FrancophonIA/ELRC3.0 huggingface dataset:
English: To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Za poslušanje ali če želite kopijo tega navodila v <Braillovi pisavi>, <večji pisavi> ali <avdio obliki>, se obrnite na predstavništvo imetnika dovoljenja za promet.
English: The safety and efficacy of Maviret in children aged less than 12 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Maviret pri otrocih, mlajših od 12 let, še nista ugotovljeni.
English: Take all 3 tablets in 1 blister once daily with food
Slovenian: Vzemite vse 3 tablete v enem pretisnem omotu enkrat na dan s hrano.
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).
Slovenian: (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The effects of Maviret during pregnancy are not known.
Slovenian: Učinki zdravila Maviret med nosečnostjo niso znani.
English: Caution and therapeutic concentration monitoring of digoxin is recommended.
Slovenian: Priporočljiva sta previdnost in nadzor terapevtske koncentracije digoksina.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Maviret therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja z zdravilom Maviret, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
English: Bilirubin elevations were asymptomatic, transient, and typically occurred early during treatment.
Slovenian: Zvišanja bilirubina so bila asimptomatska, prehodna in so se praviloma pojavila zgodaj med zdravljenjem.
English: • Do not chew, crush or break the tablets as it may affect the amount of Maviret in your blood.
Slovenian: • Tablet ne žvečite, drobite ali lomite, saj lahko to vpliva na količino zdravila Maviret v vaši krvi.
English: Blood tests
Slovenian: Preiskave krvi
English: Hepatitis B Virus reactivation
Slovenian: Reaktivacija virusa hepatitisa B
English: It is not known whether the two medicines in Maviret pass into breast milk.
Slovenian: Ni znano ali ti dve učinkovini v zdravilu Maviret prehajata v materino mleko.
English: SOF+DCV 12 weeks N=115
Slovenian: SOF+DCV 12 tednov N = 115
English: It is important not to miss a dose of this medicine.
Slovenian: Pomembno je, da ne pozabite vzeti odmerka tega zdravila.
English: Medicinal product by therapeutic areas/possible mechanism of interaction
Slovenian: Zdravila po terapevtskih področjih/možnih mehanizmih medsebojnega delovanja
English: This is due to liver function changes during treatment with Maviret.
Slovenian: To je posledica sprememb v delovanju jeter med zdravljenjem z zdravilom Maviret.
English: If you forget to take Maviret
Slovenian: Če ste pozabili vzeti zdravilo Maviret
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Slovenian: Neporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Very common: may affect more than 1 in 10 people
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
English: Your doctor will test your blood before, during and after your treatment with Maviret.
Slovenian: Zdravnik bo opravil preiskave krvi pred, med in po zdravljenju z zdravilom Maviret.
English: The most commonly reported adverse reactions (incidence ≥ 10%) were headache and fatigue.
Slovenian: Najpogosteje opisana neželena učinka (incidenca ≥ 10 %) sta bila glavobol in utrujenost.
English: Nervous system disorders Very common headache
Slovenian: Bolezni živčevja zelo pogosti glavobol
English: The adverse reactions are listed below by body system organ class and frequency.
Slovenian: Neželeni učinki so navedeni spodaj po organskem sistemu in pogostnosti.
English: The response rates observed for patients ≥ 65 years of age were similar to that of patients < 65 years of age, across treatment groups.
Slovenian: Deleži odziva, ugotovljeni pri bolnikih, starih ≥ 65 let, so bili v vseh terapevtskih skupinah podobni kot pri bolnikih, starih < 65 let.
English: What Maviret is and what it is used for
Slovenian: Kaj je zdravilo Maviret in za kaj ga uporabljamo
English: Direct hyperbilirubinemia was reported in 0.3% of subjects.
Slovenian: ALT. Direktna hiperbilirubinemija je bila poročana pri 0,3 % preiskovancih.
English: Pravastatin dose should not exceed 20 mg per day and rosuvastatin dose should not exceed 5 mg per day.
Slovenian: Odmerek pravastatina ne sme preseči 20 mg na dan in odmerek rosuvastatina ne sme preseči 5 mg na dan.
English: If used, lovastatin should not exceed a dose of 20 mg/day and patients should be monitored.
Slovenian: Če je lovastatin uporabljen, odmerek ne sme preseči 20 mg/dan in bolnika je treba kontrolirati.
English: 35 µg/250 µg once daily
Slovenian: 35 µg/250 µg enkrat na dan
English: Contraceptive medicines that contain ethinylestradiol must not be used in combination with Maviret.
Slovenian: Zdravila, ki se uporabljajo kot kontracepcija in vsebujejo etinilestradiol, se ne smejo uporabljati v kombinaciji z zdravilom Maviret.
English: In case of overdose, the patient should be monitored for any signs and symptoms of toxicities (see section 4.8).
Slovenian: V primeru prevelikega odmerjanja je treba bolnika nadzirati glede morebitnih znakov in simptomov toksičnih učinkov (glejte poglavje 4.8).
English: Median EC50, nM (range)
Slovenian: Mediana EC50, nM (razpon)
English: HMG-COA REDUCTASE INHIBITORS Atorvastatin
Slovenian: ZAVIRALCI REDUKTAZE HMG-CoA atorvastatin
English: Fluvastatin, Pitavastatin
Slovenian: ↑ rosuvastatin fluvastatin, pitavastatin
English: As liver function may change during treatment with Maviret, a close monitoring of International Normalised Ratio (INR) values is recommended.
Slovenian: Med zdravljenjem z zdravilom Maviret se lahko delovanje jeter spremeni, zato je priporočljivo natančno spremljanje vrednosti mednarodnega normaliziranega razmerja (INR - International Normalised Ratio).
English: Maviret works by stopping the hepatitis C virus from multiplying and infecting new cells.
Slovenian: Zdravilo Maviret deluje tako, da zaustavi razmnoževanje virusa hepatitisa C in okužbo novih celic.
English: A resistance algorithm predictive of the risk for failure by baseline resistance has not been established.
Slovenian: Algoritem odpornosti, ki predvidi tveganje za neuspeh glede na izhodiščno odpornost, ni bil ugotovljen.
English: d. Oxidative metabolites or their byproducts accounted for 26% of radioactive dose.
Slovenian: d. Na račun drugih oksidativnih presnovkov ali njihovih stranskih produktov je šlo 26 % radioaktivnega odmerka.
English: • ethinyl oestradiol-containing medicines (such as contraception medicines, including vaginal rings and tablets)
Slovenian: • zdravila z etinilestradiolom (kot so kontraceptivi, vključno z vaginalnimi obročki in tabletami);
English: The non-linear exposure increase <120 mg may be related to saturation of efflux transporters.
Slovenian: Nelinearno povečanje izpostavljenosti < 120 mg je morda povezano z zasičenjem iztočnih prenašalcev.
English: Maviret should not affect your ability to drive or use any tools or machines.
Slovenian: Zdravilo Maviret ne bi smelo vplivati na sposobnost vožnje, uporabe orodij ali strojev.
English: 8 weeks
Slovenian: 8 tednov
English: Interactions with fluvastatin and pitavastatin are likely and caution is recommended during the combination.
Slovenian: Medsebojna delovanja s fluvastatinom in pitavastatinom so verjetna in pri sočasni uporabi je priporočljiva previdnost.
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with Maviret, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Slovenian: Za ovrednotenje ponovnega pojava hepatocelularnega karcinoma, povezanega z zdravilom Maviret, mora imetnik dovoljenja za promet z zdravilom opraviti in predložiti rezultate varnostne študije z uporabo podatkov, ki izhajajo iz kohorte natančno opredeljene skupine bolnikov, na podlagi dogovorjenega protokola.
English: What you need to know before you take Maviret Do not take Maviret if:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Maviret Ne jemljite zdravila Maviret, če:
English: The mechanism of action of pibrentasvir has been characterized based on cell culture antiviral activity and drug resistance mapping studies.
Slovenian: Mehanizem delovanja pibrentasvirja so opredelili na podlagi protivirusne aktivnosti v celični kulturi in s študijami mapiranja odpornosti proti zdravilu.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake »Uporabno do« ali »EXP«.
English: Paediatric Population
Slovenian: Pediatrična populacija
English: Other medicines and Maviret
Slovenian: Druga zdravila in zdravilo Maviret
English: • atazanavir (for HIV infection)
Slovenian: • atazanavir (za zdravljenje okužbe s HIV);
English: The proportion of subjects treated with Maviret who permanently discontinued treatment due to adverse reactions was 0.1%.
Slovenian: Delež bolnikov, ki so zaradi neželenih učinkov trajno prenehali jemati zdravilo Maviret, je bil 0,1 %.
English: Contains lactose monohydrate.
Slovenian: Vsebuje laktozo monohidrat.
English: HIV-ANTIVIRAL AGENTS Atazanavir + ritonavir
Slovenian: PROTIVIRUSNA ZDRAVILA PROTI HIV atazanavir + ritonavir
English: Omeprazole 40 mg once daily (1 hour before breakfast)
Slovenian: ↔ pibrentasvir omeprazol 40 mg enkrat na dan (1 uro pred zajtrkom)
English: Not studied.
Slovenian: Ni raziskano.
English: b. Includes a total of 154 subjects coinfected with HIV-1 in ENDURANCE-1 and EXPEDITION-2 who received the recommended duration.
Slovenian: b. Vključuje skupno 154 preiskovancev, sočasno okuženih s HIV-1 iz študij ENDURANCE-1 in EXPEDITION2, ki so prejeli zdravljenje v priporočenem trajanju.
English: Genotype 1, 2, 4, 5, and 6: Baseline polymorphisms in genotypes 1, 2, 4, 5 and 6 had no impact on treatment outcome.
Slovenian: Genotipi 1, 2, 4, 5 in 6: Izhodiščni polimorfizmi genotipov 1, 2, 4, 5 in 6 niso vplivali na izid zdravljenja.
English: c. Single dose administration of [14C]glecaprevir or [14C]pibrentasvir in mass balance studies.
Slovenian: c. Uporaba enega odmerka [14C]glekaprevirja ali [14C]pibrentasvirja v študijah masnega ravnovesja.
English: Expected: ↑ fluvastatin and ↑ pitavastatin
Slovenian: Pričakovano: ↑ fluvastatin in ↑ pitavastatin
English: Table 3: Interactions between Maviret and other medicinal products
Slovenian: Preglednica 3: Medsebojna delovanja zdravila Maviret in drugih zdravil
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Maviret.
Slovenian: Če kar koli od zgoraj navedenega velja za vas (ali pa niste prepričani), se posvetujte z zdravnikom ali farmacevtom, preden vzamete zdravilo Maviret.
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.
Slovenian: Največji dokumentirani odmerek, uporabljen pri zdravih prostovoljcih, je 1200 mg enkrat na dan 7 dni za glekaprevir in 600 mg enkrat na dan 10 dni za pibrentasvir.
English: • atorvastatin or simvastatin (to lower blood cholesterol)
Slovenian: • atorvastatin ali simvastatin (za zniževanje holesterola v krvi);
English: Co-administration is not recommended with several medicinal products as detailed in section 4.5.
Slovenian: Sočasna uporaba ni priporočljiva z več zdravili, natančneje opisano v poglavju 4.5.
English: • rifampicin (for infections)
Slovenian: • rifampicin (za zdravljenje okužb);
English: This medicine does not require any special storage.
Slovenian: Za shranjevanje zdravila niso potrebna posebna navodila.
English: The adverse reactions observed were comparable with those observed in clinical studies of Maviret in adults.
Slovenian: Opaženi neželeni učinki so bili primerljivi s tistimi, ki so jih opazili v kliničnih študijah zdravila Maviret pri odraslih.
English: Each film-coated tablet contains 7.48 mg lactose (as lactose monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 7,48 mg laktoze (v obliki laktoze monohidrata).
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).
Slovenian: Bolnike je treba poučiti, naj tablete zaužijejo cele in s hrano; tablet ne smejo gristi, drobiti ali prelomiti, saj lahko to vpliva na biorazpoložljivost učinkovin (glejte poglavje 5.2).
English: See Table 3 for specific recommendations on interactions with sensitive substrates of P-gp, BCRP, and OATP1B1/3.
Slovenian: Glejte preglednico 3 za posebna priporočila o medsebojnem delovanju z občutljivimi substrati P-gp, BCRP in OATP1B1/3.
English: Studies in rats/mice with glecaprevir or pibrentasvir do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Slovenian: Študije z glekaprevirjem ali pibrentasvirjem na podganah/miših ne kažejo neposrednih ali posrednih škodljivih učinkov, kar zadeva toksične vplive na sposobnost razmnoževanja.
English: Exposures of glecaprevir and pibrentasvir in adolescents aged 12 to <18 years were comparable to those in adults from Phase 2/3 studies.
Slovenian: Izpostavljenost glekaprevirju in pibrentasvirju pri mladostnikih, starih od 12 do <18 let, je bila primerljiva s tistimi pri odraslih iz študij 2/3 faze.
English: Carcinogenicity studies with glecaprevir and pibrentasvir have not been conducted.
Slovenian: Raziskav kancerogenosti z glekaprevirjem in pibrentasvirjem niso izvedli.
English: Medicines you must tell your doctor about before taking Maviret Medicine
Slovenian: Zdravila, o katerih morate obvestiti zdravnika, preden vzamete zdravilo Maviret Zdravilo
English: Among treatment-experienced subjects, 46% (42/91) failed a previous regimen containing sofosbuvir.
Slovenian: Med že zdravljenimi preiskovanci je bilo 46 % (42/91) takih, pri katerih je bila predhodno neuspešna shema, ki je vključevala sofosbuvir.
English: VITAMIN K ANTAGONISTS Vitamin K antagonists
Slovenian: ANTAGONISTI VITAMINA K antagonisti vitamina K
English: 47 subjects were enrolled in DORA (Part 1).
Slovenian: V študiji DORA (1. del) je bilo vključenih 47 preiskovancev.
English: Established and other potential medicinal product interactions
Slovenian: Ugotovljena in druga možna medsebojna delovanja zdravil
English: For other P-gp, BCRP, or OATP1B1/3 substrates, dose adjustment may be needed.
Slovenian: Za ostale substrate P-gp, BCRP ali OATP1B1/3 je morda potrebna prilagoditev odmerka.
English: to prevent blood clots *Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.
Slovenian: *Možno je, da bo zdravnik moral pri vas pogosteje opravljati preiskave krvi, da bi preveril, kako dobro se kri strjuje.
English: Therefore, a therapeutic drug monitoring of tacrolimus is recommended and a dose adjustment of tacrolimus made accordingly.
Slovenian: Zato se priporoča terapevtsko spremljanje takrolimusa in ustrezna prilagoditev odmerka takrolimusa.
English: Maviret treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection.
Slovenian: Zdravljenje z zdravilom Maviret mora uvesti in nadzirati zdravnik, ki ima izkušnje z zdravljenjem bolnikov, okuženih s HCV.
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.
Slovenian: DORA (1. del) je bila študija odprtega tipa z namenom ocenjevanja varnosti in učinkovitosti pri mladostnikih, starih od 12 do manj kot 18 let, ki so prejemali zdravilo Maviret 300 mg/120 mg (tri 100 mg/40 mg filmsko obložene tablete) 8 ali 16 tednov.
English: Maviret has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Maviret nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Clinical studies of Maviret included 328 patients aged 65 and over (13.8% of the total number of subjects).
Slovenian: Klinične študije zdravila Maviret so zajele 328 bolnikov, starih 65 let ali več (13,8 % celotnega števila preiskovancev).
English: ETHINYL-OESTRADIOL-CONTAINING PRODUCTS Ethinyloestradiol (EE)/Norgestimate
Slovenian: ZDRAVILA, KI VSEBUJEJO ETINILESTRADIOL etinilestradiol (EE)/norgestimat
English: Contents of the pack and other information What Maviret contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Maviret
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).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s kombinacijo glekaprevir/pibrentasvir za eno ali več podskupin pediatrične populacije v starosti od 3 do manj kot 12 let za zdravljenje kroničnega hepatitisa C (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: (Inhibition of UGT1A1)
Slovenian: (zavrtje UGT1A1)
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.
Slovenian: Substitucije na aminokislinskem položaju 80 niso zmanjšale občutljivosti za glekaprevir, razen za Q80R pri genotipu 3a, ki je zmanjšala občutljivost za glekaprevir za 21-krat.
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.
Slovenian: pibrentasvirja je bila pri preiskovancih v razredu Child-Pugh A podobna, v razredu Child-Pugh B 26 % večja in v razredu Child-Pugh C 114 % večja.
English: Table 4: Adverse reactions identified with Maviret Frequency
Slovenian: Preglednica 4: Neželeni učinki, ugotovljeni z zdravilom Maviret Pogostnost
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.
Slovenian: Vpliva efavirenza/emtricitabina/ dizoproksiltenofovirat a na glekaprevir in pibrentasvir v tej študiji niso neposredno kvantificirali, vendar sta bili izpostavljenosti glekaprevirju in pibrentasvirju pomembno manjši kot v retrospektivnih kontrolah.
English: If you are sick (vomit) after taking Maviret it may affect the amount of Maviret in your blood.
Slovenian: Če vam je po jemanju zdravila Maviret slabo (bruhate), lahko to vpliva na količino zdravila v krvi.
English: Available pharmacokinetic data in animals have shown excretion of glecaprevir and pibrentasvir in milk (for details see section 5.3).
Slovenian: Farmakokinetični podatki, ki so na voljo za živali, so pokazali izločanje glekaprevirja in pibrentasvirja v mleko (za podrobnosti glejte poglavje 5.3).
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.
Slovenian: Pri replikonu genotipa 3b je prisotnost naravnih polimorfizmov K30 in M31 v NS5A zmanjšala občutljivost za pibrentasvir za 24-krat glede na aktivnost pibrentasvirja v replikonu genotipa 3a.
English: 6a NA = not available
Slovenian: 6a NP = ni podatka.
English: EE/Levonorgestrel 20 µg/100 µg once daily
Slovenian: EE/levonorgestrel 20 µg/100 µg enkrat na dan
English: It is unknown whether glecaprevir or pibrentasvir are excreted in human milk.
Slovenian: Ni znano, ali se glekaprevir ali pibrentasvir pri človeku izločata v materino mleko.
English: Skin and subcutaneous tissue disorders Not known pruritus
Slovenian: Bolezni kože in podkožja neznana pruritus
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.
Slovenian: c. Prejemniki presadka, okuženi s HCV, ki so prejemali odmerek ciklosporina v povprečju 100 mg na dan, so bili 2,4-krat bolj izpostavljeni glekaprevirju kot tisti, ki niso prejemali ciklosporina.
English: Some substitutions at position 156 reduced susceptibility to glecaprevir (genotypes 1 to 4) by > 100-fold.
Slovenian: Nekatere substitucije na položaju 156 so zmanjšale občutljivost za glekaprevir (genotipi 1 do 4) za več kot 100-krat.
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine, as the use of Maviret in pregnancy is not recommended.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo, ker uporaba zdravila
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.
Slovenian: Ocena farmakokinetičnih parametrov z uporabo populacijskih farmakokinetičnih modelov ima zaradi nelinearnosti odmerka in medsebojnih interakcij med glekaprevirjem in pibrentasvirjem inherentno negotovost.
English: film-coated tablets 21 film-coated tablets
Slovenian: filmsko obložena tableta 21 filmsko obloženih tablet
English: Race/ethnicity No dose adjustment of Maviret is required based on race or ethnicity.
Slovenian: Rasa/etnična pripadnost Odmerka zdravila Maviret ni treba prilagoditi glede na raso ali etnično pripadnost.
English: Elvitegravir/cobicist at/emtricitabine/ tenofovir alafenamide
Slovenian: elvitegravir/kobicist at/emtricitabin/ tenofoviralafenamid
English: The in vitro activity of glecaprevir was also studied in a biochemical assay, with similarly low IC50 values across genotypes.
Slovenian: Aktivnost glekaprevirja in vitro so raziskali tudi v biokemičnem preizkusu; vrednosti IC50 med genotipi so bile podobno nizke.
English: Bilirubin elevations were predominantly indirect and not associated with ALT elevations.
Slovenian: Pretežno je šlo za zvišanja indirektnega bilirubina, nepovezana z zvišanjem
English: Glecaprevir and pibrentasvir are weak inhibitors of cytochrome P450 (CYP) 3A and uridine glucuronosyltransferase (UGT) 1A1 in vivo.
Slovenian: Glekaprevir in pibrentasvir sta in vivo šibka zaviralca citokroma P450 (CYP) 3A in uridin glukuronoziltransferaze (UGT) 1A1.
English: A166S or Q168R were present at baseline and post-treatment in 5 subjects.
Slovenian: A166S ali Q168R sta bili izhodiščno in po zdravljenju prisotni pri 5 preiskovancih.
English: The recommended dose of Maviret is 300 mg/120 mg (three 100 mg/40 mg tablets), taken orally, once daily with food (see section 5.2).
Slovenian: Priporočeni odmerek zdravila Maviret je 300 mg/120 mg (tri tablete 100 mg/40 mg) peroralno enkrat na dan s hrano (glejte poglavje 5.2).
English: No human data on the effect of glecaprevir and/or pibrentasvir on fertility are available.
Slovenian: Podatkov o vplivu glekaprevirja in/ali pibrentasvirja na plodnost pri človeku ni.
English: • you have severe liver problems other than from hepatitis C.
Slovenian: • imate hude težave z jetri poleg hepatitisa C.
English: Co-administration of moderate inducers is not recommended (see section 4.4).
Slovenian: Sočasna uporaba zmernih induktorjev ni priporočljiva (glejte poglavje 4.4).