FrancophonIA/ELRC3.0 huggingface dataset:
English: SVR12 was achieved in 18 of 19 (95%) patients who had baseline NS5B NI RAVs in POLARIS-1, including 2 patients who had virus with the S282T NS5B NI RAV in addition to NS5A RAVs at baseline.
Croatian: SVR12 postignut je u 18 od 19 (95 %) bolesnika koji su imali početne NS5B NI RAV-ove u ispitivanju POLARIS-1, uključujući 2 bolesnika koji su imali virus sa S282T NS5B NI RAV-om uz početne NS5A RAV-ove.
English: Close monitoring of INR is recommended when Vosevi is co-administered with all vitamin K antagonists.
Croatian: Preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) kad se lijek Vosevi primjenjuje istodobno s antagonistima vitamina K.
English: Additionally, velpatasvir is active in vitro against most of the NS5A RAVs that confer resistance to ledipasvir and daclatasvir.
Croatian: Uz to, velpatasvir djeluje in vitro protiv većine NS5A RAV-ova koji dovode do rezistencije na ledipasvir i daklatasvir.
English: Vosevi is not recommended during pregnancy.
Croatian: Trudnoća Vosevi se ne preporučuje tijekom trudnoće.
English: In patients with genotype 1a without cirrhosis treated with Vosevi for 8 weeks, outcome was influenced by the following baseline factors: BMI ≥ 30 kg/m2, Q80K/L/R RAVs, IL28B non-CC, HCV RNA ≥ 800,000 IU/mL.
Croatian: U bolesnika s genotipom 1a bez ciroze liječenih lijekom Vosevi tijekom 8 tjedana, na ishod su utjecali sljedeći početni čimbenici: indeks tjelesne mase ≥ 30 kg/m2, Q80K/L/R RAV-ovi, IL28B ne-CC, HCV RNK ≥ 800 000 IU/ml.
English: DAA: direct-acting antiviral; GT: genotype; SOF: sofosbuvir; VEL: velpatasvir; VOX: voxilaprevir
Croatian: GT: genotip; SOF: sofosbuvir; VEL: velpatasvir; VOX: voksilaprevir
English: Velpatasvir plasma exposure (AUCinf) was similar in patients with moderate hepatic impairment, severe hepatic impairment, and control subjects with normal hepatic function.
Croatian: Izloženost velpatasviru u plazmi (AUCinf) bila je slična u bolesnika s umjerenim oštećenjem jetre, onih s teškim oštećenjem jetre i kontrolnih ispitanika s normalnom funkcijom jetre.
English: Sofosbuvir was not carcinogenic in the 2-year mouse and rat carcinogenicity studies at GS-331007 exposures up to 17 and 10-times higher, respectively than human exposure.
Croatian: Sofosbuvir nije bio kancerogen u dvogodišnjim ispitivanjima kancerogenosti na miševima i štakorima pri izloženosti GS-331007 do 17 odnosno 10 puta višim od ljudske izloženosti.
English: d. Data from a chimeric NS5A replicon carrying NS5A amino acids 9-184. e. Stable cell lines expressing Renilla luciferase-encoding replicons.
Croatian: d. Podaci iz kimeričkih replikona NS5A koji nose aminokiseline NS5A 9-184. e. Stabilne stanične linije s ekspresijom replikona koji kodiraju Renilla luciferazu.
English: However, a possible teratogenic effect was indicated in rabbits where an increase in total visceral malformations was seen in exposed animals at AUC exposures up to 0.5 fold the human exposure at recommended clinical dose.
Croatian: Međutim, mogući teratogeni učinak indiciran je u kunića pri čemu je povećanje ukupnih visceralnih malformacija primijećeno u izloženim životinjama pri izloženosti AUC do najviše za 0,5 puta većim od ljudske izloženosti pri preporučenoj kliničkoj dozi.
English: For sofosbuvir, the NS5B substitution S282T was selected in genotype 1-6 replicons and was associated with 2- to 18-fold reduced susceptibility to sofosbuvir.
Croatian: Za sofosbuvir, u replikonima genotipa 1 do 6 izdvojena je supstitucija S28ST u NS5B koja je bila povezana s 2 do 18 puta smanjenom osjetljivošću na sofosbuvir.
English: Sofosbuvir, velpatasvir and voxilaprevir are substrates of drug transporters P-gp and BCRP while GS-331007 is not.
Croatian: Sofosbuvir, velpatasvir i voksilaprevir supstrati su prijenosnika lijekova P-gp-a i BCRP-a, dok GS-331007 to nije.
English: • Placebo 12 weeks (N=152)
Croatian: • Placebo 12 tjedana (N=152)
English: As Vosevi contains sofosbuvir, velpatasvir and voxilaprevir, any interactions that have been identified with these active substances individually may occur with Vosevi.
Croatian: Budući da Vosevi sadrži sofosbuvir, velpatasvir i voksilaprevir, sve interakcije koje su bile utvrđene s ovim djelatnim tvarima zasebno mogu nastati i s lijekom Vosevi.
English: • If it is 18 hours or more after the time you usually take Vosevi, wait and take the next dose at your usual time.
Croatian: • Ako je prošlo 18 sati ili više od vremena kad obično uzimate lijek Vosevi, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
English: The medicinal product interactions described are based on studies conducted with either sofosbuvir/velpatasvir/voxilaprevir, its components (sofosbuvir, velpatasvir, and/or voxilaprevir), or are predicted medicinal product interactions that may occur with Vosevi.
Croatian: Opisane interakcije lijekova temelje se na ispitivanjima provedenima sa sofosbuvirom/velpatasvirom/voksilaprevirom ili njegovim komponentama (sofosbuvirom, velpatasvirom i/ili voksilaprevirom) ili su predviđene interakcije lijekova koje mogu nastati s lijekom Vosevi.
English: • rifapentine (an antibiotic used to treat infections, including tuberculosis);
Croatian: • rifapentin (antibiotik koji se primjenjuje za liječenje infekcija, uključujući tuberkulozu);
English: Ciclosporin ↔ ↓
Croatian: Ciklosporin ↔ ↔
English: Site directed mutagenesis of known NS3 RAVs showed that substitutions conferring a > 100-fold reduction in voxilaprevir susceptibility are A156V, A156T or A156L in genotype 1a, 1b, 2a, 3a and 4.
Croatian: Ciljane mutageneze poznatih NS3 RAV-ova pokazale su da su supstitucije koje su dovele do smanjenja osjetljivosti na voksilaprevir za > 100 puta bile A156V, A156T ili A156L u genotipovima 1a, 1b, 2a, 3a i 4.
English: DAA: direct-acting antiviral agent * In clinical trials the DAA experienced patients had been exposed to combination regimens containing any of the following: daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, sofosbuvir, velpatasvir, voxilaprevir (administered with sofosbuvir and velpatasvir for less than 12 weeks)
Croatian: * U kliničkim ispitivanjima bolesnici prethodno liječeni direktno djelujućim antivirusnim lijekovima bili su izloženi kombiniranim režimima koji su sadržavali jedno od sljedećeg: daklatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, sofosbuvir, velpatasvir, voksilaprevir (primjenjivano sa sofosbuvirom i velpatasvirom manje od 12 tjedana).
English: For voxilaprevir in genotype 1-6 replicons, resistance-associated substitutions selected in 2 or more genotypes were Q41H, A156V/T/L and D168E/H/Y.
Croatian: Za voksilaprevir u replikonima genotipa 1 do 6, supstitucije povezane s rezistencijom izdvojene u 2 ili više genotipa bile su Q41H, A156V/T/L i D168E/H/Y.
English: Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 85 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir, GS-331007, velpatasvir or voxilaprevir.
Croatian: Analiza populacijske farmakokinetike u bolesnika zaraženih HCV-om pokazala je da unutar analiziranog raspona dobi (18 do 85 godina), dob nije imala klinički značajan učinak na izloženost sofosbuviru, GS-331007, velpatasviru ili voksilapreviru.
English: The safety assessment of Vosevi was based on data from Phase 2 and 3 clinical trials in which 1383 patients received sofosbuvir/velpatasvir/voxilaprevir or sofosbuvir/velpatasvir + voxilaprevir for 8 or 12 weeks.
Croatian: Procjena sigurnosti primjene lijeka Vosevi temeljila se na podacima iz kliničkih ispitivanja faze 2 i 3 u kojima je 1383 bolesnika primalo sofosbuvir/velpatasvir/voksilaprevir ili sofosbuvir/velpatasvir + voksilaprevir tijekom 8 ili 12 tjedana.
English: Paediatric population The pharmacokinetics of Vosevi in paediatric patients have not been established (see section 4.2).
Croatian: Pedijatrijska populacija Farmakokinetika lijeka Vosevi u pedijatrijskih bolesnika nije ustanovljena (vidjeti dio 4.2).
English: * 23% of patients enrolled into POLARIS-2 had received prior treatment with an interferon-based regimen.
Croatian: * 23% bolesnika uključenih u ispitivanje POLARIS-2 prethodno je bilo liječeno režimima na temelju interferona. a.
English: The proportion of patients who permanently discontinued treatment due to adverse reactions was 0.1% for patients receiving sofosbuvir/velpatasvir/voxilaprevir for 8 weeks.
Croatian: Udio bolesnika koji su trajno prekinuli liječenje zbog nuspojava iznosio je 0,1 % među onima koji su primali sofosbuvir/velpatasvir/voksilaprevir tijekom 8 tjedana.
English: • dabigatran (a medicine used to prevent blood clots);
Croatian: • dabigatran (lijek koji se primjenjuje za sprječavanje nastanka krvnih ugrušaka);
English: Taking Vosevi with any of these may stop your medicines from working properly, or make any side effects worse.
Croatian: Uzimanje lijeka Vosevi s bilo kojim od ovih lijekova može spriječiti pravilno djelovanje Vaših lijekova ili pogoršati neke nuspojave.
English: Famotidine dosed simultaneously with Vosevi
Croatian: Famotidin primijenjen u isto vrijeme s lijekom Vosevi
English: Mean ratio (90% confidence interval)a,b Recommendation concerning co-administration with Vosevi
Croatian: Omjer srednjih vrijednosti (90 % interval pouzdanosti)a,b
English: Potential for other medicinal products to affect Vosevi
Croatian: Mogućnost utjecaja drugih lijekova na lijek Vosevi
English: Clinically significant medicinal product interactions with Vosevi mediated by P-gp, BCRP and CYP inhibitors are not expected.
Croatian: Ne očekuju se klinički značajne interakcije lijekova s lijekom Vosevi posredovane inhibitorima P-gp-a, BCRP-a ili CYP-a.
English: It is recommended to separate antacid and Vosevi administration by 4 hours.
Croatian: Preporučuje se primijeniti antacid i lijek Vosevi u razmaku od 4 sata.
English: Vosevi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).
Croatian: U tih se bolesnika Vosevi može primjenjivati bez prilagodbe doze kada nikakve druge odgovarajuće mogućnosti liječenja nisu dostupne (vidjeti dijelove 4.4, 4.8, 5.1 i 5.2).
English: (Induction of CYPs)
Croatian: (Indukcija CYP-ova)
English: The adverse reactions are listed below by system organ class and frequency.
Croatian: Nuspojave su navedene niže prema klasifikaciji organskih sustava i učestalosti.
English: The pharmacokinetics of voxilaprevir have not been studied in subjects with ESRD requiring dialysis (see section 4.2).
Croatian: Farmakokinetika voksilaprevira nije bila ispitana u bolesnika s ESRD-om kojima je bila potrebna dijaliza (vidjeti dio 4.2).
English: Sofosbuvir, velpatasvir, and voxilaprevir were fully active against substitutions associated with resistance to other classes of DAAs with different mechanisms of actions, e.g. voxilaprevir was fully active against NS5A and NS5B NI RAVs.
Croatian: Sofosbuvir, velpatasvir i voksilaprevir bili su potpuno djelatni protiv supstitucija povezanih s rezistencijom na druge skupine direktno djelujućih antivirusnih lijekova s različitim mehanizmima djelovanja, npr. voksilaprevir je bio potpuno djelatan protiv NS5A i NS5B RAV-ova na nukleozidne inhibitore (NI).
English: Velpatasvir was not carcinogenic in the 26-week transgenic mouse and 2-year rat carcinogenicity studies at exposures up to 67- and 5-times higher than human exposure, respectively.
Croatian: Velpatasvir nije bio kancerogen u 26-tjednom ispitivanju u transgeničnih miševa i 2-godišnjem ispitivanju kancerogenosti u štakora pri izloženostima do 67 odnosno 5 puta većima od izloženosti u ljudi.
English: Table 4: Activity of sofosbuvir, velpatasvir and voxilaprevir against full-length or chimeric laboratory replicons
Croatian: Tablica 4: Djelovanje sofosbuvira, velpatasvira i voksilaprevira protiv replikona pune duljine ili kimeričkih laboratorijskih replikona
English: Voxilaprevir is active in vitro against most of the NS3 RAVs that confer resistance to first generation NS3/4A protease inhibitors.
Croatian: Voksilaprevir djeluje in vitro protiv većine NS3 RAV-ova koji dovode do rezistencije na prvu generaciju inhibitora NS3/4A proteaze.
English: SOF/VEL/VOX 8 weeks
Croatian: SOF/VEL/VOX 8 tjedana
English: For velpatasvir in genotype 1-6 replicons, resistance-associated substitutions selected in 2 or more genotypes were L31I/V and Y93H.
Croatian: Za velpatasvir u replikonima genotipa 1 do 6, supstitucije povezane s rezistencijom izdvojene u 2 ili više genotipa bile su L31I/V i Y93H.
English: Animal studies do not indicate harmful effects of sofosbuvir, velpatasvir or voxilaprevir on fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke sofosbuvira, velpatasvira ili voksilaprevira na plodnost.
English: • digoxin, used to treat heart conditions;
Croatian: • digoksin koji se primjenjuje za liječenje srčanih bolesti;
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir containing regimens are used in combination with amiodarone and/or other medicinal products that lower heart rate (see sections 4.4 and 4.5).
Croatian: Slučajevi teške bradikardije i srčanog bloka uočeni su kada su se režimi koji sadrže sofosbuvir koristili u kombinaciji s amiodaronom i/ili lijekovima koji snižavaju srčanu frekvenciju (vidjeti dijelove 4.4 i
English: No individual RAV tested in genotypes 2a, 4a or 5a conferred a > 100-fold reduction in velpatasvir susceptibility.
Croatian: Nijedan pojedinačni RAV ispitan u genotipovima 2a, 4a ili 5a nije doveo do smanjenja osjetljivosti na velpatasvir za > 100 puta.
English: Vosevi should not be used if you have moderate or severe liver problems.
Croatian: Tegobe s jetrom Vosevi se ne smije primjenjivati ako imate umjerene ili teške tegobe s jetrom.
English: Dabigatran etexilate (P-gp substrate) and rosuvastatin (OATP1B and BCRP substrate) are contraindicated (see section 4.3 and Table 2).
Croatian: Kontraindicirana je primjena dabigatraneteksilata (supstrat P-gp-a) i rosuvastatina (supstrat prijenosnika OATP1B i BCRP) (vidjeti dio 4.3 i tablicu 2).
English: Vosevi can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2).
Croatian: U tih se bolesnika Vosevi može primjenjivati bez prilagodbe doze kada nisu dostupne nikakve druge odgovarajuće mogućnosti liječenja (vidjeti dijelove 4.8, 5.1 i 5.2).
English: Pack size: outer carton containing 1 bottle of 28 film-coated tablets.
Croatian: Veličine pakiranja: kutija koja sadrži 1 bočicu s 28 filmom obloženih tableta.
English: The SVR12 was 98% among those with two or fewer factors and 81% among those with three or four factors.
Croatian: Među bolesnicima s dva ili više čimbenika SVR12 je iznosio 98 %, a među onima s tri ili četiri čimbenika 81 %.
English: Site directed mutagenesis of NS5A resistance associated variants (RAVs) showed that substitutions conferring a > 100-fold reduction in velpatasvir susceptibility are M28G, A92K and Y93H/N/R/W in genotype 1a, A92K in genotype 1b, C92T and Y93H/N in genotype 2b, Y93H in genotype 3, and L31V and P32A/L/Q/R in genotype 6.
Croatian: Ciljane mutageneze poznatih varijanti NS5A povezanih s rezistencijom (engl. resistance-associated variants, RAV) pokazale su da su supstitucije koje su dovele do smanjene osjetljivosti na velpatasvitr za > 100 puta bile M28G, A92K i Y93H/N/R/W u genotipu 1a, A92K u genotipu 1b, C92T i Y93H/N u genotipu 2b, Y93H u genotipu 3 te L31V i P32A/L/Q/R u genotipu
English: Totalb (n = 150)
Croatian: Ukupnob (n = 150)
English: sofosbuvir (400 mg single dose)e
Croatian: sofosbuvir (jedna doza od 400 mg)e
English: Biliary excretion of parent drug was the major route of elimination for voxilaprevir.
Croatian: Izlučivanje ishodišnog lijeka putem žuči bio je glavni put eliminacije voksilaprevira.
English: The patient with genotype 1a and virologic breakthrough developed the NS5A RAVs L31M and Y93H.
Croatian: Taj bolesnik s genotipom 1a i virološkim probojem razvio je NS5A RAV-ove L31M i Y93N.
English: Population pharmacokinetic analysis in HCV-infected patients indicated that patients with cirrhosis (CPT Class A) had 73% higher exposure of voxilaprevir than those without cirrhosis (see section 4.2).
Croatian: Analiza populacijske farmakokinetike u bolesnika zaraženih HCV-om pokazala je da su bolesnici s cirozom (CPT stadij A) imali 73 % veću izloženost voksilapreviru nego oni bez ciroze (vidjeti dio 4.2).
English: k. Lack of pharmacokinetics interaction bounds 50-200%.
Croatian: k. Raspon u kojem nema farmakokinetičkih interakcija 50 %-200 %.
English: No individual RAV tested in genotypes 2b, 5a or 6a conferred a > 100-fold reduction in voxilaprevir susceptibility.
Croatian: Nijedan pojedinačni RAV ispitan u genotipovima 2b, 5a ili 6a nije doveo do smanjenja osjetljivosti na voksilaprevir za > 100 puta.
English: 1.7-fold↑
Croatian: 1,7 puta↑
English: Velpatasvir is a pan-genotypic HCV inhibitor targeting the HCV NS5A protein, which is required for viral replication.
Croatian: Velpatasvir je pan-genotipski inhibitor HCV-a usmjeren na NS5A protein HCV-a, koji je potreban za replikaciju virusa.
English: In POLARIS-4, a total of 14 patients had virus with NS5B NI RAVs at baseline and all achieved SVR12.
Croatian: U ispitivanju POLARIS-4, ukupno je 14 bolesnika imalo virus s početnim NS5B NI RAV-ovima i svi su postigli SVR12.
English: Although exposures of the fixed-dose combination sofosbuvir, GS-331007, velpatasvir, and voxilaprevir were not directly evaluated in HCV-infected patients with ESRD requiring dialysis after administration of Vosevi, the exposures of sofosbuvir, GS-331007, and velpatasvir are expected to be similar to those observed after administration of sofosbuvir/velpatasvir 400/100 mg in HCV-infected patients with ESRD requiring dialysis.
Croatian: Iako izloženost fiksnoj kombinaciji sofosbuvira, GS-331007, velpatasvira i voksilaprevira u bolesnika zaraženih HCV-om s ESRD-om koji je zahtijevao dijalizu nije bila izravno procijenjena nakon primjene lijeka Vosevi, očekuje se da će izloženost sofosbuviru, GS-331007 i velpatasviru biti slična onoj opaženoj nakon primjene sofosbuvira/velpatasvira u dozi od 400/100 mg u bolesnika zaraženih HCV-om s ESRD-om koji zahtijeva dijalizu.
English: Voxilaprevir had no adverse effects on mating and fertility.
Croatian: Voksilaprevir nije imao štetne učinke na parenje i plodnost.
English: If you need high doses of these medicines your doctor may give you a different medicine instead or adjust the dose of the medicine you are taking;
Croatian: Ako su Vam potrebne visoke doze ovih lijekova, liječnik Vam može u zamjenu dati neki drugi lijek ili prilagoditi dozu lijeka koji uzimate;
English: One patient with genotype 4d who relapsed developed the NS5A RAV Y93H.
Croatian: Jedan bolesnik s genotipom 4d koji je imao relaps razvio je NS5A RAV Y93H.
English: • carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures);
Croatian: • karbamazepin, fenobarbital i fenitoin (lijekovi koji se primjenjuju za liječenje epilepsije i sprječavanje napadaja);
English: H2-receptor antagonists may be administered simultaneously with or staggered from Vosevi at a dose that does not exceed doses comparable with famotidine 40 mg twice daily.
Croatian: H2-receptora mogu se primijeniti u isto vrijeme s lijekom Vosevi ili s vremenskim razmakom u dozi koja ne prelazi doze usporedive s dozom famotidina od 40 mg dvaput na dan.
English: In HCV-infected patients with severe renal impairment treated with sofosbuvir 200 mg with ribavirin (n=10) or sofosbuvir 400 mg with ribavirin (n=10) for 24 weeks or ledipasvir/sofosbuvir 90/400 mg (n=18) for 12 weeks, the pharmacokinetics of sofosbuvir and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Croatian: U bolesnika zaraženih HCV-om i s teškim oštećenjem bubrega liječenih dozom sofosbuvira od 200 mg i ribavirinom (n = 10) ili dozom sofosbuvira od 400 mg i ribavirinom (n = 10) tijekom 24 tjedna ili ledipasvirom/sofosbuvirom u dozi od 90/400 mg (n = 18) tijekom 12 tjedana, farmakokinetika sofosbuvira i GS-331007 bila je u skladu s onom opaženom u HCV-negativnih bolesnika s teškim oštećenjem bubrega.
English: The median time between prior DAA failure and first dose of Vosevi for patients enrolled into POLARIS-1 was 39 weeks (range: 11 to 299 weeks).
Croatian: Medijan vremena između prethodnog neuspjeha liječenja direktno djelujućim antivirusnim lijekom i prve doze lijeka Vosevi u bolesnika uključenih u ispitivanje POLARIS-1 iznosio je 39 tjedana (raspon: od 11 do 299 tjedana).
English: Voriconazole (Inhibition of CYP3A)
Croatian: Vorikonazol (Inhibicija CYP3A)
English: Each film-coated tablet contains 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir.
Croatian: Jedna filmom obložena tableta sadrži 400 mg sofosbuvira, 100 mg velpatasvira i 100 mg voksilaprevira.
English: In the sofosbuvir/velpatasvir 12-week treatment group, 2 of 109 (2%) patients qualified for resistance analysis due to virologic failure.
Croatian: U skupini liječenoj sofosbuvirom/velpatasvirom tijekom 12 tjedana, 2 od 109 (2%) bolesnika kvalificiralo se za analizu rezistencije zbog virološkog neuspjeha.
English: If a dose of Vosevi is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time.
Croatian: Ako se propusti uzeti doza lijeka Vosevi, a još nije proteklo 18 sati od uobičajenog vremena uzimanja, bolesnike treba uputiti da uzmu tabletu čim prije i zatim uzmu sljedeću dozu u uobičajeno vrijeme.
English: The pharmacokinetics of sofosbuvir was studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir,relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2).
Croatian: Farmakokinetika sofosbuvira bila je ispitana u HCV-negativnih bolesnika s blagim (eGFR ≥ 50 i < 80 ml/min/1,73 m2), umjerenim (eGFR ≥ 30 i < 50 ml/min/1,73 m2), teškim oštećenjem bubrega (eGFR < 30 ml/min/1,73 m2) i bolesnika sa završnim stadijem bolesti bubrega kojima je potrebna hemodijaliza, nakon jedne doze od 400 mg sofosbuvira u odnosu na bolesnike s normalnom funkcijom bubrega (eGFR > 80 ml/min/1,73 m2).
English: Voxilaprevir acts as a noncovalent, reversible inhibitor of the NS3/4A protease.
Croatian: Voksilaprevir djeluje kao nekovalentni, reverzibilni inhibitor NS3/4A proteaze.
English: At clinically relevant concentrations, voxilaprevir is not an inhibitor of hepatic transporters OCT1, renal transporters OCT2, OAT1, OAT3 or MATE1, or CYP or UGT1A1 enzymes.
Croatian: Pri klinički relevantnoj koncentraciji, voksilaprevir nije inhibitor jetrenih prijenosnika OCT1, bubrežnih prijenosnika OCT2, OAT1, OAT3 ili MATE1 ili enzima CYP ili UGT1A1.
English: Relative to healthy subjects (n = 63), voxilaprevir AUC0-24 and Cmax were both 260% higher in HCV-infected patients.
Croatian: U odnosu na one u zdravih ispitanika (n = 63), vrijednosti i AUC0-24 i Cmax voksilaprevira bile su u bolesnika zaraženih HCV-om 260 % više.
English: Medicinal products that inhibit OATP1B, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentrations of velpatasvir or voxilaprevir.
Croatian: Lijekovi koji inhibiraju OATP1B, CYP2B6, CYP2C8 ili CYP3A4 mogu povisiti koncentracije velpatasvira ili voksilaprevira u plazmi.
English: f. Lack of pharmacokinetics interaction bounds 70-143%.
Croatian: f. Raspon u kojem nema farmakokinetičkih interakcija 70 %-143 %.
English: NS5A inhibitor-experienced adults (POLARIS-1)
Croatian: Odrasli koji su prethodno bili liječeni NS5A-inhibitorom (POLARIS-1)