FrancophonIA/ELRC3.0 huggingface dataset:
English: In genotype 3b replicon, the presence of naturally occurring polymorphisms K30 and M31 in NS5A reduced susceptibility to pibrentasvir by 24-fold relative to the activity of pibrentasvir in genotype 3a replicon.
Croatian: Kod replikona genotipa 3b, prisutnost polimorfizama K30 i M31 koji se prirodno pojavljuju u proteinu NS5A smanjila je osjetljivost na pibrentasvir 24 puta u odnosu na aktivnost pibrentasvira u replikonu genotipa 3a.
English: Glecaprevir and pibrentasvir are not significantly removed by haemodialysis.
Croatian: Glekaprevir i pibrentasvir neće se u značajnoj mjeri ukloniti hemodijalizom.
English: • atazanavir (for HIV infection)
Croatian: • ako uzimate sljedeće lijekove: • atazanavir (za liječenje HIV infekcije)
English: c. Single dose administration of [14C]glecaprevir or [14C]pibrentasvir in mass balance studies.
Croatian: Primjena jednokratne doze [14C]-glekaprevira ili [14C]-pibrentasvira u ispitivanjima masene bilance.
English: Genotype 2 Genotype 4 Genotype 5 Genotype 6
Croatian: Genotip 4 Genotip 5 Genotip 6
English: Maviret contains lactose
Croatian: Maviret sadrži laktozu
English: In animal reproduction studies, no adverse developmental effects were observed when the components of Maviret were administered separately during organogenesis at exposures up to 53 times (rats; glecaprevir) or 51 and 1.5 times (mice and rabbits, respectively; pibrentasvir) the human exposures at the recommended dose of Maviret.
Croatian: U ispitivanjima reprodukcije na životinjama nisu primijećeni štetni učinci na razvoj kada su se sastavnice lijeka Maviret primjenjivale zasebno tijekom organogeneze pri izloženosti do 53 puta (štakori; glekaprevir), 51 put (miševi, pibrentasvir) ili 1,5 puta (kunići; pibrentasvir) većoj od izloženosti koja se postiže u ljudi nakon primjene preporučene doze lijeka Maviret.
English: ENDURANCE-5,6 Maviret for 12 weeks (n=9)
Croatian: ENDURANCE-5,6 Maviret tijekom 12 tjedana (n=9)
English: Elvitegravir/cobicist at/emtricitabine/ tenofovir alafenamide
Croatian: Elvitegravir/ kobicistat/ emtricitabin/ tenofoviralafenamid
English: Gender/weight No dose adjustment of Maviret is required based on gender or body weight.
Croatian: Nije potrebno prilagođavati dozu lijeka Maviret s obzirom na spol ili tjelesnu težinu.
English: Maviret tablets are pink, oblong, curved on both sides (biconvex), film-coated tablets with dimensions of 18.8 mm x 10.0 mm and debossed on one side with ‘NXT'.
Croatian: Maviret tablete su ružičaste, ovalne, zaobljene s obje strane (bikonveksne), filmom obložene tablete dimenzija 18,8 mm x 10,0 mm, s utisnutom oznakom „NXT” na jednoj strani.
English: Maviret contains lactose.
Croatian: Maviret sadrži laktozu.
English: ANGIOTENSIN-II RECEPTOR BLOCKERS Losartan
Croatian: BLOKATORI RECEPTORA ANGIOTENZINA II Losartan jednokratna doza od
English: Amino acid substitutions in NS3 or NS5A selected in cell culture or important for the inhibitor class were phenotypically characterized in replicons.
Croatian: Aminokiselinske supstitucije u proteinima NS3 ili NS5A koje su izdvojene u staničnoj kulturi ili važne za tu skupinu inhibitora fenotipski su okarakterizirane u replikonima.
English: Maviret should not affect your ability to drive or use any tools or machines.
Croatian: Maviret ne bi trebao utjecati na sposobnost upravljanja vozilima te rada s alatima ili strojevima.
English: Established and other potential medicinal product interactions
Croatian: Utvrđene i druge moguće interakcije između lijekova
English: Animal studies do not indicate harmful effects of glecaprevir or pibrentasvir on fertility at exposures higher than the exposures in humans at the recommended dose (see Section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke glekaprevira ili pibrentasvira na plodnost pri razinama izloženosti većima od onih koje se postižu u ljudi nakon primjene preporučene doze (vidjeti dio 5.3).
English: Potential for Maviret to affect other medicinal products
Croatian: Mogući utjecaj lijeka Maviret na druge lijekove
English: Twenty two of the approximately 2,300 subjects treated with Maviret for 8, 12, or 16 weeks in registrational Phase 2 and 3 clinical studies experienced virologic failure (2 with genotype 1, 2 with genotype 2, 18 with genotype 3 infection).
Croatian: Od približno 2300 ispitanika liječenih lijekom Maviret tijekom 8, 12 ili 16 tjedana u kliničkim registracijskim ispitivanjima lijeka faze 2 i 3, njih 22 je doživjelo virološki neuspjeh (2 s infekcijom genotipom 1, 2 s infekcijom genotipom 2, 18 s infekcijom genotipom 3).
English: Glecaprevir is a pan-genotypic inhibitor of the HCV NS3/4A protease, which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication.
Croatian: Glekaprevir je pangenotipski inhibitor proteaze NS3/4A HCV-a, koja je potrebna za proteolitičko cijepanje poliproteina kojeg kodira HCV (u zrele oblike proteina NS3, NS4A, NS4B, NS5A i NS5B) i neophodna za virusnu replikaciju.
English: The overall SVR12 rate was 100% (47/47).
Croatian: Ukupna stopa SVR12 iznosila je 100% (47/47).
English: Potential for other medicinal products to affect Maviret
Croatian: Mogući utjecaj drugih lijekova na Maviret
English: It is not known whether the two medicines in Maviret pass into breast milk.
Croatian: Nije poznato izlučuju li se dva lijeka koja Maviret sadrži u majčino mlijeko.
English: Subjects with genotype 3b infection
Croatian: Ispitanici s infekcijom genotipom 3b
English: ↑ GS-331007
Croatian: ↑ GS-331007 ↔ glekaprevir
English: Tell your doctor or pharmacist before taking Maviret, if you are taking any of the medicines in the table below.
Croatian: Obavijestite svog liječnika ili ljekarnika prije nego uzmete Maviret ako uzimate neki od lijekova navedenih u sljedećoj tablici.
English: Maviret 12 weeks N=233
Croatian: Maviret, 12 tjedana N=233
English: − Tablet film-coating: hypromellose (E464), lactose monohydrate, titanium dioxide, macrogol 3350, iron oxide red (E172).
Croatian: Film ovojnica tablete: hipromeloza (E464), laktoza hidrat, titanijev dioksid, makrogol 3350, crveni željezov oksid (E172).
English: EXPEDITION-4 Maviret for 12 weeks (n=104)
Croatian: EXPEDITION-4 Maviret tijekom 12 tjedana (n=104)
English: Pink, oblong, biconvex, film-coated tablet of dimensions 18.8 mm x 10.0 mm, debossed on one side with ‘NXT'.
Croatian: Ružičasta, ovalna, bikonveksna, filmom obložena tableta dimenzija 18,8 mm x 10,0 mm, s utisnutom oznakom „NXT” na jednoj strani.
English: Studies in rats/mice with glecaprevir or pibrentasvir do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Croatian: Ispitivanja primjene glekaprevira ili pibrentasvira u štakora/miševa ne ukazuju na izravan ili neizravan štetan učinak na reprodukciju.
English: The safety of Maviret in HCV GT1-6 infected adolescents is based on data from a Phase 2/3 openlabel study in 47 subjects aged 12 years to <18 years treated with Maviret for 8 to 16 weeks (DORAPart 1).
Croatian: Sigurnost lijeka Maviret u adolescenata s HCV infekcijom genotipa 1-6 temelji se na podacima iz otvorenog ispitivanja faze 2/3 koje je uključivalo 47 ispitanika u dobi od 12 do <18 godina liječenih lijekom Maviret tijekom 8 do 16 tjedana (DORA-1. dio).
English: There were no developmental effects with either compound in rodent peri/postnatal developmental studies in which maternal systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 47 and 74 times, respectively, the exposure in humans at the recommended dose.
Croatian: Ni jedna od sastavnica nije pokazala učinak na razvoj u ispitivanjima perinatalnog i postnatalnog razvoja u glodavaca, u kojima je sistemska izloženost (AUC) majke glekapreviru i pibrentasviru bila približno 47 odnosno 74 puta veća od izloženosti koja se postiže u ljudi nakon primjene preporučene doze.
English: It is unknown whether glecaprevir or pibrentasvir are excreted in human milk.
Croatian: Nije poznato izlučuju li se glekaprevir ili pibrentasvir u majčino mlijeko.
English: Not known: cannot be estimated from the available data • itching
Croatian: • slabost ili nedostatak energije (astenija) Nepoznato: ne može se procijeniti iz dostupnih podataka
English: Overall, the changes in exposures of Maviret in HCV-infected subjects with renal impairment with or without dialysis were not clinically significant.
Croatian: Sveukupno, promjene u izloženosti lijeku Maviret u ispitanika s HCV infekcijom i oštećenjem bubrežne funkcije, neovisno o dijalizi, nisu klinički značajne.
English: Specifically in genotype 3a, A30K or Y93H had no impact on pibrentasvir activity.
Croatian: Konkretno, kod genotipa 3a supstitucija A30K ili Y93H nije utjecala na aktivnost pibrentasvira.
English: GT 1, 2, 4-6 8 weeks
Croatian: GT 1, 2, 4-6 8 tjedana 12 tjedana GT 3
English: The non-linear exposure increase <120 mg may be related to saturation of efflux transporters.
Croatian: < 120 mg može biti povezano sa zasićenjem efluksnih prijenosnika.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Maviret Lijek čuvajte izvan pogleda i dohvata djece.
English: Co-administration of moderate inducers is not recommended (see section 4.4).
Croatian: Istodobna primjena s umjerenim induktorima se ne preporučuje (vidjeti dio 4.4).
English: Carcinogenicity studies with glecaprevir and pibrentasvir have not been conducted.
Croatian: Nisu provedena ispitivanja kancerogenosti glekaprevira i pibrentasvira.
English: Medicinal products that inhibit OATP1B1/3 (e.g. elvitegravir, ciclosporin, darunavir, lopinavir) increase systemic concentrations of glecaprevir.
Croatian: Lijekovi koji inhibiraju OATP1B1/3 (npr. elvitegravir, ciklosporin, darunavir, lopinavir) povisuju sistemske koncentracije glekaprevira.
English: The overall SVR12 rate in post-transplant subjects was 98.0% (98/100).
Croatian: Ukupna stopa SVR12 u ispitanika nakon transplantacije iznosila je 98,0% (98/100).
English: Genotype 3: For subjects who received the recommended regimen (n=309), baseline polymorphisms in NS5A (Y93H included) or NS3 did not have a relevant impact on treatment outcomes.
Croatian: Genotip 3: U ispitanika koji su primali preporučeni režim (n=309), polimorfizmi prisutni na početku ispitivanja u proteinu NS5A (uključujući Y93H) ili NS3 nisu imali značajnog utjecaja na ishode liječenja.
English: Additional drug-drug interaction studies were performed with the following medical products and showed no clinically significant interactions with Maviret: abacavir, amlodipine, buprenorphine, caffeine, dextromethorphan, dolutegravir, emtricitabine, felodipine, lamivudine, lamotrigine, methadone, midazolam, naloxone, norethindrone or other progestin-only contraceptives, rilpivirine, tenofovir alafenamide and tolbutamide.
Croatian: Provedena su dodatna ispitivanja interakcija između lijekova, koja nisu ukazala na klinički značajne interakcije lijeka Maviret sa sljedećim lijekovima: abakavirom, amlodipinom, buprenorfinom, kofeinom, dekstrometorfanom, dolutegravirom, emtricitabinom, felodipinom, lamivudinom, lamotriginom, metadonom, midazolamom, naloksonom, noretindronom ili drugim kontraceptivima koji sadrže samo progestin, rilpivirinom, tenofoviralafenamidom i tolbutamidom.
English: Purpose of the medicine ciclosporin, tacrolimus to suppress the immune system darunavir, efavirenz, lopinavir, ritonavir for HIV infection digoxin for heart problems fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin to lower blood cholesterol warfarin and other similar medicines*
Croatian: Namjena lijeka ciklosporin, takrolimus za potiskivanje imunološkog sustava darunavir, efavirenz, lopinavir, ritonavir za liječenje HIV infekcije digoksin za liječenje srčanih tegoba fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin za snižavanje razine kolesterola u krvi varfarin i drugi slični lijekovi*
English: Pack containing 84 (4 x 21) film-coated tablets.
Croatian: Pakiranje sadrži 84 (4 x 21) filmom obložene tablete.
English: In patients with chronic hepatitis C infection without cirrhosis, following 3 days of monotherapy with either glecaprevir 300 mg per day (N=6) or pibrentasvir 120 mg per day (N=8) alone, geometric mean AUC24 values were 13600 ng∙h/mL for glecaprevir and 459 ng∙h/mL for pibrentasvir.
Croatian: U bolesnika s kroničnom infekcijom virusom hepatitisa C bez ciroze, nakon 3 dana monoterapije glekaprevirom u dozi od 300 mg na dan (N=6) ili pibrentasvirom u dozi od 120 mg na dan (N=8), geometrijske srednje vrijednosti AUC24 iznosile su 13 600 ng∙h/ml za glekaprevir te 459 ng∙h/ml za pibrentasvir.
English: Table 1: Recommended Maviret treatment duration for patients without prior HCV therapy Genotype
Croatian: Tablica 1: Preporučeno trajanje liječenja lijekom Maviret u bolesnika koji prethodno nisu primali terapiju za HCV
English: No effects on mating, female or male fertility, or early embryonic development were observed in rodents at up to the highest dose tested.
Croatian: U glodavaca nisu primijećeni učinci na parenje, plodnost ženki i mužjaka ili rani razvoj embrija kada su se primjenjivale doze sve do najviše ispitivane doze.
English: Glecaprevir AUC increased in a greater than dose-proportional manner (1200 mg QD had 516-fold higher exposure than 200 mg QD) which may be related to saturation of uptake and efflux transporters.
Croatian: AUC glekaprevira povećavao se više nego proporcionalno dozi (uz 1200 mg jedanput na dan izloženost je bila 516 puta veća nego uz 200 mg jedanput na dan), što može biti povezano sa zasićenjem prijenosnika za unos tvari i efluksnih prijenosnika.
English: One subject experienced on-treatment virologic failure (0.6%, 1/168) and no subjects relapsed (0%, 0/166).
Croatian: Jedan je ispitanik (0,6%, 1/168) doživio virološki neuspjeh tijekom liječenja, a ni u jednoga (0%, 0/166) nije zabilježen relaps.
English: Maviret 8 weeks N=157
Croatian: Maviret, 8 tjedana N=157
English: Maviret is not recommended for the re-treatment of patients with prior exposure to NS3/4A- and/or NS5A-inhibitors.
Croatian: Maviret se ne preporučuje za ponovno liječenje bolesnika koji su prethodno bili izloženi inhibitorima NS3/4A i/ili inhibitorima NS5A.
English: The adverse reactions are listed below by body system organ class and frequency.
Croatian: Nuspojave u nastavku razvrstane su prema klasifikaciji organskih sustava i učestalosti.
English: Glecaprevir was fully active against resistance-associated substitutions in NS5A, while pibrentasvir was fully active against resistance-associated substitutions in NS3.
Croatian: Glekaprevir je iskazao potpunu djelatnost protiv supstitucija povezanih s rezistencijom u proteinu NS5A, dok je pibrentasvir bio potpuno djelatan protiv supstitucija povezanih s rezistencijom u proteinu NS3.
English: Glecaprevir and pibrentasvir are inhibitors of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide (OATP) 1B1/3.
Croatian: Glekaprevir i pibrentasvir inhibiraju P-glikoprotein (P-gp), protein koji uzrokuje otpornost raka dojke na liječenje (engl. breast cancer resistance protein, BCRP) te polipeptidni prijenosnik organskih aniona (engl. organic anion transporting polypeptide, OATP) 1B1/3.
English: Unchanged glecaprevir was the main component observed in the milk of lactating rats without effect on nursing pups.
Croatian: Nepromijenjeni glekaprevir bio je glavna sastavnica primijećena u mlijeku ženki štakora u laktaciji, ali nije imao učinka na mladunčad koja je sisala.
English: Subjects without cirrhosis received Maviret for 8 weeks, and subjects with compensated cirrhosis received Maviret for 12 weeks.
Croatian: Ispitanici bez ciroze primali su lijek Maviret tijekom 8 tjedana, a ispitanici s kompenziranom cirozom primali su lijek Maviret tijekom 12 tjedana.
English: Elevations in total bilirubin of at least 2x upper limit normal (ULN) were observed in 1.3% of subjects related to glecaprevir-mediated inhibition of bilirubin transporters and metabolism.
Croatian: U 1,3% ispitanika primijećena su povišenja vrijednosti ukupnog bilirubina najmanje 2 puta iznad gornje granice normale (GGN), koja su povezana s inhibicijom prijenosnika i metabolizma bilirubina posredovanom glekaprevirom.
English: The overall safety profile in HCV/HIV-1 co-infected subjects (ENDURANCE-1 and EXPEDITION2) was comparable to that observed in HCV mono-infected subjects.
Croatian: Sigurnost u bolesnika s istodobnom HCV/HIV-1 infekcijom Sveukupan sigurnosni profil u bolesnika s istodobnom HCV/HIV-1 infekcijom (ENDURANCE-1 i EXPEDITION-2) bio je usporediv s onim opaženim u bolesnika koji su imali samo HCV infekciju.
English: b. Includes a total of 154 subjects coinfected with HIV-1 in ENDURANCE-1 and EXPEDITION-2 who received the recommended duration.
Croatian: b. Uključuje ukupno 154 ispitanika s istodobnom HIV-1 infekcijom u ispitivanjima ENDURANCE-1 i
English: No subject experienced virologic failure.
Croatian: Niti jedan ispitanik nije doživio virološki neuspjeh.
English: Bilirubin elevations were predominantly indirect and not associated with ALT elevations.
Croatian: Zabilježena su prvenstveno povišenja vrijednosti indirektnog bilirubina, koja nisu povezana s povišenjima vrijednosti ALT-a.
English: Pibrentasvir is a pan-genotypic inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly.
Croatian: Pibrentasvir je pangenotipski inhibitor proteina NS5A HCV-a, koji je neophodan za replikaciju virusne RNK i sklapanje viriona.
English: Pibrentasvir was the only component observed in the milk of lactating rats without effect on nursing pups.
Croatian: Pibrentasvir je bio jedina sastavnica primijećena u mlijeku ženki štakora u laktaciji, ali nije imao učinka na mladunčad koja je sisala.
English: Population pharmacokinetic analysis demonstrated that following administration of Maviret in HCVinfected subjects with compensated cirrhosis, exposure of glecaprevir was approximately 2-fold and pibrentasvir exposure was similar to non-cirrhotic HCV-infected subjects.
Croatian: Populacijska farmakokinetička analiza pokazala je da je nakon primjene lijeka Maviret u ispitanika s HCV infekcijom s kompenziranom cirozom izloženost glekapreviru bila približno dvostruko veća, dok je izloženost pibrentasviru bila slična onoj u ispitanika s HCV infekcijom bez ciroze.
English: c. HCV-infected transplant recipients who received a median ciclosporin dose of 100 mg per day had increased glecaprevir exposures to 2.4-fold of those not receiving ciclosporin.
Croatian: U ispitanika s HCV infekcijom i presatkom organa koji su primali medijan doze ciklosporina od 100 mg na dan, izloženost glekapreviru povećala se 2,4 puta u odnosu na one koji nisu primali ciklosporin.
English: film-coated tablets 84 (4 x 21) film-coated tablets
Croatian: filmom obložene tablete 84 (4 x 21) filmom obložene tablete
English: Subjects with genotype 3 infection
Croatian: Ispitanici s infekcijom genotipom 3
English: Darunavir + ritonavir 800/100 mg once daily
Croatian: Darunavir + ritonavir 800/100 mg jedanput na dan
English: No dose adjustment of Maviret is required in patients with mild hepatic impairment (Child-Pugh A).
Croatian: Nije potrebno prilagođavati dozu lijeka Maviret u bolesnika s blagim oštećenjem jetrene funkcije (Child-Pugh stadij A).
English: GT1, 2, 4, 5, 6 EXPEDITION-8 Maviret for 8 weeks (n=280) (TN only) Subjects with CKD stage 3b, 4 and 5 with or without cirrhosis GT1-6
Croatian: GT1, 2, 4, 5, 6 EXPEDITION-8 Maviret tijekom 8 tjedana (n=280) (samo PN) Ispitanici s KBB-om stadija 3b, 4 i 5, s cirozom ili bez nje GT1-6
English: Patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.4, and 5.2).
Croatian: Bolesnici s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C) (vidjeti dijelove 4.2, 4.4 i 5.2).
English: The overall SVR12 rate was 97% (98/101).
Croatian: Ukupna stopa SVR12 bila je 97% (98/101).
English: Raltegravir 400 mg twice daily
Croatian: Raltegravir 400 mg dvaput na dan
English: Pibrentasvir AUC increased in a greater than dose-proportional manner at doses up to 120 mg, (over 10-fold exposure increase at 120 mg QD compared to 30 mg QD), but exhibited linear pharmacokinetics at doses ≥ 120 mg.
Croatian: U dozama do 120 mg AUC pibrentasvira povećavao se više nego proporcionalno dozi (uz 120 mg jedanput na dan izloženost je bila za više od 10 puta veća nego uz 30 mg jedanput na dan), dok je u dozama ≥ 120 mg pokazao linearnu farmakokinetiku.
English: Larger increases may be expected when unbound concentration is considered.
Croatian: Kada se u obzir uzme koncentracija nevezanog lijeka, mogu se očekivati veća povećanja.
English: Co-administration with Maviret may increase plasma concentrations of medicinal products that are substrates of P-gp (e.g. dabigatran etexilate, digoxin), BCRP (e.g. rosuvastatin), or OATP1B1/3 (e.g. atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin).
Croatian: Istodobna primjena s lijekom Maviret može povisiti plazmatske koncentracije lijekova koji su supstrati P-gp-a (npr. dabigatran eteksilat, digoksin), BCRP-a (npr. rosuvastatin) ili prijenosnika OATP1B1/3 (npr. atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin).
English: HCV Subtype
Croatian: Podtip HCV-a
English: The overall SVR12 rate was 97.9% (274/280).
Croatian: Ukupna stopa SVR12 bila je 97,9% (274/280).
English: Maviret for 8 weeks (n=58)
Croatian: Maviret tijekom 8 tjedana (n=58)
English: (P-gp, BCRP, and OATP inhibition by cobicistat, OATP inhibition by elvitegravir)
Croatian: (inhibicija P-gp-a, BCRP-a i OATP-a kobicistatom, inhibicija OATP-a elvitegravirom)
English: Immunosuppressants allowed for co-administration were ciclosporin ≤100 mg/day, tacrolimus, sirolimus, everolimus, azathioprine, mycophenolic acid, prednisone, and prednisolone.
Croatian: Imunosupresivi čija je istodobna primjena bila dozvoljena bili su ciklosporin u dozi od ≤ 100 mg/dan, takrolimus, sirolimus, everolimus, azatioprin, mikofenolatna kiselina, prednizon i prednizolon.
English: Co-administration with atazanavir is contraindicated due to the risk of ALT elevations (see section 4.3).
Croatian: Istodobna primjena s atazanavirom kontraindicirana je zbog rizika od povišenja vrijednosti ALT-a (vidjeti dio 4.3).
English: The mechanism for the differences between glecaprevir exposure in chronic Hepatitis C patients with or without cirrhosis is unknown.
Croatian: Mehanizam koji dovodi do razlike između izloženosti glekapreviru u bolesnika s kroničnim hepatitisom C i cirozom te onih bez ciroze nije poznat.
English: Co-administration may lead to reduced therapeutic effect of Maviret and is contraindicated (see section 4.3).
Croatian: Istodobna primjena može dovesti do smanjenog terapijskog učinka lijeka Maviret te je kontraindicirana (vidjeti dio 4.3).
English: Drug-drug interactions
Croatian: Interakcije između lijekova
English: Studies VOYAGE-1 and VOYAGE-2 were conducted in China, Singapore, and South Korea in HCV genotype 1-6 subjects without cirrhosis (VOYAGE-1) or with compensated cirrhosis (VOYAGE-2) that were treatmentnaïve (TN) or treatment-experienced to combinations of interferon, peg-interferon, ribavirin and/or sofosbuvir (TE-PRS).
Croatian: VOYAGE-2 provedena su u Kini, Singapuru i Južnoj Koreji u ispitanika s HCV infekcijom genotipa 1-6 bez ciroze (VOYAGE-1) ili s kompenziranom cirozom (VOYAGE-2) koji prethodno nisu bili liječeni ili su prethodno liječeni kombinacijama interferona, peginterferona, ribavirina i/ili sofosbuvira
English: There was one relapse and no on-treatment virologic failure.
Croatian: Zabilježen je jedan relaps i nijedan virološki neuspjeh tijekom liječenja.
English: (Inhibition of P-gp)
Croatian: (inhibicija P-gp-a)
English: Table 9: SVR12 in treatment-naïve, genotype 3-infected subjects without cirrhosis (ENDURANCE-3)
Croatian: Tablica 9: SVR12 u prethodno neliječenih bolesnika s infekcijom genotipom 3 bez ciroze (ENDURANCE-3)