FrancophonIA/ELRC3.0 huggingface dataset:
English: At the clinical dose, compared to non-HCV infected subjects with normal hepatic function, glecaprevir AUC was 33% higher in Child-Pugh A subjects, 100% higher in Child-Pugh B subjects, and increased to 11-fold in Child-Pugh C subjects.
Croatian: Oštećenje jetrene funkcije U usporedbi s ispitanicima bez HCV infekcije i normalnom jetrenom funkcijom, nakon primjene kliničke doze AUC glekaprevira bio je 33% veći u ispitanika s Child-Pugh stadijem A te 100% veći u ispitanika s Child-Pugh stadijem B, dok se u ispitanika s Child-Pugh stadijem C povećao 11 puta.
English: weeks (GT3 TE only) (n=6)
Croatian: tjedana (GT3 samo PL) (n=6)
English: All subjects (15/15) with Y93H and 75% (15/20) with A30K in NS5A at baseline achieved SVR12.
Croatian: Svi ispitanici (15/15) s polimorfizmom Y93H te 75% (15/29) njih s polimorfizmom A30K u proteinu NS5A na početku ispitivanja postigli su SVR12 (engl.
English: Pibrentasvir AUC was similar in Child-Pugh A subjects, 26% higher in Child-Pugh B subjects, and 114% higher in Child-Pugh C subjects.
Croatian: AUC pibrentasvira bio je sličan u ispitanika s Child-Pugh stadijem A, 26% veći u ispitanika s
English: Maviret is a fixed-dose combination of two pan-genotypic, direct-acting antiviral agents, glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor), targeting multiple steps in the HCV viral lifecycle.
Croatian: Maviret je fiksna kombinacija doza dvaju pangenotipska direktno djelujuća antivirusna lijeka: glekaprevira (inhibitora proteaze NS3/4A) i pibrentasvira (inhibitora NS5A), koji ciljano djeluju na
English: Therefore, a therapeutic drug monitoring of tacrolimus is recommended and a dose adjustment of tacrolimus made accordingly.
Croatian: Stoga se preporučuje terapijsko praćenje koncentracija takrolimusa te odgovarajuća prilagodba njegove doze.
English: Hypromellose 2910 (E464) Lactose monohydrate Titanium dioxide Macrogol 3350
Croatian: Film ovojnica hipromeloza 2910 (E464) laktoza hidrat titanijev dioksid makrogol 3350 željezov oksid, crveni (E172)
English: Co-administration is not recommended.
Croatian: Istodobna primjena se ne preporučuje.
English: • If you notice within 18 hours of the time you usually take Maviret take the dose as soon as possible.
Croatian: • Ako primijetite da ste propustili uzeti Maviret unutar 18 sati od uobičajenog vremena uzimanja lijeka, uzmite dozu što je prije moguće.
English: Co-administration of Maviret with medicinal products that inhibit P-gp and BCRP (e.g. ciclosporin, cobicistat, dronedarone, itraconazole, ketoconazole, ritonavir) may slow elimination of glecaprevir and pibrentasvir and thereby increase plasma exposure of the antivirals.
Croatian: Istodobna primjena lijeka Maviret s lijekovima koji inhibiraju P-gp i BCRP (npr. ciklosporin, kobicistat, dronedaron, itrakonazol, ketokonazol, ritonavir) može usporiti eliminaciju glekaprevira i pibrentasvira te tako povećati plazmatsku izloženost antiviroticima.
English: Valsartan 80 mg single dose
Croatian: Valsartan jednokratna doza od 80 mg
English: Elderly No dose adjustment of Maviret is required in elderly patients (see sections 5.1 and 5.2).
Croatian: Nije potrebno prilagođavati dozu lijeka Maviret u starijih bolesnika (vidjeti dijelove 5.1 i 5.2).
English: Efavirenz/emtricitab ine/tenofovir disoproxil fumarate 600/200/300 mg once daily
Croatian: Istodobna primjena s efavirenzom može tenofovirdizoproksilfumarat 600/200/300 mg jedanput na dan
English: The SVR12 rate was 95.7% (22/23) for GT5-infected subjects and 98.4% (60/61) for GT6-infected subjects.
Croatian: Stopa SVR12 bila je 95,7% (22/23) u ispitanika s infekcijom genotipom 5 i 98,4% (60/61) u ispitanika s infekcijom genotipom
English: Maviret for 8 weeks (n=199) or 12 weeks (n=25)
Croatian: Maviret tijekom 8 tjedana (n=199) ili 12 tjedana (n=25)
English: Activity of glecaprevir and pibrentasvir against transient replicons containing NS3 or
Croatian: Tablica 6: Aktivnost glekaprevira i pibrentasvira protiv prolaznih replikona koji sadrže NS3 ili
English: Overall SVR12 Rate from the Clinical Studies in Treatment-Naïve or Treatment-Experienced Subjects with or without Cirrhosis
Croatian: Ukupna stopa SVR12 iz kliničkih ispitivanja provedenih u prethodno neliječenih ili prethodno liječenih ispitanika s cirozom ili bez nje
English: Three GT3b TN subjects experienced relapse and two GT3b TEPRS subjects experienced on-treatment virologic failure.
Croatian: Tri ispitanika s genotipom 3b koja prethodno nisu bila liječena doživjela su relaps i dva ispitanika s genotipm 3b koji su prethodno bili liječeni PRS-om doživjela su virološki neuspjeh tijekom liječenja.
English: In population pharmacokinetic analysis of HCV-infected subjects, 86% higher glecaprevir and 54% higher pibrentasvir AUC were observed for subjects with end stage renal disease, with or without dialysis, compared to subjects with normal renal function.
Croatian: U populacijskoj farmakokinetičkoj analizi u ispitanika zaraženih HCV-om primijećen je 86% veći AUC glekaprevira i 54% veći AUC pibrentasvira u bolesnika u terminalnoj fazi bubrežne bolesti, neovisno o dijalizi, u usporedbi s ispitanicima s normalnom bubrežnom funkcijom.
English: (Inhibition of OATP1B1/3)
Croatian: (inhibicija OATP1B1/3)
English: Maviret 12 weeks (N=40)
Croatian: Maviret 12 tjedana (N=40)
English: • your treatment has worked and you are free of the hepatitis C virus.
Croatian: • potvrdio da je liječenje bilo učinkovito i da u Vašem tijelu više nema virusa hepatitisa C
English: Of the genotype 1-, 2-, 4-, 5-, or 6-infected subjects with end stage renal disease enrolled in EXPEDITION-4, 97.8% (91/93) achieved SVR12 with no virologic failures.
Croatian: Među ispitanicima s infekcijom genotipom 1, 2, 4, 5 ili 6 u terminalnoj fazi bubrežne bolesti koji su uključeni u ispitivanje EXPEDITION-4, njih 97,8% (91/93) postiglo je SVR12 i nijedan nije doživio virološki neuspjeh.
English: The overall SVR12 rates were 97.2% (352/362) and 99.4% (159/160) in VOYAGE-1 and VOYAGE-2, respectively.
Croatian: Ukupna stopa SVR12 iznosila je 97,2% (352/362) u ispitivanju VOYAGE-1, odnosno 99,4% (159/160) u ispitivanju VOYAGE-2.
English: Concomitant use with atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John's wort (Hypericum perforatum), phenobarbital, phenytoin, and primidone) (see section 4.5).
Croatian: Istodobna primjena s lijekovima koji sadrže atazanavir, atorvastatinom, simvastatinom, dabigatran eteksilatom, lijekovima koji sadrže etinilestradiol, snažnim induktorima P-gp-a i CYP3A (npr. rifampicinom, karbamazepinom, gospinom travom (Hypericum perforatum), fenobarbitalom, fenotoinom i primidonom) (vidjeti dio 4.5).
English: The overall SVR12 rate was 97.6% (82/84).
Croatian: Ukupna stopa SVR12 bila je 97,6% (82/84).
English: The EC50 values of glecaprevir and pibrentasvir against full-length or chimeric replicons encoding NS3 or NS5A from laboratory strains are presented in Table 5.
Croatian: Vrijednosti EC50 glekaprevira i pibrentasvira protiv replikona pune duljine ili kimeričkih replikona koji kodiraju NS3 ili NS5A iz laboratorijskih sojeva prikazane su u Tablici 5.
English: Substitutions important for the HCV protease inhibitor class at positions 36, 43, 54, 55, 56, 155, 166, or 170 in NS3 had no impact on glecaprevir activity.
Croatian: Supstitucije u proteinu NS3 na položajima 36, 43, 54, 55, 56, 155, 166 ili 170, koje su važne za skupinu inhibitora HCV proteaze, nisu utjecale na aktivnost glekaprevira.
English: (CYP3A4 and P-gp inhibition)
Croatian: (inhibicija CYP3A4 i P-gp-a)
English: Maviret for 12 weeks (TN only, n=64) or 16 weeks (TE only, n=51)
Croatian: Maviret tijekom 12 tjedana (samo PN, n=64) ili 16 tjedana (samo PL, n=51)
English: Relative to healthy subjects (N=230), population estimates of AUC24, ss were similar (10% difference) for glecaprevir and 34% lower for pibrentasvir in HCV-infected patients without cirrhosis.
Croatian: U odnosu na zdrave ispitanike (N=230), za ispitanike s HCV infekcijom bez ciroze procijenjene vrijednosti AUC24, ss bile su slične (razlika od 10%) za glekaprevir i 34% niže za pibrentasvir.
English: Table 7: Clinical studies conducted with Maviret in subjects with HCV genotype 1, 2, 3, 4, 5 or 6 Infection
Croatian: Tablica 7: Klinička ispitivanja lijeka Maviret provedena u ispitanika s HCV infekcijom genotipa 1, 2, 3, 4, 5 ili 6.
English: Biliary excretion Biliary excretion t1/2 (h) at steady-state % of dose excreted in urinec % of dose excreted in faecesc
Croatian: Izlučivanje putem žuči t1/2 (h) u stanju dinamičke ravnoteže % doze koja se izlučuje mokraćomc % doze koja se izlučuje kroz fecesc
English: Maviret for 8 weeks (GT1, 2, 4, 5, and 6 and GT3 TN) (n=356) or 16
Croatian: Maviret tijekom 8 tjedana (GT1, 2, 4, 5 i 6 i GT3 PN) (n=356) ili 16
English: Maviret 16 weeks (N=69)
Croatian: Maviret 16 tjedana (N=69)
English: Activity of glecaprevir and pibrentasvir against HCV genotypes 1-6 replicon cell lines
Croatian: Tablica 5: Aktivnost glekaprevira i pibrentasvira protiv staničnih linija replikona HCV-a genotipa 1-6
English: Lopinavir/ritonavir 400/100 mg twice daily
Croatian: Lopinavir/ritonavir 400/100 mg dvaput na dan
English: Co-administration of such medicinal products with Maviret is contraindicated (see section 4.3).
Croatian: Istodobna primjena takvih lijekova s lijekom Maviret je kontraindicirana (vidjeti dio 4.3).
English: Maternal toxicity associated with embryo-foetal loss has been observed in the rabbit with glecaprevir which precluded evaluation of glecaprevir at clinical exposures in this species (see section 5.3).
Croatian: Kod primjene glekaprevira u kunića primijećena je toksičnost za majku povezana s gubitkom embrija/fetusa, zbog čega u toj vrsti nije bilo moguće ocijeniti glekaprevir pri kliničkim razinama izloženosti (vidjeti dio 5.3).
English: As liver function may change during treatment with Maviret, a close monitoring of International Normalised Ratio (INR) values is recommended.
Croatian: Bolesnici liječeni antagonistima vitamina K Budući da tijekom liječenja lijekom Maviret može doći do promjene jetrene funkcije, preporučuje se pažljivo praćenje vrijednosti internacionalnog normaliziranog omjera (engl.
English: Genotype 1-infected (and a very limited number of genotype 4-infected) patients with prior failure on regimens that may confer resistance to glecaprevir/pibrentasvir were studied in the MAGELLAN-1 study (section 5.1).
Croatian: U ispitivanju MAGELLAN-1 ispitivani su bolesnici zaraženi virusom genotipa 1 (i vrlo mali broj bolesnika zaraženih virusom genotipa 4) koji nisu uspješno odgovorili na prethodne režime liječenja koji mogu uzrokovati rezistenciju na glekaprevir/pibrentasvir (vidjeti dio 5.1).
English: Glecaprevir
Croatian: Glekaprevir
English: No dose adjustment of Maviret is required in patients with any degree of renal impairment including patients on dialysis (see sections 5.1 and 5.2).
Croatian: Nije potrebno prilagođavati dozu lijeka Maviret u bolesnika s bilo kojim stupnjem oštećenja bubrežne funkcije, uključujući bolesnike na dijalizi (vidjeti dijelove 5.1 i 5.2).
English: Glecaprevir and pibrentasvir were not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, chromosome aberration using human peripheral blood lymphocytes and in vivo rodent micronucleus assays.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Glekaprevir i pibrentasvir nisu bili genotoksični u nizu in vitro ili in vivo testova, uključujući test mutagenosti na bakterijama, test kromosomskih aberacija na limfocitima iz ljudske periferne krvi te in vivo mikronukleusni test na glodavcima.
English: Maviret for 12 weeks (n=66) or 16 weeks (n=47) HCV/HIV-1 Co-Infected Subjects with or without Cirrhosis GT1-6
Croatian: Maviret tijekom 12 tjedana (n=66) ili 16 (n=47) tjedana Ispitanici s cirozom ili bez nje koji su istodobno imali HCV/HIV-1 infekciju GT1-6
English: c. Relapse is defined as HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment.
Croatian: Relaps se definirao kao vrijednost HCV RNK ≥ LLOQ u bolesnika koji su završili liječenje a u kojih je na kraju liječenja utvrđen odgovor.
English: EXPEDITION-5 was an open-label study in 101 HCV GT1-6 infected subjects without cirrhosis or with compensated cirrhosis and chronic kidney disease (CKD) stage 3b, 4, or 5.
Croatian: EXPEDITION-5 bilo je otvoreno ispitivanje provedeno u 101 ispitanika s HCV infekcijom genotipa 1-6 bez ciroze ili s kompenziranom cirozom i kroničnom bubrežnom bolešću (KBB) stadija
English: Baseline polymorphisms relative to a subtype-specific reference sequence at amino acid positions 155, 156, and 168 in NS3, and 24, 28, 30, 31, 58, 92, and 93 in NS5A were evaluated at a 15% detection threshold by next-generation sequencing.
Croatian: Polimorfizmi povezani s referentnom sekvencom specifičnom za pojedini podtip i prisutni na početku ispitivanja na aminokiselinskim položajima 155, 156 i 168 u proteinu NS3 te položajima 24, 28, 30, 31, 58, 92 i 93 u proteinu NS5A ocijenjeni su sekvenciranjem nove generacije
English: ENDURANCE-4 Maviret for 12 weeks (n=121) ENDURANCE-5,6 Maviret for 8 weeks (n=75) SURVEYOR-1 Maviret for 12 weeks (n=32) SURVEYOR-2c
Croatian: ENDURANCE-4 Maviret tijekom 12 tjedana (n=121) ENDURANCE-5,6 Maviret tijekom 8 tjedana (n=75) SURVEYOR-1 Maviret tijekom 12 tjedana (n=32) SURVEYOR-2c
English: Rifampicin 600 mg once dailya
Croatian: Rifampicin 600 mg jedanput na dana
English: If vomiting occurs more than 3 hours after dosing, an additional dose of Maviret is not needed.
Croatian: Ako bolesnik povrati više od 3 sata nakon primjene doze, ne treba uzeti dodatnu dozu lijeka Maviret.
English: For patients who failed prior therapy with an NS3/4A- and/or an NS5A-inhibitor, see section 4.4.
Croatian: Za informacije o bolesnicima koji nisu uspješno odgovorili na prethodnu terapiju inhibitorom NS3/4A i/ili NS5A, vidjeti dio 4.4.
English: Subjects were either treatment-naïve or treatment-experienced to combinations of (peg) interferon, ribavirin, and/or sofosbuvir and received Maviret for 8, 12, or 16 weeks per approved treatment durations.
Croatian: 3b, 4 ili 5. Ispitanici nisu bili prethodno liječeni ili su bili prethodno liječeni kombinacijama (peg)interferona, ribavirina i/ili sofosbuvira te su primali lijek Maviret tijekom 8, 12 ili 16 tjedana prema odobrenim trajanjima liječenja.
English: Rosuvastatin 5 mg once daily
Croatian: Rosuvastatin 5 mg jedanput na dan
English: • If you notice 18 hours or more after the time you usually take Maviret, wait and take the next dose at your usual time.
Croatian: • Ako primijetite da ste propustili uzeti Maviret 18 ili više sati nakon uobičajenog vremena uzimanja lijeka, pričekajte i uzmite sljedeću dozu prema uobičajenom rasporedu.
English: % Bound to human plasma proteins Blood-to-plasma ratio
Croatian: % lijeka koji se veže za proteine u plazmi ljudi
English: The SVR12 rate in TN or TE-PRS HCV/HIV-1 co-infected subjects treated for 8 or 12 weeks (without cirrhosis and with compensated cirrhosis, respectively) was 98.2% (165/168) from ENDURANCE-1 and EXPEDITION-2.
Croatian: Stopa SVR12 među ispitanicima s istodobnom HCV/HIV-1 infekcijom koji prethodno nisu bili liječeni ili su prethodno bili liječeni PRS-om, a primali su lijek tijekom 8 tjedana (ispitanici bez ciroze) ili tijekom 12 tjedana (ispitanici s kompenziranom cirozom), iznosila je 98,2% (165/168) u ispitivanjima ENDURANCE-1 i EXPEDITION-2.
English: Table 10: SVR12 in genotype 3-infected subjects with or without cirrhosis who received the recommended duration (SURVEYOR-2 Part 3)
Croatian: Tablica 10: SVR12 u bolesnika s infekcijom genotipom 3, s cirozom ili bez nje, koji su primali lijek tijekom preporučenog razdoblja (SURVEYOR-2, 3. dio)
English: The recommended Maviret treatment durations for HCV genotype 1, 2, 3, 4, 5, or 6 infected patients with compensated liver disease (with or without cirrhosis) are provided in Table 1 and Table 2.
Croatian: Preporučena trajanja liječenja lijekom Maviret u bolesnika s HCV infekcijom genotipa 1, 2, 3, 4, 5 ili 6 i kompenziranom bolešću jetre (s cirozom ili bez nje) navedena su u Tablici 1 i Tablici 2.
English: Both glecaprevir and pibrentasvir inhibit the bile salt export pump (BSEP) in vitro.
Croatian: I glekaprevir i pibrentasvir inhibiraju pumpu za izbacivanje žučnih soli (engl. bile salt export pump,
English: HBV screening should be performed in all patients before initiation of treatment.
Croatian: Prije početka liječenja u svih bolesnika treba napraviti probir na HBV.
English: Maviret for 12 weeks (GT1, 2, 4, 5, and 6 and GT3 TN) (n=157) or
Croatian: Maviret tijekom 12 tjedana (GT1, 2, 4, 5 i 6 i GT3 PN) (n=157) ili 16
English: Adverse reactions in subjects with severe renal impairment including subjects on dialysis The safety of Maviret in subjects with chronic kidney disease (including subjects on dialysis) and genotypes 1, 2, 3, 4, 5 or 6 chronic HCV infection with compensated liver disease (with or without cirrhosis) was assessed in EXPEDITION-4 (n=104) and EXPEDITION-5 (n=101).
Croatian: Nuspojave u ispitanika s teškim oštećenjem bubrežne funkcije, uključujući ispitanike na dijalizi Sigurnost lijeka Maviret u ispitanika s kroničnom bubrežnom bolešću (uključujući ispitanike na dijalizi) te kroničnom HCV infekcijom genotipa 1, 2, 3, 4, 5 ili 6 i kompenziranom bolešću jetre (s cirozom ili bez nje) ocijenjena je u ispitivanjima EXPEDITION-4 (n=104) i EXPEDITION-5 (n=101).
English: For dosing recommendations with HIV antiviral agents, refer to section 4.5.
Croatian: Za preporuke za doziranje kod istodobne primjene s antiviroticima za liječenje HIV-a vidjeti dio 4.5.
English: Maviret treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Croatian: 4.2 Doziranje i način primjene Liječenje lijekom Maviret treba započeti i nadzirati liječnik s iskustvom u liječenju bolesnika s HCV
English: ENDURANCE-3 Maviret for 8 weeks (n=157) or 12 weeks (n=233) Sofosbuvir + daclatasvir for 12 weeks (n=115) SURVEYOR-2 Maviret for 8 weeks (TN only, n=29) or 12 weeks (n=76) or 16 weeks (TE only, n=22)
Croatian: ENDURANCE-3 Maviret tijekom 8 tjedana (n=157) ili 12 tjedana (n=233) Sofosbuvir + daklatazvir tijekom 12 tjedana (n=115) SURVEYOR-2 Maviret tijekom 8 tjedana (samo PN, n=29) ili 12 tjedana (n=76) ili 16 tjedana (samo PL, n=22)
English: Table 8: SVR12 in treatment-naïve and treatment-experienceda subjects to peginterferon, ribavirin and/or sofosbuvir with genotype 1, 2, 4, 5 and 6 infection who received the recommended duration (pooled data from ENDURANCE-1b, SURVEYOR-1, -2, and EXPEDITION-1, 2b, -4 and 8)
Croatian: Tablica 8: SVR12 u bolesnika zaraženih genotipom 1, 2, 4, 5 i 6 koji prethodno nisu bili liječeni i onih koji su prethodno liječenia peginterferonom, ribavirinom i/ili sofosbuvirom, a koji su primali lijek tijekom preporučenog razdoblja (objedinjeni podaci iz ispitivanja ENDURANCE-1b, SURVEYOR-1, -2 i EXPEDITION-1, -2b, -4 i 8)
English: Clinical Study in Liver or Kidney Transplant Recipients MAGELLAN-2 was a single-arm, open-label study in 100 post-liver or -kidney transplant HCV GT1-6 infected subjects without cirrhosis who received Maviret for 12 weeks.
Croatian: Kliničko ispitivanje u primatelja jetrenog ili bubrežnog presatka MAGELLAN-2 bilo je otvoreno ispitivanje s jednom skupinom provedeno nakon transplantacije u 100 primatelja jetrenog ili bubrežnog presatka s HCV infekcijom genotipa 1-6 bez ciroze, koji su primali Maviret tijekom 12 tjedana.
English: Follow the dosing recommendations in Tables 1 and 2.
Croatian: Bolesnici s istodobnom HIV-1 infekcijom Slijediti preporuke za doziranje navedene u Tablicama 1 i 2.
English: Maviret for 8 weeks (n=44) or 16 weeks (n=3)
Croatian: Maviret tijekom 8 tjedana (n=44) ili 16 tjedana (n=3)
English: No dose adjustment of Maviret is required in adolescents aged 12 to <18 years (see sections 5.1 and 5.2).
Croatian: Pedijatrijska populacija Nije potrebno prilagođavati dozu lijeka Maviret u adolescenata u dobi od 12 do <18 godina (vidjeti dijelove 5.1 i 5.2).
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Maviret.
Croatian: Nakon što počnete uzimati lijek Maviret, možda ćete trebati pažljivije pratiti razinu glukoze u krvi i/ili prilagoditi lijek protiv šećerne bolesti.
English: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Croatian: Tijekom ili nakon liječenja direktno djelujućim antivirusnim lijekovima zabilježeni su slučajevi reaktivacije virusa hepatitisa B (HBV), od kojih su neki imali smrtni ishod.
English: Among the 18 genotype 3-infected subjects treated with Maviret for 8, 12, or 16 weeks who experienced virologic failure, treatment-emergent NS3 substitutions Y56H/N, Q80K/R, A156G, or Q168L/R were observed in 11 subjects.
Croatian: Među 18 ispitanika s infekcijom genotipom 3 koji su liječeni lijekom Maviret tijekom 8, 12 ili 16 tjedana i doživjeli virološki neuspjeh, u njih 11 primijećene su supstitucije Y56H/N, Q80K/R, A156G ili Q168L/R u proteinu NS3 nastale tijekom liječenja.
English: ↑ EE ↑ norgestrel norethidrone or norgestimate as contraceptive progestagen.
Croatian: Nije potrebno prilagođavati dozu kod istodobne primjene s levonorgestrelom, noretindronom ili norgestimatom kao kontraceptivnim progestagenom.
English: GT 1, 2, 4, 5, 6 8 weeks
Croatian: GT 1, 2, 4, 5, 6
English: • If you vomit less than 3 hours after taking Maviret, take another dose.
Croatian: • Ako povratite unutar 3 sata od uzimanja lijeka Maviret, uzmite još jednu dozu.
English: Among GT3b subjects without cirrhosis, a numerically lower SVR12 rate of 58.3% (7/12) [62.5% (5/8) for TN subjects and 50% (2/4) for TE-PRS subjects] was observed compared to GT3a subjects without cirrhosis (92.9% (13/14)).
Croatian: Među ispitanicima s genotipom 3b bez ciroze, primijećena je brojčano niža stopa SVR12 od 58,3% (7/12) [62,5% (5/8) za ispitanike koji prethodno nisu bili liječeni i 50% (2/4) za ispitanike koji su prethodno bili liječeni PRS-om] u odnosu na ispitanike s genotipom 3a bez ciroze (92,9% (13/14)).
English: ↑ simvastatin acid
Croatian: ↑ simvastatin simvastatinska kiselina
English: Transport
Croatian: PROMET
English: Simvastatin 5 mg once daily
Croatian: Simvastatin 5 mg jedanput na dan
English: Maviret is not recommended in patients with moderate hepatic impairment (Child Pugh-B) and is contraindicated in patients with severe hepatic impairment (Child-Pugh C) (see sections 4.3, 4.4, and
Croatian: Primjena lijeka Maviret ne preporučuje se u bolesnika s umjerenim oštećenjem jetrene funkcije (Child-Pugh stadij B), a kontraindicirana je u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C) (vidjeti dijelove 4.3, 4.4 i 5.2).
English: − Tablet core: copovidone (Type K 28), vitamin E polyethylene glycol succinate, silica, anhydrous colloidal, propylene glycol monocaprylate (type II), croscarmellose sodium, sodium stearyl fumarate.
Croatian: Jezgra tablete: kopovidon (tip K 28), vitamin E polietilenglikolsukcinat, bezvodni koloidni silicijev dioksid, propilenglikolmonokaprilat (tip II), umrežena karmelozanatrij, natrijev stearilfumarat.
English: Maviret 100 mg/40 mg film-coated tablets
Croatian: Maviret 100 mg/40 mg filmom obložene tablete
English: (Induction of Pgp/CYP3A)
Croatian: (indukcija P-gp-a/CYP3A)
English: Based on population pharmacokinetic models for Maviret in chronic hepatitis C patients, steady-state AUC24 values for glecaprevir and pibrentasvir were 4800 and 1430 ng∙h/mL in subjects without cirrhosis (N=1804), and 10500 and 1530 ng∙h/mL in subjects with cirrhosis (N=280), respectively.
Croatian: Na temelju populacijskog farmakokinetičkog modela lijeka Maviret, u bolesnika s kroničnim hepatitisom C, vrijednosti AUC24 u stanju dinamičke ravnoteže za glekaprevir i pibrentasvir iznosile su 4800 odnosno 1430 ng∙h/ml u ispitanika bez ciroze (N=1804), dok su i ispitanika s cirozom