FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Vosevi in the treatment of HCV infection in patients who are post-liver transplant have not been assessed.
Croatian: Sigurnost i djelotvornost lijeka Vosevi u liječenju infekcije HCV-om u bolesnika kojima je transplantirana jetra nisu procijenjene.
English: If you are lactose intolerant, or if you have been told that you have an intolerance to other sugars, talk to your doctor before taking this medicine.
Croatian: Ako ne podnosite laktozu ili ako su Vam rekli da ne podnosite druge šećere, obratite se liječniku prije nego što uzmete ovaj lijek.
English: Velpatasvir is > 99% bound to human plasma proteins and binding is independent of drug concentration over the range of 0.09 μg/mL to 1.8 μg/mL.
Croatian: Velpatasvir je > 99 % vezan za proteine ljudske plazme i vezanje ne ovisi o koncentraciji lijeka u rasponu od 0,09 μg/ml do 1,8 μg/ml.
English: Carcinogenicity studies for voxilaprevir have not been conducted.
Croatian: Ispitivanja kancerogenosti voksilaprevira nisu provedena.
English: • atorvastatin, pravastatin, or other statins, used to treat high cholesterol;
Croatian: • atorvastatin, pravastatin ili druge statine koji se primjenjuju za liječenje visokog kolesterola;
English: Table 2 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined interaction boundaries).
Croatian: U tablici 2 prikazan je popis ustanovljenih ili potencijalno klinički značajnih interakcija lijekova (gdje je 90 % interval pouzdanosti [CI] omjera geometrijskih srednjih vrijednosti dobivenih metodom najmanjih kvadrata [engl. geometric least squares mean, GLSM] bio unutar „↔“, protezao se iznad „↑“, ili ispod „↓“ unaprijed određenih granica interakcije).
English: Observed: Raltegravir
Croatian: Raltegravir
English: No specific antidote is available for overdose with Vosevi.
Croatian: Nije dostupan specifični antidot za predoziranje lijekom Vosevi.
English: Demographics and baseline characteristics for all studies are detailed in Table 9.
Croatian: Demografska slika i početne značajke za sva ispitivanja prikazani su u tablici 9.
English: Overall SVR12a Genotype 1b
Croatian: Ukupni SVR12a Genotip 1b
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 28 film-coated tablets with polyester coil and a silica gel desiccant.
Croatian: Bočica od polietilena visoke gustoće (HDPE), s polipropilenskim zatvaračem sigurnim za djecu, koja sadrži 28 filmom obloženih tableta s poliesterskom vaticom i sredstvom za sušenje od silika gela.
English: Some of the active substances of Vosevi may pass into human breast milk.
Croatian: Neke od djelatnih tvari u lijeku Vosevi mogu prelaziti u majčino mlijeko.
English: Concomitant use with ethinylestradiol-containing medicinal products may increase the risk of alanine aminotransferase (ALT) elevations and is contraindicated (see section 4.3 and Table 2).
Croatian: Istodobna primjena s lijekovima koji sadrže etinilestradiol može povećati rizik od povišenja vrijednosti alanin aminotransferaze (ALT) te je kontraindicirana (vidjeti dio 4.3 i tablicu 2).
English: Beige, capsule-shaped, film-coated tablet of dimensions 10 mm x 20 mm, debossed with “GSI” on one side and “3” on the other side.
Croatian: Filmom obložena tableta bež boje, u obliku kapsule, dimenzija 10 mm x 20 mm, s utisnutim „GSI“ na jednoj strani i „3“ na drugoj strani.
English: The effects of Vosevi during pregnancy are not known.
Croatian: Učinci lijeka Vosevi tijekom trudnoće nisu poznati.
English: Use with moderate P-gp inducers or moderate CYP inducers
Croatian: Primjena s umjerenim induktorima P-gp-a ili umjerenim induktorima CYP-a
English: The hydrolysed and dehydrogenated voxilaprevir were the major metabolites identified in human plasma.
Croatian: Hidrolizirani i dehidrogenirani oblici voksilaprevira bili su glavni metaboliti identificirani u ljudskoj plazmi.
English: Otherc a. The majority (85%) of patients previously failed a regimen containing sofosbuvir.
Croatian: U većine (85 %) je bolesnika prethodni režim koji je sadržavao sofosbuvir bio neuspješan.
English: The film-coated tablets are beige, capsule-shaped tablets debossed with “GSI” on one side and “3” on the other side.
Croatian: Filmom obložene tablete su tablete bež boje, u obliku kapsule, s utisnutim „GSI“ na jednoj strani i „3“ na drugoj strani.
English: Most subjects had genotype 1 (61% (19/31) [1a, 48% (15/31); 1b, 13% (4/31)]) or genotype 3 (26% (8/31)) HCV infection.
Croatian: Većina bolesnika imala je infekciju HCV-om genotipa 1 (61 % (19/31) [1a, 48 % (15/31); 1b, 13 % (4/31)]) ili genotipa 3 (26 % (8/31)).
English: Vosevi has not been studied in patients with ESRD requiring dialysis.
Croatian: Vosevi nije ispitivan u bolesnika s ESRD-om koji zahtijeva dijalizu.
English: Glucose levels of diabetic patients initiating DAA therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Croatian: Razine glukoze u bolesnika s dijabetesom koji započinju liječenje DAA treba pažljivo nadzirati, posebno unutar prva tri mjeseca, te prema potrebi prilagoditi lijek protiv dijabetesa.
English: Additional study details
Croatian: Dodatni podaci o ispitivanju
English: Table 1: Recommended treatment durations for Vosevi for all HCV genotypes
Croatian: Tablica 1: Preporučena trajanja liječenja lijekom Vosevi za sve genotipove HCV-a Populacija bolesnika
English: Sofosbuvir is approximately 61-65% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1 μg/mL to 20 μg/mL.
Croatian: Sofosbuvir je približno 61-65 % vezan za proteine ljudske plazme i vezanje ne ovisi o koncentraciji lijeka u rasponu od 1 μg/ml do 20 μg/ml.
English: POLARIS-1 (randomised double blind)
Croatian: POLARIS-1 (randomizirano, dvostruko slijepo)
English: The NS5B NI RAV S282T was not detected in any patient in POLARIS-2 and POLARIS-3 studies.
Croatian: NS5B NI RAV S282T nije bio otkriven ni u jednog bolesnika u ispitivanjima POLARIS-2 i POLARIS-3.
English: Get advice from a doctor or pharmacist if you take warfarin or other similar medicines called vitamin K antagonists used to thin the blood.
Croatian: Potražite savjet liječnika ili ljekarnika ako uzimate varfarin ili druge slične lijekove koji se nazivaju antagonisti vitamina
English: Table 8: Studies conducted with Vosevi
Croatian: Tablica 8: Ispitivanja provedena s lijekom Vosevi
English: • modafinil, used to treat sleep disorders;
Croatian: • modafinil koji se primjenjuje se liječenja poremećaja spavanja;
English: The highest documented doses of sofosbuvir, velpatasvir and voxilaprevir were single doses of 1,200 mg, 500 mg, and 900 mg, respectively.
Croatian: Najviše zabilježene doze sofosbuvira, velpatasvira i voksilaprevira bile su jednokratne doze od 1200 mg, 500 mg odnosno 900 mg.
English: (Increase in gastric pH decreases velpatasvir solubility)
Croatian: (Povećanje želučanog pH smanjuje topljivost velpatasvira)
English: Voxilaprevir ↑
Croatian: Voksilaprevir ↑
English: Co-administration of Vosevi with digoxin may increase the concentration of digoxin.
Croatian: Istodobna primjena lijeka Vosevi s digoksinom može povećati koncentraciju digoksina.
English: The most common adverse reactions in patients receiving voxilaprevir 900 mg were diarrhoea (34%), nausea (17%) and headache
Croatian: Najčešće nuspojave u bolesnika koji su primali voksilaprevir u dozi od 900 mg bile su proljev (34 %), mučnina (17 %) i glavobolja (9 %).
English: The physician in charge of the diabetic care of the patient should be informed when DAA therapy is initiated.
Croatian: Liječnik zadužen za praćenje dijabetesa u bolesnika mora biti obaviješten o uvođenju terapije DAA.
English: Of the 31 patients enrolled, 74% (23/31) were male, 81% (25/31) were white, 71% (22/31) had a baseline body mass index < 30 kg/m2, 48% (15/31) had compensated cirrhosis, 58% (18/31) had previously received sofosbuvir, velpatasvir and voxilaprevir, and 42% (13/31) had previously received sofosbuvir and velpatasvir.
Croatian: Od 31 uključenog bolesnika, 74 % (23/31) ispitanika su bili muškaraci, 81 % (25/31) bijelci, 71 % (22/31) je imalo početni indeks tjelesne mase < 30 kg/m2, 48 % (15/31) imalo je kompenziranu cirozu, 58 % (18/31) prethodno je primalo sofosbuvir, velpatasvir i voksilaprevir, a 42 % (13/31) je prethodno primalo sofosbuvir i velpatasvir.
English: Vosevi is not recommended in patients with moderate or severe hepatic impairment (CPT Class B or C) (see section 5.2).
Croatian: Vosevi se ne preporučuje u bolesnika s umjerenim ili teškim oštećenjem jetre (CPT stadij B ili C) (vidjeti dio 5.2).
English: Your doctor may need to closely monitor these other medicines you are taking and make adjustments after starting Vosevi.
Croatian: Vaš će liječnik možda morati pažljivo pratiti druge lijekove koje uzimate i prilagoditi njihovu dozu nakon što počnete uzimati lijek Vosevi.
English: Following oral administration of Vosevi, sofosbuvir was absorbed quickly and the peak median plasma concentration was observed 2 hours post-dose.
Croatian: Nakon peroralne primjene lijeka Vosevi, sofosbuvir se brzo apsorbirao i medijan vršne koncentracije u plazmi opažen je 2 sata nakon uzimanja doze.
English: a. Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
Croatian: Omjer srednjih vrijednosti (90 % CI) farmakokinetičkih parametara istodobno primijenjenih lijekova s ispitivanim lijekovima zasebno ili u kombinaciji.
English: Vosevi has no or negligible influence on the ability to drive and use machines.
Croatian: Vosevi ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: There was an increase in tenofovir exposure (AUC and Cmax) of around 40% during co-treatment with Vosevi and darunavir + ritonavir + tenofovir disoproxil fumarate/emtricitabine.
Croatian: Povećanje izloženosti tenofoviru (AUC i Cmax) iznosilo je otprilike 40 % tijekom istodobnog liječenja lijekom Vosevi i darunavirom + ritonavirom + tenofovirdizoproksilfumaratom/emtricitabinom.
English: Do not stop taking Vosevi
Croatian: Nemojte prestati uzimati lijek Vosevi
English: The safety of sofosbuvir in a fixed dose combination with either ledipasvir or velpatasvir has been studied in 154 patients with ESRD requiring dialysis (Study 4062 and Study 4063).
Croatian: Sigurnost primjene sofosbuvira u fiksnoj kombinaciji s ledipasvirom ili velpatasvirom ispitana je u 154 bolesnika s ESRD-om koji zahtijeva hemodijalizu (ispitivanje 4062 i ispitivanje 4063).
English: If it is after 18 hours then patients should be instructed to wait and take the next dose of Vosevi at the usual time.
Croatian: Ako je proteklo više od 18 sati, onda bolesnike treba uputiti da pričekaju i uzmu sljedeću dozu lijeka Vosevi u uobičajeno vrijeme.
English: b. Stable chimeric 1b replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing.
Croatian: b. Stabilni kimerički replikoni 1b koji nose NS5B gene iz genotipova 2b, 5a ili 6a upotrijebljeni su za ispitivanje.
English: Haemodialysis is unlikely to result in significant removal of velpatasvir or voxilaprevir since velpatasvir and voxilaprevir are highly bound to plasma proteins.
Croatian: Hemodijaliza najvjerojatnije neće dovesti do značajnog uklanjanja velpatasvira ili voksilaprevira, jer su velpatasvir i voksilaprevir u visokom postotku vezani za proteine plazme.
English: As a precautionary measure, Vosevi use is not recommended during pregnancy.
Croatian: Kao mjera opreza, Vosevi se ne preporučuje tijekom trudnoće.
English: In this setting, exposure of sofosbuvir metabolite GS-331007 is 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials.
Croatian: U takvim okolnostima, izloženost metabolitu sofosbuvira GS-331007 povećana je 20 puta i premašuje razine pri kojima su nuspojave opažene u pretkliničkim ispitivanjima.
English: Animal studies have shown a possible link to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su moguću vezu sa štetnim učinkom na reprodukciju (vidjeti dio 5.3)
English: In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a, and 4a.
Croatian: U biokemijskom testu, GS-461203 inhibirao je djelovanje polimeraze rekombinantnog NS5B iz HCV-a genotipa 1b, 2a, 3a i 4a.
English: Sofosbuvir is extensively metabolised in the liver to form the pharmacologically active nucleoside analogue triphosphate GS-461203.
Croatian: Sofosbuvir se opsežno metabolizira u jetri pri čemu nastaje farmakološki djelatan nukleozidni analog trifosfat GS-461203.
English: The unbound fraction of voxilaprevir was approximately 2-fold higher in severe hepatic impairment compared with moderate hepatic impairment or normal hepatic function.
Croatian: Nevezani dio voksilaprevira bio je približno 2 puta veći kod teškog oštećenja jetre u usporedbi s onim kod umjerenog oštećenja jetre ili normalne funkcije jetre.
English: Effect on fluvastatin, lovastatin, pitavastatin and simvastatin not studied.
Croatian: Učinak na fluvastatin, lovastatin, pitavastatin i simvastatin nije ispitan.
English: Medicinal products that are strong OATP1B inhibitors (e.g. ciclosporin) may substantially increase voxilaprevir plasma concentrations, the safety of which has not been established.
Croatian: Lijekovi koji su jaki inhibitori OATP1B (npr. ciklosporin) mogu znatno povećati koncentraciju voksilaprevira u plazmi, sigurnost takve primjene nije ustanovljena.
English: Co-administration of Vosevi with atazanavir is expected to increase the concentration of voxilaprevir.
Croatian: Očekuje se da će istodobna primjena lijeka Vosevi s atazanavirom povećati koncentraciju voksilaprevira.
English: • If you notice within 18 hours of the time you usually take Vosevi, you must take the tablet as soon as possible.
Croatian: • Ako to opazite u roku od 18 sati od vremena kad obično uzimate lijek Vosevi, morate što prije uzeti tabletu.
English: When Vosevi or its components taken together were administered with food, sofosbuvir AUC0-inf and Cmax were 64% to 144% and 9% to 76% higher, respectively; velpatasvir AUC0-inf and Cmax were 40% to 166% and 37% to 187% higher, respectively; and voxilaprevir AUC0-inf and Cmax were 112% to 435% and 147% to 680% higher, respectively.
Croatian: Kad su lijek Vosevi ili njegove komponente koje su se uzimale zajedno bili primijenjeni s hranom, AUC0-inf i Cmax sofosbuvira bili su 64 % do 144 % odnosno 9 % do 76 % viši; AUC0-inf i Cmax velpatasvira bili su 40 % do 166 % odnosno 37 % do 187 % viši; a AUC0-inf i Cmax voksilaprevira bili su 112 % do 435 % odnosno 147 % do 680 % viši.
English: Treatment with Vosevi for 8 weeks in POLARIS-2 did not demonstrate noninferiority to treatment with sofosbuvir/velpatasvir for 12 weeks with a prespecified margin of -5%.
Croatian: Liječenje lijekom Vosevi tijekom 8 tjedana u ispitivanju POLARIS-2 nije pokazalo neinferiornost u odnosu na liječenje sofosbuvirom/velpatasvirom tijekom 12 tjedana uz prethodno utvrđenu granicu od -5 %.
English: HCV/HBV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
Croatian: U bolesnika istodobno zaraženih HCV-om/HBV-om postoji rizik od reaktivacije HBV-a te ih je stoga potrebno pratiti i liječiti sukladno važećim kliničkim smjernicama.
English: There are no data on the use of Vosevi in patients with HCV/hepatitis B virus (HBV) co-infection.
Croatian: Nema podataka o primjeni lijeka Vosevi u bolesnika s istodobnom infekcijom HCV-om/virusom hepatitisa B (HBV).
English: The safety of tenofovir disoproxil fumarate in the setting of Vosevi and a pharmacokinetic enhancer has not been established.
Croatian: Sigurnost tenofovirdizoproksilfumarata uz lijek Vosevi i farmakokinetički pojačivač nije ustanovljena.
English: Patients treated with ethinylestradiol-containing medicinal products
Croatian: Bolesnici liječeni lijekovima koji sadrže etinilestradiol
English: NA: Not available a. Mean value from multiple experiments of same laboratory replicon.
Croatian: Srednja vrijednost iz višestrukih pokusa istog laboratorijskog replikona.
English: • tenofovir disoproxil fumarate, or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
Croatian: • tenofovirdizoproksilfumarat ili bilo koji lijek koji sadrži tenofovirdizoproksilfumarat, koji se primjenjuje za liječenje HIV-infekcije;
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate.
Croatian: Slučajevi teške bradikardije i srčanog bloka uočeni su kada su se režimi koji sadrže sofosbuvir koristili u kombinaciji s amiodaronom sa ili bez drugih lijekova koji snižavaju srčanu frekvenciju.
English: Voxilaprevir metabolites also identified in faeces included des[methylcyclopropylsulphonamide]-voxilaprevir (22.1%), which is formed intestinally, dehydrovoxilaprevir (7.5%), and two des-[methylcyclopropylsulphonamide]-oxy-voxilaprevir metabolites (5.4% and 3.9%).
Croatian: Metaboliti voksilaprevira također otkriveni u stolici uključivali su de[metilciklopropilsulfonamid]-voksilaprevir (22,1 %), koji nastaje u crijevima, dehidro-voksilaprevir (7,5%), te dva metabolita de-[ metilciklopropilsulfonamid]-oksi-voksilaprevira (5,4 % odnosno 3,9 %).
English: Unchanged velpatasvir was the major species in faeces accounting for a mean of 77% of the administered dose, followed by monohydroxylated velpatasvir (5.9%) and desmethylated velpatasvir (3.0%).
Croatian: Nepromijenjeni je velpatasvir bio glavni oblik u stolici sa srednjim udjelom od 77 % primijenjene doze, nakon čega slijedi monohidroksilirani velpatasvir (5,9 %) i demetilirani velpatasvir (3,0 %).
English: Among subjects with genotype 1a in POLARIS-2, SVR12 was 87% (53/61) for those with Q80K/L/R RAVs and 94% (99/105) for those without Q80K/L/R RAVs.
Croatian: POLARIS-2, SVR12 bio je 87 % (53/61) u onih s Q80K/L/R RAV-ovima i 94 % (99/105) u onih bez Q80K/L/R RAV-ova.
English: Table 15: Effect of Varying Degrees of Renal Impairment on Exposures (AUC) of SOF, GS331007, Velpatasvir and Voxilaprevir Compared to Subjects with Normal Renal Function
Croatian: Tablica 15: Utjecaj različitih stupnjeva oštećenja bubrega na izloženost (AUC) sofosbuviru, GS-331007, velpatasviru i voksilapreviru u usporedbi s ispitanicima s normalnom funkcijom bubrega
English: • atazanavir, efavirenz or lopinavir, used to treat HIV infection;
Croatian: • atazanavir, efavirenz ili lopinavir koji se primjenjuju za liječenje HIV-infekcije;
English: • If you are sick (vomit) more than 4 hours after taking Vosevi, you do not need to take another tablet until your next scheduled tablet.
Croatian: • Ako povratite nakon više od 4 sata nakon uzimanja lijeka Vosevi, ne trebate uzeti drugu tabletu do sljedeće tablete prema rasporedu.
English: Sofosbuvir EC50, nMa Velpatasvir EC50, nMa Voxilaprevir EC50, nMa
Croatian: Genotip replikona Sofosbuvir EC50, nMa Velpatasvir EC50, nMa Voksilaprevir EC50, nMa
English: Table 14: SVR12 and virologic outcome in study POLARIS-3 (HCV genotype 3 with compensated cirrhosis)*
Croatian: Tablica 14: SVR12 i virološki ishod u ispitivanju POLARIS-3 (HCV genotipa 3 s kompenziranom cirozom)*
English: No human data on the effect of Vosevi on fertility are available.
Croatian: Nema dostupnih podataka o utjecaju lijeka Vosevi na plodnost u ljudi.
English: When administered to lactating rats, voxilaprevir was detected in the plasma of nursing pups.
Croatian: Kad se primjenjivao ženkama štakora tijekom laktacije, voksilaprevir je pronađen u plazmi dojene mladunčadi.
English: This medicine does not require any special temperature storage conditions.
Croatian: Lijek ne zahtijeva posebne uvjete čuvanja na određenoj temperaturi.
English: Relative to patients with normal hepatic function, the voxilaprevir AUCinf was 299% and 500% higher in patients with moderate and severe hepatic impairment, respectively.
Croatian: U odnosu na bolesnike s normalnom funkcijom jetre, AUCinf voksilaprevira bio je 299 % i 500 % viši u bolesnika s umjerenim odnosno teškim oštećenjem jetre.
English: Cimetidined Nizatidined Ranitidined
Croatian: Cimetidind Nizatidind Ranitidind
English: Close monitoring is recommended if this medicinal product is administered with Vosevi (see sections 4.4 and 4.8).
Croatian: Preporučuje se pažljivo praćenje ako se ovaj lijek primjenjuje s lijekom Vosevi (vidjeti dijelove 4.4 i 4.8).
English: Vosevi is a medicine that contains the active substances sofosbuvir, velpatasvir and voxilaprevir in a single tablet.
Croatian: Vosevi je lijek koji sadrži djelatne tvari, sofosbuvir, velpatasvir i voksilaprevir, u jednoj tableti.
English: c. Data from various strains of full length NS5A replicons or chimeric NS5A replicons carrying full-length NS5A genes that contain L31 or M31 polymorphisms.
Croatian: c. Podaci iz raznih sojeva replikona NS5A pune duljine ili kimeričkih replikona NS5A koji nose gene NS5A pune duljine koji sadrže polimorfizme L31 ili M31.
English: Vosevi has been shown to increase tenofovir exposure when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Croatian: Pokazalo se da Vosevi povećava izloženost tenofoviru kada se primjenjuje zajedno s režimom za HIV koji sadrži tenofovirdizoproksilfumarat i farmakokinetički pojačivač (ritonavir ili kobicistat).
English: Serum HCV RNA values were measured during the clinical studies using the COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) with a lower limit of quantification (LLOQ) of 15 IU per mL.
Croatian: Vrijednosti HCV RNK u serumu tijekom kliničkih ispitivanja bile su mjerene s pomoću testa COBAS AmpliPrep/COBAS Taqman HCV (inačica 2.0) s donjom granicom kvantifikacije (LLOQ) od 15 IU/ml.
English: Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in patients with moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Croatian: U odnosu na bolesnike s normalnom funkcijom jetre, AUC0-24 sofosbuvira bio je 126 % odnosno 143 % viši u bolesnika s umjerenim i teškim oštećenjem funkcije jetre, dok je AUC0-24 GS-331007 bio 18 % odnosno 9 % viši.
English: Body weight did not have a clinically significant effect on sofosbuvir, velpatasvir or voxilaprevir exposure according to a population pharmacokinetic analysis.
Croatian: Tjelesna težina nije imala klinički značajni učinak na izloženost sofosbuviru, velpatasviru ili voksilapreviru prema analizi populacijske farmakokinetike.
English: The monohydroxylated and desmethylated velpatasvir were the metabolites identified in human plasma.
Croatian: Monohidroksilirani i demetilirani velpatasvir bili su metaboliti identificirani u ljudskoj plazmi.
English: * 29% of patients enrolled into POLARIS-3 had received prior treatment with an interferon-based regimen.
Croatian: * 29 % bolesnika uključenih u ispitivanje POLARIS-3 prethodno je bilo liječeno režimom na temelju interferona. a.
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 tih lijekova može zaustaviti pravilno djelovanje Vašeg lijeka ili pogoršati nuspojave:
English: Famotidine dosed 12 hours prior to Vosevi
Croatian: Famotidin primijenjen 12 sati prije lijeka Vosevi
English: Effect on atazanavir and ritonavir exposure not studied.
Croatian: Učinak na izloženost atazanaviru i ritonaviru nije ispitana.
English: What you need to know before you take Vosevi Do not take Vosevi
Croatian: Što morate znati prije nego počnete uzimati lijek Vosevi
English: Ciclosporin ↔ ↔ Voxilaprevir ↑
Croatian: Ciklosporin ↔ ↔ Voksilaprevir ↑
English: Median peak plasma concentration of GS-331007 was observed 4 hours post-dose.
Croatian: Medijan vršne koncentracije GS-331007 u plazmi bio je opažen 4 sata nakon uzimanja doze.