FrancophonIA/ELRC3.0 huggingface dataset:
English: Sovaldi is always taken with other medicines to treat hepatitis C. It will not work on its own.
Croatian: Sovaldi se uvijek uzima s drugim lijekovima za liječenje hepatitisa C jer sam neće djelovati.
English: The efficacy of sofosbuvir in HCV-infected patients aged 12 to <18 years was evaluated in a Phase 2, open label clinical trial that enrolled 50 patients with genotype 2 (n = 13) or genotype 3 (n = 37) chronic HCV infection.
Croatian: Djelotvornost sofosbuvira u bolesnika zaraženih HCV­om u dobi od 12 do <18 godina procijenjena je u otvorenom kliničkom ispitivanju faze 2 u koje je bilo uključeno 50 bolesnika s kroničnom infekcijom HCV­om genotipa 2 (n = 13) ili genotipa 3 (n = 37).
English: • low blood platelet count
Croatian: ● smanjen broj krvnih pločica
English: A starting ribavirin dose of 400 mg administered orally in two divided doses with food is recommended.
Croatian: Preporučuje se početna doza ribavirina od 400 mg, koja se primjenjuje peroralno, podijeljeno u dvije doze, s hranom.
English: Dose modification in adults Dose reduction of Sovaldi is not recommended.
Croatian: Prilagodba doze u odraslih Ne preporučuje se sniženje doze Sovaldija.
English: Each film-coated tablet contains 400 mg of sofosbuvir.
Croatian: Jedna filmom obložena tableta sadrži 400 mg sofosbuvira.
English: The mean ± SD EC50 of sofosbuvir against chimeric replicons encoding NS5B sequences from clinical isolates was 0.068 ± 0.024 μM for genotype 1a (n = 67), 0.11 ± 0.029 μM for genotype 1b (n = 29), 0.035 ± 0.018 μM for genotype 2 (n = 15) and 0.085 ± 0.034 μM for genotype 3a (n = 106).
Croatian: Srednja vrijednost ± SD EC50 sofosbuvira za kimerične replikone koji kodiraju sekvence NS5B iz kliničkih izolata iznosila je 0,068 ± 0,024 μM za genotip 1a (n = 67), 0,11 ± 0,029 μM za genotip 1b (n = 29), 0,035 ± 0,018 μM za genotip 2 (n = 15) i 0,085 ± 0,034 μM
English: Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0
Croatian: Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890­0
English: Sofosbuvir in a fixed dose combination with ledipasvir was administered for 12 weeks to 18 patients with genotype 1 CHC and severe renal impairment in an open-label study (Study 0154).
Croatian: Sofosbuvir u fiksnoj kombinaciji s ledipasvirom primjenjivan je tijekom 12 tjedana u 18 bolesnika s CHC­om uzrokovanim genotipom 1 i s teškim oštećenjem bubrega u otvorenom ispitivanju (ispitivanje 0154).
English: Safety data are limited in patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Croatian: Podaci o sigurnosti primjene ograničeni su u bolesnika s teškim oštećenjem bubrega (eGFR< 30 ml/min/1,73 m2) i ESRD­om koji zahtijeva hemodijalizu.
English: Patients were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence), HCV genotype (2 versus 3) and baseline HCV RNA level (<6 log10 IU/mL versus ≥6 log10 IU/mL).
Croatian: Bolesnici su bili randomizirani u omjeru 1:1 i stratificirani prema cirozi (prisutna naspram odsutna), genotipu HCV­a (2 naspram 3) i početnoj razini HCV RNK (< 6 log10 IU/ml naspram ≥ 6 log10 IU/ml).
English: Dosed 1 hr After Dialysis Sofosbuvir 1.6-fold↑ 2.1-fold↑ 2.7-fold↑ 1.3-fold↑ 1.6-fold↑ ~2-fold↑ 1.9-fold↑ GS331007 1.6-fold↑ 1.9-fold↑ 5.5-fold↑ ≥10-fold↑ ≥20-fold↑ ~7-fold↑ 21-fold↑
Croatian: Sofosbuvir 1,6 puta↑ 2,1 puta↑ 2,7 puta↑ 1,3 puta↑ 1,6 puta↑ ~2 puta↑ 1,9 puta↑ GS­331007 1,6 puta↑ 1,9 puta↑ 5,5 puta↑ ≥ 10 puta↑ ≥ 20 puta↑ ~7 puta↑ 21 put↑
English: The safety and efficacy of Sovaldi in children and adolescents aged <12 years have not yet been established.
Croatian: Sigurnost i djelotvornost Sovaldija u djece i adolescenata u dobi
English: Common abdominal discomfort, constipation, dyspepsia constipation, dry mouth, gastroesophageal reflux
Croatian: Često nelagoda u abdomenu, konstipacija, dispepsija konstipacija, suha usta, gastroezofagealni refluks
English: Patients received 400 mg sofosbuvir and weight-based ribavirin (1,000 mg for patients weighing <75 kg or 1,200 mg for patients weighing ≥75 kg).
Croatian: Bolesnici su primali 400 mg sofosbuvira i ribavirin na temelju tjelesne težine (1000 mg za bolesnike tjelesne težine < 75 kg ili 1200 mg za bolesnike tjelesne težine ≥ 75 kg).
English: a. For previously treated patients with HCV genotype 1 infection, no data exists with the combination of Sovaldi, ribavirin and peginterferon alfa (see section 4.4).
Croatian: Za prethodno liječene bolesnike s infekcijom HCV-om genotipa 1 ne postoje podaci za kombinaciju Sovaldija, ribavirina i peginterferona alfa (vidjeti dio 4.4).
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of sofosbuvir and GS-331007 compared to subjects with normal renal function, as described in the text below, are provided in Table 24.
Croatian: Sažeti prikaz utjecaja različitih stupnjeva oštećenja bubrega na izloženost sofosbuviru i GS­331007 u usporedbi s ispitanicima s normalnom funkcijom bubrega, kako je opisano u nastavku, prikazan je u tablici 24.
English: The pharmacokinetics of sofosbuvir, and GS-331007 were studied in HCV-infected patients with ESRD requiring dialysis treated with ledipasvir/sofosbuvir (n = 94) for 8, 12, or 24 weeks or sofosbuvir/velpatasvir (n = 59) for 12 weeks, and compared to patients without renal impairment in the ledipasvir/sofosbuvir and sofosbuvir/velpatasvir Phase 2/3 trials (see section 4.4).
Croatian: Farmakokinetika sofosbuvira i GS­331007 ispitana je u bolesnika zaraženih HCV­om s ESRD­om koji je zahtijevao dijalizu liječenih ledipasvirom/sofosbuvirom (n = 94) tijekom 8, 12 ili 24 tjedna ili sofosbuvirom/velpatasvirom (n = 59) tijekom 12 tjedana i uspoređenih s bolesnicima bez oštećenja bubrega u ispitivanjima ledipasvira/sofosbuvira i sofosbuvira/velpatasvira faze 2/3 (vidjeti dio 4.4).
English: In HCV-infected patients with severe renal impairment treated with sofosbuvir 200 mg with ribavirin (n=10) or sofosbuvir 400 mg with ribavirin (n=10) for 24 weeks or ledipasvir/sofosbuvir 90/400 mg (n=18) for 12 weeks, the pharmacokinetics of sofosbuvir and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Croatian: U bolesnika zaraženih HCV­om i s teškim oštećenjem bubrega koji su bili liječeni sofosbuvirom u dozi od 200 mg i ribavirinom (n = 10) ili sofosbuvirom u dozi od 400 mg i ribavirinom (n = 10) tijekom 24 tjedna ili ledipasvirom/sofosbuvirom u dozi od 90/400 mg (n = 18) tijekom 12 tjedana, farmakokinetika sofosbuvira i GS­331007 bila je u skladu s onom opaženom u HCV­negativnih bolesnika s teškim oštećenjem bubrega.
English: - If you have any further questions, ask your doctor or pharmacist.
Croatian: ­ Ako imate dodatnih pitanja, obratite se liječniku ili ljekarniku.
English: Patients were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence) and HCV genotype (2 versus 3).
Croatian: Bolesnici su bili randomizirani u omjeru 1:1 i stratificirani prema cirozi (prisutnost naspram odsutnost) i genotipu HCV­a (2 naspram 3).
English: Patients were randomised in 3:1 ratio and stratified by cirrhosis (presence versus absence).
Croatian: Bolesnici su bili randomizirani u omjeru 3:1 i stratificirani prema cirozi (prisutna naspram odsutna).
English: The recommended treatment regimen and durations for Sovaldi combination therapy are provided in Table 3 and Table 4.
Croatian: Preporučeni režim i trajanje liječenja kombiniranom terapijom sa Sovaldijem prikazani su u tablici 3 i tablici
English: a. For previously treated patients with genotype 1 HCV infection, no data exists with the combination of sofosbuvir, peginterferon alfa and ribavirin.
Croatian: Za prethodno liječene bolesnike s infekcijom genotipom 1 HCV­a ne postoje podaci za kombinaciju sofosbuvira, peginterferona alfa i ribavirina.
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Croatian: Za djelovanje na pojedini genotip virusa hepatitisa C (HCV), vidjeti dijelove 4.4 i 5.1. 4.2 Doziranje i način primjene
English: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
Croatian: Sofosbuvir i GS­331007 nisu inhibitori prijenosnika lijekova P­gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 i OCT1.
English: • changes in your mood, feeling depressed, feeling anxious and feeling agitated
Croatian: ● promjene raspoloženja, deprimiranost, tjeskobnost i uznemirenost
English: • weight loss
Croatian: ● gubitak na tjelesnoj težini
English: Medicinal products that are moderate P-gp inducers in the intestine (e.g. modafinil, oxcarbazepine and rifapentine) may decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of Sovaldi.
Croatian: Lijekovi koji su umjereni induktori P­gp­a u crijevima (npr. modafinil, okskarbazepin i rifapentin) mogu smanjiti koncentraciju sofosbuvira u plazmi i tako dovesti do smanjenog terapijskog učinka Sovaldija.
English: • shortness of breath when exercising
Croatian: ● nedostatak zraka kod fizičkog napora
English: The starting dose of ribavirin was 400 mg given in a divided daily dose.
Croatian: Početna dnevna doza ribavirina bila je 400 mg podijeljena u dvije doze.
English: Common pyrexia, asthenia chest pain, asthenia a. SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa.
Croatian: SOF = sofosbuvir; b. RBV = ribavirin; c. PEG = peginterferon alfa.
English: 24 weeks (n = 28)
Croatian: 24 tjedna (n = 114)
English: • Peginterferon alfa and ribavirin
Croatian: ● ribavirinom ili ● peginterferonom alfa i ribavirinom
English: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Croatian: Tijekom ili nakon liječenja direktno djelujućim antiviroticima, zabilježeni su slučajevi reaktivacije virusa hepatitisa B (HBV), neki od njih sa smrtnim ishodom.
English: If you have any questions about your medicines, please ask your doctor or pharmacist.
Croatian: Ako imate bilo kakvih pitanja o ovim lijekovima, molimo da se obratite svom liječniku ili ljekarniku.
English: Response rates for patients with cirrhosis at baseline are presented in Table 10 by HCV genotype.
Croatian: Stope odgovora kod bolesnika s cirozom na početku prikazane su u tablici 10 prema genotipu HCV­a.
English: The primary endpoint of the study was post-transplant virologic response (pTVR, HCV RNA <LLOQ at 12 weeks post-transplant).
Croatian: Primarni ishod ispitivanja bio je virološki odgovor nakon transplantacije (pTVR, HCV RNK < donje granice kvantifikacije u 12. tjednu nakon transplantacije).
English: Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the dose was greater than 92%, consisting of approximately 80%, 14%, and 2.5% recovered in urine, faeces, and expired air, respectively.
Croatian: Nakon jedne peroralne doze od 400 mg [14C]­sofosbuvira, srednja vrijednost ukupno otkrivene doze bila je veća od 92% i sastojala se od približno 80% one otkrivene u mokraći, 14% u stolici i 2,5% u izdahnutom zraku.
English: It is not known whether sofosbuvir, the active substance of Sovaldi, passes into human breast milk.
Croatian: Nije poznato prelazi li sofosbuvir, djelatna tvar u lijeku Sovaldi, u majčino mlijeko kod ljudi.
English: Table 1: Recommended co-administered medicinal product(s) and treatment duration for adults treated with Sovaldi combination therapy
Croatian: Tablica 1: Preporučeni lijek(ovi) za istodobnu primjenu i trajanje liječenja kombiniranom terapijom sa Sovaldijem u odraslih
English: The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 6).
Croatian: Sljedeće nuspojave utvrđene su za sofosbuvir u kombinaciji s ribavirinom ili u kombinaciji s peginterferonom alfa i ribavirinom (tablica 6).
English: Gilead Sciences Slovakia s.r.o Tel: + 421 232 121 210
Croatian: Slovenská republika Gilead Sciences Slovakia s.r.o. Tel: + 421 232 121 210
English: Interferon intolerant, ineligible or unwilling adults - POSITRON (study 107) POSITRON was a randomised, double-blinded, placebo-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin (n = 207) compared to placebo (n = 71) in patients who are interferon intolerant, ineligible or unwilling.
Croatian: Odrasli koji ne podnose, nisu pogodni ili nisu pristali na interferon - POSITRON (ispitivanje 107) POSITRON je bilo randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje u kojem se ocjenjivalo 12 tjedana liječenja sofosbuvirom i ribavirinom (n = 207) u usporedbi s placebom (n = 71) u bolesnika koji nisu podnosili, nisu bili pogodni ili nisu pristali na interferon.
English: Tenofovir disoproxilf (245 mg once daily)d
Croatian: Tenofovirdizoproksilf (245 mg jedanput na dan)d
English: No dose adjustment of Sovaldi is required when concomitantly used with rifabutin.
Croatian: Nije potrebna prilagodba doze lijeka Sovaldi kad se primjenjuje istodobno s rifabutinom..
English: No drug-drug interaction data exists regarding the co-administration of Sovaldi with boceprevir or telaprevir.
Croatian: Ne postoje podaci o interakcijama lijekova kod istodobne primjene Sovaldija s boceprevirom ili telaprevirom.
English: Treatment duration was 12 weeks in treatment-naïve patients with genotype 2 or 3 HCV infection, and 24 weeks in treatment-experienced patients with genotype 3 HCV infection, as well as patients with genotype 1 HCV infection.
Croatian: Liječenje je trajalo 12 tjedana u bolesnika s infekcijom genotipom 2 ili 3 HCV­a koji prethodno nisu bili liječeni, a 24 tjedna u prethodno liječenih bolesnika s infekcijom genotipom 3 HCV­a, kao i bolesnika s infekcijom genotipom 1 HCV­a.
English: Treatment of patients with genotype 5 or 6 HCV infection
Croatian: Liječenje bolesnika s infekcijom HCV­om genotipa 5 ili 6
English: No dose adjustment of sofosbuvir is recommended for patients with mild, moderate and severe hepatic impairment (see section 4.2).
Croatian: Ne preporučuje se prilagodba doze u bolesnika s blagim, umjerenim ili teškim oštećenjem jetre (vidjeti dio 4.2).
English: Until liver transplantationc
Croatian: Do transplantacije jetrec
English: Sovaldi 400 mg film-coated tablets
Croatian: NAZIV LIJEKA Sovaldi 400 mg filmom obložene tablete
English: Study 0154 was an open-label clinical study that evaluated the safety and efficacy of 24 weeks of treatment with sofosbuvir in combination with ribavirin in 20 genotype 1 or 3 HCV-infected patients with severe renal impairment not requiring dialysis.
Croatian: Ispitivanje 0154 bilo je otvoreno kliničko ispitivanje u kojem se procijenila sigurnost i djelotvornost 24­tjednog liječenja sofosbuvirom u kombinaciji s ribavirinom u 20 bolesnika zaraženih HCV­om genotipa 1 ili 3 i s teškim oštećenjem bubrega koje nije zahtijevalo dijalizu.
English: • fever, chills, flu-like symptoms
Croatian: ● vrućica, zimica, simptomi nalik gripi
English: • shortness of breath, cough
Croatian: ● nedostatak zraka, kašalj
English: Haemodialysis can efficiently remove (53% extraction ratio) the predominant circulating metabolite GS-331007.
Croatian: Hemodijalizom se može učinkovito odstraniti glavni cirkulirajući metabolit GS­331007 (omjer ekstrakcije od 53%).
English: Very common haemoglobin decreased anaemia, neutropenia, lymphocyte count decreased, platelet count decreased
Croatian: Vrlo često smanjeni hemoglobin anemija, neutropenija, smanjeni broj limfocita, smanjeni broj trombocita
English: Such co-administration is not recommended (see also section 4.5).
Croatian: Ne preporučuje se njihova istodobna primjena (vidjeti također dio 4.5).
English: Sofosbuvir ↑ Cmax 2.54 (1.87, 3.45) ↑ AUC 4.53 (3.26, 6.30) Cmin (NA)
Croatian: ↑ Cmax 2,54 (1,87; 3,45) ↑ AUC 4,53 (3,26; 6,30) Cmin (ND/NP)
English: Treatment-naïve and previously treated adults - VALENCE (study 133) VALENCE was a Phase 3 study that evaluated sofosbuvir in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve patients or patients who did not achieve SVR with prior interferon-based treatment, including patients with compensated cirrhosis.
Croatian: Odrasli koji prethodno nisu i oni koji jesu bili liječeni - VALENCE (ispitivanje 133) VALENCE je bilo ispitivanje faze 3 u kojem se procijenio sofosbuvir u kombinaciji s ribavirinom primjenjivanim na temelju tjelesne težine u liječenju infekcije genotipovima 2 ili 3 HCV­a u bolesnika koji prethodno nisu bili liječeni i bolesnika koji nisu postigli SVR uz prethodno liječenje temeljeno na interferonu, uključujući bolesnike s kompenziranom cirozom.
English: RBV daily dose* 15 mg/kg/day 600 mg/day 800 mg/day 1000 mg/day 1200 mg/day
Croatian: Dnevna doza ribavirina* 15 mg/kg/dan 600 mg/dan
English: Table 11 presents the response rates for the treatment groups of sofosbuvir + ribavirin and placebo.
Croatian: Tablica 11 prikazuje stope odgovora u terapijskim skupinama koje su primale sofosbuvir + ribavirin i placebo.
English: • stomach discomfort, constipation, dry mouth, indigestion, acid reflux
Croatian: ● nelagoda u trbuhu, zatvor, suha usta, probavne tegobe, povrat želučane kiseline
English: Eleven HCV genotype 3 patients had already completed treatment with sofosbuvir and ribavirin for 12 weeks at the time of the amendment.
Croatian: U vrijeme ove promjene već je jedanaest bolesnika s genotipom 3 HCV­a bilo završilo liječenje sofosbuvirom i ribavirinom tijekom 12 tjedana.
English: Table 6: Adverse drug reactions identified with sofosbuvir in combination with ribavirin or peginterferon alfa and ribavirin
Croatian: Tablica 6: Nuspojave utvrđene uz sofosbuvir u kombinaciji s ribavirinom ili peginterferonom alfa i ribavirinom
English: If patients maintained haemoglobin levels ≥12 g/dL, ribavirin dose was increased at weeks 2, 4, and up to every 4 weeks until the appropriate weight-based dose was reached (1,000 mg daily in patients <75 kg, 1,200 mg daily in patients ≥75 kg).
Croatian: Ako su se u bolesnika razine hemoglobina održale na ≥ 12 g/dl, doza ribavirina bila je povišena u 2. i 4. tjednu te nakon toga svaka 4 tjedna sve dok nije postignuta odgovarajuća doza prema tjelesnoj težini (1000 mg na dan u bolesnika tjelesne težine < 75 kg, a 1200 mg na dan u bolesnika tjelesne težine ≥ 75 kg).
English: • Oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
Croatian: ● okskarbazepin (lijek koji se primjenjuje za liječenje epilepsije i sprječavanje napadaja);
English: Sovaldi [Outer packaging only]
Croatian: PODACI NA BRAILLEOVOM PISMU Sovaldi [samo vanjsko pakiranje]
English: Gilead Sciences Belgium SPRL-BVBA Tél/Tel: + 32 (0) 24 01 35 50
Croatian: België/Belgique/Belgien Gilead Sciences Belgium SPRL­BVBA Tél/Tel: + 32 (0) 24 01 35 50
English: Patients should be informed that fatigue and disturbance in attention, dizziness and blurred vision have been reported during treatment with sofosbuvir in combination with peginterferon alfa and ribavirin (see section 4.8).
Croatian: Bolesnike treba obavijestiti da su tijekom liječenja sofosbuvirom u kombinaciji s peginterferonom alfa i ribavirinom zabilježeni umor i poremećaj pozornosti, omaglica i zamagljen vid (vidjeti dio 4.8).
English: The recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy are provided in Table 1.
Croatian: Preporučeni lijekovi za istodobnu primjenu i trajanje liječenja kombiniranom terapijom sa Sovaldijem prikazani su u tablici 1.
English: Table 2: Ribavirin dose modification guideline for co-administration with Sovaldi in adults
Croatian: Tablica 2: Smjernica za prilagodbu doze ribavirina kod istodobne primjene sa Sovaldijem u odraslih
English: If the starting dose of ribavirin is well-tolerated, the dose can be titrated up to a maximum of 1,000-1,200 mg daily (1,000 mg for patients weighing <75 kg and 1,200 mg for patients weighing ≥75 kg).
Croatian: Ako se početna doza ribavirina dobro podnosi, doza se može postupno povisiti na najviše 1000­1200 mg na dan (1000 mg u bolesnika tjelesne težine < 75 kg, a 1200 mg u bolesnika tjelesne težine ≥ 75 kg).
English: Genotype 2 and 3 patients were either treatment-naïve or experienced, whereas genotype 1 patients were naïve to prior treatment.
Croatian: Bolesnici s infekcijom genotipom 2 ili 3 prethodno nisu ili jesu bili liječeni, dok bolesnici s genotipom 1 prethodno nisu bili liječeni.
English: 27/28 patients with genotype 4 HCV achieved SVR12.
Croatian: SVR12 postiglo je 27/28 bolesnika s genotipom 4 HCV­a.
English: How to store Sovaldi
Croatian: Kako čuvati Sovaldi
English: No dose adjustment of sofosbuvir or darunavir (ritonavir boosted) is required when sofosbuvir and darunavir are used concomitantly.
Croatian: Nije potrebna prilagodba doze sofosbuvira ili darunavira (pojačanog ritonavirom) kad se sofosbuvir i darunavir primjenjuju istodobno.
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) and end stage renal disease (ESRD) requiring haemodialysis.
Croatian: Podaci o sigurnosti primjene ograničeni su u bolesnika s teškim oštećenjem bubrega (procjena brzine glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) i završnim stadijem bolesti bubrega (engl. end stage renal disease, ESRD) koji zahtijeva hemodijalizu.
English: Table 13 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 16 weeks.
Croatian: Tablica 13 prikazuje stope odgovora u terapijskim skupinama koje su primale sofosbuvir + ribavirin tijekom 12 tjedana i 16 tjedana.
English: Table 17 presents the response rates by genotype and exposure to prior HCV treatment.
Croatian: Tablica 17 prikazuje stope odgovora prema genotipu i izloženosti prethodnom liječenju HCV­a
English: ↔ GS-331007 (Induction of P-gp)
Croatian: ↓ Sofosbuvir ↔ GS­331007 (Indukcija P­gp)
English: Table 15 presents the response rates for the treatment groups of sofosbuvir + ribavirin for 12 weeks and 24 weeks.
Croatian: Tablica 15 prikazuje stope odgovora u terapijskim skupinama koje su primale sofosbuvir + ribavirin tijekom 12 tjedana i 24 tjedna.
English: Table 9 presents the response rates for the treatment groups of sofosbuvir + ribavirin and peginterferon alfa + ribavirin.
Croatian: Tablica 9 prikazuje stope odgovora u terapijskim skupinama koje su primale sofosbuvir + ribavirin i peginterferon alfa + ribavirin.
English: Table 10: SVR12 rates by cirrhosis and genotype in study FISSION
Croatian: Tablica 10: Stope SVR12 prema cirozi i genotipu u ispitivanju FISSION Genotip 2
English: Drug interaction information for Sovaldi with potential concomitant medicinal products is summarised in Table 5 below (where 90% confidence interval (CI) of the geometric least-squares mean (GLSM)
Croatian: Podaci o interakcijama Sovaldija s drugim lijekovima koji bi se mogli istodobno primjenjivati sažeto su prikazani u tablici 5 niže (gdje je 90% interval pouzdanosti (CI) omjera geometrijske srednje vrijednosti najmanjih kvadrata (GLSM) bio unutar “↔”, protezao se iznad “↑”, ili ispod “↓” unaprijed određenih granica ekvivalencije).
English: On-treatment virologic failure 0/207 Relapsea
Croatian: Ishod u bolesnika bez SVR12 Virološki neuspjeh uz liječenje 0/207 Relapsa
English: ANTIMYCOBACTERIALS Rifampicinf (600 mg single dose)
Croatian: Rifampicin (jedna doza od 600 mg)
English: The ribavirin doses used in the sofosbuvir + ribavirin and peginterferon alfa 2a + ribavirin arms were weight-based 1,000-1,200 mg/day and 800 mg/day regardless of weight, respectively.
Croatian: Primjenjivane doze ribavirina u skupini koja je primala sofosbuvir + ribavirin bile su temeljene na tjelesnoj težini i iznosile su 1000­1200 mg na dan, a u skupini koja je primala peginterferon alfa 2a + ribavirin iznosile su 800 mg na dan bez obzira na tjelesnu težinu.
English: Outcome for patients without SVR12 On-treatment virologic failure Relapseb
Croatian: Ishod u bolesnika bez SVR12 Virološki neuspjeh uz liječenje