FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Patients should be instructed to swallow tablets whole with food and not to chew, crush or break the tablets as it may alter the bioavailability of the agents (see section 5.2).
Croatian: Bolesnicima treba napomenuti da tablete progutaju cijele, s hranom, te da ih ne smiju žvakati, drobiti ni lomiti jer to može promijeniti bioraspoloživost djelatnih tvari (vidjeti dio 5.2).
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Maviret.
Croatian: U nekih bolesnika sa šećernom bolesti zabilježene su niske razine šećera u krvi (hipoglikemija) nakon početka liječenja lijekovima kao što je Maviret
English: Omeprazole 40 mg once daily (1 hour before breakfast)
Croatian: Omeprazol 40 mg jedanput na dan (1 sat prije doručka)
English: 35 µg/250 µg once daily
Croatian: 35 µg/250 µg jedanput na dan
English: The adverse reactions observed were comparable with those observed in clinical studies of Maviret in adults.
Croatian: Opažene nuspojave bile su usporedive s onima opaženima u kliničkim ispitivanjima lijeka Maviret u odraslih.
English: • Swallow the tablets whole.
Croatian: • Tablete progutajte cijele.
English: Interactions with fluvastatin and pitavastatin are likely and caution is recommended during the combination.
Croatian: Vjerojatno će doći do interakcija s fluvastatinom i pitavastatinom te se tijekom istodobne primjene preporučuje oprez.
English: b. Mean systemic exposure with moderate to high fat meals.
Croatian: b. Srednja vrijednost sistemske izloženosti uz obrok s umjerenim do visokim udjelom masti.
English: Among treatment-experienced subjects, 46% (42/91) failed a previous regimen containing sofosbuvir.
Croatian: Od svih prethodno liječenih bolesnika, njih 46% (42/91) nije uspješno odgovorilo na prethodni režim liječenja koji je sadržavao sofosbuvir.
English: Median EC50, nM (range)
Croatian: Medijan vrijednosti EC50, nM (raspon)
English: Maviret has no or negligible influence on the ability to drive and use machines.
Croatian: Maviret ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Significant inhibition of CYP1A2, CYP2C9, CYP2C19, CYP2D6, UGT1A6, UGT1A9, UGT1A4, UGT2B7, OCT1, OCT2, OAT1, OAT3, MATE1 or MATE2K are not expected.
Croatian: Ne očekuje se značajna inhibicija CYP1A2, CYP2C9, CYP2C19, CYP2D6, UGT1A6, UGT1A9, UGT1A4, UGT2B7, OCT1, OCT2, OAT1, OAT3, MATE1 ili MATE2K.
English: Serum bilirubin elevations
Croatian: Povišenja serumskih vrijednosti bilirubina
English: Phenytoin, phenobarbital, primidone
Croatian: Fenitoin, fenobarbital, primidon
English: Your doctor will test your blood before, during and after your treatment with Maviret.
Croatian: Liječnik će napraviti krvne pretrage prije, tijekom i nakon liječenja lijekom Maviret kako bi:
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“ ili „EXP“.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with glecaprevir/pibrentasvir in one or more subsets of the paediatric population from 3 years to less than 12 years in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka glekaprevir/pibrentasvir u jednoj ili više podskupina pedijatrijske populacije u dobi od 3 do manje od 12 godina za liječenje kroničnog hepatitisa C (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Each film-coated tablet contains 7.48 mg lactose (as lactose monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 7,48 mg laktoze (u obliku laktoze hidrata).
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
Croatian: Učestalost je definirana kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i
English: Clinical studies of Maviret included 328 patients aged 65 and over (13.8% of the total number of subjects).
Croatian: U klinička ispitivanja lijeka Maviret bilo je uključeno 328 ispitanika u dobi od 65 i više godina (13,8% od ukupnog broja ispitanika).
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines.
Croatian: U bolesnika s istodobnom HBV/HCV infekcijom postoji rizik od reaktivacije HBV-a pa ih stoga treba nadzirati i liječiti u skladu s važećim kliničkim smjernicama.
English: Race/ethnicity No dose adjustment of Maviret is required based on race or ethnicity.
Croatian: Rasa/etničko podrijetlo Nije potrebno prilagođavati dozu lijeka Maviret s obzirom na rasu ili etničko podrijetlo.
English: If the combination is unavoidable, use can be considered if the benefit outweighs the risk with a close clinical monitoring.
Croatian: Ako nije moguće izbjeći ovu kombinaciju te ako njezina korist nadilazi rizik, može se razmotriti istodobna primjena ovih lijekova uz pažljivo kliničko praćenje.
English: Maviret is an antiviral medicine used to treat adults and adolescents (12 to less than 18 years old) with long-term (‘chronic') hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Croatian: Maviret je antivirusni lijek koji se koristi za liječenje odraslih osoba i adolescenata (od 12 do manje od 18 godina) s dugotrajnim („kroničnim”) hepatitisom C (zaraznom bolešću koja zahvaća jetru, a uzrokuje ju virus hepatitisa C).
English: Some substitutions at position 156 reduced susceptibility to glecaprevir (genotypes 1 to 4) by > 100-fold.
Croatian: Neke su supstitucije na položaju 156 smanjile osjetljivost na glekaprevir (genotipovi 1-4) > 100 puta.
English: HMG-COA REDUCTASE INHIBITORS Atorvastatin
Croatian: INHIBITORI HMG-CoA REDUKTAZE Atorvastatin
English: SVR12 in subjects without cirrhosis 8 weeks
Croatian: SVR12 u ispitanika bez ciroze 8 tjedana
English: (Inhibition of UGT1A1)
Croatian: (inhibicija UGT1A1)
English: Expected: ↑ fluvastatin and ↑ pitavastatin
Croatian: Očekuje se: ↑ fluvastatin i ↑ pitavastatin
English: Glecaprevir and pibrentasvir are weak inhibitors of cytochrome P450 (CYP) 3A and uridine glucuronosyltransferase (UGT) 1A1 in vivo.
Croatian: Glekaprevir i pibrentasvir slabi su inhibitori enzima citokroma P450 (CYP) 3A i uridin glukuronoziltransferaze (UGT) 1A1 in vivo.
English: No dose adjustment of Maviret is required in adolescents 12 years and older.
Croatian: Nije potrebno prilagođavati dozu lijeka Maviret u adolescenata u dobi od 12 godina i starijih.
English: The effect of efavirenz/emtricitabine/tenofovir disoproxil fumarate on glecaprevir and pibrentasvir was not directly quantified within this study, but glecaprevir and pibrentasvir exposures were significantly lower than historical controls.
Croatian: Učinak kombinacije efavirenz/emtricitabin/tenofovir dizoproksilfumarat na glekaprevir i pibrentasvir nije izravno kvantitativno mjeren u ovom ispitivanju, no izloženosti glekapreviru i pibrentasviru bile su značajno niže nego u povijesnim kontrolama.
English: ETHINYL-OESTRADIOL-CONTAINING PRODUCTS Ethinyloestradiol (EE)/Norgestimate
Croatian: LIJEKOVI KOJI SADRŽE ETINILESTRADIOL Etinilestradiol (EE)/norgestimat
English: The direction of the arrow indicates the direction of the change in exposures (Cmax, AUC, and Cmin) in glecaprevir, pibrentasvir, and the coadministered medicinal product (↑ = increase (more than 25%), ↓ = decrease (more than 20%), ↔ = no change (equal to or less than 20% decrease or 25% increase)).
Croatian: Smjer strelice označava smjer promjene izloženosti (Cmax, AUC i Cmin) glekapreviru, pibrentasviru i istodobno primijenjenom lijeku (↑ = povećanje (više od 25%), ↓ = smanjenje (više od 20%), ↔ = nema promjene (smanjenje za najviše 20% ili povećanje za najviše 25%)).
English: The overall prevalence of A30K and Y93H at baseline was 6.5% and 4.9%, respectively.
Croatian: Ukupna prevalencija A30K i Y93H na početku ispitivanja iznosila je 6,5% odnosno 4,9%.
English: • carbamazepine, phenobarbital, phenytoin, primidone (normally used for epilepsy)
Croatian: • karbamazepin, fenobarbital, fenitoin, primidon (obično se koriste za liječenje epilepsije)
English: Relapsec
Croatian: Relapsa
English: Glucose levels of diabetic patients initiating direct acting antiviral 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 direktno djelujućim antivirotikom treba pažljivo nadzirati, posebno unutar prva tri mjeseca, te prema potrebi prilagoditi lijek protiv dijabetesa.
English: The mechanism of action of pibrentasvir has been characterized based on cell culture antiviral activity and drug resistance mapping studies.
Croatian: Mehanizam djelovanja pibrentasvira opisan je na temelju antivirusne aktivnosti u staničnoj kulturi i ispitivanja provedenih radi mapiranja rezistencije na lijek.
English: Tell your doctor or pharmacist if you notice any of the following side effects:
Croatian: Obratite se svom liječniku ili ljekarniku ako primijetite bilo koju od sljedećih nuspojava:
English: b. Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
Croatian: b. Uključuje ispitanike koji su prekinuli liječenje zbog štetnog događaja, koji su izgubljeni iz praćenja ili koji su se povukli iz ispitivanja.
English: film-coated tablets 21 film-coated tablets
Croatian: filmom obložene tablete 21 filmom obložena tableta
English: Maviret tablets are packed into foil blisters, each containing 3 tablets.
Croatian: Maviret tablete zapakirane su u blistere od folije od kojih svaki sadrži 3 tablete.
English: The pharmacokinetics of glecaprevir and pibrentasvir have not been established in paediatric patients <12 years of age.
Croatian: Farmakokinetika glekaprevira i pibrentasvira u pedijatrijskih bolesnika u dobi od <12 godina nije ustanovljena.
English: Estimation of the pharmacokinetic parameters using population pharmacokinetic models has inherent uncertainty due to dose non-linearity and cross interaction between glecaprevir and pibrentasvir.
Croatian: Procjena farmakokinetičkih parametara uz pomoć populacijskih farmakokinetičkih modela nosi inherentnu nesigurnost zbog nelinearnosti doze i križne interakcije između glekaprevira i pibrentasvira.
English: If you are sick (vomit) after taking Maviret it may affect the amount of Maviret in your blood.
Croatian: Ako povratite nakon što uzmete Maviret, to može utjecati na količinu lijeka u krvi.
English: The in vitro activity of glecaprevir was also studied in a biochemical assay, with similarly low IC50 values across genotypes.
Croatian: Aktivnost glekaprevira in vitro ispitivala se i u biokemijskom testu, u kojem su vrijednosti IC50 bile podjednako niske u svim genotipovima.
English: Omeprazole 40 mg once daily (evening without food)
Croatian: Omeprazol 40 mg jedanput na dan (navečer, bez hrane)
English: Pravastatin dose should not exceed 20 mg per day and rosuvastatin dose should not exceed 5 mg per day.
Croatian: 20 mg na dan, dok doza rosuvastatina ne smije biti veća od 5 mg na dan.
English: Medicines you must tell your doctor about before taking Maviret Medicine
Croatian: Lijekovi o kojima morate obavijestiti liječnika prije nego uzmete Maviret
English: NS5A from HCV genotypes 1-6 clinical isolates
Croatian: NS5A iz kliničkih izolata HCV-a genotipa 1-6
English: Systemic exposures (AUC) to glecaprevir and pibrentasvir were approximately 63 and 102 times higher, respectively, than the exposure in humans at the recommended dose.
Croatian: Sistemske izloženosti (AUC) glekapreviru i pibrentasviru bile su približno 63 odnosno 102 puta veće od izloženosti koja se postiže u ljudi nakon primjene preporučene doze.
English: Exposures of glecaprevir and pibrentasvir in adolescents aged 12 to <18 years were comparable to those in adults from Phase 2/3 studies.
Croatian: Izloženost glekapreviru i pibrentasviru u adolescenata u dobi od 12 do <18 godina bila je usporediva onoj u odraslih iz ispitivanja faze 2/3.
English: Bilirubin elevations were asymptomatic, transient, and typically occurred early during treatment.
Croatian: Povišenja vrijednosti bilirubina bila su asimptomatska i prolazna te su se obično javljala u ranoj fazi liječenja.
English: Some combinations of substitutions in genotypes 1a and 3a (including A30K+Y93H in genotype 3a) showed reductions in susceptibility to pibrentasvir.
Croatian: Neke kombinacije supstitucija kod genotipova 1a i 3a (uključujući A30K+Y93H kod genotipa 3a) pokazale su smanjenje osjetljivosti na pibrentasvir.
English: Maternal toxicity (anorexia, lower body weight, and lower body weight gain) with some embryofoetal toxicity (increase in post-implantation loss and number of resorptions and a decrease in mean foetal body weight), precluded the ability to evaluate glecaprevir in the rabbit at clinical exposures.
Croatian: Zbog toksičnosti za majku (anoreksija, manja tjelesna težina i manji porast tjelesne težine) i određene embriofetalne toksičnosti (povećanje broja postimplantacijskih gubitaka i broja resorpcija te smanjenje srednje vrijednosti tjelesne težine fetusa) nije bilo moguće ocijeniti glekaprevir u kunića pri kliničkim razinama izloženosti.
English: d. Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
Croatian: d. Uključuje ispitanike koji su prekinuli liječenje zbog štetnog događaja, koji su izgubljeni iz praćenja ili koji su se povukli iz ispitivanja.
English: No dose adjustment of Maviret is required in elderly patients.
Croatian: Nije potrebno prilagođavati dozu lijeka Maviret u starijih bolesnika.
English: • current or previous infection with the hepatitis B virus
Croatian: • imate ili ste ranije imali infekciju virusom hepatitisa B
English: ENDURANCE-2 Maviret (n=202) or Placebo (n=100) for 12 weeks SURVEYOR-2b
Croatian: ENDURANCE-2 Maviret (n=202) ili placebo (n=100) tijekom 12 tjedana SURVEYOR-2b
English: A resistance algorithm predictive of the risk for failure by baseline resistance has not been established.
Croatian: Nije utvrđen algoritam rezistencije na temelju kojega bi se mogao predvidjeti rizik od neuspjeha liječenja prema početnoj rezistenciji.
English: EE/Levonorgestrel 20 µg/100 µg once daily
Croatian: EE/levonorgestrel 20 µg/100 µg jedanput na dan
English: b. Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Croatian: Naveden je učinak atazanavira i ritonavira na prvu dozu glekaprevira i pibrentasvira.
English: Clinically significant increases in exposure were not observed for sensitive substrates of CYP3A (midazolam, felodipine) or UGT1A1 (raltegravir) when administered with Maviret.
Croatian: Nisu primijećena klinički značajna povećanja izloženosti osjetljivim supstratima CYP3A (midazolam, felodipin) ili UGT1A1 (raltegravir) kada su se primjenjivali istodobno s lijekom Maviret.
English: If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: Maviret works by stopping the hepatitis C virus from multiplying and infecting new cells.
Croatian: Maviret djeluje tako da sprječava umnožavanje virusa hepatitisa C te širenje zaraze na druge stanice.
English: ↑ losartan carboxylic acid
Croatian: ↑ losartan karboksilatna kiselina
English: What you need to know before you take Maviret 3.
Croatian: Što morate znati prije nego počnete uzimati Maviret
English: In case a dose of Maviret is missed, the prescribed dose can be taken within 18 hours after the time it was supposed to be taken.
Croatian: Ako bolesnik propusti uzeti dozu lijeka Maviret, propisanu dozu može uzeti unutar 18 sati nakon trenutka kada ju je trebao uzeti.
English: Effect on medicinal product levels
Croatian: Učinak na razine lijeka
English: Available pharmacokinetic data in animals have shown excretion of glecaprevir and pibrentasvir in milk (for details see section 5.3).
Croatian: Dostupni farmakokinetički podaci iz ispitivanja na životinjama pokazali su da se glekaprevir i pibrentasvir izlučuju u mlijeko (za pojedinosti vidjeti dio 5.3).
English: VITAMIN K ANTAGONISTS Vitamin K antagonists
Croatian: ANTAGONISTI VITAMINA K Antagonisti vitamina
English: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AP57 glecaprevir and pibrentasvir Mechanism of action
Croatian: Farmakoterapijska skupina: direktno djelujući antivirotici, ATK oznaka: J05AP57 glekaprevir i pibrentasvir
English: • you have severe liver problems other than from hepatitis C.
Croatian: • imate druge jetrene tegobe osim hepatitisa C
English: Substitutions at amino acid position 80 did not reduce susceptibility to glecaprevir except for Q80R in genotype 3a, which reduced susceptibility to glecaprevir by 21-fold.
Croatian: Supstitucije na aminokiselinskom položaju 80 nisu smanjile osjetljivost na glekaprevir, osim supstitucije Q80R kod genotipa 3a, koja je smanjila osjetljivost na glekaprevir 21 put.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Maviret.
Croatian: Ako se bilo što od navedenoga odnosi na Vas (ili niste sigurni), razgovarajte sa svojim liječnikom ili ljekarnikom prije nego uzmete Maviret.
English: Table 3 provides the least-squares mean Ratio (90% Confidence Interval) effect on concentration of Maviret and some common concomitant medicinal products.
Croatian: Tablici 3 navodi se omjer srednjih vrijednosti dobivenih metodom najmanjih kvadrata (interval pouzdanosti od 90%) učinka na koncentraciju lijeka Maviret i nekih čestih istodobno primjenjivanih lijekova.
English: Substitutions at amino acid position 168 in NS3 had no impact in genotype 2, while some substitutions at position 168 reduced glecaprevir susceptibility by up to 55-fold (genotypes 1, 3, 4), or reduced susceptibility by > 100-fold (genotype 6).
Croatian: Supstitucije na aminokiselinskom položaju 168 u proteinu NS3 nisu imale učinka kod genotipa 2, dok su neke supstitucije na položaju 168 smanjile osjetljivost na glekaprevir do 55 puta (genotipovi 1, 3, 4) ili smanjile osjetljivost > 100 puta (genotip 6).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA
English: Glecaprevir EC50, nM Pibrentasvir EC50, nM
Croatian: EC50 glekaprevira, nM EC50 pibrentasvira, nM
English: Population pharmacokinetic analysis in HCV-infected subjects showed that within the age range (12 to 88 years) analysed, age did not have a clinically relevant effect on the exposure to glecaprevir or pibrentasvir.
Croatian: Populacijska farmakokinetička analiza u ispitanika zaraženih HCV-om pokazala je da unutar analiziranog dobnog raspona (12 do 88 godina) dob nije imala klinički značajnog učinka na izloženost glekapreviru ili pibrentasviru.
English: No human data on the effect of glecaprevir and/or pibrentasvir on fertility are available.
Croatian: Nema dostupnih podataka o učinku glekaprevira i/ili pibrentasvira na plodnost u ljudi.
English: MAGELLAN-2 Maviret for 12 weeks (n=100) Adolescent subjects (12 to <18 years) GT1-6
Croatian: MAGELLAN-2 Maviret tijekom 12 tjedana (n=100) Ispitanici adolescenti (12 do <18 godina) GT1-6
English: Glecaprevir and pibrentasvir are substrates of the efflux transporters P-gp and/or BCRP.
Croatian: Glekaprevir i pibrentasvir supstrati su efluksnih prijenosnika P-gp-a i/ili BCRP-a.
English: Ten of 113 subjects treated with Maviret in the MAGELLAN-1 study for 12 or 16 weeks experienced virologic failure.
Croatian: Od 113 ispitanika koji su u ispitivanju MAGELLAN-1 liječeni lijekom Maviret tijekom 12 ili 16 tjedana, njih 10 je doživjelo virološki neuspjeh.
English: P-gp, BCRP, and OATP1B1/3
Croatian: P-gp, BCRP i OATP1B1/3
English: Genotype 1, 2, 4, 5, and 6: Baseline polymorphisms in genotypes 1, 2, 4, 5 and 6 had no impact on treatment outcome.
Croatian: Genotip 1, 2, 4, 5 i 6: Polimorfizmi prisutni na početku ispitivanja kod genotipova 1, 2, 4, 5 i 6 nisu utjecali na ishod liječenja.
English: DORA (Part 1) was an open-label study to evaluate safety and efficacy in adolescents aged 12 years to less than 18 years who received Maviret 300 mg/120 mg (three 100 mg/40 mg film-coated tablets), for 8, or 16 weeks.
Croatian: DORA (1. dio) bilo je otvoreno ispitivanje koje je ocjenjivalo sigurnost i djelotvornost u adolescenata u dobi od 12 do manje od 18 godina koji su primali lijek Maviret u dozi od 300 mg/120 mg (tri 100 mg/40 mg filmom obložene tablete) tijekom 8 ili 16 tjedana.
English: If more than 18 hours have passed since Maviret is usually taken, the missed dose should not be taken and the patient should take the next dose per the usual dosing schedule.
Croatian: Ako je od vremena kada se Maviret obično uzima prošlo više od 18 sati, propuštena doza ne smije se uzeti, a sljedeću dozu bolesnik treba uzeti prema uobičajenom rasporedu.
English: 47 subjects were enrolled in DORA (Part 1).
Croatian: U ispitivanje DORA (1. dio) bilo je uključeno 47 ispitanika.
English: The highest documented doses administered to healthy volunteers is 1,200 mg once daily for 7 days for glecaprevir and 600 mg once daily for 10 days for pibrentasvir.
Croatian: Najveća zabilježena doza primijenjena u zdravih dobrovoljaca iznosila je 1200 mg glekaprevira jedanput na dan tijekom 7 dana te 600 mg pibrentasvira jedanput na dan tijekom 10 dana.
English: In case of overdose, the patient should be monitored for any signs and symptoms of toxicities (see section 4.8).
Croatian: U slučaju predoziranja, bolesnika treba nadzirati zbog moguće pojave znakova i simptoma toksičnosti (vidjeti dio 4.8) te odmah uvesti odgovarajuće simptomatsko liječenje.
English: ENDURANCE-3 was a partially-randomized, open-label, active-controlled study in treatment-naïve subjects.
Croatian: Ispitivanje ENDURANCE-3 bilo je djelomično randomizirano, otvoreno, aktivnim lijekom kontrolirano ispitivanje provedeno u prethodno neliječenih ispitanika.
English: Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and in adolescents aged 12 to <18 years (see sections 4.2, 4.4. and 5.1).
Croatian: Maviret je indiciran za liječenje kronične infekcije virusom hepatitisa C (HCV) u odraslih i adolescenata u dobi od 12 do <18 godina (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Of the genotype 3-infected subjects with end stage renal disease enrolled in EXPEDITION-4, 100% (11/11) achieved SVR12.
Croatian: Među ispitanicima s infekcijom genotipom 3 u terminalnoj fazi bubrežne bolesti koji su uključeni u ispitivanje EXPEDITION-4, njih 100% (11/11) postiglo je SVR12.
English: The recommended dose for adults and adolescents (12 to <18 years old) is three tablets of Maviret 100mg/40mg taken together, once a day.
Croatian: Preporučena doza za odrasle i adolescente (od 12 do <18 godina) je tri tablete lijeka Maviret 100 mg/40 mg odjednom, jedanput na dan.
English: Maviret is available in a pack of 84 tablets as 4 cartons, each containing 21 film-coated tablets.
Croatian: Maviret je dostupan u pakiranju od 84 tablete, koje se sastoji od 4 kutije, od kojih svaka sadrži 21 filmom obloženu tabletu.
English: Both glecaprevir and pibrentasvir were fully active against substitutions associated with resistance to NS5B nucleotide and non-nucleotide inhibitors.
Croatian: I glekaprevir i pibrentasvir bili su potpuno djelatni protiv supstitucija povezanih s rezistencijom na nukleotidne i nenukleotidne inhibitore NS5B.