestui medicament;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă sunteţi gravidă sau dacă alăptaţi. Dacă rămâneţi gravidă în timpul tratamentului cu Rosuvastatină, opriţi imediat tratamentul şi spuneţi-i medicului dumneavoastră.Femeile trebuie să evite să rămână gravide în timpul tratamentului cu Rosuvastatină, utilizând metode de contracepţie adecvate.\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi afecţiuni ale ficatului;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi probleme severe la nivelul rinichilor;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi dureri musculare repetate sau inexplicabile;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă utilizaţi un medicament denumit ciclosporină (utilizat de exemplu, după transplantul de organe).\u003c\/div\u003e\r\n\u003cdiv\u003eDacă oricare dintre cele de mai sus sunt valabile în cazul dumneavoastră (sau dacă nu sunteţi sigur), vă rugăm să vă adresaţi din nou medicului dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003eÎn plus, nu utilizaţi Rosuvastatină 40 mg (doza maximă):\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi probleme de intensitate moderată la nivelul rinichilor (dacă nu sunteţi sigur, adresaţi-vă medicului dumneavoastră);\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă glanda tiroidă nu vă funcţionează corect;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aţi avut orice dureri musculare repetate sau inexplicabile, antecedente personale sau familiale de probleme musculare sau antecedente personale de probleme musculare în timpul tratamentului cu alte medicamente care scad colesterolul;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă, în mod regulat, consumaţi cantităţi mari de alcool etilic;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă sunteţi de origine asiatică (japoneză, chineză, filipineză, vietnameză, coreeană sau indiană);\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă utilizaţi alte medicamente denumite fibraţi pentru a vă scădea colesterolul din sânge.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă oricare dintre cele de mai sus sunt valabile în cazul dumneavoastră (sau dacă nu sunteţi sigur), vă rugăm să vă adresaţi din nou medicului dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003e \u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cdiv\u003eAtenţionări şi precauţii\u003c\/div\u003e\r\n\u003cdiv\u003eÎnainte să luaţi Rosuvastatină Atb, adresaţi-vă medicului dumneavoastră sau farmacistului:\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi probleme cu rinichii dumneavoastră;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi probleme cu ficatul dumneavoastră;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aţi avut dureri musculare repetate sau inexplicabile, antecedente personale sau familiale de probleme musculare sau antecedente personale de probleme musculare în timpul tratamentului cu alte medicamente care scad colesterolul. Informaţi-l imediat pe medicul dumneavoastră dacă aveţi dureri musculare inexplicabile, în special dacă vă simţiţi rău sau aveţi febră. De asemenea, spuneţi medicului dumneavoastră sau farmacistului dacă aveţi o slăbiciune musculară constantă.\u003c\/div\u003e\r\n\u003cdiv\u003eTeste suplimentare şi medicamente pot fi necesare pentru a diagnostica şi trata acest simptom.\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă, în mod regulat, consumaţi cantităţi mari de alcool etilic;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă glanda dumneavoastră tiroidă nu funcţionează normal;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă utilizaţi alte medicamente denumite fibraţi pentru a vă scădea colesterolul din sânge. Vă rugăm să citiţi cu atenţie acest prospect, chiar dacă aţi mai utilizat înainte alte medicamente pentru valori mari ale colesterolului;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă luaţi medicamente utilizate pentru tratatarea infecţiei cu HIV, de exemplu ritonavir cu lopinavir şi\/sau atazanavir vă rugăm să citiţi şi „Rosuvastatină Atb împreună cu alte medicamente”;\u003c\/div\u003e\r\n\u003cdiv\u003e- în cazul în care luați antibiotice care conțin acid fusidic, vă rugăm să citiți și pct. „Rosuvastatină împreună cu alte medicamente”.\u003c\/div\u003e\r\n\u003cdiv\u003eCopii şi adolescenţi\u003c\/div\u003e\r\n\u003cdiv\u003e• Dacă pacientul este un copil cu vârsta sub 6 ani: Rosuvastatina nu trebuie administrată la copii cu vârsta sub 6 ani.\u003c\/div\u003e\r\n\u003cdiv\u003e• Dacă pacientul are vârsta sub 18 ani: Rosuvastatina 40 mg nu este adecvată pentru administrare la copii şi adolescenţi cu vârsta sub 18 ani.\u003c\/div\u003e\r\n\u003cdiv\u003e- Dacă aveţi vârsta peste 70 de ani (deoarece medicul dumneavoastră trebuie să stabilească doza iniţială de Rosuvastatină adecvată pentru dumneavoastră);\u003c\/div\u003e\r\n\u003cdiv\u003e- Dacă aveţi insuficienţă respiratorie severă;\u003c\/div\u003e\r\n\u003cdiv\u003e- Dacă sunteţi de origine asiatică – adică japoneză, chineză, filipineză, vietnameză, coreeană sau indiană.\u003c\/div\u003e\r\n\u003cdiv\u003eMedicul dumneavoastră trebuie să stabilească o doză iniţială de Rosuvastatină adecvată pentru dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă oricare din cele de mai sus este valabilă în cazul dumneavoastră (sau dacă nu sunteţi sigur):\u003c\/div\u003e\r\n\u003cdiv\u003eNu utilizaţi Rosuvastatină 40 mg (doza maximă) şi adresaţi-vă medicului dumneavoastră sau farmacistului înainte de a începe să luaţi orice doză de Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003eLa un număr mic de persoane statinele pot afecta ficatul.Aceasta se identifică printr-un test simplu care analizează prezenţa concentraţiilor crescute de enzime hepatice în sânge. Din acest motiv, medicul dumneavoastră vă va recomanda, de obicei, aceste analize de sânge (teste funcţionale\u003c\/div\u003e\r\n\u003cdiv\u003ehepatice), înainte şi în timpul tratamentului cu Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003eÎn timp ce luaţi acest medicament medicul dumneavoastră vă va monitoriza cu atenţie dacă aveţi diabet zaharat sau aveţi risc de a dezvolta diabet zaharat. Sunteti susceptibil pentru riscul de a dezvolta diabet zaharat, dacă aveţi o valoare ridicată de zaharuri şi grăsimi în sânge, sunteţi supraponderal şi aveţi tensiune arterială crescută.\u003c\/div\u003e\r\n\u003cdiv\u003eRosuvastatină împreună cu alte medicamente\u003c\/div\u003e\r\n\u003cdiv\u003eSpuneţi medicului dumneavoastră sau farmacistului dacă luaţi, aţi luat recent sau s-ar putea să luaţi orice alte medicamente.\u003c\/div\u003e\r\n\u003cdiv\u003eInformaţi-l pe medicul dumneavoastră dacă luaţi oricare dintre următoarele medicamente:\u003c\/div\u003e\r\n\u003cdiv\u003e- ciclosporină (utilizată, de exemplu, după transplantul de organe);\u003c\/div\u003e\r\n\u003cdiv\u003e- warfarină sau clopidogrel (sau orice medicament utilizat pentru „subţierea” sângelui);\u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cdiv\u003e- fibraţi (de exemplu gemfibrozil, fenofibrat) sau orice alte medicamente utilizate pentru a scădea valorile colesterolului din sânge (cum este ezetimib);\u003c\/div\u003e\r\n\u003cdiv\u003e- medicamente pentru indigestie (utilizate pentru neutralizarea acidului din stomac);\u003c\/div\u003e\r\n\u003cdiv\u003e- eritromicină (un antibiotic), acid fusidic (un antibiotic-vezi pct. „Atenţionări şi precauţii”,contraceptive orale („pilula”);\u003c\/div\u003e\r\n\u003cdiv\u003e- terapie de substituţie hormonală sau medicaţie anti-virală cum ar fi ritonavir cu lopinavir şi\/sau atazanavir sau simeprevir (utilizate pentru tratamentul infecţiei cu HIV sau a hepatitei C-\u003c\/div\u003e\r\n\u003cdiv\u003evă rugăm să citiţi şi „Atenţionări şi precauţii”). Efectele acestor medicamente pot fi modificate de Rosuvastatină sau acestea pot modifica efectul Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003eSarcina, alăptarea şi fertilitatea\u003c\/div\u003e\r\n\u003cdiv\u003eNu luaţi Rosuvastatină dacă sunteţi gravidă sau dacă alăptaţi. Dacă rămâneţi gravidă în timpul tratamentului cu Rosuvastatină, opriţi imediat administrarea acestuia şi informaţi-l pe medicul dumneavoastră. Femeile trebuie să evite apariţia unei sarcini în timpul tratamentului cu Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003eprin utilizarea de metode contraceptive adecvate. Adresaţi-vă medicului dumneavoastră sau farmacistului înainte de a lua orice medicamente.\u003c\/div\u003e\r\n\u003cdiv\u003eConducerea vehiculelor şi folosirea utilajelor\u003c\/div\u003e\r\n\u003cdiv\u003eAbilitatea de a conduce vehicule şi de a folosi utilaje nu este afectată la majoritatea pacienţilor în timpul tratamentului cu Rosuvastatină.Cu toate acestea, unii pacienţi se pot simţi ameţiţi în timpul tratamentului cu Rosuvastatină. În această situaţie adresaţi-vă medicului dumneavoastră înainte de a conduce vehicule sau de a folosi utilaje.\u003c\/div\u003e\r\n\u003cdiv\u003eRosuvastatină conţine lactoză, galben amurg și roşu Allura AC Aluminium Lake.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă medicul dumneavoastră v-a atenţionat că aveţi intoleranţă la unele categorii de glucide, vă rugăm să-l întrebaţi înainte de a lua Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003e \u003c\/div\u003e\r\n\u003cdiv\u003eCum să luaţi Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003eUtilizaţi întotdeauna acest medicament exact aşa cum v-a spus medicul sau farmacistul. Discutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur.\u003c\/div\u003e\r\n\u003cdiv\u003eDoza obişnuită la adulţi:\u003c\/div\u003e\r\n\u003cdiv\u003eDacă luaţi Rosuvastatină pentru valori mari ale colesterolului.\u003c\/div\u003e\r\n\u003cdiv\u003eDoza iniţială:\u003c\/div\u003e\r\n\u003cdiv\u003eTratamentul dumneavoastră cu Rosuvastatină trebuie început cu doza de 5 mg sau 10 mg, chiar dacă înainte aţi luat o doză mai mare dintr-o altă statină. Alegerea dozei iniţiale va depinde de:\u003c\/div\u003e\r\n\u003cdiv\u003e- Concentraţia de colesterol din sângele dumneavoastră;\u003c\/div\u003e\r\n\u003cdiv\u003e- Gradul de risc pe care îl aveţi pentru un infarct miocardic sau accident vascular cerebral;\u003c\/div\u003e\r\n\u003cdiv\u003e- Prezenţa unui factor care v-ar putea face mai susceptibil la posibilele reacţii adverse.\u003c\/div\u003e\r\n\u003cdiv\u003eVă rugăm să vă adresaţi medicului dumneavoastră sau farmacistului pentru a vedea care doză iniţială de Rosuvastatină este cea mai potrivită pentru dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003eMedicul dumneavoastră poate decide să vă administreze doza minimă (5 mg) dacă:\u003c\/div\u003e\r\n\u003cdiv\u003e- Sunteţi deorigine asiatică (japoneză, chineză, filipineză, vietnameză, coreeană şi indiană);\u003c\/div\u003e\r\n\u003cdiv\u003e- Aveţi vârsta peste 70 de ani;\u003c\/div\u003e\r\n\u003cdiv\u003e- Aveţi probleme renale moderate;\u003c\/div\u003e\r\n\u003cdiv\u003e- Sunteţi supus unui risc de a dezvolta dureri musculare (miopatie).\u003c\/div\u003e\r\n\u003cdiv\u003eCreşterea dozei şi doza zilnică maximă:\u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cdiv\u003eMedicul dumneavoastră poate decide să vă crească doza, pentru a ajunge să luaţi doza de Rosuvastatină care este potrivită pentru dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă aţi început tratamentul cu doza de 5 mg, medicul dumneavoastră poate decide să vă dubleze doza la 10 mg, ulterior la 20 mg, şi apoi, dacă este necesar, la 40 mg.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă aţi început cu doza de 10 mg, medicul dumneavoastră poate decide să vă dubleze doza la 20 mg şi ulterior, dacă este necesar, la 40 mg. Va exista o perioadă de 4 săptămâni între fiecare creştere a dozei.\u003c\/div\u003e\r\n\u003cdiv\u003eDoza maximă zilnică de Rosuvastatină este de 40 mg.Această doză este numai pentru pacienţii cu valori mari ale colesterolului şi cu risc crescut de infarct miocardic sau accident vascular cerebral, ale căror concentraţii de colesterol din sânge nu sunt suficient controlate (scăzute) cu doza de 20 mg.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă luaţi Rosuvastatină pentru a vă reduce riscul de a face infarct miocardic, accident vascular cerebral sau probleme asemănătoare de sănătate:\u003c\/div\u003e\r\n\u003cdiv\u003eDoza recomandată este de 20 mg pe zi. Cu toate acestea, medicul dumneavoastră poate decide să utilizaţi o doză mai mică dacă prezentaţi oricare din factorii menţionaţi mai sus.\u003c\/div\u003e\r\n\u003cdiv\u003eDozele uzuale la copii cu vârsta cuprinsă între 6-17 ani și adolescenţi\u003c\/div\u003e\r\n\u003cdiv\u003eDoza iniţială uzuală este de 5 mg. Medicul dumneavoastră vă poate creşte doza, pentru a ajunge să luaţi doza de Rosuvastatină care este potrivită pentru dumneavoastră.Doza zilnică maximă de Rosuvastatină este de 10 mg pentru copii cu vârsta cuprinsă între 6 şi 9 ani şi 20 mg pentru copii\u003c\/div\u003e\r\n\u003cdiv\u003eşi adolescenţi cu vârsta cuprinsă între 10 şi 17 ani. Luaţi-vă doza o dată pe zi. Rosuvastatină 40 mg nu trebuie utilizat la copii.\u003c\/div\u003e\r\n\u003cdiv\u003eCum să luaţi comprimatele\u003c\/div\u003e\r\n\u003cdiv\u003eÎnghiţiţi fiecare comprimat întreg, cu o cantitate suficientă de apă.\u003c\/div\u003e\r\n\u003cdiv\u003eLuaţi Rosuvastatină o dată pe zi.Puteţi lua medicamentul în orice moment al zilei, cu sau fără alimente. Încercaţi să luaţi comprimatul la aceeaşi oră, în fiecare zi, pentru a nu uita.\u003c\/div\u003e\r\n\u003cdiv\u003eControale regulate ale valorilor colesterolului din sânge\u003c\/div\u003e\r\n\u003cdiv\u003eEste important să vă prezentaţi la medicul dumneavoastră, pentru a vi se efectua controale regulate ale valorilor colesterolului din sânge; în acest mod, vă asiguraţi că valoarea concentraţiei colesterolului a ajuns şi se menţine în limite normale.\u003c\/div\u003e\r\n\u003cdiv\u003eMedicul dumneavoastră poate decide să vă crească doza, astfel încât să luaţi cantitatea de Rosuvastatină adecvată pentru dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă aţi luat mai mult Rosuvastatină decât trebuie\u003c\/div\u003e\r\n\u003cdiv\u003eContactaţi medicul dumneavoastră sau cel mai apropiat spital pentru consult medical.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă mergeţi la spital sau sunteţi tratat pentru o altă afecţiune, spuneţi personalului medical că aţi luat Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă aţi uitat să luaţi Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003eNu vă îngrijoraţi, luaţi doar doza următoare la momentul corespunzător. Nu luaţi o doză dublă pentru a compensa doza uitată.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă încetaţi să luaţi Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003eDiscutaţi cu medicul dumneavoastră dacă doriţi să opriţi tratamentul cu Rosuvastatină. Este posibil ca valoarea concentraţiei colesterolului din sângele dumneavoastră să înceapă să crească din nou, dacă încetaţi să luaţi Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă aveţi orice întrebări suplimentare cu privire la acest medicament, adresaţi-vă medicului dumneavoastră, farmacistului sau asistentei medicale.\u003c\/div\u003e\r\n\u003cdiv\u003eReacţii adverse posibile\u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cdiv\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele.\u003c\/div\u003e\r\n\u003cdiv\u003eEste important să cunoaşteţi care pot fi aceste reacţii adverse. De obicei, acestea sunt uşoare şi dispar după o scurtă perioadă de timp.\u003c\/div\u003e\r\n\u003cdiv\u003eOpriţi tratamentul cu rosuvastatină şi solicitaţi imediat asistenţă medicală, dacă prezentaţi oricare dintre următoarele reacţii alergice:\u003c\/div\u003e\r\n\u003cdiv\u003e- respiraţie dificilă, cu sau fără umflarea feţei, buzelor, limbii şi\/sau gâtului;\u003c\/div\u003e\r\n\u003cdiv\u003e- umflarea feţei, buzelor, limbii şi\/sau gâtului, care poate determina dificultate la înghiţire;\u003c\/div\u003e\r\n\u003cdiv\u003e- mâncărimi severe ale pielii (cu mici umflături).\u003c\/div\u003e\r\n\u003cdiv\u003eDe asemenea, opriţi tratamentul cu rosuvastatină şi contactaţi-vă imediat medicul dacă aveţi orice dureri neobişnuite ale muşchilor, care se prelungesc mai mult decât vă aşteptaţi.Simptomele musculare sunt mai frecvente la copii şi adolescenţi decât la adulţi. Similar altor statine, un număr\u003c\/div\u003e\r\n\u003cdiv\u003efoarte mic de persoane au prezentat efecte musculare neplăcute şi, rareori, acestea au progresat spre leziuni musculare potenţial letale, cunoscute sub denumirea de rabdomioliză.\u003c\/div\u003e\r\n\u003cdiv\u003ePosibile reacţii adverse frecvente (pot afecta până la 1 din 10 persoane):\u003c\/div\u003e\r\n\u003cdiv\u003e- dureri de cap;\u003c\/div\u003e\r\n\u003cdiv\u003e- dureri de stomac;\u003c\/div\u003e\r\n\u003cdiv\u003e- constipaţie;\u003c\/div\u003e\r\n\u003cdiv\u003e- greaţă;\u003c\/div\u003e\r\n\u003cdiv\u003e- dureri musculare;\u003c\/div\u003e\r\n\u003cdiv\u003e- stare de slăbiciune;\u003c\/div\u003e\r\n\u003cdiv\u003e- ameţeli;\u003c\/div\u003e\r\n\u003cdiv\u003e- creşterea cantităţii de proteine din urină – aceasta revine, de obicei, la normal de la sine, fără să fie nevoie să opriţi tratamentul cu rosuvastatină (valabil numai pentru doza de 40 mg rosuvastatină).\u003c\/div\u003e\r\n\u003cdiv\u003e- diabet zaharat. Acest lucru este mult mai probabil dacă aveţi un nivel ridicat de zaharuri şi grăsimi în sânge, sunteţi supraponderal şi aveţi tensiune arterială mare. Medicul dumneavoastră vă va monitoriza în timp ce luaţi acest medicament.\u003c\/div\u003e\r\n\u003cdiv\u003ePosibile reacţii adverse mai puţin frecvente (pot afecta până la 1 din 100 persoane):\u003c\/div\u003e\r\n\u003cdiv\u003e- erupţii trecătoare pe piele, mâncărimi sau alte reacţii ale pielii;\u003c\/div\u003e\r\n\u003cdiv\u003e- creşterea cantităţii de proteine din urină – aceasta revine, de obicei, la normal de la sine, fără să fie nevoie să opriţi tratamentul cu rosuvastatină (la dozele de 5 mg, 10 mg şi 20 mg rosuvastatină).\u003c\/div\u003e\r\n\u003cdiv\u003ePosibile reacţii adverse rare (pot afecta până la 1 din 1000 de persoane):\u003c\/div\u003e\r\n\u003cdiv\u003e-reacţii alergice severe – semnele includ umflarea feţei, buzelor, limbii şi\/sau a gâtului, dificultate la înghiţit şi respirat, mâncărimi severe ale pielii (cu mici umflături).\u003c\/div\u003e\r\n\u003cdiv\u003eDacă credeţi că aveţi o reacţie alergică, nu mai luaţi rosuvastatină şi solicitaţi imediat asistenţă medicală.\u003c\/div\u003e\r\n\u003cdiv\u003e- leziuni musculare la adulţi – ca măsură de precauţie, nu mai luaţi rosuvastatină şi contactaţi- vă imediat medicul dacă aveţi orice dureri musculare neobişnuite, care se prelungesc mai mult decât v-aţi aştepta.\u003c\/div\u003e\r\n\u003cdiv\u003e- durere severă de stomac (inflamaţia pancreasului);\u003c\/div\u003e\r\n\u003cdiv\u003e- creşterea valorilor enzimelor hepatice în sânge.\u003c\/div\u003e\r\n\u003cdiv\u003ePosibile reacţii adverse foarte rare (pot afecta până la 1 din 10000 de persoane):\u003c\/div\u003e\r\n\u003cdiv\u003e- icter (coloraţia galbenă a pielii şi a albului ochilor);\u003c\/div\u003e\r\n\u003cdiv\u003e- hepatită (inflamaţia ficatului);\u003c\/div\u003e\r\n\u003cdiv\u003e- urme de sânge în urină;\u003c\/div\u003e\r\n\u003cdiv\u003e- leziuni ale nervilor de la nivelul picioarelor şi mâinilor (de exemplu, amorţeală);\u003c\/div\u003e\r\n\u003cdiv\u003e- dureri articulare;\u003c\/div\u003e\r\n\u003cdiv\u003e- pierderi de memorie\u003c\/div\u003e\r\n\u003cdiv\u003e- creşterea glandelor mamare la bărbaţi (ginecomastia)\u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePosibile reacţii adverse cu frecvenţă necunoscută (frecvenţa nu poate fi estimată din datele disponibile) pot include:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Diaree (scaune moi)\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Sindrom Stevens-Johnson (afectiune gravă cu apariţia de vezicule la nivelul pielii, gurii, ochilor şi organelor genitale)\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Tuse\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Scurtarea respiraţiei\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Edeme (umflarea extremităţilor)\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Tulburări ale somnului, incluzând insomnie şi coşmaruri\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Disfuncţii sexuale\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Depresie\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Probleme respiratorii, incluzând tuse persistentă şi\/sau scurtarea respiraţiei sau febră\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Afectarea tendoanelor\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Slăbiciune musculară constantă\u003c\/p\u003e\r\n\u003c\/div\u003e","brand":"Lekpharm SRL","offers":[{"title":"Default Title","offer_id":50665670377612,"sku":"86126","price":64.84,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/86126.jpg?v=1781168175"},{"product_id":"rosuvastatin-lf-20mg-comp-film","title":"Rosuvastatin-LF 20mg comp. film.","description":"\u003cdiv\u003e\r\n\u003cdiv\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCe este Rosuvastatină şi pentru ce se utilizează\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eRosuvastatină face parte dintr-un grup de medicamente numite statine.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eVi s-a prescris Rosuvastatină deoarece:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAveţi o valoare mare a colesterolului în sânge. Aceasta înseamnă că prezentaţi risc de a face infarct miocardic sau accident vascular cerebral. Rosuvastatină este utilizat la adulţi, adolescenţi şi copii cu vârsta de 6 ani şi peste pentru tratamentul colesterolului mare.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eVi s-a recomandat să utilizaţi o statină, deoarece modificarea regimului alimentar şi efectuarea mai multor exerciţii fizice nu au fost suficiente pentru a corecta valoarea colesterolului din sângele dumneavoastră. În timpul tratamentului cu Rosuvastatină Atb trebuie să continuaţi regimul dumneavoastră alimentar de scădere a colesterolului şi exerciţiile fizice, sau\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAveţi alţi factori care vă cresc riscul de a prezenta un infarct miocardic, accident vascular cerebral sau probleme asemănătoare de sănătate.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eInfarctul miocardic, accidentul vascular cerebral şi alte probleme pot fi determinate de o afecţiune denumită ateroscleroză.Ateroscleroza este determinată de acumularea de depozite de grăsimi în arterele dumneavoastră.\u003c\/p\u003e\r\n\u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cdiv\u003eDe ce este important să continuaţi să luaţi Rosuvastatină?\u003c\/div\u003e\r\n\u003cdiv\u003eRosuvastatină este utilizată pentru a corecta valorile substanţelor grase din sânge denumite lipide, cea mai cunoscută dintre acestea fiind colesterolul.\u003c\/div\u003e\r\n\u003cdiv\u003eÎn sânge sunt prezente diferite tipuri de colesterol– colesterolul “rău” (LDL-C) şi colesterolul “bun” (HDL-C).\u003c\/div\u003e\r\n\u003cdiv\u003e-Rosuvastatină poate să scadă colesterolul “rău” şi să crească colesterolul “bun”.\u003c\/div\u003e\r\n\u003cdiv\u003e-Medicamentul acţionează ajutând organismul să blocheze producerea de colesterol “rău”. De asemenea, Rosuvastatină îmbunătăţeşte capacitatea organismului dumneavoastră de a-l elimina din sânge.\u003c\/div\u003e\r\n\u003cdiv\u003eLa majoritatea persoanelor, valorile mari ale colesterolului nu influenţează starea generală, deoarece nu produc niciun simptom. Cu toate acestea, în absenţa tratamentului, în pereţii vaselor de sânge se pot dezvolta depozite de grăsimi care determină îngustarea lor.\u003c\/div\u003e\r\n\u003cdiv\u003eUneori, aceste vase de sânge îngustate se pot bloca, ceea ce poate opri aportul de sânge la inimă sau creier, determinând infarct miocardic sau accident vascular cerebral.Prin scăderea valorilor\u003c\/div\u003e\r\n\u003cdiv\u003ecolesterolului din sânge, puteţi micşora riscul de a face infarct miocardic, accident vascular cerebral sau probleme asemănătoare de sănătate.\u003c\/div\u003e\r\n\u003cdiv\u003eTrebuie să continuaţi să utilizaţi Rosuvastatină, chiar dacă colesterolul dumneavoastră a revenit la o valoare normală, deoarece acesta previne creşterea ulterioară a valorilor colesterolului din sângele dumneavoastră şi acumularea de depozite de grăsimi.Cu toate acestea, dacă medicul dumneavoastră vă sfătuieşte altfel sau dacă rămâneţi gravidă, trebuie să întrerupeţi utilizarea.\u003c\/div\u003e\r\n\u003cdiv\u003eCe trebuie să ştiţi înainte să luaţi Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003eNu utilizaţi Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aţi avut vreodată o reacţie alergică la rosuvastatină sau la oricare dintre celelalt componente ale acestui medicament;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă sunteţi gravidă sau dacă alăptaţi. Dacă rămâneţi gravidă în timpul tratamentului cu Rosuvastatină, opriţi imediat tratamentul şi spuneţi-i medicului dumneavoastră.Femeile trebuie să evite să rămână gravide în timpul tratamentului cu Rosuvastatină, utilizând metode de contracepţie adecvate.\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi afecţiuni ale ficatului;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi probleme severe la nivelul rinichilor;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi dureri musculare repetate sau inexplicabile;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă utilizaţi un medicament denumit ciclosporină (utilizat de exemplu, după transplantul de organe).\u003c\/div\u003e\r\n\u003cdiv\u003eDacă oricare dintre cele de mai sus sunt valabile în cazul dumneavoastră (sau dacă nu sunteţi sigur), vă rugăm să vă adresaţi din nou medicului dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003eÎn plus, nu utilizaţi Rosuvastatină 40 mg (doza maximă):\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi probleme de intensitate moderată la nivelul rinichilor (dacă nu sunteţi sigur, adresaţi-vă medicului dumneavoastră);\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă glanda tiroidă nu vă funcţionează corect;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aţi avut orice dureri musculare repetate sau inexplicabile, antecedente personale sau familiale de probleme musculare sau antecedente personale de probleme musculare în timpul tratamentului cu alte medicamente care scad colesterolul;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă, în mod regulat, consumaţi cantităţi mari de alcool etilic;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă sunteţi de origine asiatică (japoneză, chineză, filipineză, vietnameză, coreeană sau indiană);\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă utilizaţi alte medicamente denumite fibraţi pentru a vă scădea colesterolul din sânge.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă oricare dintre cele de mai sus sunt valabile în cazul dumneavoastră (sau dacă nu sunteţi sigur), vă rugăm să vă adresaţi din nou medicului dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003e \u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cdiv\u003eAtenţionări şi precauţii\u003c\/div\u003e\r\n\u003cdiv\u003eÎnainte să luaţi Rosuvastatină Atb, adresaţi-vă medicului dumneavoastră sau farmacistului:\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi probleme cu rinichii dumneavoastră;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aveţi probleme cu ficatul dumneavoastră;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă aţi avut dureri musculare repetate sau inexplicabile, antecedente personale sau familiale de probleme musculare sau antecedente personale de probleme musculare în timpul tratamentului cu alte medicamente care scad colesterolul. Informaţi-l imediat pe medicul dumneavoastră dacă aveţi dureri musculare inexplicabile, în special dacă vă simţiţi rău sau aveţi febră. De asemenea, spuneţi medicului dumneavoastră sau farmacistului dacă aveţi o slăbiciune musculară constantă.\u003c\/div\u003e\r\n\u003cdiv\u003eTeste suplimentare şi medicamente pot fi necesare pentru a diagnostica şi trata acest simptom.\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă, în mod regulat, consumaţi cantităţi mari de alcool etilic;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă glanda dumneavoastră tiroidă nu funcţionează normal;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă utilizaţi alte medicamente denumite fibraţi pentru a vă scădea colesterolul din sânge. Vă rugăm să citiţi cu atenţie acest prospect, chiar dacă aţi mai utilizat înainte alte medicamente pentru valori mari ale colesterolului;\u003c\/div\u003e\r\n\u003cdiv\u003e- dacă luaţi medicamente utilizate pentru tratatarea infecţiei cu HIV, de exemplu ritonavir cu lopinavir şi\/sau atazanavir vă rugăm să citiţi şi „Rosuvastatină Atb împreună cu alte medicamente”;\u003c\/div\u003e\r\n\u003cdiv\u003e- în cazul în care luați antibiotice care conțin acid fusidic, vă rugăm să citiți și pct. „Rosuvastatină împreună cu alte medicamente”.\u003c\/div\u003e\r\n\u003cdiv\u003eCopii şi adolescenţi\u003c\/div\u003e\r\n\u003cdiv\u003e• Dacă pacientul este un copil cu vârsta sub 6 ani: Rosuvastatina nu trebuie administrată la copii cu vârsta sub 6 ani.\u003c\/div\u003e\r\n\u003cdiv\u003e• Dacă pacientul are vârsta sub 18 ani: Rosuvastatina 40 mg nu este adecvată pentru administrare la copii şi adolescenţi cu vârsta sub 18 ani.\u003c\/div\u003e\r\n\u003cdiv\u003e- Dacă aveţi vârsta peste 70 de ani (deoarece medicul dumneavoastră trebuie să stabilească doza iniţială de Rosuvastatină adecvată pentru dumneavoastră);\u003c\/div\u003e\r\n\u003cdiv\u003e- Dacă aveţi insuficienţă respiratorie severă;\u003c\/div\u003e\r\n\u003cdiv\u003e- Dacă sunteţi de origine asiatică – adică japoneză, chineză, filipineză, vietnameză, coreeană sau indiană.\u003c\/div\u003e\r\n\u003cdiv\u003eMedicul dumneavoastră trebuie să stabilească o doză iniţială de Rosuvastatină adecvată pentru dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă oricare din cele de mai sus este valabilă în cazul dumneavoastră (sau dacă nu sunteţi sigur):\u003c\/div\u003e\r\n\u003cdiv\u003eNu utilizaţi Rosuvastatină 40 mg (doza maximă) şi adresaţi-vă medicului dumneavoastră sau farmacistului înainte de a începe să luaţi orice doză de Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003eLa un număr mic de persoane statinele pot afecta ficatul.Aceasta se identifică printr-un test simplu care analizează prezenţa concentraţiilor crescute de enzime hepatice în sânge. Din acest motiv, medicul dumneavoastră vă va recomanda, de obicei, aceste analize de sânge (teste funcţionale\u003c\/div\u003e\r\n\u003cdiv\u003ehepatice), înainte şi în timpul tratamentului cu Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003eÎn timp ce luaţi acest medicament medicul dumneavoastră vă va monitoriza cu atenţie dacă aveţi diabet zaharat sau aveţi risc de a dezvolta diabet zaharat. Sunteti susceptibil pentru riscul de a dezvolta diabet zaharat, dacă aveţi o valoare ridicată de zaharuri şi grăsimi în sânge, sunteţi supraponderal şi aveţi tensiune arterială crescută.\u003c\/div\u003e\r\n\u003cdiv\u003eRosuvastatină împreună cu alte medicamente\u003c\/div\u003e\r\n\u003cdiv\u003eSpuneţi medicului dumneavoastră sau farmacistului dacă luaţi, aţi luat recent sau s-ar putea să luaţi orice alte medicamente.\u003c\/div\u003e\r\n\u003cdiv\u003eInformaţi-l pe medicul dumneavoastră dacă luaţi oricare dintre următoarele medicamente:\u003c\/div\u003e\r\n\u003cdiv\u003e- ciclosporină (utilizată, de exemplu, după transplantul de organe);\u003c\/div\u003e\r\n\u003cdiv\u003e- warfarină sau clopidogrel (sau orice medicament utilizat pentru „subţierea” sângelui);\u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cdiv\u003e- fibraţi (de exemplu gemfibrozil, fenofibrat) sau orice alte medicamente utilizate pentru a scădea valorile colesterolului din sânge (cum este ezetimib);\u003c\/div\u003e\r\n\u003cdiv\u003e- medicamente pentru indigestie (utilizate pentru neutralizarea acidului din stomac);\u003c\/div\u003e\r\n\u003cdiv\u003e- eritromicină (un antibiotic), acid fusidic (un antibiotic-vezi pct. „Atenţionări şi precauţii”,contraceptive orale („pilula”);\u003c\/div\u003e\r\n\u003cdiv\u003e- terapie de substituţie hormonală sau medicaţie anti-virală cum ar fi ritonavir cu lopinavir şi\/sau atazanavir sau simeprevir (utilizate pentru tratamentul infecţiei cu HIV sau a hepatitei C-\u003c\/div\u003e\r\n\u003cdiv\u003evă rugăm să citiţi şi „Atenţionări şi precauţii”). Efectele acestor medicamente pot fi modificate de Rosuvastatină sau acestea pot modifica efectul Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003eSarcina, alăptarea şi fertilitatea\u003c\/div\u003e\r\n\u003cdiv\u003eNu luaţi Rosuvastatină dacă sunteţi gravidă sau dacă alăptaţi. Dacă rămâneţi gravidă în timpul tratamentului cu Rosuvastatină, opriţi imediat administrarea acestuia şi informaţi-l pe medicul dumneavoastră. Femeile trebuie să evite apariţia unei sarcini în timpul tratamentului cu Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003eprin utilizarea de metode contraceptive adecvate. Adresaţi-vă medicului dumneavoastră sau farmacistului înainte de a lua orice medicamente.\u003c\/div\u003e\r\n\u003cdiv\u003eConducerea vehiculelor şi folosirea utilajelor\u003c\/div\u003e\r\n\u003cdiv\u003eAbilitatea de a conduce vehicule şi de a folosi utilaje nu este afectată la majoritatea pacienţilor în timpul tratamentului cu Rosuvastatină.Cu toate acestea, unii pacienţi se pot simţi ameţiţi în timpul tratamentului cu Rosuvastatină. În această situaţie adresaţi-vă medicului dumneavoastră înainte de a conduce vehicule sau de a folosi utilaje.\u003c\/div\u003e\r\n\u003cdiv\u003eRosuvastatină conţine lactoză, galben amurg și roşu Allura AC Aluminium Lake.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă medicul dumneavoastră v-a atenţionat că aveţi intoleranţă la unele categorii de glucide, vă rugăm să-l întrebaţi înainte de a lua Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003e \u003c\/div\u003e\r\n\u003cdiv\u003eCum să luaţi Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003eUtilizaţi întotdeauna acest medicament exact aşa cum v-a spus medicul sau farmacistul. Discutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur.\u003c\/div\u003e\r\n\u003cdiv\u003eDoza obişnuită la adulţi:\u003c\/div\u003e\r\n\u003cdiv\u003eDacă luaţi Rosuvastatină pentru valori mari ale colesterolului.\u003c\/div\u003e\r\n\u003cdiv\u003eDoza iniţială:\u003c\/div\u003e\r\n\u003cdiv\u003eTratamentul dumneavoastră cu Rosuvastatină trebuie început cu doza de 5 mg sau 10 mg, chiar dacă înainte aţi luat o doză mai mare dintr-o altă statină. Alegerea dozei iniţiale va depinde de:\u003c\/div\u003e\r\n\u003cdiv\u003e- Concentraţia de colesterol din sângele dumneavoastră;\u003c\/div\u003e\r\n\u003cdiv\u003e- Gradul de risc pe care îl aveţi pentru un infarct miocardic sau accident vascular cerebral;\u003c\/div\u003e\r\n\u003cdiv\u003e- Prezenţa unui factor care v-ar putea face mai susceptibil la posibilele reacţii adverse.\u003c\/div\u003e\r\n\u003cdiv\u003eVă rugăm să vă adresaţi medicului dumneavoastră sau farmacistului pentru a vedea care doză iniţială de Rosuvastatină este cea mai potrivită pentru dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003eMedicul dumneavoastră poate decide să vă administreze doza minimă (5 mg) dacă:\u003c\/div\u003e\r\n\u003cdiv\u003e- Sunteţi deorigine asiatică (japoneză, chineză, filipineză, vietnameză, coreeană şi indiană);\u003c\/div\u003e\r\n\u003cdiv\u003e- Aveţi vârsta peste 70 de ani;\u003c\/div\u003e\r\n\u003cdiv\u003e- Aveţi probleme renale moderate;\u003c\/div\u003e\r\n\u003cdiv\u003e- Sunteţi supus unui risc de a dezvolta dureri musculare (miopatie).\u003c\/div\u003e\r\n\u003cdiv\u003eCreşterea dozei şi doza zilnică maximă:\u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cdiv\u003eMedicul dumneavoastră poate decide să vă crească doza, pentru a ajunge să luaţi doza de Rosuvastatină care este potrivită pentru dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă aţi început tratamentul cu doza de 5 mg, medicul dumneavoastră poate decide să vă dubleze doza la 10 mg, ulterior la 20 mg, şi apoi, dacă este necesar, la 40 mg.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă aţi început cu doza de 10 mg, medicul dumneavoastră poate decide să vă dubleze doza la 20 mg şi ulterior, dacă este necesar, la 40 mg. Va exista o perioadă de 4 săptămâni între fiecare creştere a dozei.\u003c\/div\u003e\r\n\u003cdiv\u003eDoza maximă zilnică de Rosuvastatină este de 40 mg.Această doză este numai pentru pacienţii cu valori mari ale colesterolului şi cu risc crescut de infarct miocardic sau accident vascular cerebral, ale căror concentraţii de colesterol din sânge nu sunt suficient controlate (scăzute) cu doza de 20 mg.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă luaţi Rosuvastatină pentru a vă reduce riscul de a face infarct miocardic, accident vascular cerebral sau probleme asemănătoare de sănătate:\u003c\/div\u003e\r\n\u003cdiv\u003eDoza recomandată este de 20 mg pe zi. Cu toate acestea, medicul dumneavoastră poate decide să utilizaţi o doză mai mică dacă prezentaţi oricare din factorii menţionaţi mai sus.\u003c\/div\u003e\r\n\u003cdiv\u003eDozele uzuale la copii cu vârsta cuprinsă între 6-17 ani și adolescenţi\u003c\/div\u003e\r\n\u003cdiv\u003eDoza iniţială uzuală este de 5 mg. Medicul dumneavoastră vă poate creşte doza, pentru a ajunge să luaţi doza de Rosuvastatină care este potrivită pentru dumneavoastră.Doza zilnică maximă de Rosuvastatină este de 10 mg pentru copii cu vârsta cuprinsă între 6 şi 9 ani şi 20 mg pentru copii\u003c\/div\u003e\r\n\u003cdiv\u003eşi adolescenţi cu vârsta cuprinsă între 10 şi 17 ani. Luaţi-vă doza o dată pe zi. Rosuvastatină 40 mg nu trebuie utilizat la copii.\u003c\/div\u003e\r\n\u003cdiv\u003eCum să luaţi comprimatele\u003c\/div\u003e\r\n\u003cdiv\u003eÎnghiţiţi fiecare comprimat întreg, cu o cantitate suficientă de apă.\u003c\/div\u003e\r\n\u003cdiv\u003eLuaţi Rosuvastatină o dată pe zi.Puteţi lua medicamentul în orice moment al zilei, cu sau fără alimente. Încercaţi să luaţi comprimatul la aceeaşi oră, în fiecare zi, pentru a nu uita.\u003c\/div\u003e\r\n\u003cdiv\u003eControale regulate ale valorilor colesterolului din sânge\u003c\/div\u003e\r\n\u003cdiv\u003eEste important să vă prezentaţi la medicul dumneavoastră, pentru a vi se efectua controale regulate ale valorilor colesterolului din sânge; în acest mod, vă asiguraţi că valoarea concentraţiei colesterolului a ajuns şi se menţine în limite normale.\u003c\/div\u003e\r\n\u003cdiv\u003eMedicul dumneavoastră poate decide să vă crească doza, astfel încât să luaţi cantitatea de Rosuvastatină adecvată pentru dumneavoastră.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă aţi luat mai mult Rosuvastatină decât trebuie\u003c\/div\u003e\r\n\u003cdiv\u003eContactaţi medicul dumneavoastră sau cel mai apropiat spital pentru consult medical.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă mergeţi la spital sau sunteţi tratat pentru o altă afecţiune, spuneţi personalului medical că aţi luat Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă aţi uitat să luaţi Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003eNu vă îngrijoraţi, luaţi doar doza următoare la momentul corespunzător. Nu luaţi o doză dublă pentru a compensa doza uitată.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă încetaţi să luaţi Rosuvastatină\u003c\/div\u003e\r\n\u003cdiv\u003eDiscutaţi cu medicul dumneavoastră dacă doriţi să opriţi tratamentul cu Rosuvastatină. Este posibil ca valoarea concentraţiei colesterolului din sângele dumneavoastră să înceapă să crească din nou, dacă încetaţi să luaţi Rosuvastatină.\u003c\/div\u003e\r\n\u003cdiv\u003eDacă aveţi orice întrebări suplimentare cu privire la acest medicament, adresaţi-vă medicului dumneavoastră, farmacistului sau asistentei medicale.\u003c\/div\u003e\r\n\u003cdiv\u003eReacţii adverse posibile\u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cdiv\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele.\u003c\/div\u003e\r\n\u003cdiv\u003eEste important să cunoaşteţi care pot fi aceste reacţii adverse. De obicei, acestea sunt uşoare şi dispar după o scurtă perioadă de timp.\u003c\/div\u003e\r\n\u003cdiv\u003eOpriţi tratamentul cu rosuvastatină şi solicitaţi imediat asistenţă medicală, dacă prezentaţi oricare dintre următoarele reacţii alergice:\u003c\/div\u003e\r\n\u003cdiv\u003e- respiraţie dificilă, cu sau fără umflarea feţei, buzelor, limbii şi\/sau gâtului;\u003c\/div\u003e\r\n\u003cdiv\u003e- umflarea feţei, buzelor, limbii şi\/sau gâtului, care poate determina dificultate la înghiţire;\u003c\/div\u003e\r\n\u003cdiv\u003e- mâncărimi severe ale pielii (cu mici umflături).\u003c\/div\u003e\r\n\u003cdiv\u003eDe asemenea, opriţi tratamentul cu rosuvastatină şi contactaţi-vă imediat medicul dacă aveţi orice dureri neobişnuite ale muşchilor, care se prelungesc mai mult decât vă aşteptaţi.Simptomele musculare sunt mai frecvente la copii şi adolescenţi decât la adulţi. Similar altor statine, un număr\u003c\/div\u003e\r\n\u003cdiv\u003efoarte mic de persoane au prezentat efecte musculare neplăcute şi, rareori, acestea au progresat spre leziuni musculare potenţial letale, cunoscute sub denumirea de rabdomioliză.\u003c\/div\u003e\r\n\u003cdiv\u003ePosibile reacţii adverse frecvente (pot afecta până la 1 din 10 persoane):\u003c\/div\u003e\r\n\u003cdiv\u003e- dureri de cap;\u003c\/div\u003e\r\n\u003cdiv\u003e- dureri de stomac;\u003c\/div\u003e\r\n\u003cdiv\u003e- constipaţie;\u003c\/div\u003e\r\n\u003cdiv\u003e- greaţă;\u003c\/div\u003e\r\n\u003cdiv\u003e- dureri musculare;\u003c\/div\u003e\r\n\u003cdiv\u003e- stare de slăbiciune;\u003c\/div\u003e\r\n\u003cdiv\u003e- ameţeli;\u003c\/div\u003e\r\n\u003cdiv\u003e- creşterea cantităţii de proteine din urină – aceasta revine, de obicei, la normal de la sine, fără să fie nevoie să opriţi tratamentul cu rosuvastatină (valabil numai pentru doza de 40 mg rosuvastatină).\u003c\/div\u003e\r\n\u003cdiv\u003e- diabet zaharat. Acest lucru este mult mai probabil dacă aveţi un nivel ridicat de zaharuri şi grăsimi în sânge, sunteţi supraponderal şi aveţi tensiune arterială mare. Medicul dumneavoastră vă va monitoriza în timp ce luaţi acest medicament.\u003c\/div\u003e\r\n\u003cdiv\u003ePosibile reacţii adverse mai puţin frecvente (pot afecta până la 1 din 100 persoane):\u003c\/div\u003e\r\n\u003cdiv\u003e- erupţii trecătoare pe piele, mâncărimi sau alte reacţii ale pielii;\u003c\/div\u003e\r\n\u003cdiv\u003e- creşterea cantităţii de proteine din urină – aceasta revine, de obicei, la normal de la sine, fără să fie nevoie să opriţi tratamentul cu rosuvastatină (la dozele de 5 mg, 10 mg şi 20 mg rosuvastatină).\u003c\/div\u003e\r\n\u003cdiv\u003ePosibile reacţii adverse rare (pot afecta până la 1 din 1000 de persoane):\u003c\/div\u003e\r\n\u003cdiv\u003e-reacţii alergice severe – semnele includ umflarea feţei, buzelor, limbii şi\/sau a gâtului, dificultate la înghiţit şi respirat, mâncărimi severe ale pielii (cu mici umflături).\u003c\/div\u003e\r\n\u003cdiv\u003eDacă credeţi că aveţi o reacţie alergică, nu mai luaţi rosuvastatină şi solicitaţi imediat asistenţă medicală.\u003c\/div\u003e\r\n\u003cdiv\u003e- leziuni musculare la adulţi – ca măsură de precauţie, nu mai luaţi rosuvastatină şi contactaţi- vă imediat medicul dacă aveţi orice dureri musculare neobişnuite, care se prelungesc mai mult decât v-aţi aştepta.\u003c\/div\u003e\r\n\u003cdiv\u003e- durere severă de stomac (inflamaţia pancreasului);\u003c\/div\u003e\r\n\u003cdiv\u003e- creşterea valorilor enzimelor hepatice în sânge.\u003c\/div\u003e\r\n\u003cdiv\u003ePosibile reacţii adverse foarte rare (pot afecta până la 1 din 10000 de persoane):\u003c\/div\u003e\r\n\u003cdiv\u003e- icter (coloraţia galbenă a pielii şi a albului ochilor);\u003c\/div\u003e\r\n\u003cdiv\u003e- hepatită (inflamaţia ficatului);\u003c\/div\u003e\r\n\u003cdiv\u003e- urme de sânge în urină;\u003c\/div\u003e\r\n\u003cdiv\u003e- leziuni ale nervilor de la nivelul picioarelor şi mâinilor (de exemplu, amorţeală);\u003c\/div\u003e\r\n\u003cdiv\u003e- dureri articulare;\u003c\/div\u003e\r\n\u003cdiv\u003e- pierderi de memorie\u003c\/div\u003e\r\n\u003cdiv\u003e- creşterea glandelor mamare la bărbaţi (ginecomastia)\u003c\/div\u003e\r\n\u003c\/div\u003e\r\n\u003cdiv\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePosibile reacţii adverse cu frecvenţă necunoscută (frecvenţa nu poate fi estimată din datele disponibile) pot include:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Diaree (scaune moi)\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Sindrom Stevens-Johnson (afectiune gravă cu apariţia de vezicule la nivelul pielii, gurii, ochilor şi organelor genitale)\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Tuse\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Scurtarea respiraţiei\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Edeme (umflarea extremităţilor)\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Tulburări ale somnului, incluzând insomnie şi coşmaruri\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Disfuncţii sexuale\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Depresie\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Probleme respiratorii, incluzând tuse persistentă şi\/sau scurtarea respiraţiei sau febră\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Afectarea tendoanelor\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e- Slăbiciune musculară constantă\u003c\/p\u003e\r\n\u003c\/div\u003e","brand":"Lekpharm SRL","offers":[{"title":"Default Title","offer_id":50665678831756,"sku":"86127","price":83.25,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/86127.jpg?v=1781168177"},{"product_id":"rosuvastatina-stada-10mg-comp-film","title":"Rosuvastatina STADA 10mg comp. film.","description":"\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STA DA 5 mg comprimate lilimite\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 10 mg comprimate lllmatc\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatimi STADA 20 mg comprimate Minate\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCe este Rosuvastatina STADA şl pentru ce se utilizează\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina aparţine unui grup de medicamente numite statine.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVi s-a prescris Rosuvastatina STA DA deoarece:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eAveţi un nivel ridicat de colesterol în sânge. Aceasta înseamnă că prezentaţi risc de a face un atac do eoni sau un accident vascular cerebral. Rosuvastatina STADA este utilizată la adulţi, adolescenţi şi copii cu vârsta de 6 ani şi peste pentru a trata colesterolul crescut.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVi s-a recomandat să utilizaţi o slatină, deoarece modificarea regimului alimentar şi efectuarea mai multor exerciţii fizice nu au fost suficiente pentru a vă corecta nivelul colesterolului din sângele dumneavoastră. în timpul tratamentului cu Rosuvastatina STADA trebuie să continuaţi regimul dumneavoastră alimentar de scădere a colesterolului şi exerciţiile fizice, sau\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eAveţi alţi factori care vă cresc riscul de a avea un atac de cord, un accident vascular cerebral sau alte probleme asemănătoare de sănătate.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAtacul de cord, accidentul vascular cerebral şi alte probleme de sănătate pot fi determinate de o boală, denumită ateroscleroză. Ateroseleroza este cauzată de acumularea de depozite de grăsimi în arterele dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDe ce este important să continuaţi utilizarea Rosuvastatina STADA?\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA este utilizată pentru a corecta nivelurile de substanţe grase din sânge numite lipide, cea mai cunoscută dintre acestea fiind colesterolul. In sânge sunt prezente diferite tipuri dc colesterol, colesterolul „rău” (LDL-C) şi colesterolul „bun” (HDL-C).\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eRosuvastatina STADA scade cantitatea de colesterol „rău” şi creşte colesterolu 1 „bun”.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eMedicamentul acţionează prin blocarea producerii de colesterol „rău” şi îmbunătăţeşte capacitatea organismului de a-1 elimina din sânge.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLa majoritatea persoanelor, valorile mari ale colesterolului nu influenţează starea generală, deoarece nu produc niciun simptom. Cu toate acestea, în absenţa tratamentului, în pereţii vaselor de sânge se pot dezvolta depozite de grăsimi care determină îngustarea lor.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eUneori, aceste vase de sânge îngustate se pot bloca şi pot împiedica alimentarea cu sânge a inimii sau a creierului, provocând un atac de cord sau un accident vascular cerebral. Prin scăderea nivelului do colesterol din sânge puteţi reduce riscul de a face atac de cord, accident vascular cerebral sau probleme asemănătoare dc sănătate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eTrebuio să continuaţi să luaţi Rosuvastatina STADA, chiar dacă colesterolul dumneavoastră a revenit la o valoare normală, deoarece previne creşterea ulterioară a valorilor colesterolului din sângele dumneavoastră şi acumularea de depozite de grăsimi. Cu toate acestea, dacă medicul dumneavoastră vă slătuieşte astfel sau dacă rămâneţi gravidă, trebuie să întrerupeţi utilizarea.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"2\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCe trebuie să ştiţi înainte să luaţi Rosuvastatina STADA\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNU luaţi Kosuvastatina STADA:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi alergie la rosuvastatină sau la oricare dintre celelalte componente ale acestui medicament (enumerate la pct. 6);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în timp ce administraţi rosuvastatina, opriţi imediat tratamentul şi informaţi medicului dumneavoastră, femeile trebuie să evite să rămână gravide în timpul tratamentului cu rosuvastatină, utilizând o metodă de contracepţie adecvată;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi o boală hepatică;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme severe cu rinichii;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi dureri şi crampe musculare repetate sau inexplicabile;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă luaţi un medicament combinat de solbsbuvir\/velpatasvir\/voxilaprevir (utilizat pentru o infecţie virală a ficatului, numită hepatită C);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă luaţi un medicament numit ciclosporină (utilizat, de exemplu, după un transplant de organ).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre situaţiile de mai sus se aplică în cazul dumneavoastră (sau dacă nu sunteţi sigur), vă rugăm să vă adresaţi din nou medicului dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDe asemenea, nu luaţi Kosuvastatina STADA 40 mg (doza maximă):\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme moderate cu rinichii (dacă nu sunteţi sigur, adresaţi-vă medicului dumneavoastră);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă glanda tiroidă nu vă funcţionează corect;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aţi avut orice dureri şi crampe musculare repetate sau inexplicabile, antecedente personale sau familiale de probleme musculare sau antecedente personale dc probleme musculare în timpul tratamentului cu alte medicamente care scad colesterolul;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă consumaţi în mod regulat cantităţi mari de alcool;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi de origine asiatică (japoneză, chineză, filipineză, vietnameză, coreeană sau indiană);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă luaţi alte medicamente numite librnţi pentru a reduce colesterolul.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre situaţiile de mai sus se aplică în cazul dumneavoastră (sau nu sunteţi sigur), vă rugăm să vă adresaţi din nou medicul dumneavoastră. Atenţionări şi precauţii\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎnainte să utilizaţi Rosuvastatina STADA, adresaţi-vă medicului dumneavoastră sau farmacistului:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme cu rinichii;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme cu ficatul;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi dureri şi crampe musculare repetate sau inexplicabile, antecedente personale sau familiale de probleme musculare sau antecedente deprobleme musculare în timpul tratamentului cu alte medicamente care scad colesterolul. Informaţi imediat medicul dumneavoastră dacă aveţi dureri sau crampe musculare inexplicabile, în special dacă vă simţiţi rău sau aveţi febră. De asemenea, spuneţi medicului dumneavoastră sau farmacistului dacă aveţi o slăbiciune musculară constantă;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă consumaţi în mod regulat cantităţi mari de alcool;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă glanda dumneavoastră tiroidă nu funcţionează corect;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă utilizaţi alte medicamente numite fibraţi pentru a vă reduce colesterolul din sânge. Vă rugăm să citiţi cu atenţie acest prospect, chiar dacă aţi mai utilizat înainte alte medicamente pentru valori mari ale colesterolului;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă utilizaţi medicamente pentru tratarea infecţiei cu HIV, cum ar fi ritonavir cu lopinavir şi\/sau atazanavir, vezi „Rosuvastatina STADA împreună cu alte medicamente”;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă utilizaţi sau aţi utilizat în ultimele 7 zile un medicament numit acid fusidic (un medicament utilizat în tratamentul infecţiilor bacteriene) administrat oral sau injectabil.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCombinaţia de acid fusidic şi rosuvastatină poate provoca probleme musculare grave (rabdomioliză), vezi „Rosuvastatina STADA împreună cu alte medicamente”;\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi vârsta peste 70 ani (deoarece medicul dumneavoastră trebuie să stabilească doza iniţială de Rosuvastatina STADA adecvată pentru dumneavoastră);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi insuficienţă respiratorie severă;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi de origine asiatică (de exemplu, japoneză, chineză, filipineză, vietnameză, coreeană sau indiană). Medicul dumneavoastră trebuie să stabilească o doză iniţială adecvată de rosuvastatină pentru dumneavoastră;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aţi avut vreodată o erupţie cutanată severă sau descuamare a pielii, vezicule şi\/sau afte la nivelul gurii după ce aţi luat rosuvastatină sau alte medicamente care conţin rosuvastatină.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eÎn asociere cu tratamentul cu rosuvastatină, au fost raportate reacţii cutanate grave, inclusiv sindromul Stevens-Johnson şi reacţie la medicament cu eozinofilie şi simptome sistemice (DRESS).\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eOpriţi utilizarea rosuvastatinci şi solicitaţi imediat asistenţă medicală dacă observaţi oricare dintre simptomele enumerate la pct. 4.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă oricare dintre cele de mai sus este valabilă în cazul dumneavoastră (sau dacă nu sunteţi sigur):\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eNu utilizaţi Rosuvastatină STADA 40 mg (doza maximă) şi adresaţi-vă medicului dumneavoastră sau farmacistului înainte de a începe să luaţi orice doză de Rosuvastatina STADA.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLa un număr mic de persoane statinele pot afecta ficatul. Aceasta se identifică printr-un test simplu care detectează niveluri crescute de enzime hepatice (transaminaze) în sânge. Din acest motiv, medicul dumneavoastră va efectua, de obicei, aceste analize de sânge (teste ale funcţiei hepatice) înainte şi în timpul tratamentul cu rosuvastatină.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eîn timp ce luaţi acest medicament, medicul dumneavoastră vă va monitoriza cu atenţie dacă aveţi diabet zaharat sau aveţi risc de a dezvolta diabet zaharat. Sunteţi susceptibil pentru riscul de a dezvolta diabet zaharat, dacă aveţi o valoare ridicată de zaharuri şi grăsimi în sânge, sunteţi supraponderal şi aveţi tensiune arterială crescută.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCopii şi adolescenţi\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă pacientul are vârsta sub 6 ani:Rosuvastatina STADA nu trebuie administrată copiilor cu vârsta sub 6 ani.\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eDacă pacientul are vârsta sub 18 ani:Rosuvastatina STADA40 mg nu trebuie administrată copiilor şi adolescenţilor cu vârsta sub 18 ani.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatină STADA împreună cu alte medicamente\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSpuneţi medicului dumneavoastră sau farmacistului dacă utilizaţi, aţi utilizat recent sau s-ar putea să utilizaţi orice alte medicamente.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eInformaţi-1 pe medicul dumneavoastră dacă luaţi oricare dintre următoarele medicamente:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eciclosporină (utilizată după un transplant de organe);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ewar farină, ticagrelor sau clopidogrel (sau orice alt medicament pentru subţierea sângelui);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003efibraţi (cum ar fi gemfibrozil, fenofibrat) sau orice alt medicament utilizat pentru scăderea colesterolului (cum ar fi ezetimib);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emedicamente pentru indigestie (folosite pentru a neutraliza acidul din stomac);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eeritromicină (un antibiotic), acid fusidic (un antibiotic - vedeţi mai sus „Atenţionări şi precauţii”);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003econtraceptive orale (pilula);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eregorafenib (utilizat pentru tratarea cancerului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edarolutamidă (utilizată pentru tratarea cancerului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eterapie de substituţie hormonală;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eoricare dintre următoarele medicamente utilizate pentru tratamentul infecţiilor virale, inclusiv infecţia cu HIV sau hepatita C, singur sau în combinaţie (vezi „Atenţionări şi precauţii”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eEfectele acestor medicamente pot fi modificate de rosuvastatină sau pot modifica efectul rosuvastatinei.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă trebuie să utilizaţi acid fusidic pe cale orală pentru a trata o infecţie bacteriană, va trebui să încetaţi temporar administrarea acestui medicament. Medicul dumneavoastră vă va spune când este sigur să reîncepeţi tratamentul cu rosuvastatină. Administrarea de rosuvastatină cu acid fusidic poate provoca ocazional slăbiciune musculară, sensibilitate musculară sau dureri musculare (rabdomioliză). Pentru mai multe informaţii privind rabdomioliza vezi pct. 4.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSarcina şi alăptarea\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă sunteţi gravidă sau alăptaţi, credeţi că aţi putea fi gravidă sau intenţionaţi să rămâneţi gravidă, adresaţi-vă medicului dumneavoastră sau farmacistului înainte de a utiliza acest medicament.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu luaţi Rosuvastatina STADA dacă sunteţi gravidă sau alăptaţi. Dacă rămâneţi gravidă în timpul tratamentului cu Rosuvastatină STADA, opriţi imediat să o administraţi şi spuneţi medicului dumneavoastră. Femeile trebuie să evite să rămână gravide în timpul tratamentului cu Rosuvastatină STADA, utilizând o metodă contraceptivă adecvată.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eConducerea şi folosirea vehiculelor\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMajoritatea pacienţilor pot conduce vehicule şi pot folosi utilaje în timpul tratamentului cu Rosuvastatină STADA, deoarece nu le va influenţa capacitatea de a desfăşura aceste activităţi. Cu toate acestea, unele persoane pot prezenta ameţeli în timpul tratamentului cu Rosuvastatină STADA. Dacă vă simţiţi ameţit, adresaţi-vă medicului dumneavoastră înainte de a încerca să conduceţi vehicule sau să folosiţi utilaje.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA conţine lactoză\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă medicul dumneavoastră v-a atenţionat că aveţi intoleranţă la unele categorii de glucide, vă rugăm să-l întrebaţi înainte de a lua acest medicament.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003ePentru lista tuturor excipienţilor, vezi pct. 6. Conţinutul ambalajului şi alte informaţii.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"3\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCum să luaţi Rosuvastatina STADA\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLuaţi întotdeauna acest medicament exact aşa cum v-a spus medicul sau farmacistul. Discutaţi cu medicul dumneavoastră sau cu farmacistul dacă nu sunteţi sigur.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza uzuală la adulţi\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luaţi Rosuvastatină STADApentru valori mari ale colesterolului:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza iniţială\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eTratamentul dumneavoastră cu Rosuvastatina STADA trebuie înceaput cu doza de 5 mg sau 10 mg, chiar dacă înainte aţi luat o doză mai mare dintr-o altă statină. Alegerea dozei iniţiale va depinde de:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003econcentraţia de colesterol din sflngcle dumneavoastră;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003egradul de risc pe care îl aveţi dc a avea un atac dc cord sau un accident vascular cerebral;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eprezenţa unui factor care v-ar putea face mai susceptibil la posibilele reacţii adverse.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVă rugăm să vă adresaţi medicului dumneavoastră sau farmacistului pentru a vedea care doză iniţială ele Rosuvastatina STADAeste cea mai potrivită pentru dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMedicul dumneavoastră poate decide să înceapă tratamentul cu doza minimă (5 mg):\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi de origine asiatică (de exemplu, japoneză, chineză, filipineză, vietnameză, coreeană sau indiană);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi vârsta peste 70 ani;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi probleme renale moderate;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă sunteţi expus unui risc de dureri şi crampe musculare (miopatie).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCreşterea dozei şi doza zilnică maximă\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMedicul dumneavoastră poate decide dacă să vă mărească doza, pentru a ajunge să luaţi doza de Rosuvastatina STADA care este potrivită pentru dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă aţi început tratamentul cu doza dc 5 mg, medicul dumneavoastră poate decide să vă dubleze doza la 10 mg, ulterior la 20 mg şi apoi, dacă este necesar, la 40 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă aţi început tratamentul cu doza de 10 mg, medicul dumneavoastră poate decide să vă dubleze doza la 20 mg şi apoi, dacă este necesar, la 40 mg. Va exista un interval de patru săptămâni între fiecare creştere a dozei.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza zilnică maximă de Rosuvastatina STADAeste de 40 mg. Această doză este doar pentru pacienţii eu niveluri mari de colesterol şi cu risc crescut de a avea un atac de cord sau un accident vascular cerebral, ale căror niveluri de colesterol nu scad suficient cu doza de 20 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luaţi Rosuvastatina STADA pentru a reduce riscul dc a face atac dc cord, accident vascular cerebral sau probleme asemănătoare dc sănătate:\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDoza recomandată este de 20 mg pe zi. Cu toate acestea, medicul dumneavoastră poate decide să utilizaţi o doză mai mică dacă aveţi oricare dintre factorii menţionaţi mai sus.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAdministrarea la copii şi adolescenţi cu vârsta cuprinsă între 6 şi 17 ani\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eIntervalul de doze la copii şi adolescenţi cu vârsta cuprinsă între 6 şi 17 ani este de 5 mg până la 20 mg o dată pe zi. Doza uzuală pentru începerea tratamentului este de 5 mg pe zi, iar medicul dumneavoastră vă poate creşte treptat doza până când ajungeţi la o doză de rosuvastatină potrivită pentru dumneavoastră. Doza zilnică maximă de rosuvastatină este de 10 sau 20 mg pentru copiii cu vârsta cuprinsă între 6 şi 17 ani, în funcţie de boala de bază tratată. Luaţi doza o dală pe zi.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 40 mg comprimate nu trebuie administrată la copii.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCum să luaţi comprimatele\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eînghiţiţi fiecare comprimat întreg, cu o cantitate suficientă de apă.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLuaţi Rosuvastatina STADA o dată pe zi. îl puteţi lua în orice moment al zilei cu sau fără alimente. încercaţi să luaţi comprimatul la aceeaşi oră în fiecare zi. Acest lucru vă va ajuta să vă amintiţi să le luaţi.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eVerificări regulate ale nivelului colesterolului\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eEste important să vă prezentaţi la medicul dumneavoastră pentru a vi sc efectua controale regulate ale valorilor colesterolului din sânge; în acest mod, vă asiguraţi că valoarea concentraţiei colesterolului a ajuns şi se menţine în limite normale.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eMedicul dumneavoastră poate decide să vă mărească doza, astfel încât să administraţi doza dc Rosuvastatina STADA potrivită pentru dumneavoastră.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă luaţi mai mult Rosuvastatina STADA decât trebuie\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eContactaţi medicul dumneavoastră sau cel mai apropiat spital pentru consult medical.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă sunteţi internat în spital sau sunteţi tratat pentru o altă afecţiune, spuneţi personalului medical că luaţi Rosuvastatina STADA.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă uitaţi să luaţi Rosuvastatina STADA\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu vă faceţi grij i, luaţi următoarea doză la ora programată. Nu luaţi o doză dublă pentru a compensa doza uitată.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă încetaţi să administraţi Rosuvastatina STADA\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDiscutaţi cu medicul dumneavoastră dacă doriţi să încetaţi să administraţi Rosuvastatina STADA.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNivelul colesterolului dumneavoastră poate creşte din nou dacă încetaţi să luaţi Rosuvastatina STADA.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă aveţi orice întrebări suplimentare cu privire la utilizarea acestui medicament, adresaţi-vă medicului dumneavoastră, sau farmacistului.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"4\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eReacţii adverse posibile\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCa toate medicamentele, acest medicament poate provoca reacţii adverse, cu toate că nu apar la toate persoanele.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eEste important să cunoaşteţi care pot fi aceste reacţii adverse. Ele sunt de obicei uşoare şi dispar într-un interval scurt de timp.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eOpriţi tratamentul cu Rosuvastatina STADA şi solicitaţi imediat asistenţă medicală dacă prezentaţi oricare dintre următoarele simptome:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003erespiraţie dificilă, cu sau fără umflarea feţei, buzelor, limbii şi\/sau gâtului;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eumflarea feţei, buzelor, limbii şi\/sau gâtului, care poate provoca dificultăţi la înghiţire;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emâncărimi intense ale pielii (cu urticarie);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003epete dc culoare roşie, care nu sunt în relief, în formă de ţintă sau circulare, apărute pe torace, adesea însoţite de vezicule în mijloc, descuamare a pielii, ulceraţii la nivelul gurii, gâtului, nasului, organelor genitale şi ochilor. Aceste erupţii cutanate severe pot fi precedate de febră şi simptome asemănătoare gripei (sindrom Stevens-Johnson);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eerupţie cutanată extinsă, temperatură crescută a corpului şi ganglioni limfal ici măriţi (sindrom DRESS sau sindrom de hipersensibilitate la medicamente). Dc asemenea, opriţi tratamentul cu Rosuvastatina STADAşi consultaţi imediat medicul dumneavoastră:\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi dureri şi crampe musculare inexplicabile, care durează mai mult decât vă aşteptaţi. Simptomele musculare sunt mai frecvente la copii şi adolescenţi decât la adulţi. Similar altor statine, un număr foarte mic de persoane au prezentat efecte musculare neplăcute care, foarte rar, au dus la leziuni musculare care pun viaţa în pericol, cunoscute sub denumirea de rabdomioliză;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă prezentaţi o ruptură musculară;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edacă aveţi un sindrom asemănător celui din lupus (inclusiv urticarie, afecţiuni ale articulaţiilor şi efecte asupra celulelor sanguine).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse frecvente (pot afecta până la 1 din 10 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri de cap;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri de stomac, constipaţie, greaţă;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri musculare;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eslăbiciune, ameţeli;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ecreşterea cantităţii de proteine din urină aceasta revine, de obicei, la normal de la sine, fără a fi necesară întreruperea tratamentului cu Rosuvastatina STADA comprimate (valabil numai pentru doza de 40 mg Rosuvastatină STADA);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ediabet zaharat. Acest lucru este mai probabil dacă aveţi niveluri ridicate dc zahăr şi grăsimi din sânge, sunteţi supraponderal şi aveţi tensiune arterială ridicată. Medicul dumneavoastră vă va monitoriza îndeaproape în timp ce luaţi acest medicament.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse mai puţin frecvente (pot afecta până la 1 din 100 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eerupţii cutanate, mâncărimc şi alte reacţii ale pielii;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ecreşterea cantităţii de proteine din urină - aceasta revine, de obicei, la normal de la sine, fără a fi necesară întreruperea tratamentului cu Rosuvastatina STADA comprimate (numai pentru Rosuvastatina STADA 5 mg, 10 mg şi 20 mg).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse rare (pot afecta până la 1 din 1000 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ereacţii alergice severe - simptomele includ umflarea feţei, buzelor, limbii şi\/sau gâtului, dificultăţi la înghiţire şi respiraţie, mâncărimi severe ale pielii (cu urticarie). Dacă credeţi că aveţi o reacţie alergică, încetaţi să luaţi Rosuvastatina STADA şi solicitaţi imediat asistenţă medicală;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eleziuni musculare la adulţi - ca măsură de precauţie, încetaţi să luaţi Rosuvastatina STADA şi consultaţi imediat medicul dumneavoastră dacă aveţi dureri sau crampe musculare neobişnuite, care durează mai mult decât v-aţi aştepta;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri severe de stomac (semn posibil de inflamare a pancreasului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ecreşterea valorilor enzimel or hepatice (transaminaze) în sânge;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esângerarea sau vânătăile apar mai uşor decât în mod normal datorită nivelului scăzut de trombocite în sânge;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003esindrom cu simptome asemănătoare celor din lupus (inclusiv urticarie, afecţiuni ale articulaţiilor şi efecte asupra celulelor sanguine).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse foarte rare (pot afecta până la 1 din 10.000 persoane)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eicter (îngălbenirea pielii şi a albului ochilor), hepatită (inflamaţia ficatului);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eurme de sânge în urină;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eleziuni ale nervilor de la nivelul picioarelor şi mâinilor (cum ar fi amorţeală);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edureri articulare;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003epierderi de memorie;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003emărirea sânilor la bărbaţi (ginecomastie).\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eReacţii adverse cu frecvenţă necunoscută (frecvenţa nu poate fi estimată din datele disponibile)\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003ediaree (scaune moi);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003etuse, dificultăţi de respiraţie;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eedem (umflare);\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003etulburări de somn, inclusiv insomnie şi coşmaruri;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edisfuncţii sexuale;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003edepresie;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eprobleme respiratorii, inclusiv tuse persistentă şi\/sau scurtarea respiraţiei sau febră;\u003c\/li\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eleziuni ale tendoanelor, slăbiciune musculară constantă.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRaportarea reacţiilor adverse\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDacă manifestaţi orice reacţii adverse, adresaţi-vă medicului dumneavoastră sau farmacistului.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eAcestea includ orice posibile reacţii adverse nemenţionate în acest prospect.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"5\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eCum se păstrează Rosuvastatina STADA\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu lăsaţi acest medicament la vederea şi îndemâna copiilor.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eA se păstra în ambalaj original pentru a fi protejat de umiditate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eNu utilizaţi acest medicament după data de expirare înscrisă pe ambalaj după EXR\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eData dc expirare se referă la ultima zi a lunii respective Nu aruncaţi niciun medicament pe calea apei sau a reziduurilor menajere. întrebaţi farmacistul cum să aruncaţi medicamentele pe care nu le mai folosiţi. Aceste măsuri vor ajuta la protejarea mediului.\u003c\/p\u003e\r\n\u003col style=\"text-align: justify;\" start=\"6\"\u003e\r\n\u003cli style=\"font-weight: 500;\"\u003eConţinutul ambalajului şi alte informaţii\u003c\/li\u003e\r\n\u003c\/ol\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCe conţine Rosuvastatina STADA\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Substanţa activă este rosuvastatina.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cu\u003eRosuvastatina STADA 5 mg:\u003c\/u\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat filmat conţine rosuvastatină (sub formă de rosuvastatină calcică) - 5 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cu\u003eRosuvastatina STADA 10 mg:\u003c\/u\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat filmat conţine rosuvastatină (sub formă de rosuvastatină calcică) -10 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e\u003cu\u003eRosuvastatina STADA 20 mg:\u003c\/u\u003e\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFiecare comprimat filmat conţine rosuvastatină (sub formă de rosuvastatină calcică) - 20 mg.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e- Celelalte componente sunt: nucleu: lactoză monohidrat, povidonă K 30, crospovidonă tip A, celuloză pulbere, copovidonă, siliciu coloidal anhidru, stearat de magneziu;\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003efilm: alcool polivinilic, macrogol (MW 3350), dioxid de titan (E171), talc.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eCum arată Rosuvastatina STADAşi conţinutul ambalajului\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 5 mg se prezintă sub formă de comprimate filmate albe, rotunde, biconvexe, cu diametrul de 5 mm.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 10 mg se prezintă sub formă de comprimate filmate albe, rotunde, biconvexe, cu diametrul de 7 mm.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA 20 mg se prezintă sub formă de comprimate filmate albe, rotunde, biconvexe, cu diametrul de 9 mm.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eRosuvastatina STADA este disponibil în cutii cu 4 blistere a câte 7 comprimate filmate.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eDeţinătorul certificatului de înregistrare\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eLaboratorio STADA, S.L.\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFrederic Mompou, 5\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003e08960 Sânt Just Desvern (Barcelona),\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSpania\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eFabricantul\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eSTADA Arzneimittel AG\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eStadastrasse,2-18\u003c\/p\u003e\r\n\u003cp style=\"font-weight: 500; text-align: justify;\"\u003eD-61118 Bad Vilbel, Germania\u003c\/p\u003e","brand":"Stada Arzneimittel AG","offers":[{"title":"Default Title","offer_id":52239153430668,"sku":"103629","price":66.03,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/103629.jpg?v=1786532719"},{"product_id":"choline-inositol-250mg-250mg-caps","title":"Choline \u0026 Inositol 250mg\/250mg caps.","description":null,"brand":"Balkan Pharmaceuticals SRL 0","offers":[{"title":"Default Title","offer_id":53845242708108,"sku":"132282","price":230.31,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/b0uZuPbqSCyKBe7AmHZzAbEBEE9QmNEHMHZwzzdn.jpg?v=1787659627"},{"product_id":"co-roswera-40-mg-10-mg-comp-film","title":"Co-Roswera 40 mg\/10 mg comp.film.","description":"\u003cp style=\"text-align: justify;\"\u003eCo-Roswera 40 mg\/10 mg comprimate filmate\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSubstanțe active: rosuvastatină \/ ezetimib\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCe este Co-Roswera și pentru ce se utilizează:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera conține două substanțe active: rosuvastatină, care aparține clasei de medicamente numite statine, și ezetimib.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eMedicamentul contribuie la scăderea valorilor colesterolului total, colesterolului LDL („colesterolul rău”) și trigliceridelor din sânge și la creșterea valorilor colesterolului HDL („colesterolul bun”).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera acționează prin două mecanisme:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli\u003ereduce absorbția colesterolului din tractul digestiv;\u003c\/li\u003e\r\n\u003cli\u003ereduce cantitatea de colesterol produsă de organism.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eEste utilizat la pacienții la care valorile colesterolului nu pot fi controlate numai prin regim alimentar și poate fi prescris persoanelor care utilizează deja rosuvastatină și ezetimib în aceleași concentrații.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eLa pacienții cu afecțiuni cardiovasculare, Co-Roswera poate contribui la reducerea riscului de infarct miocardic, accident vascular cerebral, intervenții pentru îmbunătățirea circulației sanguine sau spitalizare din cauza durerilor în piept.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePe durata tratamentului trebuie continuat regimul alimentar recomandat pentru reducerea colesterolului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eContraindicații:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu luați Co-Roswera:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli\u003edacă sunteți alergic la rosuvastatină, ezetimib sau la oricare dintre componentele medicamentului;\u003c\/li\u003e\r\n\u003cli\u003edacă sunteți gravidă sau alăptați;\u003c\/li\u003e\r\n\u003cli\u003edacă aveți afecțiuni ale ficatului;\u003c\/li\u003e\r\n\u003cli\u003edacă aveți insuficiență renală severă;\u003c\/li\u003e\r\n\u003cli\u003edacă aveți dureri musculare repetate sau inexplicabile;\u003c\/li\u003e\r\n\u003cli\u003edacă utilizați ciclosporină;\u003c\/li\u003e\r\n\u003cli\u003edacă utilizați combinația sofosbuvir\/velpatasvir\/voxilaprevir.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eÎn plus, doza de 40 mg\/10 mg nu trebuie utilizată în anumite situații, inclusiv în caz de insuficiență renală moderată, tulburări ale funcției tiroidei, antecedente de afecțiuni musculare, consum regulat de cantități mari de alcool, tratament concomitent cu fibrați sau la anumite persoane de origine asiatică.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAtenționări și precauții:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eÎnainte de administrarea Co-Roswera, informați medicul dacă:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli\u003eaveți probleme cu rinichii sau ficatul;\u003c\/li\u003e\r\n\u003cli\u003eaveți sau ați avut dureri ori slăbiciune musculară;\u003c\/li\u003e\r\n\u003cli\u003eaveți afecțiuni ale glandei tiroide;\u003c\/li\u003e\r\n\u003cli\u003econsumați regulat cantități mari de alcool;\u003c\/li\u003e\r\n\u003cli\u003eaveți vârsta peste 70 de ani;\u003c\/li\u003e\r\n\u003cli\u003eaveți insuficiență respiratorie severă;\u003c\/li\u003e\r\n\u003cli\u003eaveți diabet zaharat sau risc crescut de diabet;\u003c\/li\u003e\r\n\u003cli\u003eaveți sau ați avut miastenie gravis ori miastenie oculară;\u003c\/li\u003e\r\n\u003cli\u003eați prezentat anterior reacții cutanate severe la rosuvastatină.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAdresați-vă imediat medicului dacă apar dureri musculare inexplicabile, slăbiciune musculară persistentă, febră sau stare generală de rău.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eÎn timpul tratamentului, medicul poate recomanda periodic analize pentru monitorizarea funcției ficatului și a valorilor colesterolului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eInteracțiuni cu alte medicamente:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSpuneți medicului sau farmacistului dacă utilizați alte medicamente, în special:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli\u003eciclosporină;\u003c\/li\u003e\r\n\u003cli\u003ewarfarină, clopidogrel, ticagrelor sau alte anticoagulante;\u003c\/li\u003e\r\n\u003cli\u003efibrați, precum gemfibrozil sau fenofibrat;\u003c\/li\u003e\r\n\u003cli\u003emedicamente pentru indigestie;\u003c\/li\u003e\r\n\u003cli\u003eeritromicină;\u003c\/li\u003e\r\n\u003cli\u003econtraceptive orale sau terapie hormonală de substituție;\u003c\/li\u003e\r\n\u003cli\u003eanumite medicamente utilizate în tratamentul HIV sau hepatitei C;\u003c\/li\u003e\r\n\u003cli\u003ecolestiramină;\u003c\/li\u003e\r\n\u003cli\u003eacid fusidic;\u003c\/li\u003e\r\n\u003cli\u003eregorafenib sau darolutamidă.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSarcina și alăptarea:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera este contraindicat în timpul sarcinii și alăptării.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDacă rămâneți gravidă în timpul tratamentului, întrerupeți administrarea și adresați-vă imediat medicului. Femeile aflate la vârsta fertilă trebuie să utilizeze metode contraceptive adecvate în timpul tratamentului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eMod de administrare:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eLuați întotdeauna Co-Roswera exact așa cum v-a recomandat medicul.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDoza recomandată este de 1 comprimat o dată pe zi.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eComprimatul poate fi administrat în orice moment al zilei, cu sau fără alimente. Se înghite întreg, cu un pahar cu apă, de preferat în aceeași perioadă a zilei.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCo-Roswera 40 mg\/10 mg nu este destinat inițierii tratamentului și se utilizează la pacienții tratați anterior cu rosuvastatină și ezetimib în dozele corespunzătoare.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu luați o doză dublă pentru a compensa doza uitată.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eReacții adverse posibile:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eReacțiile adverse frecvente pot include:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli\u003edureri de cap;\u003c\/li\u003e\r\n\u003cli\u003edureri abdominale;\u003c\/li\u003e\r\n\u003cli\u003econstipație sau diaree;\u003c\/li\u003e\r\n\u003cli\u003egreață;\u003c\/li\u003e\r\n\u003cli\u003eamețeli;\u003c\/li\u003e\r\n\u003cli\u003edureri sau slăbiciune musculară;\u003c\/li\u003e\r\n\u003cli\u003eoboseală;\u003c\/li\u003e\r\n\u003cli\u003ebalonare;\u003c\/li\u003e\r\n\u003cli\u003ecreșterea valorilor transaminazelor;\u003c\/li\u003e\r\n\u003cli\u003ecreșterea proteinelor în urină;\u003c\/li\u003e\r\n\u003cli\u003ediabet zaharat la persoanele cu factori de risc.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eOpriți administrarea și solicitați imediat asistență medicală în cazul apariției:\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli\u003edificultăților de respirație sau înghițire;\u003c\/li\u003e\r\n\u003cli\u003eumflării feței, buzelor, limbii sau gâtului;\u003c\/li\u003e\r\n\u003cli\u003eunei reacții alergice severe;\u003c\/li\u003e\r\n\u003cli\u003edurerilor musculare severe sau persistente;\u003c\/li\u003e\r\n\u003cli\u003eunor erupții cutanate severe, vezicule sau descuamarea pielii;\u003c\/li\u003e\r\n\u003cli\u003esimptomelor sugestive pentru sindrom Stevens-Johnson sau DRESS.\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePăstrare:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eA nu se lăsa la vederea și îndemâna copiilor.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eA se păstra în ambalajul original, pentru a fi protejat de lumină și umiditate.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eMedicamentul nu necesită condiții speciale de temperatură pentru păstrare.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu utilizați după data de expirare înscrisă pe ambalaj.\u003c\/p\u003e","brand":"KRKA d.d., Novo mesto","offers":[{"title":"Default Title","offer_id":54572634079372,"sku":"132281","price":188.33,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/JdoKpOmuCUNDVdA3pfcNA3ToilWCBOWARj1GVrJ5.jpg?v=1787911965"},{"product_id":"aterolip-complex-caps","title":"Aterolip complex caps.","description":"\u003cp style=\"text-align: justify;\"\u003eAterolip Complex \u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAterolip Complex este un supliment alimentar cu formulă complexă, care conține colină, monacolină K din orez roșu fermentat, extract de turmeric, extract standardizat din frunze de măslin, niacină, policosanol și vitamina B12.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eExtractul de turmeric contribuie la menținerea nivelului normal al colesterolului în sânge, susține funcționarea sistemului cardiovascular și contribuie la menținerea sănătății ficatului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eColina contribuie la metabolismul normal al lipidelor și al homocisteinei. Vitamina B12 contribuie la formarea normală a globulelor roșii și la metabolismul normal al homocisteinei. Niacina și vitamina B12 contribuie la metabolismul energetic normal.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eExtractul standardizat din frunze de măslin conține 20% hidroxitirozol (polifenol).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eProdusul este destinat adulților cu vârsta cuprinsă între 18 și 70 de ani.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu conține organisme modificate genetic (OMG).\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCompoziție per 1 capsulă\u003c\/p\u003e\r\n\u003cul style=\"text-align: justify;\"\u003e\r\n\u003cli\u003eBitartrat de colină – 200 mg, din care colină 41,3% – 82,6 mg\u003c\/li\u003e\r\n\u003cli\u003ePulbere din orez roșu fermentat – 59,8 mg, din care monacolină K 5% – 2,99 mg\u003c\/li\u003e\r\n\u003cli\u003eExtract uscat standardizat din frunze de măslin – 25 mg, din care hidroxitirozol 20% – 5 mg\u003c\/li\u003e\r\n\u003cli\u003eExtract de turmeric – 20 mg, din care curcumină 95% – 19 mg\u003c\/li\u003e\r\n\u003cli\u003eNiacină – \u003cem\u003e\u003cem\u003e16 mg NE (100% VNR\u003c\/em\u003e)\u003c\/em\u003e*\u003c\/li\u003e\r\n\u003cli\u003ePolicosanol – 10 mg, din care octacosanol 60% – 6 mg\u003c\/li\u003e\r\n\u003cli\u003eVitamina B12 – \u003cem\u003e\u003cem\u003e2,5 µg (100% VNR\u003c\/em\u003e)\u003c\/em\u003e*\u003c\/li\u003e\r\n\u003c\/ul\u003e\r\n\u003cp style=\"text-align: justify;\"\u003e*VNR – valoarea nutrițională de referință pentru un adult.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eMod de administrare\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAdulți: câte 1 capsulă pe zi, administrată oral.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSe recomandă administrarea timp de 6 luni consecutiv. La necesitate, cura poate fi repetată.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eAtenționări\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu utilizați produsul în caz de hipersensibilitate (alergie) la oricare dintre componente.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu consumați zilnic o cantitate de 3 mg sau mai mult de monacoline din orez roșu fermentat.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eProdusul nu este destinat femeilor însărcinate sau care alăptează, persoanelor cu vârsta sub 18 ani și adulților cu vârsta peste 70 de ani.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eDacă apar probleme de sănătate în timpul utilizării produsului, adresați-vă medicului.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu utilizați produsul dacă administrați medicamente pentru reducerea colesterolului sau alte produse care conțin orez roșu fermentat.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSuplimentele alimentare nu trebuie utilizate ca înlocuitor al unei alimentații variate și echilibrate și al unui stil de viață sănătos.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eNu depășiți doza zilnică recomandată.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eCondiții de păstrare\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eA se păstra la temperatura camerei, în ambalajul original, bine închis și ferit de lumina directă a soarelui.\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eA nu se lăsa la îndemâna și vederea copiilor.\u003c\/p\u003e","brand":"SIA AD Smart,Riga","offers":[{"title":"Default Title","offer_id":56260654563468,"sku":"132477","price":317.39,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/9g9iu8O5bIa9ah1xhyzU9cmeubmQm4eeo3n53mtY.jpg?v=1788760080"},{"product_id":"hitozan-comp","title":"Hitozan comp.","description":null,"brand":"Evalar","offers":[{"title":"Default Title","offer_id":57474052980876,"sku":"16827","price":500.46,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/16827.jpg?v=1789128331"},{"product_id":"3chenes-liposterol-fort-comp","title":"3Chenes Liposterol fort comp.","description":"\u003cp style=\"text-align: justify;\"\u003e\u003cspan lang=\"EN-US\"\u003eLiposterol fort \u003c\/span\u003e\u003cspan lang=\"EN-US\"\u003eeste destinat  pentru  menținerea  nivelului normal de colesterol.\u003c\/span\u003e\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eComponenţa  per  1 comprimat:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eExtract de coriandru- 500 mg\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eExtract de bergamot -200 mg\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eExtract de olive (MEDITEANOX H7) -75 mg din care hidroxitrosol- 5 mg\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003ePolicosanol -5 mg\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eMod de administrare:\u003c\/p\u003e\r\n\u003cp style=\"text-align: justify;\"\u003eSe administrează 1 comprimat zilnic după-amiaza sau seara, în timp ce mâncați cu suficientă apă.\u003c\/p\u003e","brand":"Les 3 Chenes","offers":[{"title":"Default Title","offer_id":61729671348364,"sku":"86588","price":276.0,"currency_code":"MDL","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0377\/7092\/0076\/files\/86588.jpg?v=1790665127"}],"url":"https:\/\/ff.md\/collections\/hipolipemiante.oembed?page=3","provider":"Farmacia Familiei","version":"1.0","type":"link"}