FrancophonIA/ELRC3.0 huggingface dataset:
English: Tenofovir alafenamide Sofosbuvir
Slovenian: Alafenamid tenofovirijev fumarat Sofosbuvir
English: Do not stop taking Epclusa
Slovenian: Ne prenehajte jemati zdravila Epclusa
English: Afterwards, close monitoring and potential dose adjustment of tacrolimus may be required.
Slovenian: Pozneje bo morda potrebno skrbno spremljanje in morebitno prilagajanje odmerka takrolimusa.
English: However, on the basis of NS5A resistance associated variants (RAVs) typically seen in patients who have failed therapy with other NS5A inhibitor containing regimens, the in vitro pharmacology of velpatasvir, and the outcomes of sofosbuvir/velpatasvir treatment in NS5A-naïve patients with baseline NS5A RAVs enrolled into the ASTRAL-studies, treatment with Epclusa + RBV for 24 weeks can be considered for patients who have failed therapy on an NS5A-containing regimen and who are deemed at high risk for clinical disease progression and who do not have alternative treatment options.
Slovenian: Vendar pa je na podlagi z odpornostjo povezanih različic (RAV, resistance associated variants) NS5A, ki se običajno pojavljajo pri bolnikih, pri katerih zdravljenje z režimi, ki so vključevali drugi zaviralec NS5A, ni bilo uspešno, in vitro farmakologije velpatasvirja in izidov zdravljenja s sofosbuvirjem/velpatasvirjem pri bolnikih, ki se predhodno še niso zdravili z NS5A z izhodiščnimi RAV NS5A in so bili vključeni v študije ASTRAL, mogoče razmisliti o 24-tedenskem zdravljenju z zdravilom Epclusa + RBV pri bolnikih, pri katerih zdravljenje z režimom, ki je vključeval NS5A, ni bilo uspešno in pri katerih obstaja visoko tveganje za klinično napredovanje bolezni, druge možnosti zdravljenja pa nimajo na voljo.
English: Tablet core: Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Slovenian: Jedro tablete: kopovidon, mikrokristalna celuloza, premrežen natrijev karmelozat, magnezijev stearat.
English: Epclusa has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Epclusa nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir.
Slovenian: Ena filmsko obložena tableta vsebuje 400 mg sofosbuvirja in 100 mg velpatasvirja.
English: • The active substances are sofosbuvir and velpatasvir.
Slovenian: • Učinkovini sta sofosbuvir in velpatasvir.
English: • amiodarone used to treat irregular heartbeats;
Slovenian: • amiodaron, ki se uporablja za zdravljenje nerednega srčnega utripa;
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to velpatasvir (see section 4.2).
Slovenian: Analiza populacijske farmakokinetike pri bolnikih, okuženih s HCV, je pokazala, da ciroza (vključno z dekompenzirano cirozo) ni imela klinično pomembnega učinka na izpostavljenost velpatasvirju (glejte poglavje 4.2).
English: If ribavirin is co-administered with Epclusa, refer to the Summary of Product Characterisitics for ribavirin for detailed recommendations regarding pregnancy, contraception, and breast-feeding.
Slovenian: Če se ribavirin uporablja sočasno z zdravilom Epclusa, glejte podrobna priporočila glede nosečnosti, kontracepcije in dojenja v glavnih značilnostih zdravila za ribavirin.
English: Table 9: Studies conducted with Epclusa in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection
Slovenian: Preglednica 9: Študije, ki so jih izvedli z zdravilom Epclusa pri bolnikih z okužbo s HCV genotipa 1, 2, 3, 4, 5 ali 6
English: Effect on amiodarone, velpatasvir, and sofosbuvir concentrations unknown.
Slovenian: Učinek na koncentracije amiodarona, velpatasvirja in sofosbuvirja ni znan.
English: The potential risks and benefits associated with co-administration of Epclusa with the fixed-dose combination tablet containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or tenofovir disoproxil fumarate given in conjunction with a boosted HIV protease inhibitor (e.g. atazanavir or darunavir) should be considered, particularly in patients at increased risk of renal dysfunction.
Slovenian: Upoštevati je treba možna tveganja in koristi, povezana s sočasno uporabo zdravila Epclusa s tableto s kombinacijo fiksnih odmerkov, ki vsebuje elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirijev fumarat ali dizoproksiltenofovirijevim fumaratom, dajanim v povezavi z okrepljenim zaviralcem proteaze HIV (npr. atazanavirjem ali darunavirjem), zlasti pri bolnikih, pri katerih je tveganje za ledvično disfunkcijo povečano.
English: Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
Slovenian: Mehanizem delovanja Sofosbuvir je pan-genotipski zaviralec RNK-polimeraze HCV NS5B, odvisne od RNK, ki je bistvena za replikacijo virusa.
English: Patients with genotype 1, 2, 4 or 6 HCV infection were randomised in a 5:1 ratio to treatment with Epclusa for 12 weeks or placebo for 12 weeks.
Slovenian: Bolniki z okužbo s HCV genotipa 1, 2, 4 ali 6 so bili randomizirani v razmerju 5 : 1 za 12-tedensko zdravljenje z zdravilom Epclusa ali za 12-tedensko prejemanje placeba.
English: Safety and efficacy of Epclusa have been assessed in patients with CPT Class B cirrhosis, but not in patients with CPT Class C cirrhosis (see sections 4.4, 4.8 and 5.1).
Slovenian: Varnost in učinkovitost zdravila Epclusa so ocenili pri bolnikih s cirozo jeter stopnje B po CPT, ne pa tudi pri bolnikih s cirozo jeter stopnje C po CPT (glejte poglavja 4.4., 4.8 in 5.1).
English: Epclusa 400 mg/100 mg film-coated tablets sofosbuvir/velpatasvir
Slovenian: Epclusa 400 mg/100 mg filmsko obložene tablete sofosbuvir/velpatasvir
English: Epclusa has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Slovenian: Uporaba z nekaterimi protiretrovirusnimi režimi proti HIV Pokazalo se je, da zdravilo Epclusa poveča izpostavljenost tenofovirju, zlasti, če se uporablja skupaj z režimom proti HIV, ki vsebuje dizoproksiltenofovirijev fumarat in farmakokinetični ojačevalec (ritonavir ali kobicistat).
English: Oxcarbazepine (Induction of P-gp and CYPs)
Slovenian: Okskarbazepin (indukcija P-gp in citokromov CYP)
English: Genotype 1b 11% (2/18) Genotype 3
Slovenian: Genotip 1b 11 % (2/18)
English: Patients receiving Epclusa concomitantly with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or with tenofovir disoproxil fumarate and a boosted HIV protease inhibitor should be monitored for tenofovir-associated adverse reactions.
Slovenian: Bolnike, ki prejemajo zdravilo Epclusa sočasno z elvitegravirjem/kobicistatom/emtricitabinom/ dizoproksiltenofovirijevim fumaratom ali z dizoproksiltenofovirijevim fumaratom in okrepljenim zaviralcem proteaze HIV, je treba spremljati za pojav s tenofovirjem povezanih neželenih reakcij.
English: Median peak plasma concentration of GS-331007 was observed 3 hours post-dose.
Slovenian: Mediano najvišje koncentracije GS-331007 v plazmi so opazili 3 ure po odmerku.
English: The efficacy of Epclusa was evaluated in three Phase 3 studies in patients with genotype 1 to 6 HCV infection with or without compensated cirrhosis, one Phase 3 study in patients with genotype 1 to 6 HCV infection with decompensated cirrhosis, one Phase 3 study in HCV/HIV-1 co-infected patients with genotype 1 to 6 HCV infection and one Phase 2 trial in patients with HCV infection and ESRD requiring dialysis, as summarised in Table 9.
Slovenian: Učinkovitost zdravila Epclusa so ocenili v treh študijah 3. faze pri bolnikih z okužbo s HCV genotipa od 1 do 6 s kompenzirano cirozo ali brez nje, v eni študiji 3. faze pri bolnikih z okužbo s HCV genotipa od 1 do 6 z dekompenzirano cirozo, v eni študiji 3. faze pri bolnikih s sočasno okužbo s HCV genotipa od 1 do 6 in HIV-1 in v enem preskušanju 2. faze pri bolnikih z okužbo s HCV in ESRD,
English: Treatmentexperienced (n = 71)
Slovenian: Predhodno zdravljeni bolniki (n = 71)
English: Otherb a The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Slovenian: Drugob a. Denominator za relaps je število bolnikov z HCV RNK < LLOQ ob zadnji oceni med zdravljenjem.
English: Treatmentexperienced (n = 69)
Slovenian: Predhodno zdravljeni bolniki (n = 69)
English: (Inhibition of P-gp)
Slovenian: (zaviranje P-gp)
English: Epclusa 12 weeks (134) SOF+RBV 12 weeks (132)
Slovenian: Zdravilo Epclusa 12 tednov (134) SOF + RBV 12 tednov (132)
English: Effect on ketoconazole exposure not studied.
Slovenian: Učinka na izpostavljenost ketokonazolu niso preučevali.
English: (n = 331), velpatasvir AUC0-24 and Cmax were 37% lower and 41% lower, respectively in HCV-infected patients.
Slovenian: V primerjavi z zdravimi osebami (n = 331) sta bili vrednosti AUC0-24 in Cmax za velpatasvir pri bolnikih, okuženih s HCV, za 37 % oz. 41 % manjši.
English: If you are taking a proton pump inhibitor, take Epclusa with food 4 hours before using a proton pump inhibitor.
Slovenian: Če uporabljate zaviralec protonske črpalke, morate zdravilo Epclusa vzeti s hrano 4 ure pred zaviralcem protonske črpalke.
English: • oxcarbazepine (medicine used to treat epilepsy and prevent seizures);
Slovenian: • okskarbazepin (zdravilo, ki se uporablja za zdravljenje epilepsije in preprečevanje epileptičnih napadov);
English: In vitro selection of HCV replicons with reduced susceptibility to velpatasvir was performed in cell culture for multiple genotypes including 1a, 1b, 2a, 3a, 4a, 5a and 6a.
Slovenian: Replikoni HCV z zmanjšano dovzetnostjo za velpatasvir so bili izbrani in vitro v celični kulturi in opravljeni za več genotipov, vključno z 1a, 1b, 2a, 3a, 4a, 5a in 6a.
English: Ask your doctor for effective contraception method suitable for you and your partner.
Slovenian: O načinu kontracepcije, ki je za vas ali vašega partnerja oz. partnerico najprimernejši, se posvetujte z zdravnikom.
English: Recommendation concerning co-administration with Epclusa
Slovenian: Priporočila glede sočasne uporabe z zdravilom Epclusa
English: Following a single dose of 100 mg [14C]-velpatasvir, the majority (> 98%) of radioactivity in plasma was parent drug.
Slovenian: Po enkratnem 100-miligramskem odmerku [14C]-velpatasvirja je večina (> 98 %) radioaktivnosti v plazmi posledica izhodiščne spojine.
English: The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with Epclusa (n=59) for 12 weeks, and compared to patients without renal impairment in the sofosbuvir/velpatasvir Phase 2/3 trials.
Slovenian: Farmakokinetiko sofosbuvirja, GS-331007 in velpatasvirja so preučili pri bolnikih, okuženih s HCV, z ESRD, zaradi katere je potrebna dializa, zdravljenih z zdravilom Epclusa (n = 59) 12 tednov, in jo primerjali s farmakokinetiko pri bolnikih brez ledvične okvare v preskušanjih 2./3.
English: Studies in patients without cirrhosis and patients with compensated cirrhosis In a pooled analysis of patients without cirrhosis or with compensated cirrhosis who received Epclusa for 12 weeks in three Phase 3 studies, 12 patients (2 with genotype 1 and 10 with genotype 3) qualified for resistance analysis due to virologic failure.
Slovenian: Študije pri bolnikih brez ciroze in bolnikih s kompenzirano cirozo V združeni analizi bolnikov brez ciroze oz. bolnikov s kompenzirano cirozo, ki so v treh študijah 3. faze prejemali zdravilo Epclusa 12 tednov, je bilo 12 bolnikov (2 z genotipom 1 in 10 z genotipom 3) primernih za analizo odpornosti zaradi virološkega neuspeha.
English: Table 6: SVR12 in patients with or without baseline NS5A RAVs by HCV genotype (studies ASTRAL-1, ASTRAL-2 and ASTRAL-3)
Slovenian: Preglednica 6: SVR12 pri bolnikih z izhodiščnimi RAV NS5A ali brez njih po genotipu HCV (študije ASTRAL-1, ASTRAL-2 in ASTRAL-3)
English: • If it's 18 hours or more after the time you usually take Epclusa, wait and take the next dose at your usual time.
Slovenian: • Če se tega spomnite več kot 18 ur od takrat, ko običajno vzamete zdravilo Epclusa, počakajte in vzemite naslednji odmerek ob običajnem času.
English: No teratogenic effects were observed in the rat and rabbit developmental toxicity studies with sofosbuvir.
Slovenian: V študijah razvojne toksičnosti s sofosbuvirjem pri podganah in kuncih niso opazili teratogenih učinkov.
English: Table 15 presents the virologic outcome for patients with genotype 1 or 3 HCV infection in the ASTRAL-4 study.
Slovenian: V preglednici 15 je predstavljen virološki izid za bolnike z okužbo s HCV genotipa 1 ali 3 v študiji ASTRAL-4.
English: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
Slovenian: Sofosbuvir in GS-331007 nista zaviralca prenašalcev P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1, GS-331007 pa prav tako ni zaviralec OAT1, OCT2 in MATE1.
English: Epclusa 12 weeks (277) SOF+RBV 24 weeks (275)
Slovenian: Zdravilo Epclusa 12 tednov (277) SOF + RBV 24 tednov (275)
English: SOF+RBV 24 weeks (n = 275)
Slovenian: SOF + RBV 24 tednov (n = 275)
English: Talk to your doctor if you:
Slovenian: Opozorila in previdnostni ukrepi S svojim zdravnikom se posvetujte, če:
English: The pharmacokinetics of sofosbuvir was studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected patients with moderate and severe hepatic impairment (CPT Class B and C).
Slovenian: Farmakokinetiko sofosbuvirja so proučili po 7-dnevnem odmerjanju 400 mg sofosbuvirja pri bolnikih, okuženih s HCV, z zmerno in hudo jetrno okvaro (stopnja B ali C po CPT).
English: For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Slovenian: Smernice za prilagajanje odmerka ribavirina si oglejte v povzetku glavnih značilnosti zdravila, ki vsebuje ribavirin.
English: Among the patients who received treatment with Epclusa + RBV for 12 weeks, 29% (25/85) of patients had baseline virus with NS5A RAVs: 29% (19/66), 75% (3/4), 15% (2/13), and 50% (1/2) for patients with genotype 1, 2, 3 and 4 HCV, respectively.
Slovenian: Od bolnikov, ki so prejemali zdravljenje z zdravilom Epclusa + RBV 12 tednov, je imelo 29 % (25/85) bolnikov izhodiščni virus z RAV NS5A: 29 % (19/66) bolnikov s HCV genotipa 1, 75 % (3/4) bolnikov s HCV genotipa 2, 15 % (2/13) bolnikov s HCV genotipa 3 in 50 % (1/2) bolnikov s
English: Safety data are limited in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2)and end stage renal disease (ESRD) requiring haemodialysis.
Slovenian: Podatki o varnosti so omejeni pri bolnikih s hudo ledvično okvaro (ocenjena stopnja glomerularne filtracije [eGFR - estimated glomerular filtration rate] < 30 ml/min/1,73 m2) in pri bolnikih z boleznijo ledvic v končni fazi (ESRD - end stage renal disease), zaradi katere je potrebna hemodializa.
English: The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with severe renal impairment (eGFR < 30 mL/min by Cockcroft-Gault).
Slovenian: Farmakokinetiko velpatasvirja so preučili z enkratnim 100-miligramskim odmerkom velpatasvirja pri bolnikih, negativnih za HCV, s hudo ledvično okvaro (eGFR < 30 ml/min po metodi CockcroftGault).
English: Clinically significant medicinal product interactions with Epclusa mediated by P-gp, BCRP, OATP, or CYP450 inhibitors are not expected; Epclusa may be co-administered with P-gp, BCRP, OATP and CYP inhibitors.
Slovenian: Klinično pomembnih medsebojnih delovanj z zdravilom Epclusa, pri katerih bi posredovali zaviralci P-gp, BCRP, OATP ali CYP450, se ne pričakuje; zdravilo Epclusa se lahko uporablja sočasno z zaviralci
English: Refer to the tenofovir disoproxil fumarate-containing product's Summary of Product Characteristics for recommendations on renal monitoring (see section 4.4).
Slovenian: Za priporočila o spremljanju ledvic glejte povzetke glavnih značilnosti zdravila za zdravila, ki vsebujejo dizoproksiltenofovirijev fumarat (glejte poglavje 4.4).
English: SOF+RBV 12 weeks (n = 132)
Slovenian: SOF + RBV 12 tednov (n = 132)
English: Clinical studies in patients with HCV/HIV-1 Co-infection - ASTRAL-5 (study 1202) ASTRAL-5 evaluated 12 weeks of treatment with Epclusa in patients with genotype 1, 2, 3, or 4 HCV infection who were co-infected with HIV-1 (HCV genotype 5 and 6 allowed, but no such patients were included).
Slovenian: Klinične študije pri bolnikih s sočasno okužbo s HCV/HIV-1 - ASTRAL-5 (študija 1202) V študiji ASTRAL-5 so ocenili 12-tedensko zdravljenje z zdravilom Epclusa pri bolnikih z okužbo s HCV genotipa 1, 2, 3 ali 4, ki so bili sočasno okuženi s HIV-1 (HCV genotipa 5 in 6 sta bila tudi dovoljena, vendar taki bolniki niso bili vključeni).
English: c Administered as Epclusa.
Slovenian: c. Uporabljeno kot zdravilo Epclusa.
English: Safety and efficacy of Epclusa has not been assessed in patients with CPT Class C cirrhosis (see sections 4.8 and 5.1).
Slovenian: Varnost in učinkovitost zdravila Epclusa pri bolnikih s cirozo jeter stopnje C po CPT nista bili ocenjeni (glejte poglavji 4.8 in 5.1).
English: As Epclusa contains sofosbuvir and velpatasvir, any interactions that have been identified with these active substances individually may occur with Epclusa.
Slovenian: Zdravilo Epclusa vsebuje sofosbuvir in velpatasvir, zato se pri uporabi zdravila Epclusa lahko pojavijo katere koli interakcije, ki so jih opazili pri uporabi teh posameznih učinkovin.
English: ANTICOAGULANTS Dabigatran etexilate
Slovenian: ANTIKOAGULANTI Dabigatran eteksilat
English: Co-administration with proton pump inhibitors is not recommended.
Slovenian: Hkratno dajanje z zaviralci protonske črpalke ni priporočljivo.
English: Some medicines should not be taken with Epclusa.
Slovenian: Nekaterih zdravil ne smete uporabljati sočasno z zdravilom Epclusa.
English: The highest documented doses of sofosbuvir and velpatasvir were a single dose of 1,200 mg and a single dose of 500 mg, respectively.
Slovenian: Najvišja dokumentirana odmerka sta bila enkratni odmerek 1.200 mg sofosbuvirja in enkratni odmerek 500 mg velpatasvirja.
English: Famotidine dosed simultaneously with Epclusad
Slovenian: Famotidin uporabljen sočasno z zdravilom Epclusad
English: Epclusa + RBV 12 weeks (87) Epclusa 24 weeks (90)
Slovenian: Zdravilo Epclusa + RBV 12 tednov (87) Zdravilo Epclusa 24 tednov (90)
English: TN and TE, with CPT Class B decompensated cirrhosis
Slovenian: PN in PZ, z dekompenzirano cirozo stopnje B po CPT
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS
Slovenian: ZDRAVILA ZA ZDRAVLJENJE OKUŽBE Z VIRUSOM HIV: ZAVIRALCI INTEGRAZE
English: Safety data are limited in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Slovenian: Podatki o varnosti so omejeni pri bolnikih s hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) in pri bolnikih z boleznijo ledvic v končni fazi (ESRD), zaradi katere je potrebna hemodializa.
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: Sočasna okužba z virusoma HCV in HBV (virus hepatitisa B) Med zdravljenjem ali po zdravljenju z zdravili z direktnim delovanjem na viruse so poročali o reaktivaciji virusa hepatitisa B (HBV), nekateri primeri so bili smrtni.
English: These data indicate that biliary excretion of parent drug was a major route of elimination for velpatasvir.
Slovenian: Ti podatki kažejo, da je glavna pot izločanja velpatasvirja izločanje izhodiščne spojine skozi žolč.
English: Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1.)
Slovenian: Pri bolnikih s kompenzirano cirozo, ki so okuženi z genotipom 3, se lahko razmisli o dodajanju ribavirina (glejte poglavje 5.1).
English: Of the 267 treated patients, the median age was 59 years (range: 40 to 73); 70% of the patients were male; 90% were White, 6% were Black; 42% had a baseline body mass index of at least 30 kg/m2.
Slovenian: Mediana starosti 267 zdravljenih bolnikov je bila 59 let (razpon: 40-73 let); 70 % bolnikov je bilo moških; 90 % je bilo belcev; 6 % je bilo črncev; 42 % je imelo indeks telesne mase najmanj 30 kg/m2.
English: Note: Baseline frequency of ascites was: 20% none, 77% mild/moderate, 3% severe Baseline frequency of encephalopathy was: 38% none, 62% grade 1-2.
Slovenian: Opomba: Izhodiščna pogostost ascitesa je bila: 20 % brez, 77 % blag/zmeren, 3 % hud.
English: Genotype 2, 4, and 6 HCV-infected patients had a higher prevalence of NS5A RAVs (70%, 63% and 52%, respectively) compared to genotype 1 (23%), genotype 3 (16%), and genotype 5 (18%) HCV-infected patients.
Slovenian: 2, 4 in 6 je bila večja prevalenca RAV NS5A (70 %, 63 % in 52 %) kot pri bolnikih z okužbo s HCV genotipa 1 (23 %), 3 (16 %) in 5 (18 %).
English: Studies in patients with decompensated cirrhosis
Slovenian: Študije pri bolnikih z dekompenzirano cirozo
English: Gilead Sciences Ireland UC
Slovenian: Gilead Sciences Ireland UC Тел.
English: TN and TE, without cirrhosis or with compensated cirrhosis
Slovenian: PN in PZ, brez ciroze ali s kompenzirano cirozo
English: Rosuvastatin (10 mg single dose)/ velpatasvir (100 mg once daily)d (Inhibition of OATP1B and BCRP)
Slovenian: Rosuvastatin (10 mg enkratni odmerek)/velpatasvir (100 mg enkrat na dan)d (zaviranje prenašalcev OATP1B in BCRP)
English: Medicinal products that are moderate P-gp inducers and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentration leading to reduced therapeutic effect of Epclusa.
Slovenian: Zdravila, ki so zmerni induktorji P-gp in/ali citokroma CYP (npr. efavirenz, modafinil, okskarbazepin ali rifapentin), lahko zmanjšajo koncentracije sofosbuvirja ali velpatasvirja v plazmi, kar zmanjša terapevtski učinek zdravila Epclusa.
English: Effect on velpatasvir exposure not studied.
Slovenian: Učinka na izpostavljenost velpatasvirju niso preučevali.
English: Steady-state Cmax for sofosbuvir, GS-331007 and velpatasvir were 566, 868 and 259 ng/mL, respectively.
Slovenian: Vrednosti Cmax v stanju dinamičnega ravnovesja so bile 566 ng/ml za sofosbuvir, 868 ng/ml za GS-331007 in 259 ng/ml za velpatasvir.
English: Velpatasvir was 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 rat micronucleus assays.
Slovenian: Velpatasvir v nizu raziskav in vitro ali in vivo ni bil genotoksičen, vključno z bakterijskim testom mutagenosti, testom kromosomske aberacije z uporabo limfocitov humane periferne krvi in in vivo v testu mikronukleusa pri podganah.
English: (400/ 100 mg single dose fed)c
Slovenian: (400/100 mg enkratni odmerek po obroku)c
English: After a single 400 mg dose of [14C]-sofosbuvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity was approximately 0.7.
Slovenian: Po enkratnem 400-miligramskem odmerku [14C]-sofosbuvirja pri zdravih osebah je bilo razmerje radioaktivnosti [14C] v krvi in plazmi približno 0,7.
English: Close monitoring is recommended if this medicinal product is administered with Epclusa (see sections 4.4 and 4.8).
Slovenian: Kadar se to zdravilo uporablja sočasno z zdravilom Epclusa, se priporoča skrbno spremljanje (glejte poglavji 4.4 in 4.8).
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like Epclusa.
Slovenian: Nekateri sladkorni bolniki so imeli po začetku zdravljenja z zdravili, kot je zdravilo Epclusa,
English: Epclusa + RBV 12 weeks
Slovenian: Zdravilo Epclusa + RBV 12 tednov