FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration may lead to reduced therapeutic effect of Maviret and is contraindicated (see section 4.3).
Slovenian: Sočasna uporaba lahko zmanjša terapevtski učinek zdravila Maviret in je kontraindicirana (glejte poglavje
English: Pibrentasvir is a pan-genotypic inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly.
Slovenian: Pibrentasvir Pibrentasvir je pangenotipski zaviralec NS5A HCV, ki je nujen za replikacijo virusa in sestavljanje viriona.
English: Close monitoring of INR is recommended with all vitamin K antagonists.
Slovenian: Pri vseh antagonistih vitamina K je priporočljivo natančno nadzorovati INR.
English: ↑ EE ↑ norgestrel norethidrone or norgestimate as contraceptive progestagen.
Slovenian: Prilagoditev odmerka levonorgestrela, noretidrona ali norgestimata kot kontracepcijskega progestagena ni potrebna.
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'.
Slovenian: Tablete zdravila Maviret so rožnate, podolgovate, na obeh straneh izbočene (konveksne) filmsko obložene tablete velike 18,8 mm x 10,0 mm, z vtisnjeno oznako »NXT« na eni strani.
English: Gender/weight No dose adjustment of Maviret is required based on gender or body weight.
Slovenian: Spol/telesna masa Odmerka zdravila Maviret ni treba prilagoditi glede na spol ali telesno maso.
English: Maviret is not recommended for the re-treatment of patients with prior exposure to NS3/4A- and/or NS5A-inhibitors.
Slovenian: Zdravilo Maviret se ne priporoča za ponovno zdravljenje bolnikov, ki so predhodno že bili izpostavljeni NS3/4A in/ali NS5A zaviralcem.
English: Potential for other medicinal products to affect Maviret
Slovenian: Možen vpliv drugih zdravil na zdravilo Maviret
English: Metabolism secondary none
Slovenian: Presnova sekundarni jih ni
English: The pharmacokinetic properties of the components of Maviret are provided in Table 11.
Slovenian: 5.2 Farmakokinetične lastnosti Farmakokinetične lastnosti učinkovin v zdravilu Maviret so prikazane v preglednici 11.
English: EXPEDITION-4 Maviret for 12 weeks (n=104)
Slovenian: EXPEDITION-4 Zdravilo Maviret 12 tednov (n = 104)
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Cirrhosis a. Relapse is defined as HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment.
Slovenian: Ciroza a. Recidiv je opredeljen kot HCV RNA ≥ LLOQ po odzivu na koncu zdravljenja med bolniki, ki so dokončali zdravljenje.
English: Table 11: Pharmacokinetic properties of the components of Maviret in healthy adult subjects Glecaprevir
Slovenian: Preglednica 11: Farmakokinetične lastnosti sestavin zdravila Maviret pri zdravih odraslih preiskovancih glekaprevir pibrentasvir
English: How to store Maviret
Slovenian: Kako jemati zdravilo Maviret
English: HERBAL PRODUCTS St. John's wort (Hypericum perforatum)
Slovenian: ZDRAVILA RASTLINSKEGA IZVORA šentjanževka (Hypericum perforatum)
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines.
Slovenian: Pred začetkom zdravljenja je treba pri vseh bolnikih opraviti presejalni test za HBV. Bolniki, sočasno okuženi s HBV in HCV, imajo tveganje za reaktivacijo HBV, zato jih je treba nadzirati in voditi v skladu s trenutnimi kliničnimi smernicami.
English: Three GT3b TN subjects experienced relapse and two GT3b TEPRS subjects experienced on-treatment virologic failure.
Slovenian: Pri treh TN preiskovancih z GT3b se je pojavil recidiv, pri dveh TE-PRS preiskovancih z GT3b je med zdravljenjem prišlo do virusne neodzivnosti.
English: Maviret 8 weeks N=157
Slovenian: Zdravilo Maviret 8 tednov N = 157
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.
Slovenian: Preiskovanci so bili bodisi predhodno še nezdravljeni bodisi zdravljeni s kombinacijo (peg)interferona, ribavirina in/ali sofosbuvirja in so zdravilo Maviret prejemali 8,12 ali 16 tednov glede na odobreno trajanje zdravljenja.
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.
Slovenian: Priporočeni odmerek za odrasle in mladostnike (stare od 12 do <18 let) so tri tablete zdravila Maviret 100 mg/40 mg, ki jih vzamete hkrati, enkrat na dan. 3 tablete v pretisnem omotu so dnevni odmerek.
English: Clinical comments
Slovenian: Klinične opombe
English: • If you vomit less than 3 hours after taking Maviret, take another dose.
Slovenian: • Če bruhate v manj kot 3 urah po jemanju zdravila Maviret, vzemite še en odmerek.
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.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da je bila po uporabi zdravila Maviret pri preiskovancih, ki so bili okuženi s HCV in so imeli kompenzirano cirozo, izpostavljenost glekaprevirju približno 2-krat tolikšna in izpostavljenost pibrentasvirju podobna kot pri preiskovancih, ki so bili okuženi s HCV in niso imeli ciroze.
English: Subjects without cirrhosis received Maviret for 8 weeks, and subjects with compensated cirrhosis received Maviret for 12 weeks.
Slovenian: Preiskovanci brez ciroze so zdravilo Maviret prejemali 8 tednov, tisti s kompenzirano cirozo pa so zdravilo Maviret prejemali 12 tednov.
English: A 16-week treatment duration should be considered in genotype 3-infected patients who are treatment experienced with peg-IFN + ribavirin +/sofosbuvir, or sofosbuvir + ribavirin.
Slovenian: O 16-tedenskem zdravljenju je treba razmisliti pri bolnikih, okuženih z genotipom 3, ki so predhodno že bili zdravljeni s peg-INF + ribavirin z ali brez sofosbuvirja ali s sofosbuvirjem in ribavirinom.
English: Antiviral activity
Slovenian: Protivirusno delovanje
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.
Slovenian: Če je od časa, ko običajno vzame zdravilo Maviret, minilo že več kot 18 ur, ne sme vzeti izpuščenega odmerka, temveč mora vzeti naslednji odmerek po običajnem urniku jemanja.
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)
Slovenian: Preglednica 8: SVR12 pri še nezdravljenih preiskovancih in pri preiskovancih, že zdravljeniha s peginterferonom, ribavirinom in/ali sofosbuvirjem, okuženih z genotipom 1, 2, 4, 5 ali 6, ki so prejeli zdravljenje v priporočenem trajanju (zbrani podatki iz študij ENDURANCE-1b, SURVEYOR-1, -2 in EXPEDITION-1, 2b, -4 in 8)
English: The overall SVR12 rate in post-transplant subjects was 98.0% (98/100).
Slovenian: Skupna stopnja SVR12 pri preiskovancih po presaditvi je bila 98,0 % (98/100).
English: All subjects without cirrhosis or with compensated cirrhosis received 8 or 12 weeks of Maviret, respectively, except GT3 TE-PRS subjects who received 16 weeks of Maviret.
Slovenian: Vsi preiskovanci brez ciroze ali s kompenzirano cirozo so zdravilo Maviret prejemali 8 oziroma 12 tednov, razen TE-PRS preiskovancev z GT3b, ki so prejemali zdravilo Maviret 16 tednov.
English: No glecaprevir metabolites were observed in plasma.
Slovenian: V plazmi niso odkrili presnovkov glekaprevirja.
English: For patients who failed prior therapy with an NS3/4A- and/or an NS5A-inhibitor, see section 4.4.
Slovenian: Za bolnike, pri katerih predhodno zdravljenje z NS3/4A in/ali NS5A zaviralcem ni bilo uspešno, glejte poglavje 4.4.
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.
Slovenian: Študija EXPEDITION-5 je bila študija z odprtim načrtom zdravljenja, izvedena na 101 preiskovancih s HCV GT1-6 okužbo brez ciroze ali s kompenzirano cirozo in kronično boleznijo ledvic 3b, 4. ali 5.
English: Maviret for 8 weeks (n=199) or 12 weeks (n=25)
Slovenian: Zdravilo Maviret 8 tednov (n = 199) ali 12 tednov (n = 25)
English: Pack containing 84 (4 x 21) film-coated tablets.
Slovenian: Pakiranje s 84 (4 x 21) filmsko obloženimi tabletami.
English: Five of the 10 had combinations of V36M, Y56H, R155K/T, or D168A/E in NS3 at baseline and post-treatment.
Slovenian: Pet od 10 je imelo kombinacije V36M, Y56H, R155K/T ali D168A/E v NS3
English: Darunavir + ritonavir 800/100 mg once daily
Slovenian: ↑ pibrentasvir darunavir + ritonavir 800/100 mg enkrat na dan
English: Effect of meal (relative to fasting)b
Slovenian: Absorpcija tmax (ure)a Vpliv obroka (glede na stanje na tešče)b
English: Co-administration with efavirenz may lead to reduced therapeutic effect of Maviret and is not recommended.
Slovenian: Sočasna uporaba z efavirenzem lahko zmanjša terapevtski učinek zdravila
English: Both glecaprevir and pibrentasvir inhibit the bile salt export pump (BSEP) in vitro.
Slovenian: Tako glekaprevir kot pibrentasvir in vitro zavirata iztočno črpalko žolčnih soli (BSEP - bile salt export pump).
English: Glecaprevir and pibrentasvir are inhibitors of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptide (OATP) 1B1/3.
Slovenian: Glekaprevir in pibrentasvir sta zaviralca P-glikoproteina (P-gp), proteina odpornosti proti raku dojke (BCRP - breast cancer resistance protein) in transportnega polipeptida organskih anionov (OATP
English: Subjects were randomized (2:1) to either Maviret for 12 weeks or the combination of sofosbuvir and daclatasvir for 12 weeks; subsequently the study included a third arm (which was nonrandomized) with Maviret for 8 weeks.
Slovenian: Preiskovance so (v razmerju 2:1) za 12 tednov randomizirali ali na zdravilo Maviret ali na kombinacijo sofosbuvirja in daklatasvirja; pozneje so v študijo vključili tretjo (nerandomizirano) skupino, ki je 8 tednov prejemala zdravilo Maviret.
English: Safety in HCV/HIV-1 Co-infected Subjects
Slovenian: Varnost pri preiskovancih, sočasno okuženih s HCV/HIV-1
English: Among the 2 genotype 2-infected subjects, no treatment-emergent substitutions were observed in NS3 or NS5A (the M31 polymorphism in NS5A was present at baseline and post-treatment in both subjects).
Slovenian: Od 2 preiskovancev, okuženih z genotipom 2, niso ugotovili med zdravljenjem nastalih substitucij v NS3 ali NS5A (polimorfizem M31 v NS5A je bil pri obeh preiskovancih prisoten že izhodiščno in tudi po zdravljenju).
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.
Slovenian: Na podlagi populacijskih farmakokinetičnih modelov za zdravilo Maviret pri bolnikih s kroničnim hepatitisom C je bila pri bolnikih brez ciroze (N = 1804) v stanju dinamičnega ravnovesja AUC24 glekaprevirja 4800 ng•h/ml in pibrentasvirja 1430 ng•h/ml, pri bolnikih s cirozo (N = 280) pa 10500 ng•h/ml (glekaprevir) in 1530 ng•h/ml (pibrentasvir).
English: ↓ glecaprevir
Slovenian: ↓ glekaprevir
English: Overall SVR12 Rate from the Clinical Studies in Treatment-Naïve or Treatment-Experienced Subjects with or without Cirrhosis
Slovenian: Celotni SVR12 delež iz kliničnih študij pri še nezdravljenih in že zdravljenih preiskovancih s cirozo ali brez nje
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.
Slovenian: V študijah peri/postnatalnega razvoja pri glodalcih niso ne z eno ne z drugo učinkovino ugotovili razvojnih učinkov ob sistemski izpostavljenosti samice matere (AUC), ki je bila za glekaprevir približno 47-kratnik in za pibrentasvir približno 74kratnikizpostavljenosti pri človeku ob priporočenem odmerku.
English: • Swallow the tablets whole.
Slovenian: • Tablete pogoltnite cele.
English: 300/100 mg once dailyb
Slovenian: 300/100 mg enkrat na danb
English: Maviret for 12 weeks (TN only, n=64) or 16 weeks (TE only, n=51)
Slovenian: Zdravilo Maviret 12 tednov (samo TN, n = 64) ali 16 tednov (samo TE, n = 51)
English: Medicinal products that are strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John's wort (Hypericum perforatum), phenobarbital, phenytoin, and primidone) could significantly decrease glecaprevir or pibrentasvir plasma concentrations and may lead to reduced therapeutic effect of Maviret or loss of virologic response.
Slovenian: Zdravila, ki so močni induktorji P-gp in CYP3A (npr. karbamazepin, šentjanževka (Hypericum perforatum), fenobarbital, fenitoin ali pirimidon), lahko bistveno zmanjšajo koncentracijo glekaprevirja ali pibrentasvirja v plazmi ter povzročijo zmanjšanje terapevtskega učinka zdravila Maviret ali izgubo virološkega odziva.
English: • liver problems other than hepatitis C
Slovenian: • težave z jetri poleg hepatitisa C,
English: No dose adjustment of Maviret is required in patients with mild hepatic impairment (Child-Pugh A).
Slovenian: Okvara jeter Prilagoditev odmerka zdravila Maviret pri bolnikih z blago okvaro jeter (Child-Pugh A) ni potrebna.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Maviret.
Slovenian: Po začetku jemanja zdravila Maviret morda potrebujete skrbno spremljanje ravni sladkorja v krvi in/ali prilagoditev zdravila za zdravljenje sladkorne bolezni.
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.
Slovenian: V študijah sposobnosti razmnoževanja pri živalih niso opazili neželenih razvojnih učinkov, če so sestavini zdravila Maviret uporabljali ločeno med obdobjem organogeneze v izpostavljenosti, manjši ali enaki 53-kratniku (podgane, glekaprevir) ali 51- oz. 1,5-kratniku (miši oz. kunci, pibrentasvir)
English: One subject experienced on-treatment virologic failure (0.6%, 1/168) and no subjects relapsed (0%, 0/166).
Slovenian: Pri enem preiskovancu je med zdravljenjem prišlo do virusne neodzivnosti (0,6 %, 1/168), pri nobenem preiskovancu pa ni prišlo do pojava recidiva (0 %,
English: Rosuvastatin 5 mg once daily
Slovenian: rosuvastatin 5 mg enkrat na dan
English: Maviret 100 mg/40 mg film-coated tablets
Slovenian: Maviret 100 mg/40 mg filmsko obložene tablete
English: Tell your doctor or pharmacist before taking Maviret, if you are taking any of the medicines in the table below.
Slovenian: Obvestite zdravnika ali farmacevta, preden vzamete zdravilo Maviret, če jemljete katero od zdravil,
English: Maviret contains lactose
Slovenian: Zdravilo Maviret vsebuje laktozo
English: The study included subjects who were HCV treatment-naïve or treatment-experienced to combinations of (peg) interferon, ribavirin, and/or sofosbuvir, with the exception of GT3-infected subjects who were all treatmentnaïve.
Slovenian: Študija je vključevala preiskovance, ki predhodno še niso bili zdravljeni ali so bili zdravljeni s kombinacijo (peg) interferona, ribavirina in/ali sofosbuvirja, z izjemo preiskovancev z GT3 okužbo, ki so vsi bili predhodno nezdravljeni.
English: Glecaprevir
Slovenian: Glekaprevir
English: (Inhibition of P-gp)
Slovenian: (zavrtje P-gp)
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).
Slovenian: V študiji MAGELLAN-1 so proučevali bolnike, okužene z genotipom 1 (in zelo omejeno število bolnikov, okuženih z genotipom 4), pri katerih predhodno zdravljenje s shemami, ki bi lahko povzročile odpornost na glekaprevir/pibrentasvir, ni bilo uspešno (glejte poglavje 5.1).
English: The efficacy of Maviret in subjects who were treatment-naïve or treatment-experienced to combinations of peginterferon, ribavirin and/or sofosbuvir with genotype 3 chronic hepatitis C infection was demonstrated in the ENDURANCE-3 (treatment-naïve without cirrhosis) and SURVEYOR-2 Part 3 (subjects with and without cirrhosis and/or treatment-experienced) clinical studies.
Slovenian: Učinkovitost zdravila Maviret pri še nezdravljenih in že zdravljenih preiskovancih (zdravljenih s kombinacijami peginterferona, ribavirina in/ali sofosbuvirja) s kroničnim hepatitisom C zaradi okužbe z genotipom 3 sta dokazali klinični študiji ENDURANCE-3 (še nezdravljeni brez ciroze) in 3. del študije SURVEYOR-2 (preiskovanci brez ciroze in/ali že zdravljeni).
English: Elderly No dose adjustment of Maviret is required in elderly patients (see sections 5.1 and 5.2).
Slovenian: Starejši Prilagoditev odmerka zdravila Maviret pri starejših bolnikih ni potrebna (glejte poglavji 5.1 in 5.2).
English: (CYP3A4 and P-gp inhibition)
Slovenian: (zavrtje CYP3A4 in P-gp)
English: Table 10: SVR12 in genotype 3-infected subjects with or without cirrhosis who received the recommended duration (SURVEYOR-2 Part 3)
Slovenian: Preglednica 10: SVR12 pri preiskovancih s cirozo ali brez nje, okuženih z genotipom 3, ki so prejeli priporočeno trajanje zdravljenja (študija SURVEYOR-2, 3. del)
English: The type and severity of adverse reactions in subjects with cirrhosis were overall comparable to those seen in subjects without cirrhosis.
Slovenian: Vrsta in izrazitost neželenih učinkov sta bili pri bolnikih s cirozo v splošnem podobni kot pri bolnikih brez ciroze.
English: Asymptomatic serum ALT elevations (>5x ULN) were observed in 1 out of 70 healthy subjects following multiple doses of glecaprevir (700 mg or 800 mg) once daily for ≥ 7 days.
Slovenian: (na > 5-kratno ULN) so opazili pri 1 od 70 zdravih prostovoljcev po uporabi več odmerkov glekaprevirja (700 ali 800 mg) enkrat na dan ≥ 7 dni.
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.
Slovenian: Vrednosti EC50 za glekaprevir in pibrentasvir proti replikonom polne dolžine ali himernim replikonom za kodiranje NS3 ali NS5A laboratorijskih sevov so prikazane v preglednici 5.
English: Co-administration with atazanavir is contraindicated due to the risk of ALT elevations (see section 4.3).
Slovenian: Sočasna uporaba z atazanavirjem je kontraindicirana zaradi tveganja za zvišanje ALT (glejte poglavje
English: Among subjects with compensated cirrhosis, the overall SVR12 rate for GT3b infected subjects was 87.5% (7/8) [85.7% (6/7) for TN subjects and 100% (1/1) for TE-PRS subjects] and 100% (6/6) for GT3a infected subjects.
Slovenian: Med preiskovanci s kompenzirano cirozo je bila skupna stopnja SVR12 pri preiskovancih, okuženih z GT3b, 87,5 % (7/8) [85,7 % (6/7) pri TN preiskovancih in 100 % (1/1) pri TE-PRS preiskovancih] in 100 % (6/6) pri preiskovancih okuženih z GT3a.
English: Diabetics may experience improved glucose control, potentially resulting in symptomatic hypoglycaemia, after initiating HCV direct acting antiviral treatment.
Slovenian: Pri sladkornih bolnikih se lahko po začetku zdravljenja okužbe s HCV z zdravilom neposredno delujočim protivirusnim zdravilom izboljša nadzor nad sladkorjem, kar ima lahko za posledico simptomatsko hipoglikemijo.
English: Maviret for 8 weeks (n=58)
Slovenian: Zdravilo Maviret 8 tednov (n = 58)
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Maviret Vsebina pakiranja in dodatne informacije
English: Otherd
Slovenian: Drugod
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
Slovenian: GT1, 2, 4, 5, 6 EXPEDITION-8 Zdravilo Maviret 8 tednov (n = 280) (samo TN) Preiskovanci s KLB 3b, 4. in 5. stopnje, s cirozo ali brez nje GT1-6
English: Ten of 113 subjects treated with Maviret in the MAGELLAN-1 study for 12 or 16 weeks experienced virologic failure.
Slovenian: Virusna neodzivnost se je pojavila pri 10 od 113 preiskovancev, ki so v študiji MAGELLAN 1 prejemali zdravilo Maviret 12 ali 16 tednov.
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).
Slovenian: Neželeni učinki pri preiskovancih s hudo okvaro ledvic, vključno s preiskovanci na dializi Varnost zdravila Maviret pri bolnikih s kronično boleznijo ledvic (vključno z bolniki na dializi) in kronično okužbo s HCV genotipov 1, 2, 3, 4, 5 ali 6 ter kompenzirano boleznijo jeter (s cirozo ali brez nje) so ocenili v študiji EXPEDITION-4 (n=104) in v študiji EXPEDITION-5 (n=101).
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.
Slovenian: Priporočena trajanja zdravljenja z zdravilom Maviret pri bolnikih, okuženih s HCV genotipa 1, 2, 3, 4, 5 ali 6 in s kompenzirano boleznijo jeter (s cirozo ali brez nje), je prikazano v preglednici 1 in preglednici 2.
English: 10 mg once daily
Slovenian: 10 mg enkrat na dan
English: Less than 0.1% of subjects treated with Maviret had serious adverse reactions (transient ischaemic attack).
Slovenian: Resne neželene učinke (prehodni ishemični napad) je imelo manj kot 0,1 % bolnikov, zdravljenih z zdravilom Maviret.
English: Treatment-experienced with or without cirrhosis
Slovenian: Že zdravljeni s cirozo ali brez nje
English: Table 1: Recommended Maviret treatment duration for patients without prior HCV therapy Genotype
Slovenian: Preglednica 1: Priporočeno trajanje zdravljenja z zdravilom Maviret za bolnike, ki še niso bili zdravljeni za HCV
English: Effect on medicinal product levels
Slovenian: Vpliv na koncentracijo zdravila
English: Baseline polymorphisms in NS3 were detected in 1.1% (9/845), 0.8% (3/398), 1.6% (10/613), 1.2% (2/164), 41.9% (13/31), and 2.9% (1/34) of subjects with HCV genotype 1, 2, 3, 4, 5, and 6 infection, respectively.
Slovenian: Izhodiščne polimorfizme NS3 so odkrili pri 1,1 % (9/845), 0,8 % (3/398), 1,6 % (10/613), 1,2 % (2/164), 41,9 % (13/31) in 2,9 % (1/34) preiskovancev, okuženih z genotipom HCV 1, 2, 3, 4, 5 in 6, v tem zaporedju.
English: Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents.
Slovenian: Med ali po zdravljenju z neposredno delujočimi protivirusnimi zdravili so poročali o primerih reaktivacije virusa hepatitisa B (HBV), med njimi nekaterih s smrtnim izidom.
English: Significant inhibition of CYP1A2, CYP2C9, CYP2C19, CYP2D6, UGT1A6, UGT1A9, UGT1A4, UGT2B7, OCT1, OCT2, OAT1, OAT3, MATE1 or MATE2K are not expected.
Slovenian: UGT1A4, UGT2B7, OCT1, OCT2, OAT1, OAT3, MATE1 ali MATE2K ni pričakovati.
English: Studies in subjects with or without compensated cirrhosis who were treatment-experienced to NS3/4A protease and/or NS5A inhibitors
Slovenian: Študije pri preiskovancih s kompenzirano cirozo ali brez nje, ki so predhodno prejemali zaviralce proteaze NS3/4A in/ali NS5A
English: Use with strong P-gp/CYP3A inducers
Slovenian: Uporaba z močnimi induktorji P-gp/CYP3A
English: (Inhibition of OATP1B1/3)
Slovenian: (zavrtje OATP1B1/3)