FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use with medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort) (see section 4.5).
Croatian: Istodobna primjena s lijekovima koji su jaki induktori P-glikoproteina (P-gp) i/ili jaki induktori citokroma P450 (CYP) (npr. karbamazepin, fenobarbital, fenitoin, rifampicin, rifabutin i gospina trava) (vidjeti dio 4.5).
English: Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication.
Croatian: Sofosbuvir je pan-genotipski inhibitor HCV NS5B RNK-ovisne RNK polimeraze, koja je potrebna za replikaciju virusa.
English: Of these 21 patients, 1 patient had virus with emergent NS5A RAVs Q30R and L31M at failure.
Croatian: Od 21 bolesnika, 1 bolesnik imao je virus u kojem su nastali NS5A RAV-ovi Q30R i L31M pri neuspjehu.
English: Colloidal anhydrous silica, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose
Croatian: Koloidni bezvodni silicijev dioksid, kopovidon, umrežena karmelozanatrij, laktoza hidrat, magnezijev stearat, mikrokristalična celuloza
English: Patients should be instructed that if vomiting occurs within 4 hours of dosing an additional tablet of Vosevi should be taken.
Croatian: Bolesnicima je potrebno savjetovati da uzmu dodatnu tabletu lijeka Vosevi ako je povraćanje nastupilo unutar 4 sata od uzimanja doze.
English: Vosevi 400 mg/100 mg/100 mg film-coated tablets
Croatian: NAZIV LIJEKA Vosevi 400 mg/100 mg/100 mg filmom obložene tablete
English: Velpatasvir and voxilaprevir are inhibitors of drug transporters P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3.
Croatian: Velpatasvir i voksilaprevir inhibitori su prijenosnika lijekova P-gp-a, proteina rezistencije raka dojke (engl. breast cancer resistance protein, BCRP), polipeptida za prijenos organskih aniona (engl. organic anion transporting polypeptide, OATP) 1B1 i OATP1B3.
English: Proton pump inhibitors may be administered with Vosevi at a dose that does not exceed doses comparable with omeprazole 20 mg.
Croatian: Inhibitori protonske pumpe mogu se primijeniti s lijekom Vosevi u dozi koja nije veća od doze usporedive s dozom omeprazola od 20 mg.
English: SVR12 was achieved in all 39 patients who had baseline NS5B NI RAVs in POLARIS-2 and 2 of 3 (67%) patients in POLARIS-3.
Croatian: SVR12 postignut je u svih 39 bolesnika s početnim NS5B NI RAV-ovima u ispitivanju POLARIS-2 i 2 od 3 (67 %) bolesnika u ispitivanju POLARIS-3.
English: Unchanged voxilaprevir was the major species in faeces accounting for a mean of 40% of the administered dose.
Croatian: Nepromijenjeni je voksilaprevir bio glavni oblik u stolici sa srednjim udjelom od 40 % primijenjene doze.
English: Patients receiving Vosevi 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 Vosevi istodobno s elvitegravirom/kobicistatom/emtricitabinom/tenofovirdizoproksilfumaratom ili s tenofovirdizoproksilfumaratom i pojačanim inhibitorom HIV proteaze treba pratiti radi nuspojava povezanih s tenofovirom.
English: NS5A inhibitorexperienced patients, GT1-6, with or without cirrhosis
Croatian: Bolesnici koji su bili liječeni NS5A inhibitorom, GT1-6, s cirozom ili bez nje
English: Voxilaprevir, and to a lesser extent velpatasvir, are also substrates of OATP1B1 and OATP1B3.
Croatian: Voksilaprevir, a u manjoj mjeri i velpatasvir, također su supstrati OATP1B1 i OATP1B3.
English: Replicons containing NS3 protease from clinical isolates
Croatian: Replikoni koji sadrže NS3 proteazu iz kliničkih izolata
English: The median time between prior DAA failure and first dose of Vosevi or sofosbuvir/velpatasvir for patients enrolled into POLARIS-4 was 76 weeks (range: 10 to 549 weeks).
Croatian: Medijan vremena između prethodnog neuspjeha liječenja direktno djelujućim antivirusnim lijekovima i prve doze lijeka Vosevi ili sofosbuvira/velpatasvira u bolesnika uključenih u ispitivanje POLARIS-4 iznosio je 76 tjedana (raspon: od 10 do 549 tjedana).
English: The potential risks and benefits associated with co-administration of Vosevi 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. 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 Vosevi s tabletom fiksne kombinacije koja sadrži elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilfumarat ili tenofovirdizoproksilfumaratom danim zajedno s pojačanim inhibitorom HIV proteaze (npr. darunavirom), naročito kod bolesnika s povećanim rizikom od disfunkcije bubrega.
English: Table 5: Activity of sofosbuvir, velpatasvir and voxilaprevir against transient replicons containing NS5A, NS5B or NS3 protease from clinical isolates
Croatian: Tablica 5: Djelotvornost sofosbuvira, velpatasvira i voksilaprevira protiv prolaznih replikona koji sadrže NS5A, NS5B ili NS3 proteazu iz kliničkih izolata Genotip replikona
English: HCV/HBV co-infection
Croatian: Istodobna infekcija HCV-om/HBV-om
English: HMG-CoA REDUCTASE INHIBITORS Atorvastatin
Croatian: INHIBITORI HMG-CoA REDUKTAZE
English: The 50% effective concentration (EC50) values of sofosbuvir, velpatasvir and voxilaprevir against full-length or chimeric replicons encoding NS5B, NS5A and NS3 protease sequences from the laboratory strains are presented in Table 4.
Croatian: Vrijednosti 50 % učinkovite koncentracije (EC50) sofosbuvira, velpatasvira i voksilaprevira protiv replikona pune duljine ili kimeričkih replikona koji kodiraju sekvence NS5B, NS5A i NS3 proteaza iz laboratorijskih sojeva navedene su u tablici 4. Vrijednosti EC50 sofosbuvira, velpatasvira i voksilaprevira protiv kliničkih izolata navedene su u tablici 5.
English: • If you are sick (vomit) less than 4 hours after taking Vosevi, take another tablet.
Croatian: • Ako povratite u razdoblju kraćem od 4 sata nakon uzimanja lijeka Vosevi, uzmite drugu tabletu.
English: The pharmacokinetic properties of sofosbuvir, GS-331007, velpatasvir and voxilaprevir have been evaluated in healthy adult subjects and in patients with chronic hepatitis C.
Croatian: Farmakokinetička svojstva sofosbuvira, GS-331007, velpatasvira i voksilaprevira ocijenjena su u zdravih odraslih ispitanika i u bolesnika s kroničnim hepatitisom C.
English: For both velpatasvir and voxilaprevir, combinations of RAVs often showed greater reductions in susceptibility than individual RAVs alone.
Croatian: Kombinacije RAV-ova često su pokazivale veća smanjenja osjetljivosti i na velpatasvir i na voksilaprevir nego sami pojedinačni RAV-ovi.
English: Renal impairment No dose adjustment of Vosevi is required for patients with mild or moderate renal impairment.
Croatian: Nije potrebna prilagodba doze lijeka Vosevi u bolesnika s blagim ili umjerenim oštećenjem bubrega.
English: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, multidrug resistanceassociated protein 2 (MRP2), bile salt export pump (BSEP), OATP1B1, OATP1B3 and organic cation transporter (OCT) 1 and GS-331007 is not an inhibitor of OAT1, OAT3, OCT2, and multidrug and toxin extrusion protein (MATE) 1.
Croatian: Sofosbuvir i GS-331007 nisu inhibitori prijenosnika lijekova P-gp-a, BCRP-a, proteina povezanog s rezistencijom na više lijekova 2 (engl. multidrug resistance-associated protein 2, MRP2), pumpe za izlučivanje žučnih soli (engl. bile salt export pump, BSEP), OATP1B1, OATP1B3 i prijenosnika organskih kationa (OCT) 1, a GS-331007 nije inhibitor OAT1, OAT3, OCT2 i proteina ekstruzije više lijekova i toksina (engl. multidrug and toxin extrusion protein, MATE) 1. Sofosbuvir i GS-331007 nisu ni inhibitori niti induktori enzima CYP ili uridin glukuronoziltransferaze (UGT) 1A1.
English: Iron oxide black (E172) Iron oxide red (E172) Iron oxide yellow (E172)
Croatian: Film ovojnica željezov oksid, crni (E172) željezov oksid, crveni (E172) željezov oksid, žuti (E172) makrogol poli(vinilni alkohol)
English: Interaction only studied with sofosbuvir/ velpatasvir.
Croatian: Interakcija je ispitana samo sa sofosbuvirom/velpatasvirom
English: Sofosbuvir, velpatasvir and voxilaprevir are substrates of drug transporters P-gp and BCRP.
Croatian: Sofosbuvir, velpatasvir i voksilaprevir supstrati su prijenosnika lijekova P-gp-a i BCRP-a.
English: Patients receiving tenofovir disoproxil fumarate and Vosevi concomitantly should be monitored for adverse reactions associated with tenofovir disoproxil fumarate.
Croatian: Bolesnike koji istodobno primaju tenofovirdizoproksilfumarat i lijek Vosevi treba pratiti radi nuspojava povezanih s tenofovirdizoproksilfumaratom.
English: The efficacy of Vosevi (sofosbuvir [SOF]/velpatasvir [VEL]/voxilaprevir [VOX]) was evaluated in four Phase 3 studies, two studies in DAA-experienced patients and two studies in DAA-naïve patients with, genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis, as summarised in Table 8.
Croatian: Djelotvornost lijeka Vosevi (sofosbuvir[SOF]/velpatasvir [VEL]/voksilaprevir [VOX]) procijenjena je u četirima ispitivanjima faze 3, dva ispitivanja u bolesnika koji su prethodno bili liječeni direktno djelujućim antivirusnim lijekovima i dva ispitivanja u bolesnika koji prethodno nisu bili liječeni direktno djelujućim antivirusnim lijekovima s infekcijom HCV-om genotipa 1 do 6 bez ciroze ili s kompenziranom cirozom, kako je sažeto prikazano u tablici 8.
English: The median terminal half-life of voxilaprevir following administration of Vosevi was approximately 33 hours.
Croatian: Nakon primjene lijeka Vosevi, medijan terminalnog poluvijeka voksilaprevira iznosio je približno 33 sata.
English: Voxilaprevir is an inhibitor of drug transporters P-gp, BCRP, OATP1B1 and OATP1B3, and its involvement in drug interactions with these transporters is primarily limited to the process of absorption.
Croatian: Voksilaprevir je inhibitor prijenosnika lijekova P-gp-a, BCRP-a, OATP1B1 i OATP1B3, a njegovu uključenost u interakcije lijekova s ovim prijenosnicima prvenstveno ograničava process apsporpcije.
English: Co-administration of Vosevi with edoxaban is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka Vosevi s edoksabanom.
English: Velpatasvir is an inhibitor of drug transporter P-gp, BCRP, OATP1B1, OATP1B3 and OATP2B1, and its involvement in drug interactions with these transporters is primarily limited to the process of absorption.
Croatian: Velpatasvir je inhibitor prijenosnika lijekova P-gp-a, BCRP-a, OATP1B1, OATP1B3 i OATP2B1, a njegova uključenost u interakcije lijekova s ovim prijenosnicima primarno je ograničena procesom apsorpcije.
English: DAA-experienced patients (who have not received an NS5A inhibitor), GT1-6, with or without cirrhosis
Croatian: Bolesnici koji su bili liječeni direktno djelujućim antivirusnim lijekovima (koji nisu primali NS5A inhibitor), GT1-6, s cirozom ili bez nje
English: Following a single dose of 100 mg [14C]-velpatasvir, the majority (> 98%) of radioactivity in plasma was parent drug.
Croatian: Nakon jedne doze od 100 mg [14C]-velpatasvira, većina (> 98 %) radioaktivnosti u plazmi bila je od ishodišnog lijeka.
English: Vosevi may be co-administered with P-gp, BCRP and CYP inhibitors.
Croatian: Vosevi se može istodobno primjenjivati s inhibitorima P-gp-a, BCRP-a i CYP-a.
English: Unchanged voxilaprevir is the major species present in faeces.
Croatian: Nepromijenjeni voksilaprevir je glavni oblik prisutan u stolici.
English: Table 10: SVR12 in NS5A-inhibitor experienced patients by HCV genotype in study POLARIS-1*
Croatian: Tablica 10: SVR12 u bolesnika koji su prethodno bili liječeni NS5A inhibitorom prema genotipu HCV-a u ispitivanju POLARIS-1*
English: Both of these patients had virus with emergent NS5A RAV Y93H at failure.
Croatian: Oba ta bolesnika imali su virus u kojem je nastao NS5A RAV Y93H pri neuspjehu.
English: Of the 263 NS5A inhibitor-experienced patients treated with sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in POLARIS-1 (see Table 10), 7 of 263 (3%) patients (2 with genotype 1, 4 with genotype 3, and 1 with genotype 4) did not achieve sustained virologic response (SVR12) and qualified for resistance analysis; 6 relapsed and 1 experienced virologic breakthrough with pharmacokinetic data consistent with nonadherence.
Croatian: Ispitivanja u bolesnika koji su prethodno bili liječeni direktno djelujućim antivirusnim lijekovima Od 263 bolesnika prethodno liječenih inhibitorom NS5A koji su primali sofosbuvir/velpatasvir/voksilaprevir tijekom 12 tjedana u ispitivanju POLARIS-1 (vidjeti tablicu 10), 7 od 263 (3 %) bolesnika (dva s genotipom 1, 4 s genotipom 3 i 1 s genotipom 4) nije postiglo održan virološki odgovor (engl. sustained virologic response, SVR12) i kvalificiralo se za analizu rezistencije; 6 je imalo relaps, a u 1 je došlo do virološkog proboja s time da su farmakokinetički podaci bili sukladni nepridržavanju terapije.
English: Relative to healthy subjects (n = 137), velpatasvir AUC0-24 and Cmax were 41% lower and 39% lower, respectively, in HCV-infected patients.
Croatian: U odnosu na one u zdravih ispitanika (n = 137), vrijednosti AUC0-24 i Cmax velpatasvira bile su u bolesnika zaraženih HCV-om 41 % niže odnosno 39 % niže.
English: This may make Vosevi work less well.
Croatian: To može oslabiti djelovanje lijeka Vosevi.
English: Rifampicin (multiple dose) (Induction of P-gp and CYPs)
Croatian: Rifampicin (višestruka doza) (Indukcija P-gp-a i CYP-ova)
English: The median terminal half-life of velpatasvir following administration of Vosevi was approximately 17 hours.
Croatian: Nakon primjene lijeka Vosevi, medijan terminalnog poluvijeka velpatasvira iznosio je približno 17 sati.
English: Omeprazole dosed 2 hours prior to Vosevi
Croatian: Omeprazol primijenjen 2 sata prije lijeka Vosevi
English: Population pharmacokinetic analysis in HCV-infected patients indicated that cirrhosis (CPT Class A) had no clinically relevant effect on the exposure of velpatasvir.
Croatian: Analiza populacijske farmakokinetike u bolesnika zaraženih HCV-om pokazala je da ciroza (CPT stadij A) nije imala klinički relevantni učinak na izloženost velpatasviru.
English: Table 13: SVR12 by HCV genotype and virologic outcome in patients who received Vosevi 8 weeks without cirrhosis or with cirrhosis in study POLARIS-2
Croatian: Tablica 13: SVR12 prema gentipu HCV-a i virološkom ishodu u bolesnika bez ciroze ili s cirozom koji su primali lijek Vosevi 8 tjedana u ispitivanju POLARIS-2
English: Medicinal products that may increase plasma exposure of Vosevi Co-administration with medicinal products that inhibit P-gp or BCRP may increase sofosbuvir, velpatasvir or voxilaprevir plasma concentrations.
Croatian: Lijekovi koji mogu povećati izloženost lijeku Vosevi u plazmi Istodobna primjena s lijekovima koji inhibiraju P-gp ili BCRP može povisiti koncentracije sofosbuvira, velpatasvira ili voksilaprevira u plazmi.
English: Vosevi 400 mg/100 mg/100 mg film-coated tablets sofosbuvir/velpatasvir/voxilaprevir
Croatian: Vosevi 400 mg/100 mg/100 mg filmom obložene tablete sofosbuvir/velpatasvir/voksilaprevir
English: Co-administration of strong OATP1B inhibitors with Vosevi is not recommended (see section 4.5).
Croatian: Istodobna primjena jakih inhibitora OATP1B s lijekom Vosevi se ne preporučuje (vidjeti dio 4.5).
English: Adverse drug reaction Nervous system disorders:
Croatian: Poremećaji živčanog sustava:
English: ANTIMYCOBACTERIALS Rifampicin (single dose)
Croatian: Rifampicin (jedna doza)
English: c. Lack of pharmacokinetics interaction lower bound 70%.
Croatian: c. Donja granica raspona u kojem nema farmakokinetičkih interakcija 70 %.
English: The use of such medicinal products with Vosevi is contraindicated (see section 4.3 and Table 2).
Croatian: Primjena takvih lijekova s lijekom Vosevi je kontraindicirana (vidjeti dio 4.3 i tablicu 2).
English: DAA-naïve patients, GT 1, 2, 4, 5, or 6, with or without cirrhosis GT 3 without cirrhosis
Croatian: Bolesnici koji nisu bili liječeni direktno djelujućim antivirusnim lijekom, GT 1, 2, 4, 5, ili 6, s cirozom ili bez nje GT 3 bez ciroze
English: Therefore, Vosevi should not be used during breast-feeding.
Croatian: Stoga se lijek Vosevi ne bi trebao primjenjivati tijekom dojenja.
English: No dose adjustment of Vosevi is required for patients with mild hepatic impairment (Child-PughTurcotte [CPT] Class A).
Croatian: Nije potrebna prilagodba doze lijeka Vosevi u bolesnika s blagim oštećenjem jetre (Child-PughTurcotte [CPT] stadij A).
English: • If you are allergic to sofosbuvir, velpatasvir, voxilaprevir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Croatian: • Ako ste alergični na sofosbuvir, velpatasvir, voksilaprevir ili neki drugi sastojak ovog lijeka
English: Vosevi should not affect your ability to drive or use any tools or machinery.
Croatian: Upravljanje vozilima i strojevima Vosevi ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
Croatian: Vrijednosti AUC0-24 i Cmax sofosbuvira i GS-331007 bile su slične u zdravih odraslih ispitanika i u bolesnika zaraženih HCV-om.
English: P-gp or BCRP)
Croatian: BCRP-a)
English: Potential for Vosevi to affect other medicinal products
Croatian: Mogućnost utjecaja lijeka Vosevi na druge lijekove
English: The use of strong inhibitors of OATP1B (e.g. ciclosporin) with Vosevi is not recommended (see section 4.4 and Table 2).
Croatian: Ne preporučuje se primjena jakih inhibitora OATP1B-a (npr. ciklosporina) s lijekom Vosevi (vidjeti dio 4.4 i tablicu 2).
English: It is unknown whether sofosbuvir, metabolites of sofosbuvir, velpatasvir or voxilaprevir are excreted in human milk.
Croatian: Nije poznato izlučuju li se sofosbuvir, njegovi metaboliti, velpatasvir ili voksilaprevir u majčino mlijeko.
English: No NS3 or NS5A RAVs Any NS3 or NS5A RAV NS3 only NS5A only NS3 and NS5A RAVs not determined for both NS3 and NS5Aa a. Patients with NS3 and/or NS5A gene sequencing failure.
Croatian: Bez NS3 ili NS5A RAV-ova Bilo koji NS3 ili NS5A RAV Samo NS3 Samo NS5A NS3 i NS5A RAV-ovi nisu bili utvrđeni ni za NS3 ni za NS5Aa a.
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (CPT Class A) 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 (CPT stadij A) nije imala klinički relevantni učinak na izloženost sofosbuviru i GS-331007.
English: Cases of HBV reactivation, some of them fatal, have been reported during or after treatment with DAAs.
Croatian: Zabilježeni su slučajevi reaktivacije HBV-a tijekom ili nakon liječenja direktno djelujućim antivirusnim lijekovima, od kojih su neki imali smrtni ishod.
English: How to store Vosevi
Croatian: Kako čuvati lijek Vosevi
English: How to take Vosevi
Croatian: Kako uzimati lijek Vosevi
English: Velpatasvir median peak concentrations were observed at 4 hours post-dose.
Croatian: Medijan vršne koncentracije velpatasvira opažen je 4 sata nakon uzimanja doze.
English: Omeprazole dosed 4 hours after Vosevi
Croatian: Omeprazol primijenjen 4 sata nakon lijeka Vosevi
English: EU/1/17/1223/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1223/001
English: Velpatasvir Voxilaprevir ↔ ↔
Croatian: Velpatasvir Voksilaprevir ↔ ↔
English: There were no patients receiving sofosbuvir/velpatasvir/voxilaprevir for 12 weeks who permanently discontinued treatment due to adverse reactions.
Croatian: Među bolesnicima koji su primali sofosbuvir/velpatasvir/voksilaprevir tijekom 12 tjedana nije bilo onih koji su trajno prekinuli liječenje zbog nuspojava.
English: Methadone (Methadone maintenance therapy [30 to 130 mg daily]) + sofosbuvir (400 mg once daily)f
Croatian: Metadon (terapija održavanja metadonom [30 do 130 mg na dan]) + sofosbuvir (400 mg jedanput na dan)f
English: Co-administration of Vosevi with atazanavircontaining regimens is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka Vosevi s režimima koji sadrže atazanavir.
English: Observed: Velpatasvir ↑
Croatian: Velpatasvir ↑
English: Voxilaprevir is a pan-genotypic inhibitor of the HCV NS3/4A protease.
Croatian: Voksilaprevir je pan-genotipski inhibitor NS3/4A proteaze HCV-a.
English: If you are sick (vomit) after taking Vosevi it may affect the amount of Vosevi in your blood.
Croatian: Ako povratite nakon uzimanja lijeka Vosevi, to može utjecati na količinu lijeka Vosevi u Vašoj krvi.
English: Of the 182 DAA-experienced patients treated with sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in POLARIS-4 (see Table 11), 1 of 182 (1%) patients relapsed and qualified for resistance analysis.
Croatian: Od 182 bolesnika prethodno liječenih direktno djelujućim antivirusnim lijekovima koji su primali sofosbuvir/velpatasvir/voksilaprevir tijekom 12 tjedana u ispitivanju POLARIS-4 (vidjeti tablicu 11), 1 od 182 (1 %) bolesnika imao je relaps i kvalificirao se za analizu rezistencije.
English: h. Administered as sofosbuvir, velpatasvir fixed-dose combination.
Croatian: h. Primjenjivani kao fiksna kombinacija sofosbuvira i velpatasvira.
English: Of these 3 patients, 1 patient (33%) had virus with emergent NS5A RAV Y93N at failure.
Croatian: 1 bolesnik (33%) imao je virus u kojem je nastao NS5A RAV Y93N pri neuspjehu.
English: Edoxaban (Inhibition of OATP1B1)
Croatian: Edoksaban (Inhibicija OATP1B1)
English: Following a single dose of 100 mg [14C]-voxilaprevir, the majority (approximately 91%) of radioactivity in plasma was parent drug.
Croatian: Nakon jedne doze od 100 mg [14C]-voksilaprevira, većina (približno 91 %) radioaktivnosti u plazmi bila je od ishodišnog lijeka.
English: No dose adjustment of Vosevi is required for patients with mild hepatic impairment (CPT Class A).
Croatian: Nije potrebna prilagodba doze lijeka Vosevi u bolesnika s blagim oštećenjem jetre (CPT stadij A).
English: • The active substances are sofosbuvir, velpatasvir and voxilaprevir.
Croatian: • Djelatne tvari su sofosbuvir, velpatasvir i voksilaprevir.
English: Othere a. Two patients without cirrhosis with undetermined genotype in the SOF/VEL/VOX group achieved SVR12.
Croatian: Dva bolesnika bez ciroze s neodređenim genotipom u skupini koja je primala SOF/VEL/VOX postigla su SVR12.
English: Interactions between Vosevi and other medicinal products
Croatian: Interakcije lijeka Vosevi s drugim lijekovima
English: Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 and Cmax for sofosbuvir (n = 1038) were 1665 ng•hr/mL and 678 ng/mL, respectively; mean steady-state AUC0-24 and Cmax for GS-331007 (n = 1593) were 12834 ng•hr/mL and 744 ng/mL, respectively.
Croatian: Na temelju analize populacijske farmakokinetike u bolesnika zaraženih HCV-om, srednje vrijednosti AUC0-24 i Cmax u stanju dinamičke ravnoteže za sofosbuvir (n = 1038) iznosile su 1665 ng•h/ml odnosno 678 ng/ml; srednje vrijednosti AUC0-24 i Cmax u stanju dinamičke ravnoteže za GS-331007 (n = 1593) iznosile su 12 834 ng•h/ml odnosno 744 ng/ml.
English: In the sofosbuvir/velpatasvir 12-week treatment group, a total of 3 of 440 (1%) patients (2 with genotype 1, 1 with genotype 4) qualified for resistance analysis due to relapse.
Croatian: U skupini liječenoj sofosbuvirom/velpatasvirom tijekom 12 tjedana, ukupno 3 od 440 (1%) bolesnika (2 s genotipom 1, 1 s genotipom 4) kvalificirao za analizu rezistencije zbog relapsa.
English: Observed: Efavirenz Sofosbuvir
Croatian: Efavirenz Sofosbuvir
English: Vosevi contains lactose monohydrate.
Croatian: Vosevi sadrži laktozu hidrat.