FrancophonIA/ELRC3.0 huggingface dataset:
English: Rosuvastatin, at a dose that does not exceed 10 mg, may be administered with Epclusa.
Croatian: Rosuvastatin se u dozi koja ne premašuje 10 mg može primjenjivati s lijekom Epclusa.
English: d Lack of pharmacokinetics interaction bounds 70-143%.
Croatian: d. Raspon u kojem nema farmakokinetičkih interakcija 70-143 %.
English: These data indicate that renal clearance is the major elimination pathway for GS-331007.
Croatian: Ovi podaci pokazuju da je bubrežni klirens glavni put eliminacije GS-331007.
English: GS-461203 (the active metabolite of sofosbuvir) is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Croatian: GS-461203 (djelatni metabolit sofosbuvira) nije inhibitor ni ljudskih DNK i RNK polimeraza niti je inhibitor mitohondrijske RNK polimeraze.
English: Tell your doctor or pharmacist if you are taking any of the medicines below:
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova:
English: GS-331007 is not an inhibitor of OAT1, OCT2, and MATE1.
Croatian: GS-331007 nije inhibitor OAT1, OCT2 i MATE1.
English: Table 1: Recommended treatment and duration for all HCV genotypes
Croatian: Tablica 1: Preporučeno liječenje i trajanje za sve genotipove HCV-a Populacija bolesnikaa
English: Following a single 400 mg dose of sofosbuvir, a 4 hour haemodialysis removed 18% of administered dose.
Croatian: Nakon jedne doze od 400 mg sofosbuvira, tijekom 4 sata hemodijalize uklonilo se 18 % primijenjene doze.
English: b One patient had on-treatment virologic failure; pharmacokinetic data from this patient was consistent with non-adherence to treatment.
Croatian: b. Jedan bolesnik imao je virološki neuspjeh tijekom liječenja; farmakokinetički podaci ovog bolesnika bili su konzistentni s nepridržavanjem liječenja.
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS
Croatian: ANTIVIRUSNI LIJEKOVI ZA HIV: INHIBITORI INTEGRAZE
English: Epclusa is sometimes used together with ribavirin.
Croatian: Epclusa se ponekad primjenjuje zajedno s ribavirinom.
English: The overall mean CD4+ count was 598 cells/µL (range: 183−1513 cells/µL).
Croatian: Ukupan prosječan broj CD4+ stanica bio je 598 stanica/μL (raspon: 183−1513 stanica/μL).
English: H2-receptor antagonists may be administered simultaneously with or staggered from Epclusa at a dose that does not exceed doses comparable to famotidine 40 mg twice daily.
Croatian: H2-receptora mogu se primijeniti u isto vrijeme s lijekom Epclusa ili s vremenskim razmakom u dozi koja ne prelazi doze usporedive s dozom famotidina od 40 mg dvaput na dan.
English: The adverse events observed were consistent with expected clinical sequelae of decompensated liver disease, or the known toxicity profile of ribavirin for patients receiving Epclusa in combination with ribavirin.
Croatian: Opaženi štetni događaji bili su konzistentni s očekivanim kliničkim posljedicama bolesti dekompenzirane jetre ili poznatim profilom toksičnosti ribavirina za bolesnike koji su primali lijek Epclusa u kombinaciji s ribavirinom.
English: • efavirenz used to treat HIV infection;
Croatian: • efavirenz koji se primjenjuje za liječenje HIV-infekcije;
English: Site-directed mutagenesis of the S282T substitution in replicons of genotype 1 to 6 conferred 2- to 18-fold reduced susceptibility to sofosbuvir and reduced the replication viral capacity by 89% to 99% compared to the corresponding wild-type.
Croatian: Ciljana mutageneza supstitucije S282T u replikonima genotipova 1 do 6 dovela je do smanjene osjetljivosti na sofosbuvir za 2 do 18 puta i smanjila je kapacitet replikacije virusa za 89 % do 99 % u usporedbi s odgovarajućim divljim tipom.
English: Genotype 1a 6% (3/50)
Croatian: Genotip 1a 6 % (3/50)
English: Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Croatian: Liječenje lijekom Epclusa treba započeti i nadzirati liječnik iskusan u liječenju bolesnika s infekcijom HCV-a.
English: Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Epclusa.
Croatian: Vaš će liječnik možda morati pažljivo pratiti druge lijekove koje uzimate i prilagoditi njihovu dozu nakon što počnete uzimati lijek Epclusa.
English: If you are sick (vomit) after taking Epclusa it may affect the amount of Epclusa in your blood.
Croatian: Ako povratite nakon uzimanja lijeka Epclusa, to može utjecati na količinu lijeka Epclusa u Vašoj krvi.
English: Table 18: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of Sofosbuvir, GS-331007, and Velpatasvir Compared to Subjects with Normal Renal Function
Croatian: Tablica 18: Utjecaj različitih stupnjeva oštećenja bubrega na izloženost (AUC) sofosbuviru, GS-331007 i velpatasviru u usporedbi s ispitanicima s normalnom funkcijom bubrega
English: ↔ ↔ ↔ No dose adjustment of oral contraceptives is required.
Croatian: ↔ ↔ ↔ Nije potrebna prilagodba doze oralnih kontraceptiva.
English: These data indicate that biliary excretion of parent drug was a major route of elimination for velpatasvir.
Croatian: Ovi podaci ukazuju da je izlučivanje ishodišnog lijeka putem žuči bio glavni put eliminacije velpatasvira.
English: (Inhibition of OATP1B)
Croatian: (Inhibicija OATP1B)
English: Post-treatment Week 12 (N = 236), % (n/N) Decreased score (Improvement)
Croatian: 12. tjedan nakon liječenja (N=236), % (n/N) Smanjeni rezultat (poboljšanje)
English: It has not been possible to fully estimate exposure margins achieved for sofosbuvir in the rat relative to the exposure in humans at the recommended clinical dose (see section 5.3).
Croatian: Nije bilo moguće u potpunosti procijeniti granice izloženosti sofosbuviru kod štakora u odnosu na izloženost u ljudi pri preporučenoj kliničkoj dozi (vidjeti dio 5.3).
English: Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant
Croatian: Ciroza Child-Pugh-Turcotte (CPT) stadija B prije transplantacije:
English: No dose adjustment of Epclusa is required for patients with mild, moderate, or severe hepatic impairment (CPT Class A, B, or C) (see section 5.2).
Croatian: Nije potrebna prilagodba doze lijeka Epclusa u pacijenata s blagim, umjerenim ili teškim oštećenjem jetre (CPT stadij A, B ili C) (vidjeti dio 5.2).
English: 1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg
Croatian: 1000 mg po danu za bolesnike < 75 kg i 1200 mg za bolesnike težine ≥ 75 kg
English: The proportion of patients who permanently discontinued treatment due to adverse events was 0.2% and the proportion of patients who experienced any severe adverse events was 3.2% for patients receiving Epclusa for 12 weeks.
Croatian: Udio bolesnika koji su trajno prekinuli liječenje zbog štetnih događaja iznosio je 0,2 %, a udio bolesnika u kojih se javio bilo koji teški štetni događaj iznosio je 3,2 % za bolesnike koji su primali lijek Epclusa tijekom 12 tjedana.
English: • if you have had a liver transplant • have kidney problems or if you are on kidney dialysis, since Epclusa has not been fully tested in patients with some severe kidney problems;
Croatian: • ako imate tegobe s bubrezima ili se liječite dijalizom, budući da lijek Epclusa nije u potpunosti ispitan u bolesnika s teškim tegobama s bubrezima;
English: Post-treatment Week 24 (N = 236), % (n/N) Decreased score (Improvement)
Croatian: 24. tjedan nakon liječenja (N=236), % (n/N) Smanjeni rezultat (poboljšanje)
English: Velpatasvir is an inhibitor of drug transporter P-gp, BCRP, OATP1B1 and OATP1B3 and its involvement in drug interactions with these transporters is primarily limited to the process of absorption.
Croatian: Velpatasvir je inhibitor prijenosnika lijeka P-gp-a, BCRP-a, OATP1B1 i OATP1B3 i njegova uključenost u interakcije lijeka s ovim prijenosnicima primarno je ograničena procesom apsorpcije.
English: Pink, diamond-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with “GSI” and “7916” on the other side.
Croatian: Ružičasta, filmom obložena tableta u obliku dijamanta, dimenzija 20 mm x 10 mm, s utisnutim „GSI“ na jednoj strani i „7916“ na drugoj strani.
English: Elderly No dose adjustment is warranted for elderly patients (see section 5.2).
Croatian: Nije potrebna prilagodba doze u starijih pacijenata (vidjeti dio 5.2).
English: SVR with Y93H 95% CI
Croatian: SVR sa Y93H 95 % CI
English: • tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
Croatian: • tenofovirdizoproksilfumarat ili bilo koji lijek koji sadrži tenofovirdizoproksilfumarat, koji se primjenjuje za liječenje HIV-infekcije;
English: Co-administration with proton pump inhibitors is not recommended.
Croatian: Istodobna primjena s inhibitorom protonske pumpe ne preporučuje se.
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of the components of Epclusa compared to subjects with normal renal function, as described in the text below, are provided in Table 18.
Croatian: Sažeti prikaz utjecaja različitih stupnjeva oštećenja bubrega na izloženost komponentama lijeka Epclusa u usporedbi s ispitanicima s normalnom funkcijom bubrega, kako je opisano u nastavku, prikazan je u tablici 18.
English: Body weight did not have a clinically significant effect on sofosbuvir or velpatasvir exposure according to a population pharmacokinetic analysis.
Croatian: Tjelesna težina nije imala klinički značajni učinak na izloženost sofosbuviru ili velpatasviru prema analizi populacijske farmakokinetike.
English: 28 film-coated tablets
Croatian: OBLIK I SADRŽAJ 28 filmom obloženih tableta
English: The safety of tenofovir disoproxil fumarate in the setting of Epclusa and a pharmacokinetic enhancer has not been established.
Croatian: Sigurnost tenofovirdizoproksilfumarata uz lijek Epclusa i farmakokinetički pojačivač nije ustanovljena.
English: Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 µg/mL to 20 µg/mL.
Croatian: Sofosbuvir je približno 61-65 % vezan za proteine ljudske plazme i vezanje ne ovisi o koncentraciji lijeka u rasponu od 1 μg/ml do 20 μg/ml.
English: • modafinil used to treat sleep disorders;
Croatian: • modafinil koji se primjenjuje se liječenja poremećaja spavanja;
English: TN and TE, without cirrhosis or with compensated cirrhosis, with HCV/HIV-1 co-infection
Croatian: TN i TE, bez ciroze ili s kompenziranom cirozom, s koinfekcijom virusima HCV/HIV-1
English: These and other adverse events were reported at a similar frequency in placebo treated patients compared with Epclusa treated patients.
Croatian: Ovi i drugi štetni događaji prijavljeni su sa sličnom učestalosti u bolesnika koji su primali placebo u usporedbi s bolesnicima liječenim lijekom Epclusa.
English: Unchanged velpatasvir was the major species in faeces accounting for a mean of 77% of the administered dose, followed by monohydroxylated velpatasvir (5.9%) and desmethylated velpatasvir (3.0%).
Croatian: Nepromijenjeni je velpatasvir bio glavni oblik u stolici sa srednjim udjelom od 77 % primijenjene doze, nakon čega slijedi monohidroksilirani velpatasvir (5,9 %) i desmetilirani velpatasvir (3,0 %).
English: Glucose levels of diabetic patients initiating direct-acting antiviral therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Croatian: Razine glukoze u bolesnika s dijabetesom koji započinju liječenje direktno djelujućim antivirotikom treba pažljivo nadzirati, posebno unutar prva tri mjeseca, te prema potrebi prilagoditi lijek protiv dijabetesa.
English: When Epclusa is used in combination with ribavirin refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance < 50 mL/min (see section 5.2).
Croatian: Kada se Epclusa koristi u kombinaciji s ribavirinom, pogledajte sažetak opisa svojstava lijeka za ribavirin za bolesnike s klirensom kreatinina < 50 ml/min (vidjeti dio 5.2).
English: Total (n = 328)
Croatian: Ukupno (n = 328)
English: b Stable chimeric 1b replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing.
Croatian: b. Stabilni kimerički replikoni 1b koji nose NS5B gene iz genotipova 2b, 5a ili 6a upotrijebljeni su za ispitivanje.
English: In vitro data suggests that the majority of NS5A RAVs that confer resistance to ledipasvir and daclatasvir remained susceptible to velpatasvir.
Croatian: In vitro podaci ukazuju da je većina NS5A RAV-ova koji dovode do rezistencije na ledipasvir i daklatasvir ostala osjetljiva na velpatasvir.
English: The safety and efficacy of Epclusa in the treatment of HCV infection in patients who are post-liver transplant have not been assessed.
Croatian: Sigurnost i djelotvornost lijeka Epclusa u liječenju infekcije HCV-om u bolesnika u kojih je transplantirana jetra nisu procijenjene.
English: Epclusa is a medicine that contains the active substances sofosbuvir and velpatasvir in a single tablet.
Croatian: Epclusa je lijek koji sadrži djelatne tvari, sofosbuvir i velpatasvir, u jednoj tableti.
English: The medicinal product interactions described are based on studies conducted with either sofosbuvir/velpatasvir or velpatasvir and sofosbuvir as individual agents, or are predicted medicinal product interactions that may occur with sofosbuvir/velpatasvir.
Croatian: Opisane interakcije lijekova temelje se na ispitivanjima provedenima s sofosbuvirom/velpatasvirom ili velpatasvirom i sofosbuvirom kao zasebno primijenjenim lijekovima ili su predviđene interakcije lijekova koje mogu nastati sa sofosbuvirom/velpatasvirom.
English: If ribavirin is co-administered with Epclusa, refer to the Summary of Product Characterisitics for ribavirin for detailed recommendations regarding pregnancy, contraception, and breast-feeding.
Croatian: Ako se ribavirin primjenjuje istodobno s lijekom Epclusa, pogledajte sažetak opisa svojstava lijeka ribavirina radi detaljnih preporuka u pogledu trudnoće, kontracepcije i dojenja.
English: Co-administration of Epclusa with rosuvastatin increases the concentration of rosuvastatin, which is associated with increased risk of myopathy, including rhabdomyolysis.
Croatian: Istodobna primjena lijeka Epclusa s rosuvastatinom povećava koncentraciju rosuvastatina, što je povezano s povećanim rizikom od miopatije, uključujući rabdomiolizu.
English: If you are not sure talk to your doctor or pharmacist.
Croatian: Ako niste sigurni, obratite se svom liječniku ili ljekarniku.
English: All Subjects (n = 274)
Croatian: Svi ispitanici (n = 274)
English: Co-administration of Epclusa with digoxin may increase the concentration of digoxin.
Croatian: Istodobna primjena lijeka Epclusa s digoksinom može povećati koncentraciju digoksina.
English: Some medicines should not be taken with Epclusa.
Croatian: Neki lijekovi se ne smjeli uzimati s lijekom Epclusa.
English: Ciclosporin ↔ ↔
Croatian: Ciklosporin ↔ ↓
English: Dephosphorylation results in the formation of nucleoside metabolite GS-331007 that cannot be efficiently rephosphorylated and lacks anti-HCV activity in vitro.
Croatian: Defosforilacija dovodi do stvaranja nukleozidnog metabolita GS-331007 koji se ne može učinkovito ponovno fosforilirati i nema djelovanje protiv HCV-a in vitro.
English: Epclusa 12 weeks (624) Placebo 12 weeks (116)
Croatian: Epclusa 12 tjedana (624) Placebo 12 tjedana (116)
English: The highest documented doses of sofosbuvir and velpatasvir were a single dose of 1,200 mg and a single dose of 500 mg, respectively.
Croatian: Najviše zabilježene doze sofosbuvira i velpatasvira bile su jedna doza od 1200 mg odnosno jedna doza od 500 mg.
English: Table 2: Guidance for ribavirin dosing when administered with Epclusa to patients with decompensated cirrhosis
Croatian: Tablica 2: Smjernice za doziranje ribavirina kada se primjenjuje s lijekom Epclusa u bolesnika s dekompenziranom cirozom
English: The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets.
Croatian: Dostupne su sljedeće veličine pakiranja: kutije koje sadrže 1 bocu s 28 filmom obloženih tableta.
English: The moderate or high fat meal did not alter GS-331007 AUC0-inf, but resulted in a 25% and 37% decrease in its Cmax, respectively.
Croatian: Obrok s umjerenim ili visokim udjelom masti nije izmijenio AUC0-inf GS-331007, ali je rezultiralo smanjenjem njegovog Cmax od 25 % odnosno 37 %.
English: The efficacy of Epclusa has not been assessed in patients who have previously failed treatment with other regimens that include an NS5A inhibitor.
Croatian: Djelotvornost lijeka Epclusa nije procijenjena u bolesnika u kojih je prethodno liječenje drugim režimom koji uključuje inhibitor NS5A bilo neuspješno.
English: The response rates observed for patients ≥ 65 years of age were similar to that of patients < 65 years of age, across treatment groups.
Croatian: Stope odgovora opažene za bolesnike u dobi ≥ 65 godina bile su slične onima u bolesnika u dobi
English: If it is after 18 hours then patients should be instructed to wait and take the next dose of Epclusa at the usual time.
Croatian: Ako je proteklo više od 18 sati, onda bolesnike treba uputiti da pričekaju i uzmu sljedeću dozu lijeka Epclusa u uobičajeno vrijeme.
English: Table 16: Changes in CPT score parameters from baseline to week 12 and 24 post-treatment in patients achieving SVR12, ASTRAL-4
Croatian: Tablica 16: Promjene parametara bodovanja po CPT-u od početnih vrijednosti do 12. tjedna i 24. tjedna nakon liječenja kod bolesnika koji su postigli SVR12, ASTRAL-4
English: c Data from various strains of full length NS5A replicons or chimeric NS5A replicons carrying full-length NS5A genes that contain L31 or M31 polymorphisms.
Croatian: c. Podaci iz raznih sojeva replikona NS5A pune duljine ili kimeričkih replikona NS5A koji nose gene NS5A pune duljine koji sadrže polimorfizme L31 ili M31.
English: Both sofosbuvir and velpatasvir were fully active against substitutions associated with resistance to other classes of direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors and NS3 protease inhibitors.
Croatian: I sofosbuvir i velpatasvir su bili potpuno djelatni protiv supstitucija povezanih s rezistencijom na druge skupine antivirotika koji djeluju direktno s različitim mehanizmima djelovanja, kao što su NS5B nenukleozidni inhibitori i NS3 inhibitori proteaze.
English: In biochemical assays, the ability of the active triphosphate of sofosbuvir (GS-461203) to inhibit recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution was reduced compared to its ability to inhibit wild-type recombinant NS5B polymerase, as indicated by a 8.5- to 24-fold increase in the 50% inhibitory concentration (IC50).
Croatian: U biokemijskim testovima, sposobnost aktivnog trifosfata sofosbuvira (GS-461203) da inhibira rekombinantne polimeraze NS5B iz genotipova 1b, 2a, 3a i 4a koji eksprimiraju supstituciju S28ST bila je smanjena u usporedbi s njegovom sposobnosti da inhibira divlji tip rekombinantne polimeraze NS5B, na što ukazuje povećanje u 50 % inhibitornoj koncentraciji (IC50) za 8,5 do 24 puta.
English: No specific antidote is available for overdose with Epclusa.
Croatian: Nije dostupan specifični antidot za predoziranje lijekom Epclusa.
English: • If you notice within 18 hours of the time you usually take Epclusa, you must take the tablet as soon as possible.
Croatian: • Ako to opazite u roku od 18 sati od vremena kad obično uzimate lijek Epclusa, morate što prije uzeti tabletu.
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analog triphosphate GS-461203.
Croatian: Sofosbuvir se opsežno metabolizira u jetri pri čemu nastaje farmakološki djelatan nukleozidni analog trifosfat GS-461203.
English: Of the 87 patients treated with Epclusa + RBV, 85 patients were included in the analysis of NS5A RAVs; 2 patients were excluded as they neither achieved SVR12 nor had virologic failure.
Croatian: Od 87 bolesnika liječenih lijekom Epclusa + RBV, 85 bolesnika su bila uključena u analizu NS5A RAVova; dva bolesnika bila su isključena jer nisu postigli SVR12 niti virološki neuspjeh.
English: In this setting, exposure of sofosbuvir metabolite GS331007 was 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials.
Croatian: U takvim okolnostima, izloženost metabolitu sofosbuvira GS-331007 povećala se 20 puta i premašila razine pri kojima su nuspojave opažene u pretkliničkim ispitivanjima.
English: Co-administration will significantly decrease sofosbuvir or velpatasvir plasma concentrations and could result in loss of efficacy of Epclusa (see section 4.5).
Croatian: Istodobna primjena značajno će smanjiti koncentraciju sofosbuvira ili velpatasvira u plazmi i tako može dovesti do gubitka djelotvornosti lijeka Epclusa (vidjeti dio 4.5).
English: Interactions between Epclusa and other medicinal products Table 3 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined interaction boundaries).
Croatian: U tablici 3 prikazan je popis ustanovljenih ili potencijalno klinički značajnih interakcija lijekova (gdje je 90 % interval pouzdanosti [CI] omjera geometrijske srednje vrijednosti najmanjih kvadrata [engl. geometric least squares mean, GLSM] bio unutar „↔“, protezao se iznad „↑“, ili ispod „↓“ unaprijed određenih granica interakcije).
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na reprodukciju (vidjeti dio 5.3.).
English: It is recommended to separate antacid and Epclusa administration by 4 hours.
Croatian: Preporučuje se primijeniti antacid i lijek Epclusa u razmaku od 4 sata.
English: The overall SVR rate was 95% (56/59); of the three patients that did not achieve SVR12, one had completed Epclusa treatment and relapsed and two did not meet virologic failure criteria.
Croatian: Ukupna stopa SVR-a bila je 95% (56/59); od tri bolesnika koja nisu postigla SVR12, u jednog je bolesnika koji je završio liječenje lijekom Epclusa zabilježen relaps, a dva bolesnika nisu ispunila kriterije virološkog uspjeha.
English: 94.3% to 98.9% 85.3% to 97.8% 95.9% to 99.9%
Croatian: 94,3 % do 98,9 % 85,3 % do 97,8 % 95,9 % do 99,9 %
English: As Epclusa contains sofosbuvir and velpatasvir, any interactions that have been identified with these active substances individually may occur with Epclusa.
Croatian: Budući da Epclusa sadrži sofosbuvir i velpatasvir, sve interakcije koje su bile utvrđene s ove dvije djelatne tvari zasebno mogu nastati i s lijekom Epclusa.
English: The ribavirin dose was weight-based (1,000 mg daily administered in two divided doses for patients < 75 kg and 1,200 mg for those ≥ 75 kg) and administered in two divided doses when used in combination with sofosbuvir in the ASTRAL-2 and ASTRAL-3 studies or in combination with Epclusa in the ASTRAL-4 study.
Croatian: Doza ribavirina ovisila je o tjelesnoj težini (1000 mg na dan primijenjeno u dvije podijeljene doze za bolesnike < 75 kg i 1200 mg za bolesnike ≥ 75 kg) i primijenjena je u dvije podijeljene doze kad se upotrebljavao sa sofosbuvirom u ispitivanjima ASTRAL-2 i ASTRAL-3 ili u kombinaciji s lijekom Epclusa u ispitivanju ASTRAL-4.
English: Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Croatian: U odnosu na bolesnike s normalnom funkcijom jetre, AUC0-24 sofosbuvira bila je 126 % odnosno 143 % viša kod umjerenog i teškog oštećenja funkcije jetre, dok je AUC0-24 GS-331007 bila 18 % odnosno 9 % viša.