FrancophonIA/ELRC3.0 huggingface dataset:
English: Not interpretable a. One patient in the LDV/SOF 8-week treatment arm did not have a confirmed genotype 1 subtype.
Croatian: U jednog pacijenta u terapijskoj skupini liječenoj 8 tjedana LDV/SOF-om nije bila potvrđena podvrsta genotipa 1.
English: Concentrations of ledipasvir, sofosbuvir and simeprevir are increased when simeprevir is co-administered with Harvoni.
Croatian: Koncentracije ledipasvira, sofosbuvira i simeprevira povećane su kad se simeprevir primjenjuje istovremeno s lijekom Harvoni.
English: Do not take Harvoni
Croatian: Nemojte uzimati Harvoni
English: Other b
Croatian: Ostalo b
English: Clinical monitoring, looking for signs of bleeding and anaemia, is recommended when dabigatran etexilate is co-administered with Harvoni.
Croatian: Preporučuje se kliničko praćenje, u kojem se traže znakovi krvarenja i anemije, kada se dabigatran eteksilat primjenjuje istovremeno s lijekom
English: When used in combination with ribavirin, refer also to the Summary of Product Characteristics of ribavirin.
Croatian: Kad se primjenjuje u kombinaciji s ribavirinom, pročitajte također Sažetak opisa svojstava lijeka za ribavirin.
English: Nizatidinee Ranitidine e
Croatian: Nizatidine Ranitidin e
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 90 mg ledipasvira i 400 mg sofosbuvira.
English: NAME OF THE MEDICINAL PRODUCT Harvoni 90 mg/400 mg film-coated tablets
Croatian: NAZIV LIJEKA Harvoni 90 mg/400 mg filmom obložene tablete
English: In phenotypic analyses, post-baseline isolates from patients who harboured NS5A RAVs at failure showed 20- to at least a 243-fold (the highest dose tested) reduced susceptibility to ledipasvir.
Croatian: NS5A RAV u vrijeme virološkog neuspjeha pokazali su 20 do najmanje 243 puta (najviša ispitana doza) smanjenu osjetljivost na ledipasvir.
English: Previously treated adults who have failed on sofosbuvir + ribavirin ± PEG-IFN The efficacy of ledipasvir/sofosbuvir in patients who had previously failed treatment with sofosbuvir + ribavirin ± PEG-IFN is supported by two clinical studies.
Croatian: Prethodno liječeni odrasli u kojih je liječenje sofosbuvirom s ribavirinom ± PEG-IFN bilo neuspješno Djelotvornost ledipasvira/sofosbuvira u pacijenata u kojih je prethodno liječenje sofosbuvirom s ribavirinom ± PEG-IFN bilo neuspješno potkrijepljena je u dva klinička ispitivanja.
English: Medicinal products that are potent P-gp inducers (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin) may significantly decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of ledipasvir/sofosbuvir and thus are contraindicated with Harvoni (see section 4.3).
Croatian: Lijekovi koji su jaki induktori P-gp (rifampicin, rifabutin, gospina trava, karbamazepin, fenobarbital i fenitoin) mogu značajno smanjiti koncentracije ledipasvira i sofosbuvira u plazmi i tako dovesti do smanjenog terapijskog učinka ledipasvira/sofosbuvira te su stoga kontraindicirani s lijekom Harvoni
English: H2-receptor antagonists Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)
Croatian: Antagonisti H2-receptora Famotidin (jedna doza od 40 mg)/ ledipasvir (jedna doza od 90 mg)
English: In the SOLAR-1 study (see “Clinical efficacy and safety”, below) 13 patients with genotype 1 infection relapsed after treatment with ledipasvir/sofosbuvir with ribavirin.
Croatian: U ispitivanju SOLAR-1 (vidjeti niže „Klinička djelotvornost i sigurnost“) 13 pacijenata zaraženih genotipom 1 imalo je relaps nakon liječenja ledipasvirom/sofosbuvirom s ribavirinom.
English: Prior HCV therapy PEG-IFN+RBV HCV protease inhibitor + PEG-IFN+RBV
Croatian: Prethodna terapija HCV-a PEG-IFN+RBV Inhibitor proteaze HCV-a +
English: Patients were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate, administered with efavirenz, rilpivirine or raltegravir.
Croatian: koja je uključivala emtricitabin/tenofovirdizoproksilfumarat, primijenjen s efavirenzom, rilpivirinom ili raltegravirom.
English: Patients without cirrhosis
Croatian: Pacijenti bez ciroze
English: The following adverse drug reactions have been identified with Harvoni (Table 4).
Croatian: Sljedeće nuspojave utvrđene su za Harvoni (tablica 4).
English: Co-administration with medicinal products that inhibit P-gp and/or BCRP may increase ledipasvir and sofosbuvir plasma concentrations without increasing GS-331007 plasma concentration; Harvoni may be co-administered with P-gp and/or BCRP inhibitors.
Croatian: Istovremena primjena s lijekovima koji inhibiraju P-gp i/ili BCRP može povećati koncentracije ledipasvira i sofosbuvira u plazmi bez povećanja koncentracije GS-331007 u plazmi;
English: The 8-week treatment of ledipasvir/sofosbuvir without ribavirin was non-inferior to the 8-week treatment of ledipasvir/sofosbuvir with ribavirin (treatment difference 0.9%; 95% confidence interval: -3.9% to 5.7%) and the 12-week treatment of ledipasvir/sofosbuvir (treatment difference -2.3%; 97.5% confidence interval: -7.2% to 3.6%).
Croatian: Osmotjedno liječenje ledipasvirom/sofosbuvirom bez ribavirina nije bilo lošije od osmotjednog liječenja ledipasvirom/sofosbuvirom s ribavirinom (terapijska razlika 0,9 %; 95 % interval pouzdanosti: -3,9 % do 5,7 %) i 12-tjednog liječenja ledipasvirom/sofosbuvirom (terapijska razlika
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)/ ledipasvir (90 mg once daily)
Croatian: HIV ANTIVIRUSNI LIJEKOVI: INHIBITORI INTEGRAZE Raltegravir (400 mg dvaput na dan)/ ledipasvir (90 mg jedanput na dan)
English: Patients receiving Harvoni concomitantly with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovirassociated adverse reactions.
Croatian: Harvoni istovremeno s elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilfumaratom ili tenofovirdizoproksilfumaratom i pojačanim inhibitorom proteaze HIV-a treba nadzirati zbog nuspojava povezanih s tenofovirom.
English: Taking Harvoni with any of these may make Harvoni work less well or make any side effects of the medicines worse.
Croatian: Uzimanje lijeka Harvoni s bilo kojim od ovih lijekova može oslabiti djelovanje lijeka Harvoni ili pogoršati neke nuspojave ovih lijekova.
English: Your doctor may give you a different medicine or adjust the dose of the medicine you are taking.
Croatian: Vam može dati drugi lijek ili prilagoditi dozu lijeka koji uzimate.
English: The clinical studies enrolled patients with or without cirrhosis, who were treatment-naïve or with prior treatment failure after therapy with PEG-IFN + ribavirin +/- an HCV protease inhibitor.
Croatian: Klinička ispitivanja uključila su pacijente s cirozom ili bez nje, koji prethodno nisu bili liječeni ili u kojih je prethodno liječenje PEG-IFN + ribavirinom +/- inhibitorom proteaze HCV-a bilo neuspješno.
English: HCV PRODUCTS Simeprevir (150 mg once daily)/ ledipasvir (30 mg once daily)
Croatian: LIJEKOVI PROTIV HCV-a Simeprevir (150 mg jedanput na dan)/ ledipasvir (30 mg jedanput na dan)
English: Patients in the latter treatment arm received placebo (for ledipasvir/sofosbuvir and ribavirin) during the first 12 weeks, followed by active blinded therapy during the subsequent 12 weeks.
Croatian: Pacijenti u ovoj drugoj terapijskoj skupini primali su placebo (umjesto ledipasvira/sofosbuvira i ribavirina) tijekom prvih 12 tjedana,
English: Following treatment with ledipasvir/sofosbuvir with ribavirin for 12 weeks in post-liver transplant patients with compensated liver disease (SOLAR-1), none (n = 8) of the patients with baseline NS5A RAVs conferring a ledipasvir fold-change of > 100 relapsed.
Croatian: Nakon liječenja ledipasvirom/sofosbuvirom s ribavirinom provedenog tijekom 12 tjedana u pacijenata poslije transplantacije jetre s kompenziranom bolešću jetre (SOLAR-1), nijedan (n = 8) od pacijenata s početnim NS5A RAV-ovima koji nose promjenu osjetljivosti na ledipasvir > 100 nije imao relaps.
English: Other c
Croatian: Ostalo c
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analogue triphosphate GS-461203.
Croatian: Sofosbuvir je nukleotidni predlijek iz kojeg unutarstaničnim metabolizmom nastaje farmakološki djelatan uridinu analogni trifosfat (GS-461203), koji se može ugraditi u
English: Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Croatian: Primjena s određenim antiretrovirusnim režimima liječenja HIV-a Pokazalo se da Harvoni povećava izloženost tenofoviru, osobito kad se primjenjuje zajedno s režimom liječenja HIV-a koji sadrži tenofovirdizoproksilfumarat i farmakokinetički pojačivač (ritonavir ili kobicistat).
English: IL28CC genotype FibroTest-Determined Metavir score b
Croatian: Metavir rezultat određen FibroTestom b
English: AUC and Cmax of ledipasvir were 77% and 58% higher, respectively, in females than males; however, the relationship between gender and ledipasvir exposures was not considered clinically relevant.
Croatian: AUC i Cmax ledipasvira bile su 77 % odnosno 58 % više u žena nego u muškaraca;
English: Following 12 weeks of treatment with ledipasvir/sofosbuvir with ribavirin in treatment-experienced patients with compensated cirrhosis (SIRIUS, n = 77), 8/8 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir achieved SVR12.
Croatian: Nakon 12 tjedana liječenja ledipasvirom/sofosbuvirom s ribavirinom prethodno liječenih pacijenata s kompenziranom cirozom (SIRIUS, n = 77), 8/8 pacijenata s početnim NS5A RAV-ovima koji nose smanjenu osjetljivost na ledipasvir za > 100 puta postiglo je SVR12.
English: c. Analysis (by deep sequencing) included NS5A resistance-associated polymorphisms that conferred > 2.5-fold change in EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, and Y93C/F/H/N/S for genotype 1a and L31I/F/M/V, P32L, P58D, A92K, and Y93C/H/N/S for genotype 1b HCV infection).
Croatian: Analiza (detaljnim sekvencioniranjem) je uključila polimorfizme NS5A povezane s rezistencijom koji su nosili > 2,5 puta veću promjenu u EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T i Y93C/F/H/N/S za infekciju HCV-om genotipa 1a i L31I/F/M/V, P32L, P58D, A92K i Y93C/H/N/S za infekciju HCV-om genotipa 1b).
English: The safety of ledipasvir/sofosbuvir has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
Croatian: Sigurnost ledipasvira/sofosbuvira nije procijenjena u pacijenata s teškim oštećenjem bubrega (procjena brzine glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) ili završnim stadijem bolesti bubrega (ESRD) koji zahtijeva hemodijalizu (vidjeti dio 5.2).
English: Abacavir/ lamivudine (600 mg/ 300 mg once daily)/ ledipasvir (90 mg once daily)
Croatian: Abakavir/ lamivudin (600 mg/ 300 mg jedanput na dan)/ ledipasvir (90 mg jedanput na dan)
English: The majority of the sofosbuvir dose recovered in urine was GS-331007 (78%) while 3.5% was recovered as sofosbuvir.
Croatian: Veći dio doze sofosbuvira otkrivene u mokraći činio je GS-331007 (78 %), dok je
English: SIRIUS included patients with compensated cirrhosis who first failed therapy with pegylated interferon (PEG-IFN) + ribavirin, and then failed a regimen consisting of a pegylated interferon + ribavirin + an NS3/4A protease inhibitor.
Croatian: Prethodno liječeni odrasli pacijenti s cirozom - SIRIUS - genotip 1 Ispitivanje SIRIUS uključilo je pacijente s kompenziranom cirozom u kojih je prvo bila neuspješna terapija pegiliranim interferonom (PEG-IFN) + ribavirinom, a zatim je bio neuspješan režim koji se sastojao od pegiliranog interferona + ribavirina + inhibitora proteaze NS3/4A.
English: Orange, diamond-shaped, film-coated tablet of dimensions 19 mm x 10 mm, debossed with “GSI” on one side and “7985” on the other side.
Croatian: Narančasta, filmom obložena tableta u obliku dijamanta, veličine 19 mm x 10 mm, s utisnutim “GSI”
English: Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)
Croatian: Raltegravir (400 mg dvaput na dan)/ sofosbuvir (400 mg jedanput na dan)
English: d. 3/3 of these patients had cirrhosis.
Croatian: d. 3/3 pacijenta imalo je cirozu. e. 0/4 pacijenta imalo je cirozu.
English: The safety of Harvoni has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis.
Croatian: Sigurnost lijeka Harvoni nije procijenjena u pacijenata s teškim oštećenjem bubrega (procjena brzine glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) ili završnim stadijem bolesti bubrega (ESRD)
English: Not interpretable a. Two patients in the LDV/SOF 12-week treatment arm, one patient in the LDV/SOF+RBV 12-week treatment arm, two patients in the LDV/SOF 24-week treatment arm, and two patients in the LDV/SOF+RBV 24-week treatment arm did not have a confirmed genotype 1 subtype.
Croatian: LDV/SOF + RBV-om, dva pacijenta u terapijskoj skupini liječenoj 24 tjedna LDV/SOF-om i dva pacijenta u terapijskoj skupini liječenoj 24 tjedna LDV/SOF+RBV-om nije bila potvrđena podvrsta genotipa 1.
English: The group of NS5A RAVs that conferred > 100-fold shift and was observed in patients were the following substitutions in genotype 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) or in genotype 1b (Y93H).
Croatian: Skupinu NS5A RAV-ova koji su nosili povećanje > 100 puta i koji su bili opaženi u pacijenata činile su sljedeće supstitucije u genotipu 1a (M28A, Q30H/R/E, L31M/V/I, H58D, Y93H/N/C) ili u genotipu 1b (Y93H).
English: In the rat studies, exposure to sofosbuvir could not be determined but exposure margins based on the major human metabolite was approximately 5 times higher than the clinical exposure at 400 mg sofosbuvir.
Croatian: U ispitivanjima na štakorima, izloženost sofosbuviru nije se mogla odrediti, ali granice izloženosti na temelju glavnog metabolita u ljudi bile su približno
English: Harvoni + ribavirin for 24 weeks (see sections 4.4 and 5.1).
Croatian: Harvoni s ribavirinom tijekom 24 tjedna (vidjeti dijelove 4.4 i
English: Medicinal products that are potent P-glycoprotein (P-gp) inducers in the intestine (rifampicin, rifabutin, St. John's wort [Hypericum perforatum], carbamazepine, phenobarbital and phenytoin).
Croatian: Lijekovi koji su jaki induktori P-glikoproteina (P-gp) u crijevima (rifampicin, rifabutin, gospina trava
English: ↔ Cmin 1.00 (0.81, 1.23) Ethinyl estradiol ↑ Cmax 1.40 (1.18, 1.66)
Croatian: ↔ Cmin 1,00 (0,81; 1,23) Etinilestradiol ↑ Cmax 1,40 (1,18; 1,66)
English: NS5A RAVs were seen at relapse in 5/5 patients (for genotype 1a: Q30R/H + L31M/V [n = 1] and Q30R [n = 1]; for genotype 1b: Y93H [n = 3]).
Croatian: relapsu su u 5/5 pacijenata opaženi NS5A RAV-ovi (za genotip 1a: Q30R/H + L31M/V [n = 1] i Q30R [n = 1]; za genotip 1b: Y93H [n = 3]).
English: Genotype 4d 0.60 Genotype 5a
Croatian: Genotip 3a Genotip 4a Genotip 4d Genotip 5a b b
English: 24% (4/17)e a. These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms.
Croatian: Ova 4 pacijenta bez ciroze s relapsom imala su početne polimorfizme NS5A povezane s rezistencijom.
English: Very common side effects (may affect more than 1 in 10 people)
Croatian: (mogu se javiti u više od 1 na 10 osoba)
English: Famotidine (40 mg single dose)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)
Croatian: Famotidin (jedna doza od 40 mg)/ ledipasvir (jedna doza od 90 mg)c/ sofosbuvir (jedna doza od 400 mg)
English: Genotype 1b 0.004 Genotype 2a
Croatian: Genotip 1a Genotip 1b Genotip 2a Genotip 2b b b
English: Treatment-naïve Patients without cirrhosis Patients with cirrhosis Treatment-experienced
Croatian: Pacijenti bez ciroze Pacijenti s cirozom
English: ↑ Cmin 1.45 (1.27, 1.64) Emtricitabine ↔ Cmax 0.98 (0.94, 1.02)
Croatian: ↑ Cmin 1,45 (1,27; 1,64) Emtricitabin ↔ Cmax 0,98 (0,94; 1,02)
English: Male gender
Croatian: zbog spola.
English: Harvoni contains sunset yellow FCF aluminium lake (E110)
Croatian: Harvoni sadrži boju sunset yellow FCF aluminium lake (E110)
English: Mean ratio (90% confidence interval) for AUC, Cmax, Cmin a, b
Croatian: Srednja vrijednost omjera (90 % interval pouzdanosti) za AUC,
English: No clinically relevant pharmacokinetic differences due to gender have been identified for sofosbuvir or GS-331007.
Croatian: Nisu utvrđene nikakve klinički važne razlike u farmakokinetici sofosbuvira ili GS-331007
English: ION-4 was an open-label clinical study that evaluated the safety and efficacy of 12 weeks of treatment with ledipasvir/sofosbuvir without ribavirin in HCV treatment-naïve and treatment-experienced patients with genotype 1 or 4 CHC who were co-infected with HIV-1.
Croatian: Ispitivanje ION-4 bilo je otvoreno kliničko ispitivanje kojim se procijenila sigurnost i djelotvornost liječenja ledipasvirom/sofosbuvirom bez ribavirina tijekom 12 tjedana u pacijenata s CHC-om uzrokovanim HCV-om genotipa 1 ili 4 te istovremeno zaraženih virusom HIV-1, koji prethodno nisu bili liječeni i koji su prethodno bili liječeni.
English: • outer cartons containing 3 bottles of 28 (84) film-coated tablets.
Croatian: • kutije koje sadrže 1 bocu s 28 filmom obloženih tableta • kutije koje sadrže 3 boce s 28 (84) filmom obloženih tableta.
English: All patients were treatment-naïve to HCV therapy without cirrhosis, 26% (13/50) of patients were HIV antiretroviral naïve and 74% (37/50) of patients were receiving concomitant HIV antiretroviral therapy.
Croatian: Ni jedan pacijent nije bio prethodno liječen terapijom protiv HCV-a i ni jedan nije imao cirozu; 26 % (13/50) pacijenata prethodno nije bilo liječeno antiretrovirusnim lijekovima protiv
English: c. Patients with missing cirrhosis status were excluded from this subgroup analysis.
Croatian: c. Pacijenti bez podatka o statusu ciroze bili su isključeni iz analize ove podskupine.
English: Table 9: Demographics and baseline characteristics in study ION-1 Patient disposition
Croatian: Tablica 9: Demografske i početne značajke u ispitivanju ION-1
English: Table 8: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF
Croatian: Tablica 8: Stope relapsa prema početnim značajkama u ispitivanju ION-3, populacija s virološkim neuspjehom*
English: Proton pump inhibitors Omeprazole (20 mg once daily)/ ledipasvir (90 mg single dose)c/ sofosbuvir (400 mg single dose)
Croatian: Inhibitori protonske pumpe Omeprazol (20 mg jedanput na dan)/ ledipasvir (jedna doza od 90 mg)c/ sofosbuvir (jedna doza od 400 mg)
English: Darunavir boosted with ritonavir (800 mg/ 100 mg once daily)/ sofosbuvir (400 mg once daily)
Croatian: Darunavir pojačan ritonavirom (800 mg/ 100 mg jedanput na dan)/ sofosbuvir (400 mg jedanput na dan)
English: The sofosbuvir resistance-associated substitution S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies by population or deep sequencing.
Croatian: Supstitucija S282T povezana s rezistencijom na sofosbuvir nije bila otkrivena populacijskim ili detaljnim sekvencioniranjem u početnoj NS5B sekvenci ni u jednog pacijenta u ispitivanjima faze 3,
English: and L31M substitution in genotype 1a conferred high levels of reduced susceptibility to ledipasvir (fold-change in EC50 ranging from 544-fold to 1,677-fold).
Croatian: Ciljana mutageneza u vidu supstitucije Y93H u oba genotipa 1a i 1b, kao i Q30R i L31M supstitucija u genotipu 1a, dovela je do jako smanjene osjetljivosti na ledipasvir (promjena u EC50 u rasponu od 544 do 1677 puta).
English: The proportion of patients who permanently discontinued treatment due to adverse events was 0%, < 1% and 1% for patients receiving ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and < 1%, 0%, and 2% for patients receiving ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
Croatian: odnosno 1 % kod pacijenata koji su primali ledipasvir/sofosbuvir tijekom 8, 12 odnosno 24 tjedna; te < 1 %, 0 %, odnosno 2 % kod pacijenata koji su primali kombiniranu terapiju ledipasvirom/sofosbuvirom
English: In non-cirrhotic patients relapses only occurred in the presence of baseline NS5A RAVs, and during therapy with ledipasvir/sofosbuvir without ribavirin.
Croatian: NS5A RAV i tijekom terapije ledipasvirom/sofosbuvirom bez ribavirina.
English: Table 13: Relapse rates for selected subgroups in study ION-2 LDV/SOF
Croatian: Tablica 13: Stope relapsa u odabranim podskupinama u ispitivanju ION-2 LDV/SOF
English: NS5A RAVs were seen at the time of relapse in 11/13 patients (for genotype 1a: Q30R alone [n = 2], Y93C [n = 1], Y93H/C [n = 2], Q30R + H58D [n = 1], M28T + Q30H [n = 1]; for genotype 1b: Y93H [n = 3], Y93H/C [n = 1]).
Croatian: NS5A RAV-ovi su u vrijeme relapsa bili opaženi u 11/13 pacijenata (za genotip 1a: samo Q30R [n = 2], Y93C [n = 1], Y93H/C [n = 2], Q30R + H58D [n = 1], M28T + Q30H [n = 1]; za genotip 1b: Y93H [n = 3], Y93H/C [n = 1]).
English: Baseline NS5A RAVs were overrepresented in patients who experienced relapse in the Phase 3 studies (see “Clinical efficacy and safety”).
Croatian: Početni NS5A RAV bili su više zastupljeni u pacijenata koji su u ispitivanjima faze 3 imali relaps
English: ION-3 evaluated 8 weeks of treatment with ledipasvir/sofosbuvir with or without ribavirin and 12 weeks of treatment with ledipasvir/sofosbuvir in treatment-naïve non-cirrhotic patients with genotype 1 CHC.
Croatian: U ispitivanju ION-3 procjenjivalo se 8 tjedana liječenja ledipasvirom/sofosbuvirom s ribavirinom ili bez njega te 12 tjedana liječenja ledipasvirom/sofosbuvirom pacijenata s CHC-om uzrokovanim genotipom 1, bez ciroze, koji prethodno nisu bili liječeni.
English: NS5A transient replicons
Croatian: NS5A prolazni replikoni Medijan (raspon)
English: - Harvoni (without ribavirin) for 12 weeks (in patients without cirrhosis) or 24 weeks (in patients with cirrhosis) may be considered for patients who are ineligible for or intolerant to ribavirin.
Croatian: U pacijenata koji nisu pogodni za liječenje ribavirinom ili ga ne podnose može se razmotriti primjena lijeka Harvoni (bez ribavirina) tijekom 12 tjedana (u pacijenata bez ciroze) ili 24 tjedna (u pacijenata s cirozom).
English: Recommendation concerning co-administration with Harvoni
Croatian: Preporuka za istovremenu primjenu s lijekom Harvoni
English: Abacavir ↔ Cmax 0.92 (0.87, 0.97)
Croatian: Abakavir ↔ Cmax 0,92 (0,87; 0,97)
English: ↑ Cmin 1.36 (1.23, 1.49) Cobicistat ↔ Cmax 1.25 (1.18, 1.32)
Croatian: ↑ Cmin 1,36 (1,23; 1,49) Kobicistat ↔ Cmax 1,25 (1,18; 1,32)
English: Emtricitabine ↔ Cmax 1.08 (0.97, 1.21)
Croatian: Emtricitabin ↔ Cmax 1,08 (0,97; 1,21)
English: Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Croatian: Pročitajte Sažetke opisa svojstava lijeka za tenofovirdizoproksilfumarat, emtricitabin/tenofovirdizoproksilfumarat ili elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilfumarat zbog preporuka o nadziranju funkcije bubrega.
English: Table 6: Demographics and baseline characteristics in study ION-3 Patient disposition
Croatian: Tablica 6: Demografske i početne značajke u ispitivanju ION-3
English: c/ sofosbuvir (400 mg once daily)c
Croatian: c/ sofosbuvir (400 mg jedanput na dan)c