FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical monitoring, looking for signs of bleeding and anaemia, is recommended when dabigatran etexilate is co-administered with Epclusa.
Croatian: Preporučuje se kliničko praćenje, kojim se traže znakovi krvarenja i anemije, kada se dabigatraneteksilat primjenjuje istodobno s lijekom Epclusa.
English: b n = 4 for genotype 2 and n = 2 for genotype 4.
Croatian: b. n = 4 za genotip 2 i n = 2 za genotip 4
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: Koinfekcija HCV-om/HBV-om (virusom hepatitisa B) Tijekom ili nakon liječenja direktno djelujućim antiviroticima, zabilježeni su slučajevi reaktivacije virusa hepatitisa B (HBV), neki od njih sa smrtnim ishodom.
English: Epclusa 12 weeks (277) SOF+RBV 24 weeks (275)
Croatian: Epclusa 12 tjedana (277) SOF+RBV 24 tjedna (275)
English: Of the 2 genotype 1 virologic failure patients, one patient had virus with emergent NS5A RAV Y93N and the other patient had virus with emergent NS5A RAVs L31I/V and Y93H at virologic failure.
Croatian: Od dva bolesnika s genotipom 1 kod kojih je došlo do virološkog neuspjeha, jedan bolesnik imao je virus s pojavom NS5A RAV-a Y93N dok je drugi imao virus s pojavom NS5A RAV-a L31I/V i Y93H pri virološkom neuspjehu.
English: Table 6: SVR12 in patients with or without baseline NS5A RAVs by HCV genotype (studies ASTRAL-1, ASTRAL-2 and ASTRAL-3)
Croatian: Tablica 6: SVR12 u bolesnika sa ili bez početnog NS5A RAV-a prema genotipu HCV-a (ispitivanja ASTRAL-1, ASTRAL-2 i ASTRAL-3)
English: Safety and efficacy of Epclusa has not been assessed in patients with CPT Class C cirrhosis (see sections 4.8 and 5.1).
Croatian: Sigurnost i djelotvornost lijeka Epclusa nije procijenjena u bolesnika s cirozom jetre CPT stadija C (vidjeti dijelove 4.8 i 5.1).
English: Epclusa 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: Upotreba s određenim antiretrovirusnim režimima za HIV Pokazalo se da Epclusa povećava izloženost tenofoviru, naročito kada se koristi zajedno s režimom za HIV koji sadrži tenofovirdizoproksilfumarat i farmakokinetički pojačivač (ritonavir ili kobicistat).
English: Epclusa 24 weeks
Croatian: Epclusa 24 tjedna
English: The proportions of patients with genotype 1, 2, 3, 4, 6 or indeterminate HCV infection were 42%, 12%, 27%, 7% , 3%, and 9%, respectively.
Croatian: Udjeli bolesnika s infekcijom HCV-om genotipa 1, 2, 3, 4, 6 odnosno neutvrđenim bili su 42%, 12%, 27%, 7%, 3% odnosno 9%.
English: The proportions of patients with genotype 1, 2, 3, 4 or 6 HCV were 78%, 4%, 15%, 3%, and < 1% (1 patient), respectively.
Croatian: Udjeli bolesnika s genotipom 1, 2, 3, 4 ili 6 HCV-a bili su 78 %, 4 %, 15 %, 3 %, odnosno < 1 % (1 bolesnik).
English: The 50% effective concentration (EC50) values of sofosbuvir and velpatasvir against full-length or chimeric replicons encoding NS5B and NS5A sequences from the laboratory strains are presented in Table 4.
Croatian: Vrijednosti 50 % učinkovite koncentracije (EC50) sofosbuvira i velpatasvira protiv replikona pune duljine ili kimeričkih replikona koji kodiraju sekvence NS5B i NS5A iz laboratorijskih sojeva navedene su u tablici 4. Vrijednosti EC50 sofosbuvira i velpatasvira protiv kliničkih izolata navedene su u tablici 5.
English: Patients receiving Epclusa concomitantly with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovir-associated adverse reactions.
Croatian: Bolesnike koji primaju lijek Epclusa istodobno s elvitegravirom/kobicistatom/emtricitabinom/tenofovirdizoproksilfumaratom ili s tenofovirdizoproksilfumaratom i pojačanim inhibitorom HIV proteaze treba pratiti radi nuspojava povezanih s tenofovirom.
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Croatian: Ostale nuspojave koje se mogu uočiti tijekom liječenja sofosbuvirom: Učestalost sljedećih nuspojava nije poznata (učestalost se ne može procijeniti iz dostupnih podataka).
English: Total (all GTs) (n = 106)
Croatian: Ukupno (svi GT-i) (n = 106)
English: Therefore, Epclusa should not be used during breast-feeding.
Croatian: Stoga se lijek Epclusa ne bi trebao primjenjivati tijekom dojenja.
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Croatian: Analiza populacijske farmakokinetike u bolesnika zaraženih HCV-om ukazuje na to da ciroza (uključujući dekompenzirani cirozu) nije imala klinički relevantni učinak na izloženost sofosbuviru i GS-331007.
English: Interaction only studied with velpatasvir.
Croatian: Interakcije ispitana samo s velpatasvirom.
English: Table 15 presents the virologic outcome for patients with genotype 1 or 3 HCV infection in the ASTRAL-4 study.
Croatian: U tablici 15 predstavljeni su virološki ishodi za bolesnike s genotipom 1 ili 3 HCV infekcije u ispitivanju ASTRAL-4.
English: Demographics and baseline characteristics were balanced across the two treatment groups.
Croatian: Demografska slika i značajke na početku ispitivanja uravnotežene su između dviju liječenih skupina.
English: Velpatasvir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rat micronucleus assays.
Croatian: Velpatasvir nije bio genotoksičan u bateriji testova in vitro ili in vivo, uključujući test bakterijske mutagenosti, kromosomske aberacije na ljudskim limfocitima iz periferne krvi i in vivo mikronukleusni test u štakora.
English: Genotypes 2, 4, 5 or 6 Total
Croatian: Genotipi 2, 4, 5 ili 6 Ukupno
English: Randomisation was stratified by HCV genotype (1, 2, 3, 4, 5, 6 and indeterminate).
Croatian: Randomizacija je stratificirana prema genotipu (1, 2, 3, 4, 5, 6 i neutvrđeno) HCV-a.
English: • If you are sick (vomit) less than 3 hours after taking Epclusa, take another tablet.
Croatian: • Ako povratite u razdoblju kraćem od 3 sata nakon uzimanja lijeka Epclusa, uzmite drugu tabletu.
English: With any baseline NS5A RAVs Without baseline NS5A RAVs
Croatian: S bilo kojim početnim NS5A RAV-ovima Bez početnih NS5A
English: No patients with genotype 2 or 4 HCV infection in the Epclusa + RBV 12 weeks group experienced virologic failure.
Croatian: Nijedan bolesnik s infekcijom HCV-om genotipa 2 ili 4 iz skupine koja je primala lijek Epclusa + RBV tijekom 12 tjedana nije imalo virološki neuspjeh.
English: After a single 100 mg dose of [14C]-velpatasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.52 and 0.67.
Croatian: Nakon jedne doze od 100 mg [14C]-velpatasvira u zdravih ispitanika, omjer [14C]-radioaktivnosti u krvi u odnosu na plazmu kretao se u rasponu između 0,52 i 0,67.
English: The potential risks and benefits associated with co-administration of Epclusa with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Croatian: Potrebno je razmotriti moguće rizike i koristi povezane s istodobnom primjenom lijeka Epclusa s tabletom fiksne kombinacije koja sadrži elvitegravir/kobicistat/emtricitabin/ tenofovirdizoproksilfumarat ili tenofovirdizoproksilfumaratom danim zajedno s pojačanim inhibitorom HIV proteaze (npr. atazanavirom ili darunavirom), naročito kod bolesnika s povećanim rizikom od disfunkcije bubrega.
English: Epclusa + RBV 12 weeks
Croatian: Epclusa + RBV 12 tjedana
English: In vitro resistance selection and cross-resistance studies indicate velpatasvir targets NS5A as its mode of action.
Croatian: In vitro ispitivanja selekcije rezistencije i ukrižene rezistencije pokazuju da je velpatasvir po načinu djelovanja usmjeren na NS5A.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir or Epclusa in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni sofosbuvira, velpatasvira ili lijeka Epclusa u trudnica ograničeni (manje od 300 trudnoća).
English: The NS5B NI RAV S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies.
Croatian: Varijanta NS5B S282T povezana s rezistencijom na nukleozidne inhibitore nije opažena u početnoj NS5B sekvenci u niti jednog bolesnika u ispitivanjima faze 3.
English: Velpatasvir solubility decreases as pH increases.
Croatian: Topljivost velpatasvira smanjuje se s povećanjem pH.
English: Impact of DAA therapy on drugs metabolized by the liver The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV.
Croatian: Na farmakokinetiku lijekova koji se metaboliziraju putem jetre (npr. imunosupresivi kao što su inhibitori kalcineurina) mogu utjecati promjene u funkciji jetre nastale tijekom terapije direktno djelujućim antiviroticima, a koje su povezane s klirensom HCV­a.
English: Film-coating Polyvinyl alcohol Titanium dioxide Polyethylene glycol Talc
Croatian: Film ovojnica polivinilni alkohol titanijev dioksid polietilenglikol talk crveni željezov oksid
English: Clinical studies in patients with HCV/HIV-1 Co-infection - ASTRAL-5 (study 1202) ASTRAL-5 evaluated 12 weeks of treatment with Epclusa in patients with genotype 1, 2, 3, or 4 HCV infection who were co-infected with HIV-1 (HCV genotype 5 and 6 allowed, but no such patients were included).
Croatian: Klinička ispitivanja u bolesnika s koinfekcijom virusima HCV/HIV-1 - ASTRAL-5 (ispitivanje 1202) U ispitivanju ASTRAL-5 procjenjivalo se 12 tjedana liječenja lijekom Epclusa u bolesnika zaraženih HCV-om genotipa 1, 2, 3 ili 4 koji su istodobno bili zaraženi virusom HIV-1 (HCV genotipa 5 i 6 bio je dopušten, ali nijedan bolesnik s genotipom 5 ili 6 HCV-a nije uključen u analizu).
English: If you have any questions about your medicines, please ask your doctor or pharmacist.
Croatian: Ako imate bilo kakvih pitanja o lijekovima koje uzimate, molimo da se obratite svom liječniku ili ljekarniku.
English: cirrhosis and Model for End Stage Liver Disease (MELD) score ≤ 15 at baseline, respectively.
Croatian: Model for End Stage Liver Disease, MELD) ≤ 15 na početku.
English: Following a single 400 mg oral dose of [14C]-sofosbuvir, mean total recovery of the [14C]-radioactivity 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 [14C]-radioaktivnosti 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: SOF+RBV 24 weeks (n = 275)
Croatian: SOF+RBV 24 tjedna (n = 275)
English: The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Croatian: Farmakokinetika velpatasvira bila je ispitana nakon jedne doze od 100 mg velpatasvira u HCV-negativnih bolesnika s umjerenim i teškim oštećenjem jetre (CPT stadij B i C).
English: Clinical studies in patients with decompensated cirrhosis - ASTRAL-4 (study 1137) ASTRAL-4 was a randomised, open-label study in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and CPT Class B cirrhosis.
Croatian: Klinička ispitivanja u bolesnika s dekompenziranom cirozom- ASTRAL-4 (ispitivanje 1137) ASTRAL-4 bilo je randomizirano, otvoreno ispitivanje u bolesnika s genotipom 1, 2, 3, 4, 5 ili 6 HCV-a i cirozom CPT stadija B.
English: Epclusa + RBV 12 weeks (n = 87)
Croatian: Epclusa + RBV 12 tjedana (n = 87)
English: SOF+RBV 12 weeks (n = 132)
Croatian: SOF+RBV 12 tjedana (n = 132)
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 (procijenjena brzina glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) i završnim stadijem bolesti bubrega (engl. end stage renal disease, ESRD) koji zahtijeva hemodijalizu.
English: Effect on amiodarone, velpatasvir, and sofosbuvir concentrations unknown.
Croatian: Učinci na koncentracije amiodarona, velpatasvira i sofosbuvira nisu poznati.
English: Three patients in the Epclusa + RBV 12 week group had baseline NS5B NI RAVs (N142T and L159F) and all three patients achieved SVR12.
Croatian: Tri bolesnika u skupini koja je primala lijek Epclusa + RBV tijekom 12 tjedana na početku su imali varijante NS5B povezane s rezistencijom na nukleozidne inhibitore (N142T i L159F) te su sva tri bolesnika postigla SVR12.
English: Dolutegravir ↔ ↔ ↔ No dose adjustment of Epclusa or dolutegravir is required.
Croatian: Dolutegravir ↔ ↔ ↔ Nije potrebna prilagodba doze lijeka Epclusa ili dolutegravira.
English: Table 15: Virologic outcome for patients with genotype 1 and 3 HCV infection in study ASTRAL-4
Croatian: Tablica 15: Virološki ishod za bolesnike s genotipom 1 ili 3 HCV infekcije u ispitivanju ASTRAL-4.
English: Table 8: SVR12 in patients with or without baseline NS5A RAVs by HCV genotype (study ASTRAL-4)
Croatian: Tablica 8: SVR12 u bolesnika sa ili bez početnog NS5A RAV-a prema genotipu HCV-a (ispitivanje ASTRAL-4)
English: Both patients had virus at baseline harboring NS5A RAVs.
Croatian: Oba bolesnika imala su virus na početku ispitivanja koji je nosio NS5A RAV-ove.
English: CPT Class C cirrhosis pre-transplant CPT Class B or C post-transplant
Croatian: CPT stadij B ili C nakon transplantacije
English: In vitro, slow metabolic turnover of velpatasvir by CYP2B6, CYP2C8 and CYP3A4 was observed.
Croatian: In vitro je opažena spora metabolička izmjena velpatasvira putem CYP2B6, CYP2C8 i CYP3A4.
English: Of the 267 treated patients, the median age was 59 years (range: 40 to 73); 70% of the patients were male; 90% were White, 6% were Black; 42% had a baseline body mass index of at least 30 kg/m2.
Croatian: Od 267 liječenih bolesnika, medijan dobi iznosio je 59 godina (raspon: 40 do 73); 70 % bolesnika bili su muškarci; 90 % bili su bijelci; 6 % bili su crnci; 42 % imali su početni indeks tjelesne mase od najmanje 30 kg/m2.
English: Medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort).
Croatian: Primjena s jakim induktorima P-gp-a i jakim induktorima CYP-a Lijekovi koji su jaki induktori P-glikoproteina (P-gp) i/ili jaki induktori citokroma P450 (CYP) (karbamazepin, fenobarbital, fenitoin, rifampicin, rifabutin i gospina trava).
English: Outcome for patients without SVR12 On-treatment virologic failure Relapsea
Croatian: Ishod u bolesnika bez SVR12 Virološki neuspjeh uz liječenje Relapsa
English: Famotidine dosed simultaneously with Epclusad
Croatian: Famotidin primijenjen u isto vrijeme s lijekom Epclusad
English: (Induction of P-gp and CYPs)
Croatian: (Indukcija P-gp-a i CYP-ova)
English: The safety profile of Epclusa has been evaluated in one open-label study in which patients with CPT Class B cirrhosis received Epclusa for 12 weeks (n = 90), Epclusa + RBV for 12 weeks (n = 87) or Epclusa for 24 weeks (n = 90).
Croatian: Sigurnosni profil lijeka Epclusa procijenjen je u otvorenom ispitivanju u kojem su bolesnici s cirozom CPT stadija B primali lijek Epclusa tijekom 12 tjedana (n = 90), lijek Epclusa + RBV tijekom
English: • St. John's wort (herbal medicine used to treat depression);
Croatian: • gospinu travu (biljni lijek koji se primjenjuje za liječenje depresije);
English: Close monitoring is recommended if this medicinal product is administered with Epclusa (see sections 4.4 and 4.8).
Croatian: Preporučuje se pažljivo praćenje ako se ovaj lijek primjenjuje s lijekom Epclusa (vidjeti dijelove 4.4 i
English: (n = 331), velpatasvir AUC0-24 and Cmax were 37% lower and 41% lower, respectively in HCV-infected patients.
Croatian: U odnosu na one u zdravih ispitanika (n = 331), AUC0-24 i Cmax velpatasvira u bolesnika zaraženih HCV-om iznosile su 37 % manje odnosno 41 % manje.
English: No dose adjustment of Epclusa or ketoconazole is required.
Croatian: Nije potrebna prilagodba doze lijeka Epclusa ili ketokonazola.
English: For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Croatian: Za modifikacije doze ribavirina vidjeti sažetak opis svojstava lijeka koji sadrži ribavirin.
English: Median velpatasvir EC50, nM (range)
Croatian: Medijan EC50 velpatasvira, nM (raspon)
English: It is unknown whether sofosbuvir, metabolites of sofosbuvir or velpatasvir are excreted in human milk.
Croatian: Nije poznato izlučuju li se sofosbuvir, njegovi metaboliti ili velpatasvir u majčino mlijeko.
English: No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007 or velpatasvir.
Croatian: Nisu utvrđene nikakve klinički relevantne razlike u farmakokinetici sofosbuvira, GS-331007 ili velpatasvira kojima bi uzrok bila rasa ili spol.
English: Genotype 1b 11% (2/18) Genotype 3
Croatian: Genotip 1b 11 % (2/18)
English: Co-administration of Epclusa with oxcarbazepine is expected to decrease the concentration of sofosbuvir and velpatasvir, leading to reduced therapeutic effect of Epclusa.
Croatian: Očekuje se da će istodobna primjena lijeka Epclusa s okskarbazepinom smanjiti koncentraciju sofosbuvira i velpatasvira i tako dovesti do smanjenog terapijskog učinka lijeka Epclusa.
English: c Administered as Epclusa.
Croatian: c. Primjenjuje se kao lijek Epclusa.
English: Interaction only studied with sofosbuvir Expected:
Croatian: Interakcija ispitana samo sa sofosbuvirom
English: Medicinal products that are strong inducers of P-gp and/or strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. carbamazepine, phenobarbital and phenytoin, rifampicin, rifabutin and St. John's wort) may decrease plasma concentrations of sofosbuvir or velpatasvir leading to reduced therapeutic effect of sofosbuvir/velpatasvir.
Croatian: Lijekovi koji su jaki induktori P-gp-a i/ili jaki induktori CYP2B6, CYP2C8 ili CYP3A4 (npr. karbamazepin, fenobarbital i fenitoin, rifampicin, rifabutin i gospina trava) mogu smanjiti koncentracije sofosbuvira ili velpatasvira u plazmi i tako dovesti do smanjenog terapijskog učinka sofosbuvira/velpatasvira.
English: • The active substances are sofosbuvir and velpatasvir.
Croatian: • Djelatne tvari su sofosbuvir i velpatasvir.
English: Of the 2 genotype 3 virologic failure patients, one had NS5A RAV Y93H emerge at failure.
Croatian: Od dva bolesnika s genotipom 3 kod kojih je došlo do virološkog neuspjeha, jedan je imao pojavu NS5A RAV-a Y93H pri neuspjehu.
English: Median sofosbuvir EC50, nM (range)
Croatian: Medijan EC50 sofosbuvira, nM (raspon)
English: Velpatasvir is also a substrate of drug transporter OATP1B.
Croatian: Velpatasvir je također supstrat prijenosnika lijeka OATP1B.
English: Epclusa + RBV 12 weeks (87) Epclusa 24 weeks (90)
Croatian: Epclusa 12 tjedana (90) Epclusa + RBV 12 tjedana (87) Epclusa 24 tjedna (90)
English: The use of such medicinal products with Epclusa is contraindicated (see section 4.3).
Croatian: Primjena takvih lijekova s lijekom Epclusa je kontraindicirana (vidjeti dio 4.3).
English: Outcome for patients without SVR12 Ontreatment virologic failure
Croatian: Ishod u bolesnika bez SVR12 Virološki neuspjeh uz liječenje
English: Epclusa + ribavirin for 12 weeks a Includes patients co-infected with human immunodeficiency virus (HIV) and patients with recurrent HCV post-liver transplant (see section 4.4.
Croatian: Uključuje bolesnike koji su istodobno zaraženi virusom humane imunodeficijencije (HIV) i bolesnike s rekurentnim HCV-om poslije transplantacije jetre (vidjeti dio 4.4.).
English: In vitro potential for sofosbuvir/velpatasvir drug-drug interactions Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP while GS-331007 is not.
Croatian: Sofosbuvir i velpatasvir supstrati su prijenosnika lijekova P-gp-a i BCRP-a, dok GS-331007 to nije.
English: No teratogenic effects were observed in the rat and rabbit developmental toxicity studies with sofosbuvir.
Croatian: Nisu bili opaženi teratogeni učinci sofosbuvira u ispitivanjima njegove razvojne toksičnosti na štakorima i kunićima.
English: Demographics and baseline characteristics were balanced across the treatment groups.
Croatian: Demografska slika i značajke na početku ispitivanja uravnotežene su između liječenih skupina.
English: Otherd a No patients with genotype 1 HCV had on-treatment virologic failure.
Croatian: Nijedan bolesnik s infekcijom HCV-om genotipa 1 nije imao virološki neuspjeh tijekom liječenja.
English: Genotype 3 HCV-infected adults - ASTRAL-3 (study 1140) ASTRAL-3 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 24 weeks of treatment with SOF+RBV in patients with genotype 3 HCV infection.
Croatian: Odrasli zaraženi HCV-om genotipa 3 - ASTRAL-3 (ispitivanje 1140) ASTRAL-3 bilo je randomizirano, otvoreno ispitivanje u kojem se procjenjivalo 12 tjedana liječenja lijekom Epclusa u usporedbi s 24 tjedna liječenja sa SOF + RBV u bolesnika koji su imali infekciju HCV-om genotipa
English: Velpatasvir is a substrate of CYP2B6, CYP2C8, and CYP3A4 with slow turnover.
Croatian: Velpatasvir je supstrat CYP2B6, CYP2C8 i CYP3A4 sa sporom metaboličkom izmjenom.
English: Co-administration of Epclusa with efavirenz-containing regimens is not recommended (see section 4.4).
Croatian: Istodobna primjena lijeka Epclusa s režimima koji sadrže efavirenz se ne preporučuje (vidjeti dio 4.4).
English: Epclusa should not affect your ability to drive or use any tools or machinery.
Croatian: Upravljanje vozilima i strojevima Lijek Epclusa ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: f Bioequivalence/Equivalence boundary 80-125%.
Croatian: f. Granica bioekvivalencija/ekvivalencije 80 %-125 %. g. Raspon u kojem nema farmakokinetičkih interakcija 50 %-200 %.
English: Ethinyl estradiol a Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
Croatian: Srednja vrijednost omjera (90 % CI) farmakokinetičkih parametara lijekova istodobno primijenjenih s jednim ispitivanim lijekom ili u kombinaciji s oba ispitivana lijeka.
English: Table 11 presents the SVR12 for the ASTRAL-2 study.
Croatian: U tablici 11 predstavljen je SVR12 za ispitivanje ASTRAL-2.
English: Co-administration of Epclusa with rifapentine is expected to decrease the concentration of sofosbuvir and velpatasvir, leading to reduced therapeutic effect of
Croatian: Očekuje se da će istodobna primjena lijeka Epclusa s rifapentinom smanjiti koncentraciju sofosbuvira i velpatasvira i tako dovesti do smanjenog terapijskog učinka lijeka Epclusa.
English: Table 12 presents the SVR12 for the ASTRAL-3 study.
Croatian: U tablici 12 predstavljen je SVR12 za ispitivanje ASTRAL-3.
English: Genotype 2 HCV-infected adults - ASTRAL-2 (study 1139) ASTRAL-2 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of treatment with SOF+RBV in patients with genotype 2 HCV infection.
Croatian: Odrasli zaraženi HCV-om genotipa 2 - ASTRAL-2 (ispitivanje 1139) ASTRAL-2 bilo je randomizirano, otvoreno ispitivanje u kojem se procjenjivalo 12 tjedana liječenja lijekom Epclusa u usporedbi s 12 tjedna liječenja SOF+RBV u bolesnika koji su imali infekciju HCV-om genotipa