FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Croatian: Farmakokinetika velpatasvira bila je ispitana u HCV-negativnih bolesnika s teškim oštećenjem bubrega (eGFR < 30 ml/min prema Cockcroft-Gaultu) nakon jedne doze od 100 mg velpatasvira.
English: Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ velpatasvir (100 mg once daily)d
Croatian: Norgestimat/etinilestradiol (norgestimat 0,180 mg/0,215 mg/ 0,25 mg/etinilestradiol 0,025 mg)/velpatasvir (100 mg jedanput na dan)d
English: ↔ ↔ ↔ Co-administration of Epclusa with efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is expected to decrease the concentration of velpatasvir.
Croatian: Efavirenz ↔ ↔ ↔ Očekuje se da će istodobna primjena lijeka Epclusa s efavirenzom/emtricitabinom/ tenofovirdizoproksilfumaratom smanjiti koncentracije velpatasvira.
English: Digoxin (0.25 mg single dose)f/ velpatasvir (100 mg single dose)
Croatian: Digoksin (jedna doza od 0,25 mg)f/ velpatasvir (jedna doza od 100 mg)
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Tenofovir disoproxil fumarate
Croatian: ANTIVIRUSNI LIJEKOVI ZA HIV: INHIBITORI REVERZNE TRANSKRIPTAZE
English: 100% (8/8)a
Croatian: Genotip 2, 4 i 6 100 % (8/8)a
English: Epclusa is contraindicated with phenobarbital and phenytoin (see section 4.3).
Croatian: Lijek Epclusa je kontraindiciran s fenobarbitalom i fenitoinom (vidjeti dio 4.3).
English: How to take Epclusa
Croatian: Kako uzimati lijek Epclusa
English: Medicinal products that are moderate P-gp inducers and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentration leading to reduced therapeutic effect of Epclusa.
Croatian: Lijekovi koji su umjereni induktori P-gp-a i/ili umjereni induktori CYP-a (npr. efavirenz, modafinil, okskarbazepin ili rifapentin) mogu smanjiti koncentraciju sofosbuvira ili velpatasvira u plazmi i tako dovesti do smanjenog terapijskog učinka lijeka Epclusa.
English: Clinical studies in patients without cirrhosis and patients with compensated cirrhosis Genotype 1, 2, 4, 5 and 6 HCV-infected adults - ASTRAL-1 (study 1138) ASTRAL-1 was a randomised, double-blind, placebo-controlled study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of placebo in patients with genotype 1, 2, 4, 5, or 6 HCV infection.
Croatian: Klinička ispitivanja u bolesnika bez ciroze i bolesnika s kompenziranom cirozom Odrasli zaraženi HCV-om genotipa 1, 2, 4, 5 i 6 - ASTRAL-1 (ispitivanje 1138) ASTRAL-1 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje za procjenu 12-tjednog liječenja lijekom Epclusa u usporedbi s 12 tjedana primanja placeba u bolesnika zaraženih HCV-om genotipa 1, 2, 4, 5 ili 6. Bolesnici zaraženi HCV-om genotipa 1, 2, 4 ili 6 randomizirani su u omjeru 5:1 za liječenje lijekom Epclusa tijekom 12 tjedana ili primanje placeba tijekom 12 tjedana.
English: Studies in patients without cirrhosis and patients with compensated cirrhosis In a pooled analysis of patients without cirrhosis or with compensated cirrhosis who received Epclusa for 12 weeks in three Phase 3 studies, 12 patients (2 with genotype 1 and 10 with genotype 3) qualified for resistance analysis due to virologic failure.
Croatian: U objedinjenoj analizi bolesnika bez ciroze ili s kompenziranom cirozom koji su primili lijek Epclusa tijekom 12 tjedana u trima ispitivanjima faze 3, 12 bolesnika (dva s genotipom 1 i 10 s genotipom 3) kvalificiralo se za analizu rezistencije zbog virološkog neuspjeha.
English: Use with moderate P-gp inducers and/or moderate CYP inducers Medicinal products that are moderate P-gp and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentrations leading to reduced therapeutic effect of Epclusa.
Croatian: Primjena s umjerenim induktorima P-gp-a i/ili umjerenim induktorima CYP-a Lijekovi koji su umjereni induktori P-gp-a i/ili umjereni induktori CYP-a (npr. efavirenz, modafinil, okskarbazepin ili rifapentin) mogu smanjiti koncentracije sofosbuvira ili velpatasvira u plazmi što dovodi do smanjenog terapijskog učinka lijeka Epclusa.
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
Croatian: Norgestimat/etinilestradiol (norgestimat 0,180 mg/0,215 mg/ 0,25 mg/etinilestradiol 0,025 mg)/sofosbuvir (400 mg jedanput na dan)d
English: Omeprazole dosed simultaneously with Epclusad
Croatian: Omeprazol primijenjen u isto vrijeme s lijekom Epclusad
English: Following a single 100 mg oral dose of [14C]-velpatasvir, mean total recovery of the [14C]-radioactivity was 95%, consisting of approximately 94% and 0.4% recovered from the faeces and urine, respectively.
Croatian: Nakon jedne peroralne doze od 100 mg [14C]-velpatasvira, srednja vrijednost ukupno otkrivene [14C]-radioaktivnosti bila je 95 % i sastojala se od približno 94 % one otkrivene u stolici i 0,4 % u mokraći.
English: No patients with genotype 2, 4 or 6 HCV infection experienced virologic failure.
Croatian: Nijedan bolesnik s infekcijom HCV-om genotipa 2, 4 ili 6 nije imao virološki neuspjeh.
English: Studies in patients with decompensated cirrhosis
Croatian: Ispitivanja u bolesnika s dekompenziranom cirozom
English: Genotypes 2 or 4
Croatian: Genotip 3 Genotipi 2 ili 4 Ukupno
English: Velpatasvir AUC increases in a nearly dose proportional manner over the dose range of 25 mg to 150 mg. Sofosbuvir and GS-331007 AUCs are near dose-proportional over the dose range of 200 mg to 1,200 mg.
Croatian: AUC sofosbuvira i GS-331007 bili su gotovo proporcionalni dozi u rasponu doza od 200 mg do 1200 mg.
English: Effect on velpatasvir exposure not studied.
Croatian: Učinak na izloženost velpatasviru nije ispitan.
English: How to store Epclusa
Croatian: Kako čuvati lijek Epclusa
English: No patients with genotype 2, 4, 5, or 6 HCV infection experienced virologic failure.
Croatian: Nijedan bolesnik s infekcijom HCV-om genotipa 2, 4, 5 ili 6 nije imao virološki neuspjeh.
English: Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Croatian: Sofosbuvir je nukleotidni predlijek iz kojeg unutarstaničnim metabolizmom nastaje farmakološki djelatan uridinu analogni trifosfat (GS-461203), koji se može ugraditi u
English: The median terminal half-lives of sofosbuvir and GS-331007 following administration of Epclusa were 0.5 and 25 hours, respectively.
Croatian: Nakon primjene lijeka Epclusa, medijan terminalnog poluvijeka sofosbuvira iznosio je 0,5 sati, a GS-331007 25 sati.
English: (Inhibition of P-gp and CYPs)
Croatian: (Inhibicija P-gp-a i CYP-ova)
English: Ketoconazole (200 mg twice daily)/ velpatasvir (100 mg single dose)d
Croatian: Ketokonazol (200 mg dvaput na dan)/velpatasvir (jedna doza od 100 mg)d
English:  If you get any side effects tell your doctor.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: No dose adjustment of Epclusa or tacrolimus is required at initiation of co-administration.
Croatian: Nije potrebna prilagodba doze lijeka Epclusa ili takrolimusa na početku istodobne primjene.
English: TN and TE with or without cirrhosis, with ESRD requiring dialysis
Croatian: GS-US-342-4062 TN i TE, s cirozom ili bez nje, s ESRD-om koji je zahtijevao dijalizu
English: NARCOTIC ANALGESICS Methadone (Methadone maintenance therapy [30 to 130 mg daily])/ sofosbuvir (400 mg once daily)d
Croatian: (terapija održavanja metadonom [30 do 130 mg na dan])/sofosbuvir (400 mg jedanput na dan)d
English: Effect of baseline HCV resistance-associated variants on treatment outcome Studies in patients without cirrhosis and patients with compensated cirrhosis Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome for patients without cirrhosis or with compensated cirrhosis in three Phase 3 clinical studies (ASTRAL-1, ASTRAL-2 and ASTRAL-3).
Croatian: Provedene su analize kako bi se ispitala povezanost između postojećih početnih NS5A RAV-ova i ishoda liječenja u bolesnika bez ciroze ili s kompenziranom cirozom u trima kliničkim ispitivanjima faze 3 (ASTRAL-1, ASTRAL-2 i ASTRAL-3).
English: Tacrolimus (5 mg single dose)f/ sofosbuvir (400 mg single dose)d
Croatian: Takrolimus (jedna doza od 5 mg)f/sofosbuvir (jedna doza od 400 mg)d
English: Patients with decompensated cirrhosis
Croatian: Bolesnici s dekompenziranom cirozom
English: Of the 106 treated patients, the median age was 57 years (range: 25 to 72); 86% of the patients were male; 51% were white; 45% were black; 22% had a baseline body mass index ≥ 30 kg/m2; 19 patients (18%) had compensated cirrhosis; and 29% were treatment experienced.
Croatian: Od 106 liječenih bolesnika, medijan dobi iznosio je 57 godina (raspon: 25 do 72); 86 % bolesnika bili su muškarci; 51 % bijelci, 45 % crnci; 22 % bolesnika imali su početni indeks tjelesne mase ≥ 30 kg/m2; 19 bolesnika (18 %) imalo je kompenziranu cirozu; i 29 % je prethodno liječeno.
English: Epclusa 12 Weeks
Croatian: Epclusa 12 tjedana
English: Rifampicin (600 mg once daily)/ velpatasvir (100 mg single dose)
Croatian: Rifampicin (600 mg jedanput na dan)/velpatasvir (jedna doza od 100 mg)
English: Pravastatin (40 mg single dose)/ velpatasvir (100 mg once daily)d
Croatian: Pravastatin (jedna doza od 40 mg)/velpatasvir (100 mg jedanput na dan)d
English: Table 12: SVR12 in study ASTRAL-3 (HCV genotype 3)
Croatian: Tablica 13: SVR12 u ispitivanju ASTRAL-3 (genotip 3 HCV-a)
English: Co-administration of such medicinal products with Epclusa is not recommended (see section 4.5).
Croatian: Istodobna primjena takvih lijekova s lijekom Epclusa se ne preporučuje (vidjeti dio 4.5).
English: TN and TE, without cirrhosis or with compensated cirrhosis
Croatian: Genotip 2 TN i TE, bez ciroze ili s kompenziranom cirozom
English: Refer to the tenofovir disoproxil fumarate-containing product's Summary of Product Characteristics for recommendations on renal monitoring (see section 4.4).
Croatian: Preporuke o praćenju bubrežne funkcije pogledajte u sažetku opisa svojstava lijeka za lijekove koji sadrže tenofovirdizoproksilfumarat (vidjeti dio 4.4).
English: 76% of the patients had non-CC IL28B alleles (CT or TT); 56% had baseline HCV RNA levels of at least 800,000 IU/mL, 55% were treatment-experienced; 90% and 95% of patients had CPT Class B
Croatian: Nije bio uključen nijedan bolesnik s genotipom 5 HCV-a. 76 % bolesnika imali su ne-CC IL28B alele (CT ili TT); 56 % bolesnika imali su razine HCV RNK od najmanje 800.000 IU/ml, 55 % su bili prethodno liječeni; 90 % i 95 % bolesnika imali su cirozu CPT stadija B odnosno rezultat modela za završni stadij bolesti bubrega (engl.
English: Of the 740 treated patients, the median age was 56 years (range: 18 to 82); 60% of the patients were male; 79% were White, 9% were Black; 21% had a baseline body mass index of at least 30 kg/m2; the proportions of patients with genotype 1, 2, 4, 5, or 6 HCV infection were 53%, 17%, 19%, 5% and 7%, respectively; 69% had non-CC IL28B alleles (CT or TT); 74% had baseline HCV RNA levels of at least 800,000 IU/mL; 19% had compensated cirrhosis; and 32% were treatment-experienced.
Croatian: Od 740 liječenih bolesnika, medijan dobi iznosio je 56 godina (raspon: 18 do 82); 60 % bolesnika bili su muškarci; 79 % bijelci, 9 % crnci; 21 % bolesnika imali su početni indeks tjelesne mase od najmanje 30 kg/m2; udio bolesnika s genotipom 1, 2, 4, 5 ili 6 HCV-a bio je 53 %, 17 %, 19 %, 5 % odnosno 7 %; 69 % su imali ne-CC IL28B alele (CT ili TT); 74 % bolesnika su imali početne razine HCV RNK od najmanje 800.000 IU/ml; 19 % je imalo kompenziranu cirozu; i 32 % je prethodno liječeno.
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct-acting antiviral treatment.
Croatian: Nakon uvođenja liječenja HCV infekcije direktno djelujućim antivirotikom, bolesnici s dijabetesom mogu imati bolju kontrolu glukoze u krvi, što može dovesti do simptomatske hipoglikemije.
English: Epclusa for 12 weeks
Croatian: Epclusa tijekom 12 tjedana
English: It is important not to miss a dose of this medicine.
Croatian: Ako ste zaboravili uzeti lijek Epclusa Važno je da ne propustite uzeti dozu ovog lijeka.
English: Epclusa is contraindicated with carbamazepine (see section 4.3).
Croatian: Lijek Epclusa je kontraindiciran s karbamazepinom (vidjeti dio 4.3).,
English: Microcrystalline cellulose Croscarmellose sodium Magnesium stearate
Croatian: Jezgra tablete kopovidon mikrokristalična celuloza umrežena karmelozanatrij magnezijev stearat
English: Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 24 weeks.
Croatian: Bolesnici su randomizirani u omjeru 1:1 za liječenje lijekom Epclusa tijekom 12 tjedana ili sa SOF + RBV tijekom 24 tjedana.
English: Recommendation concerning co-administration with Epclusa
Croatian: Preporuka za istodobnu primjenu s lijekom Epclusa
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: Pogledajte sažetak opisa svojstava lijeka za tenofovirdizoproksilfumarat, emtricitabin/tenofovirdizoproksilfumarat ili elvitegravir/kobicistat/emtricitabin/ tenofovirdizoproksilfumarat radi preporuka o praćenju bubrega.
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Croatian: Rifampicin (600 mg jedanput na dan)/sofosbuvir (jedna doza od 400 mg)d
English: No dose adjustment of Epclusa or pravastatin is required.
Croatian: Nije potrebna prilagodba doze lijeka Epclusa ili pravastatina.
English: Epclusa is contraindicated with rifabutin (see section 4.3).
Croatian: Lijek Epclusa je kontraindiciran s rifabutinom (vidjeti dio 4.3).
English: Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 12 weeks.
Croatian: Bolesnici su randomizirani u omjeru 1:1 za liječenje lijekom Epclusa tijekom 12 tjedana ili SOF+RBV tijekom 12 tjedana.
English: Breast-feeding Do not breast-feed during treatment with Epclusa.
Croatian: Nemojte dojiti tijekom liječenja lijekom Epclusa.
English: ANTIFUNGALS Ketoconazole
Croatian: Ketokonazol
English: Gilead Sciences Ltd. Tel: + 44 (0) 8000 113 700
Croatian: Tel: + 44 (0) 8000 113700
English: Of the 552 treated patients, the median age was 52 years (range: 19 to 76); 62% of the patients were male; 89% were White, 9% were Asian; 1% were Black; 20% had a baseline body mass index of at least 30 kg/m2; 61% had non-CC IL28B alleles (CT or TT); 70% had baseline HCV RNA levels of at least 800,000 IU/mL, 30% had compensated cirrhosis and 26% were treatment-experienced.
Croatian: Od 552 liječena bolesnika, medijan dobi iznosio je 52 godina (raspon: 19 do 76); 62 % bolesnika bili su muškarci; 89 % bijelci, 9 % azijati; 1 % crnci; 20 % bolesnika imali su početni indeks tjelesne mase od najmanje 30 kg/m2; 61 % su imali ne-CC IL28B alele (CT ili TT); 70 % bolesnika su imali početne razine HCV RNK od najmanje 800.000 IU/ml; 30 % je imalo kompenziranu cirozu; i 26 % je prethodno liječeno.
English: Table 14: SVR12 in study ASTRAL-4 by HCV genotype
Croatian: Tablica 14: SVR12 u ispitivanju ASTRAL-4 prema genotipu HCV-a Epclusa
English: Tenofovir alafenamide Sofosbuvir
Croatian: Tenofovirdisoproksilfumarat
English: No dose adjustment of Epclusa or atorvastatin is required.
Croatian: Nije potrebna prilagodba doze lijeka Epclusa ili atorvastatina.
English: Observed: Pravastatin ↑
Croatian: Digoksin ↑
English: Severe RI (eGFR <30 mL/min/1.7 3m2)
Croatian: Teško oštećenje bubrega (eGFR < 30 ml/ min/ 1,73 m2)
English: Epclusa is contraindicated with rifampicin (see section 4.3).
Croatian: Lijek Epclusa je kontraindiciran s rifampicinom (vidjeti dio 4.3).
English: Patients were randomised in a 1:1:1 ratio to treatment with Epclusa for 12 weeks, Epclusa + RBV for 12 weeks or Epclusa for 24 weeks.
Croatian: Bolesnici su randomizirani u omjeru 1:1:1 za liječenje lijekom Epclusa tijekom 12 tjedana ili Epclusa + RBV tijekom 12 tjedana ili lijekom Epclusa tijekom 24 tjedna.
English: Of the 266 treated patients, the median age was 58 years (range: 23 to 81); 59% of the patients were male; 88% were White, 7% were Black; 33% had a baseline body mass index of at least 30 kg/m2; 62% had non-CC IL28B alleles (CT or TT); 80% had baseline HCV RNA levels of at least 800,000 IU/mL; 14% had compensated cirrhosis and 15% were treatment-experienced.
Croatian: Od 266 liječenih bolesnika, medijan dobi iznosio je 58 godina (raspon: 23 do 81); 59 % bolesnika bili su muškarci; 88 % bijelci, 7 % crnci; 33 % bolesnika imali su početni indeks tjelesne mase od najmanje 30 kg/m2; 62 % su imali ne-CC IL28B alele (CT ili TT); 80 % bolesnika imalo je početne razine HCV RNK od najmanje 800.000 IU/ml; 14 % je imalo kompenziranu cirozu; i 15 % je prethodno liječeno.
English: ↔ ↔ ↔ No dose adjustment of Epclusa or methadone is required.
Croatian: R-metadon ↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa ili metadona.
English: Epclusa [Outer packaging only]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Epclusa [samo vanjsko pakiranje]
English: No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Croatian: Nije potrebna prilagodba doze lijeka Epclusa, atazanavira (pojačanog ritonavirom) ili emtricitabina/ tenofovirdizoproksilfumarata.
English: Table 10 presents the SVR12 for the ASTRAL-1 study by HCV genotypes.
Croatian: U tablici 10 predstavljen je SVR12 za ispitivanje ASTRAL-1 prema genotipu HCV-a.
English: ↔ ↔ ↔ No dose adjustment of Epclusa, darunavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Croatian: ↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa, darunavira (pojačanog ritonavirom) ili emtricitabina/ tenofovirdizoproksilfumarata.
English: Table 17 presents the SVR12 for the ASTRAL-5 study by HCV genotype.
Croatian: U tablici 17 prikazan je SVR12 za ispitivanje ASTRAL-5 prema genotipu HCV-a.
English: Norelgestromin Norgestrel
Croatian: Norelges tromin
English: No NS5B nucleoside inhibitor (NI) RAVs were observed at failure in the 2 patients.
Croatian: U ova dva bolesnika nisu opažene varijante NS5B povezane s rezistencijom na nukleozidne inhibitore pri neuspjehu.
English: Rilpivirine ↔ ↔ ↔ No dose adjustment of Epclusa or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Croatian: Rilpivirin ↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa ili emtricitabina/rilpivirina/ tenofovirdizoproksilfumarata.
English: Without cirrhosis 98% (160/163) With cirrhosis a Five patients with missing cirrhosis status in the SOF+RBV 24 week group were excluded from this subgroup analysis.
Croatian: Pet bolesnika u kojih je nedostajao status ciroze u skupini sa SOF+RBV tijekom 24 tjedna bili su isključeni iz analize ove podskupine.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Epclusa.
Croatian: Nakon što počnete uzimati lijek Epclusa, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijek protiv šećerne bolesti.
English: Dolutegravir (50 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)
Croatian: Dolutegravir (50 mg/jedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
English: No dose adjustment of Epclusa, raltegravir or emtricitabine/ tenofovir disoproxil fumarate is required.
Croatian: Nije potrebna prilagodba doze lijeka Epclusa, raltegravira ili emtricitabina/ tenofovirdizoproksilfumarata.
English: Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate is required.
Croatian: Elvitegravir ↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa ili elvitegravira/kobicistata/ emtricitabina/ tenofoviralafenamidfumarata.
English: Close monitoring of INR is recommended with all vitamin K antagonists.
Croatian: Preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) uz sve antagoniste vitamina K zbog promjena u funkciji jetre tijekom liječenja Epclusa.
English: Treatment-naïve (n = 201)
Croatian: Bolesnici koji prethodno nisu bili liječeni (n = 201)
English: Table 14 presents the SVR12 for the ASTRAL-4 study by HCV genotype.
Croatian: U tablici 14 predstavljen je SVR12 za ispitivanje ASTRAL-4 prema genotipu HCV-a.
English: Interaction only studied with velpatasvir Expected:
Croatian: Interakcija ispitana samo s velpatasvirom
English: ANTIARRHYTHMICS Amiodarone
Croatian: Antagonisti vitamina
English: Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate is required.
Croatian: Elvitegravir ↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa ili elvitegravira/kobicistata/ emtricitabina/ tenofovirdizoproksilfumarata.
English: Darunavir boosted with ritonavir (800/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Croatian: Darunavir pojačan ritonavirom (800/100 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200/300 mg jedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
English: Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1.)
Croatian: Za bolesnike zaražene genotipom 3 s kompenziranom cirozom možda će se razmotriti dodavanje ribavirina (vidjeti dio 5.1) Bolesnici s dekompenziranom cirozom Epclusa + ribavirin tijekom 12 tjedana a.
English: Lopinavir boosted with ritonavir (4x200 mg/ 50 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Croatian: Lopinavir pojačan ritonavirom (4x200 mg/50 mg jedanput na dan) + emtricitabin/ tenofovirdizoproksilfumarat (200/300 mg jedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
English: CPT Class C cirrhosis
Croatian: Ciroza jetre CPT stadija C
English: Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Croatian: 40 mg)/sofosbuvir/velpatasvir (jedna doza od 400/100 mg)c
English: Dosed 1
Croatian: PRILOG I.
English: HMG-CoA REDUCTASE INHIBITORS Atorvastatin (40 mg single dose) + sofosbuvir / velpatasvir (400/ 100 mg once daily)d
Croatian: Atorvastatin (jedna doza od 40 mg) + sofosbuvir /velpatasvir (400/ 100 mg jedanput na dan)d
English: The pharmacokinetic properties of sofosbuvir, GS-331007 and velpatasvir have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration of Epclusa, sofosbuvir was absorbed quickly and the peak median plasma concentration was observed 1 hour post-dose.
Croatian: Farmakokinetička svojstva sofosbuvira, GS-331007 i velpatasvira ocijenjena su u zdravih odraslih ispitanika i u bolesnika s kroničnim hepatitisom C.
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate (150/ 150/ 200/ 10 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Croatian: Elvitegravir/kobicistat/emtricitabi n/tenofoviralafenamidfumarat (150/150/200/10 mg jedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
English: Efavirenz/ emtricitabine/ tenofovir disoproxil fumarate (600/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Croatian: Efavirenz/emtricitabin/ tenofovirdizoproksilfumarat (600/200/300 mgjedanput na dan)/sofosbuvir/velpatasvir (400/100 mg jedanput na dan)c, d
English: Ciclosporin (600 mg single dose)f/ velpatasvir (100 mg single dose)d
Croatian: 600 mg)f/velpatasvir (jedna doza od 100 mg)d