FrancophonIA/ELRC3.0 huggingface dataset:
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: No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007, velpatasvir or voxilaprevir.
Croatian: Nisu utvrđene nikakve klinički relevantne razlike u farmakokinetici sofosbuvira, GS-331007, velpatasvira ili voksilaprevira kojima bi uzrok bila rasa ili spol.
English: Table 9: Demographics and baseline characteristics for patients enrolled into POLARIS-1, -2, -3 and -4
Croatian: Tablica 9: Demografska slika i početne značajke bolesnika uključenih u ispitivanja POLARIS-1,
English: Vosevi is contraindicated with ethinylestradiol-containing medicinal products (see section 4.3).
Croatian: Vosevi je kontraindiciran s lijekovima koji sadrže etinilestradiol (vidjeti dio 4.3).
English: Velpatasvir is primarily a substrate of CYP2B6, CYP2C8, and CYP3A4 with slow turnover.
Croatian: Velpatasvir je prvenstveno supstrat CYP2B6, CYP2C8 i CYP3A4 sa sporom metaboličkom izmjenom.
English: Interaction only studied with voxilaprevir.
Croatian: Interakcija je ispitana samo s voksilaprevirom.
English: a. Two patients with undetermined genotype in the SOF/VEL/VOX group achieved SVR12.
Croatian: Dva bolesnika s neodređenim genotipom u skupini koja je primala SOF/VEL/VOX postigla su SVR12.
English: • outer cartons containing 1 bottle of 28 film-coated tablets
Croatian: Dostupna je sljedeća veličina pakiranja: • kutije koje sadrže 1 bočicu s 28 filmom obloženih tableta
English: Voxilaprevir is primarily a substrate of CYP3A4 with slow turnover.
Croatian: Voksilaprevir je prvenstveno supstrat CYP3A4 sa sporom metaboličkom izmjenom.
English: Voxilaprevir median peak concentrations were observed 4 hours post-dose.
Croatian: Medijan vršne koncentracije voksilaprevira opažen je 4 sata nakon uzimanja doze.
English: Observed: Darunavir
Croatian: Darunavir
English: Sofosbuvir and GS-331007 AUCs are near dose-proportional over the dose range of 200 mg to 1200 mg. Velpatasvir AUC increases in a greater than proportional manner from 5 to 50 mg and in a less than proportional manner from 50 to 450 mg, indicating velpatasvir absorption is solubility limited.
Croatian: AUC velpatasvira povećava se više nego proporcionalno dozi u rasponu doza od 5 do 50 mg, a manje nego proporcionalno u rasponu doza od 50 do 450 mg, što ukazuje na to da je apsorpcija velpatasvira ograničena topljivošću.
English: In vitro, slow metabolic turnover of velpatasvir primarily by CYP2B6, CYP2C8 and CYP3A4 and of voxilaprevir primarily by CYP3A4 was observed.
Croatian: In vitro je opažena spora metabolička izmjena velpatasvira prvenstveno putem CYP2B6, CYP2C8 i CYP3A4, a voksilaprevira prvenstveno putem CYP3A4.
English: Norgestrel Ethinyl estradiol
Croatian: Norgestrel Etinilestradio l
English: Effect on velpatasvir or voxilaprevir exposure not studied.
Croatian: Učinak na izloženost velpatasviru ili voksilapreviru nije ispitan.
English: No dose adjustment of Vosevi, darunavir (ritonavir boosted) or emtricitabine/tenofovir disoproxil fumarate is required.
Croatian: Nije potrebna prilagodba doze lijeka Vosevi, darunavira (pojačanog ritonavirom) ili emtricitabina/tenofovirdizopro ksilfumarata.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Vosevi.
Croatian: Nakon što počnete uzimati lijek Vosevi, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijek protiv šećerne bolesti.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir, voxilaprevir or Vosevi in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni sofosbuvira, velpatasvira, voksilaprevira ili lijeka Vosevi u trudnica ograničeni (manje od 300 trudnoća).
English: No dose adjustment of Vosevi or ketoconazole is required.
Croatian: Nije potrebna prilagodba doze lijeka Vosevi ili ketokonazola.
English: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose
Croatian: Jezgra tablete koloidni bezvodni silicijev dioksid kopovidon umrežena karmelozanatrij laktoza hidrat magnezijev stearat mikrokristalična celuloza
English: Concomitant use with rosuvastatin or dabigatran etexilate (see section 4.5).
Croatian: Istodobna primjena s rosuvastatinom ili dabigatraneteksilatom (vidjeti dio 4.5).
English: Velpatasvir and voxilaprevir are substrates of drug transporters OATP1B1 and OATP1B3.
Croatian: Velpatasvir i voksilaprevir također su supstrati prijenosnika lijekova OATP1B1 i OATP1B3.
English: Voxilaprevir ↔ ↔ ↔
Croatian: Voksilaprevir ↔ ↔ ↔
English: Medicinal products that may decrease plasma exposure of Vosevi Medicinal products that are strong inducers of P-gp and/or strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort) may decrease plasma concentrations of sofosbuvir, velpatasvir and/or voxilaprevir leading to reduced therapeutic effect of Vosevi.
Croatian: Lijekovi koji mogu smanjiti izloženost lijeku Vosevi u plazmi Lijekovi koji su jaki induktori P-gp-a i/ili jaki induktori CYP2B6, CYP2C8 ili CYP3A4 (npr. karbamazepin, fenobarbital, fenitoin, rifampicin, rifabutin i gospina trava) mogu smanjiti koncentracije sofosbuvira, velpatasvira i/ili voksilaprevira u plazmi i tako dovesti do smanjenog terapijskog učinka lijeka Vosevi.
English: At clinically relevant concentrations, velpatasvir is not an inhibitor of hepatic transporters BSEP, sodium taurocholate cotransporter protein (NTCP), OATP1A2 or OCT1, renal transporters OCT2, OAT1, OAT3, MRP2 or MATE1, or CYP or UGT1A1 enzymes.
Croatian: Pri klinički relevantnoj koncentraciji, velpatasvir nije inhibitor jetrenih prijenosnika pumpe za izbacivanje žučnih soli (engl. bile salt export pump, BSEP), natrij taurokolat kotransportnog proteina (engl. sodium taurocholate cotransporter protein, NTCP), OATP2B1 ili OCT1, bubrežnih prijenosnika OCT2, OAT1, OAT3, MRP2 ili MATE1 ili enzima CYP ili UGT1A1.
English: Vosevi contains lactose • Tell your doctor if you are lactose intolerant or intolerant to other sugars.
Croatian: • Obavijestite liječnika ako ne podnosite laktozu ili druge šećere.
English: Based on the population pharmacokinetic analysis in HCV-infected patients mean steady-state AUC0-24 and Cmax for voxilaprevir (n = 1591) were 2577 ng•hr/mL and 192 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 voksilaprevir (n = 1591) iznosile su 2577 ng•h/ml odnosno 192 ng/ml.
English: Suomi/Finland
Croatian: Hispano/Latino
English: Velpatasvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 3-fold higher than the human exposure at the recommended clinical dose.
Croatian: Nije bilo štetnih učinaka velpatasvira na ponašanje, reprodukciju ili razvoj potomstva u ispitivanjima prenatalnog i postnatalnog razvoja u štakora pri AUC izloženostima približno za 3 puta većim od ljudske izloženosti pri preporučenoj kliničkoj dozi.
English: Genotype 5
Croatian: Genotip 5
English: Efavirenz/emtricitabine/
Croatian: Emtricitabin/rilpivirin/
English: Atorvastatin may be administered with Vosevi at a dose that does not exceed atorvastatin 20 mg.
Croatian: Atorvastatin se može primijeniti s lijekom Vosevi u dozi koja nije viša od 20 mg atorvastatina.
English: Very common diarrhoea, nausea Common abdominal pain, decreased appetite, vomiting Skin and subcutaneous disorders: Uncommon rash
Croatian: Često bol u abdomenu, smanjeni apetit, povraćanje
English: Vosevi contains lactose.
Croatian: Vosevi sadrži laktozu.
English: Voxilaprevir
Croatian: Voksilaprevir
English: No teratogenic effects were observed in the mouse and rat developmental toxicity studies with velpatasvir at AUC exposures approximately 23- and 4-fold higher, respectively, than the human exposure at the recommended clinical dose.
Croatian: Nisu opaženi teratogeni učinci u ispitivanjima razvojne toksičnosti s velpatasvirom na miševima i štakorima pri izloženostima AUC približno za 23 odnosno 4 puta većim od ljudske izloženosti pri preporučenoj kliničkoj dozi.
English: Adults previously treated with sofosbuvir/velpatasvir-containing regimens Vosevi for 12 weeks was evaluated in patients who were previously treated with a sofosbuvir/velpatasvir-containing regimen.
Croatian: Liječenje lijekom Vosevi tijekom 12 tjedana ocijenjeno je u bolesnika koji su prethodno liječeni režimom koji sadrži sofosbuvir/velpatasvir.
English: Digoxin (0.25 mg single dose)e + velpatasvir (100 mg single dose)
Croatian: Digoksin (jedna doza od 0,25 mg)e + velpatasvir (jedna doza od 100 mg)
English: Ciclosporin (600 mg single dose)f +
Croatian: Ciklosporin (jedna doza od 600 mg) f +
English: (Inhibition of P-gp and CYP3A)
Croatian: (Inhibicija P-gp-a i CYP3A)
English: ACID REDUCING AGENTS Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Croatian: Antacidi npr. aluminijev ili magnezijev hidroksid, kalcijev karbonat
English: The median terminal half-lives of sofosbuvir and GS-331007 following administration of Vosevi were 0.5 and 29 hours, respectively.
Croatian: Nakon primjene lijeka Vosevi, medijan terminalnog poluvijeka sofosbuvira iznosio je 0,5 sati, a GS-331007 29 sati.
English: In the POLARIS-3 sofosbuvir/velpatasvir/voxilaprevir 8-week treatment group (see Table 14), 2 of 110 (2%) patients (genotype 3) qualified for resistance analysis due to relapse.
Croatian: U skupini liječenoj sofosbuvirom/velpatasvirom/voksilaprevirom tijekom 8 tjedana u ispitivanju POLARIS-3 (vidjeti tablicu 14), 2 od 110 (2 %) bolesnika (genotip 3) kvalificiralo se za analizu rezistencije zbog relapsa.
English: Interaction only studied with velpatasvir.
Croatian: Interakcija je ispitana samo s velpatasvirom.
English: (Inhibition of OATP1B and BCRP)
Croatian: (Inhibicija OATP1B i BCRP-a)
English: Vosevi is contraindicated with phenobarbital and phenytoin (see section 4.3).
Croatian: Vosevi je kontraindiciran s fenobarbitalom i fenitoinom (vidjeti dio 4.3).
English: Table 6: SVR12 in DAA-experienced patients with or without baseline NS3 or NS5A RAVs by study sofosbuvir/velpatasvir/voxilaprevir 12 weeks POLARIS-1 (n = 260)
Croatian: Tablica 6: SVR12 u bolesnika koji su prethodno bili liječeni direktno djelujućim antivirusnim lijekovima s početnim NS3 ili NS5A RAV-ovima ili bez njih, prema ispitivanju sofosbuvir/velpatasvir/voksilaprevir 12 tjedana POLARIS-1 (n = 260)
English: ↑ Edoxaban (active metabolite) ↔ Sofosbuvir ↔ Velpatasvir ↔ Voxilaprevir
Croatian: ↑ Edoksaban (aktivni metabolit) ↔ Sofosbuvir ↔ Velpatasvir ↔ Voksilaprevir
English: Interaction only studied with velpatasvir and voxilaprevir.
Croatian: Interakcija ispitana samo s velpatasvirom i voksilaprevirom.
English: Based on the population pharmacokinetic analysis in HCV-infected patients mean steady-state AUC0-24 and Cmax for velpatasvir (n = 1595) were 4041 ng•hr/mL and 311 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 velpatasvir (n = 1595) iznosile su 4041 ng•h/ml odnosno 311 ng/ml.
English: Patients with GT1-3 infection were randomised in a 1:1 ratio to SOF/VEL/VOX or SOF/VEL for 12 weeks.
Croatian: Bolesnici s GT1-3 infekcijom bili su randomizirani u omjeru 1:1 u skupine koje su pirmale SOF/VEL/VOX ili SOF/VEL tijekom 12 tjedana.
English: Co-administration of such medicinal products with Vosevi is not recommended (see section 4.5).
Croatian: Istodobna primjena takvih lijekova s lijekom Vosevi se ne preporučuje (vidjeti dio 4.5).
English: Effect on sofosbuvir, velpatasvir and voxilaprevir not studied.
Croatian: Učinak na sofosbuvir, velpatasvir i voksilaprevir nije ispitan.
English: No dose adjustment of Vosevi or tacrolimus is required at initiation of co-administration.
Croatian: Nije potrebna prilagodba doze lijeka Vosevi ili takrolimusa na početku istodobne primjene.
English: Other statins (Inhibition of OATP1B)
Croatian: Drugi statini (Inhibicija OATP1B)
English: It is important not to miss a dose of this medicine.
Croatian: Ako ste zaboravili uzeti lijek Vosevi Važno je da ne propustite uzeti dozu ovog lijeka.
English: Following a single 100 mg oral dose of [14C]-voxilaprevir, mean total recovery of the [14C]-radioactivity was 94%, with all radioactivity measured in the faeces and none in the urine.
Croatian: Nakon jedne peroralne doze od 100 mg [14C]-voksilaprevira, srednja vrijednost ukupno otkrivene [14C]-radioaktivnosti bila je 94 % s time da je sva radioaktivnost bila izmjerena u stolici, dok je u mokraći nije bilo.
English: ↓ Velpatasvir ↓ Voxilaprevir
Croatian: ↔ Velpatasvir ↔ Voksilaprevir
English: ↔ Velpatasvir ↔ Voxilaprevir
Croatian: ↓ Velpatasvir ↓ Voksilaprevir
English: Co-administration of Vosevi with efavirenz/emtricitabine/tenofovir disoproxil fumarate is not recommended (see section 4.4).
Croatian: Ne preporučuje se istodobna primjena lijeka Vosevi s efavirenzom/emtricitabinom/t enofovirdizopropilfumaratom (vidjeti dio 4.4).
English: In the Phase 3 trials increases in total bilirubin less than or equal to 1.5 x the upper limit of normal were observed in 4% of patients without cirrhosis and 10% of patients with compensated cirrhosis, due to inhibition of OATP1B1 and OATP1B3 by voxilaprevir.
Croatian: Zbog inhibicije OATP1B1 i OATP1B3 voksilaprevirom, u ispitivanjima faze 3 opažena su povišenja ukupnog bilirubina za 1,5x GGN ili manje u 4 % bolesnika bez ciroze i 10 % bolesnika s kompenziranom cirozom.
English: Without Cirrhosis
Croatian: Bez ciroze
English: Voxilaprevir ↔ ↔
Croatian: Voksilaprevir ↔ ↔
English: Dolutegravir (50 mg once daily) + sofosbuvir/ velpatasvir (400/100 mg once daily)h
Croatian: Dolutegravir (50 mg jedanput na dan) + sofosbuvir/velpatasvir (400/100 mg jedanput na dan)h
English: RAVs not determined for both NS3 and NS5Aa a. Patients with NS3 and/or NS5A gene sequencing failure.
Croatian: Bolesnici s neuspješnim sekvencioniranjem gena NS3 i/ili NS5A.
English: Tacrolimus (5 mg single dose)e + sofosbuvir (400 mg single dose)f
Croatian: Takrolimus (jedna doza od 5 mg)e + sofosbuvir (jedna doza od 400 mg)f
English: Table 3: Adverse drug reactions identified with Vosevi Frequency
Croatian: Tablica 3: Nuspojave utvrđene uz lijek Vosevi Učestalost
English: ORAL CONTRACEPTIVES Norgestimate/ethinyl estradiol (norgestimate 0.180 mg/0.215 mg/0.25 m g/ethinyl estradiol 0.025 mg) + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg once daily) + voxilaprevir (100 mg once daily)f
Croatian: Norgestimat/etinilestradiol (norgestimat 0,180 mg/0,215 mg/ 0,25 mg/etinilestradiol 0,025 mg) + sofosbuvir/velpatasvir/ voksilaprevir (400/100/100 mg jedanput na dan) + voksilaprevir (100 mg jedanput na dan)f
English: Medicinal products that are moderate P-gp and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir, velpatasvir and/or voxilaprevir plasma concentrations leading to reduced therapeutic effect of Vosevi.
Croatian: Lijekovi koji su umjereni induktori P-gp-a i/ili umjereni induktori CYP-a (npr. efavirenz, modafinil, okskarbazepin ili rifapentin) mogu smanjiti koncentracije sofosbuvira, velpatasvira i/ili voksilaprevira u plazmi što dovodi do smanjenog terapijskog učinka lijeka Vosevi.
English: The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with once daily sofosbuvir/velpatasvir 400/100 mg for
Croatian: Farmakokinetika sofosbuvira, GS-331007 i velpatasvira ispitana je u ispitivanjima sofosbuvira/velpatasvira faze 2/3 u bolesnika zaraženih HCV-om s ESRD-om koji zahtijeva dijalizu, liječenih jedanput dnevno dozom sofosbuvira/velpatasvira od 400/100 mg tijekom 12 tjedana i uspoređenih s bolesnicima bez oštećenja bubrega.
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: Patients were randomised in a 1:1 ratio to SOF/VEL/VOX for 8 weeks or SOF/VEL for 12 weeks.
Croatian: Bolesnici su bili randomizirani u omjeru 1:1 u skupinu koja je primala SOF/VEL/VOX tijekom 8 tjedana ili skupinu koja je primala SOF/VEL tijekom 12 tjedana.
English: Analyses were conducted to explore the association between pre-existing baseline NS3 and NS5A RAVs and treatment outcome for patients that had not previously been treated with DAA regimens and received sofosbuvir/velpatasvir/voxilaprevir for 8 weeks in POLARIS-2 and POLARIS-3.
Croatian: Ispitivanja u bolesnika koji prethodno nisu bili liječeni direktno djelujućim antivirusnim lijekovima Provedene su analize kako bi se istražila povezanost između otprije postojećih početnih NS3 i NS5A RAV-ova i ishoda liječenja u bolesnika koji prethodno nisu bili liječeni direktno djelujućim antivirusnim lijekovima i primali su sofosbuvir/velpatasvir/voksilaprevir tijekom 8 tjedana u ispitivanjima POLARIS-2 i POLARIS-3.
English: Vosevi is contraindicated with carbamazepine (see section 4.3).
Croatian: Vosevi je kontraindiciran s karbamazepinom (vidjeti dio 4.3).
English: No dose adjustment of Vosevi or dolutegravir is required.
Croatian: Nije potrebna prilagodba doze lijeka Vosevi ili dolutegravira.
English: Effect on amiodarone, voxilaprevir, velpatasvir, and sofosbuvir concentrations unknown.
Croatian: Učinci na koncentracije amiodarona, voksilaprevira,velpatasvira i sofosbuvira nisu poznati.
English: No dose adjustment of Vosevi or methadone is required.
Croatian: Nije potrebna prilagodba doze lijeka Vosevi ili metadona.
English: Patients with GT5-6 infection were enrolled into the SOF/VEL/VOX 8 week group only.
Croatian: Bolesnici s GT5-6 infekcijom bili su uključeni samo u skupinu koja je primala SOF/VEL/VOX 8 tjedana.
English: Use with strong OATP1B inhibitors
Croatian: Primjena s jakim inhibitorima OATP1B
English: • St. John's wort (a herbal medicine used to treat depression);
Croatian: • gospinu travu (biljni lijek koji se primjenjuje za liječenje depresije);
English: Genotype 6
Croatian: Genotip 6
English: Co-administration of Vosevi with lopinavir-containing regimens is not recommended.
Croatian: Ne preporučuje se istodobna primjena lijeka Vosevi s režimima koji sadrže lopinavir.
English: Vosevi [Outer packaging only]
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vosevi [samo vanjsko pakiranje]
English: POLARIS-4 (open label)
Croatian: POLARIS-4 (otvoreno)
English: Analyses were conducted to explore the association between pre-existing baseline NS3 and NS5A RAVs and treatment outcome for patients that had previously been treated with DAA regimens and received sofosbuvir/velpatasvir/voxilaprevir for 12 weeks in POLARIS-1 and POLARIS-4.
Croatian: Ispitivanja u bolesnika koji su prethodno bili liječeni direktno djelujućim antivirusnim lijekovima Provedene su analize kako bi se ispitala povezanost između postojećih početnih NS3 i NS5A RAVova i ishoda liječenja u bolesnika koji su prethodno bili liječeni direktno djelujućim antivirusnim lijekovima i primali sofosbuvir/velpatasvir/voksilaprevir tijekom 12 tjedana u ispitivanjima POLARIS-1 i POLARIS-4.
English: No dose adjustment of Vosevi or elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate is required.
Croatian: Nije potrebna prilagodba doze lijeka Vosevi ili elvitegravira/kobicistata/emtri citabina/tenofoviralafenamidf umarata.
English: Ketoconazole (200 mg twice daily) + velpatasvir (100 mg single dose)f
Croatian: Ketokonazol (200 mg dvaput na dan) + velpatasvir (jedna doza od 100 mg)f
English: After a single 100 mg dose of [14C]-velpatasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.5 and 0.7.
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 0,5 i 0,7.
English: Patients with GT1-4 were randomised in a 1:1 ratio to SOF/VEL/VOX for 8 weeks or SOF/VEL for 12 weeks.
Croatian: Bolesnici s GT1-4 bili su randomizirani u omjeru 1:1 u skupinu koja je primala SOF/VEL/VOX tijekom 8 tjedana ili skupinu koja je primala SOF/VEL tijekom 12 tjedana.
English: After a single 100 mg dose of [14C]-voxilaprevir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.5 and 0.8.
Croatian: Nakon jedne doze od 100 mg [14C]-voksilaprevira u zdravih ispitanika, omjer [14C]-radioaktivnosti u krvi u odnosu na plazmu kretao se u rasponu između 0,5 i 0,8.
English: The pharmacokinetics of voxilaprevir were studied with a single dose of 100 mg voxilaprevir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Croatian: Farmakokinetika voksilaprevira bila je ispitana nakon jedne doze od 100 mg voksilaprevira u HCV-negativnih bolesnika s umjerenim i teškim oštećenjem jetre (CPT stadij B i C).
English: POLARIS-2 (open label)
Croatian: POLARIS-2 (otvoreno)
English: (Inhibition of OATP1B, P-gp/BCRP and CYP3A)
Croatian: (Inhibicija OATP1B, P-gpa/BCRP-a i CYP3A)
English: Outcome for patients without SVR On-treatment virologic failure
Croatian: Ishod u bolesnika bez SVR-a
English: POLARIS-3 (open label)
Croatian: POLARIS-3 (otvoreno)
English: Vosevi is contraindicated with rifabutin (see section 4.3).
Croatian: Vosevi je kontraindiciran s rifabutinom (vidjeti dio 4.3).
English: Darunavir boosted with ritonavir (800 + 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/300 mg once daily)j + sofosbuvir/ velpatasvir/voxilaprevir (400/100/100 mg once daily) + voxilaprevir (100 mg once daily)f
Croatian: Darunavir pojačan ritonavirom (800 + 100 mg jedanput na dan) + emtricitabin/tenofovirdizop roksilfumarat (200/300 mg jedanput na dan)j + sofosbuvir/velpatasvir/voksilaprev ir (400/100/100 mg jedanput na dan) + voksilaprevir (100 mg jedanput na dan)f
English: The pharmacokinetics of velpatasvir were 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: Table 10 presents the SVR12 by HCV genotype for the POLARIS-1 trial.
Croatian: U tablici 10 predstavljen je SVR12 za ispitivanje POLARIS-1 prema genotipu HCV-a.
English: Elvitegravir/cobicistat/ emtricitabine/tenofovir alafenamide fumarate (150/150/200/10 mg once daily)l + sofosbuvir/velpatasvir/ voxilaprevir (400/100/ 100 mg once daily) + voxilaprevir (100 mg once daily)f
Croatian: Elvitegravir/kobicistat/emtricitabi n/tenofoviralafenamidfumarat (150/150/200/10 mg jedanput na dan) l + sofosbuvir/velpatasvir/voksilaprevi r (400/100/100 mg jedanput na dan) + voksilaprevir (100 mg jedanput na dan)f
English: Rifampicin (600 mg once daily) + sofosbuvir (400 mg single dose)f
Croatian: Rifampicin (600 mg jedanput na dan) + sofosbuvir (jedna doza od 400 mg)f
English: Median voxilaprevir EC50, nM (range)
Croatian: Medijan EC50 voksilaprevira, nM (raspon)
English: SOF/VEL 12 weeks (n = 151)
Croatian: SOF/VEL 12 tjedana (n = 151)
English: • SOF/VEL 12 weeks (N=151)
Croatian: • SOF/VEL 12 tjedana (N=151)