natgillin/translations-raw huggingface dataset:
Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
Vrednosti AUC0-24 in Cmax za sofosbuvir in GS-331007 so bile podobne tako pri zdravih odraslih osebah kot bolnikih z okužbo s HCV.
The overall SVR rate was 95% (56/59); of the three patients that did not achieve SVR12, one had completed Epclusa treatment and relapsed and two did not meet virologic failure criteria.
Celokupna stopnja SVR je bila 95 % (56/59); od treh bolnikov, ki niso dosegli SVR12, je eden končal zdravljenje z zdravilom
Talk to your doctor or pharmacist before taking Epclusa if:
Pred začetkom jemanja zdravila Epclusa se posvetujte z zdravnikom ali farmacevtom, če:
The pharmacokinetics of sofosbuvir was studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir, relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2).
Farmakokinetiko sofosbuvirja so preučili pri bolnikih, negativnih za HCV, z blago (eGFR ≥ 50 in < 80 ml/min/1,73 m2), zmerno (eGFR ≥ 30 in < 50 ml/min/1,73m2) in hudo ledvično okvaro (eGFR < 30 ml/min/1,73 m2) ter pri bolnikih z ESRD, zaradi katere je potrebna hemodializa, po enkratnem 400-miligramskem odmerku sofosbuvirja, v primerjavi z bolniki z normalnim delovanjem ledvic (eGFR > 80 ml/min/1,73 m2).
Treatment with Epclusa for 12 weeks demonstrated the statistical superiority (p = 0.018) over treatment with SOF+RBV for 12 weeks (treatment difference +5.2%; 95% confidence interval: +0.2% to +10.3%).
12-tedensko zdravljenje z zdravilom Epclusa se je pokazalo kot statistično boljše (p = 0,018) od 12-tedenskega zdravljenja s SOF + RBV (razlika v zdravljenju +5,2 %, 95-odstotni interval zaupanja: +0,2 % do +10,3 %).
Film-coating: Polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red
Filmska obloga: polivinilalkohol, titanov dioksid, polietilenglikol, smukec, rdeči železov oksid.
Impact of DAA therapy on drugs metabolized by the liver The pharmacokinetics of drugs that are metabolized by the liver (e.g. immunosuppressive agents such as calcineurin inhibitors) may be impacted by changes in liver function during DAA therapy, related to clearance of HCV.
Na farmakokinetiko zdravil, ki se presnavljajo prek jeter (npr. imunosupresivna zdravila, kot so zaviralci kalcinevrina), lahko vplivajo spremembe delovanja jeter med zdravljenjem z DAA, ki so povezane z odstranitvijo virusa HCV.
Epclusa can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).
Epclusa se lahko pri teh bolnikih uporablja brez prilagajanja odmerka, ko druge ustrezne možnosti zdravljenja niso na voljo (glejte poglavja 4.4, 4.5, 5.1 in 5.2).
Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analogue triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Sofosbuvir je nukleotidno predzdravilo, ki se znotraj celice presnavlja in tvori farmakološko aktivni uridinski analog trifosfat (GS-461203), ki ga polimeraza NS5B lahko vgradi v HCV RNK, in deluje kot terminator verige.
b Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria.
b. Med drugo so bile vključene osebe, ki niso dosegle SVR12 in niso izpolnjevale meril za virološki neuspeh.
Velpatasvir median peak concentrations were observed at 3 hours post-dose.
Mediano najvišje koncentracije velpatasvirja so zabeležili 3 ure po odmerku.
Velpatasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions.
Velpatasvir je zaviralec HCV, ki deluje na beljakovino HCV NS5A, ki je bistvena za replikacijo RNK in sestavljanje virionov HCV.
Treatment with Epclusa for 12 weeks demonstrated the statistical superiority (p < 0.001) compared to treatment with SOF+RBV for 24 weeks (treatment difference +14.8%; 95% confidence interval: +9.6% to +20.0%).
12-tedensko zdravljenje z zdravilom Epclusa se je pokazalo kot statistično boljše (p < 0,001) od 24tedenskega zdravljenja s SOF + RBV (razlika v zdravljenju +14,8 %, 95-odstotni interval zaupanja: +9,6 % do +20,0 %).
Therefore, Epclusa should not be used during breast-feeding.
Zato se zdravila Epclusa med dojenjem ne sme uporabljati.
Non-Cirrhotic (n = 197)
Brez ciroze (n = 197)
In one Phase 3 study in patients with decompensated cirrhosis who received Epclusa + RBV for 12 weeks, 3 patients (1 with genotype 1 and 2 with genotype 3) qualified for resistance analysis due to virologic failure.
V eni študiji 3. faze pri bolnikih z dekompenzirano cirozo, ki so prejemali zdravilo Epclusa + RBV 12 tednov, so bili 3 bolniki (1 z genotipom 1 in 2 z genotipom 3) primerni za analizo odpornosti zaradi virološkega neuspeha.
Patients were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate or abacavir/lamivudine administered with a ritonavir boosted protease inhibitor (atazanavir, darunavir, or lopinavir), rilpivirine, raltegravir or emtricitabine/tenofovir disoproxil fumarate /elvitegravir/cobicistat.
Bolniki so bili na stabilnem zdravljenju s protivirusnimi zdravili za HIV-1, ki je vključevalo emtricitabin/dizoproksiltenofovirijev fumarat ali abakavir/lamivudin, danima skupaj z ritonavirjem okrepljenim zaviralcem proteaze (atazanavir, darunavir ali lopinavir), rilpivirinom, raltegravirom ali emtricitabinom/dizoproksiltenofovirijevim fumaratom/elvitegravirjem/kobicistatom.
Patients who have previously failed therapy with an NS5A-containing regimen There are no clinical data to support the efficacy of sofosbuvir/velpatasvir for the treatment of patients who have failed treatment with a regimen containing another NS5A inhibitor.
Bolniki, pri katerih predhodno zdravljenje z režimom, ki je vključeval zaviralec NS5A, ni bilo uspešno Ni na voljo kliničnih podatkov, ki bi podprli učinkovitost sofosbuvirja in velpatasvirja pri zdravljenju bolnikov, pri katerih predhodno zdravljenje z režimom, ki je vključeval drugi zaviralec NS5A, ni bilo uspešno.
GT = genotype a The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Drugob GT = genotip a. Denominator za relaps je število bolnikov z HCV RNK < LLOQ ob zadnji oceni med zdravljenjem.
Patients should be instructed that if vomiting occurs within 3 hours of dosing an additional tablet of Epclusa should be taken.
Bolnikom je treba naročiti, naj vzamejo dodatno tableto zdravila Epclusa, če v 3 urah po odmerjanju bruhajo.
Epclusa 400 mg/100 mg film-coated tablets.
IME ZDRAVILA Epclusa 400 mg/100 mg filmsko obložene tablete.
Patients receiving tenofovir disoproxil fumarate and Epclusa concomitantly should be monitored for adverse reactions associated with tenofovir disoproxil fumarate.
Bolnike, ki prejemajo dizoproksiltenofovirijev fumarat sočasno z zdravilom Epclusa, je treba spremljati glede pojava neželenih učinkov, povezanih z dizoproksiltenofovirijevim fumaratom.
Tenofovir alafenamide Sofosbuvir
Alafenamid tenofovirijev fumarat Sofosbuvir
Do not stop taking Epclusa
Ne prenehajte jemati zdravila Epclusa
Afterwards, close monitoring and potential dose adjustment of tacrolimus may be required.
Pozneje bo morda potrebno skrbno spremljanje in morebitno prilagajanje odmerka takrolimusa.
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.
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.
Tablet core: Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Jedro tablete: kopovidon, mikrokristalna celuloza, premrežen natrijev karmelozat, magnezijev stearat.
Epclusa has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Epclusa nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir.
Ena filmsko obložena tableta vsebuje 400 mg sofosbuvirja in 100 mg velpatasvirja.
• The active substances are sofosbuvir and velpatasvir.
• Učinkovini sta sofosbuvir in velpatasvir.
• amiodarone used to treat irregular heartbeats;
• amiodaron, ki se uporablja za zdravljenje nerednega srčnega utripa;
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).
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).
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.
Če se ribavirin uporablja sočasno z zdravilom Epclusa, glejte podrobna priporočila glede nosečnosti, kontracepcije in dojenja v glavnih značilnostih zdravila za ribavirin.
Table 9: Studies conducted with Epclusa in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection
Preglednica 9: Študije, ki so jih izvedli z zdravilom Epclusa pri bolnikih z okužbo s HCV genotipa 1, 2, 3, 4, 5 ali 6
Effect on amiodarone, velpatasvir, and sofosbuvir concentrations unknown.
Učinek na koncentracije amiodarona, velpatasvirja in sofosbuvirja ni znan.
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.
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.
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
Mehanizem delovanja Sofosbuvir je pan-genotipski zaviralec RNK-polimeraze HCV NS5B, odvisne od RNK, ki je bistvena za replikacijo virusa.
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.
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.
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).
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).
Epclusa 400 mg/100 mg film-coated tablets sofosbuvir/velpatasvir
Epclusa 400 mg/100 mg filmsko obložene tablete sofosbuvir/velpatasvir
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).
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).
Oxcarbazepine (Induction of P-gp and CYPs)
Okskarbazepin (indukcija P-gp in citokromov CYP)
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.
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.
Median peak plasma concentration of GS-331007 was observed 3 hours post-dose.
Mediano najvišje koncentracije GS-331007 v plazmi so opazili 3 ure po odmerku.
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.
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,
Treatmentexperienced (n = 71)
Predhodno zdravljeni bolniki (n = 71)
Otherb a The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Drugob a. Denominator za relaps je število bolnikov z HCV RNK < LLOQ ob zadnji oceni med zdravljenjem.
Treatmentexperienced (n = 69)
Predhodno zdravljeni bolniki (n = 69)
(Inhibition of P-gp)
(zaviranje P-gp)
Epclusa 12 weeks (134) SOF+RBV 12 weeks (132)
Zdravilo Epclusa 12 tednov (134) SOF + RBV 12 tednov (132)
Effect on ketoconazole exposure not studied.
Učinka na izpostavljenost ketokonazolu niso preučevali.
(n = 331), velpatasvir AUC0-24 and Cmax were 37% lower and 41% lower, respectively in HCV-infected patients.
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.
If you are taking a proton pump inhibitor, take Epclusa with food 4 hours before using a proton pump inhibitor.
Če uporabljate zaviralec protonske črpalke, morate zdravilo Epclusa vzeti s hrano 4 ure pred zaviralcem protonske črpalke.
• oxcarbazepine (medicine used to treat epilepsy and prevent seizures);
• okskarbazepin (zdravilo, ki se uporablja za zdravljenje epilepsije in preprečevanje epileptičnih napadov);
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.
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.
Ask your doctor for effective contraception method suitable for you and your partner.
O načinu kontracepcije, ki je za vas ali vašega partnerja oz. partnerico najprimernejši, se posvetujte z zdravnikom.
Recommendation concerning co-administration with Epclusa
Priporočila glede sočasne uporabe z zdravilom Epclusa
Following a single dose of 100 mg [14C]-velpatasvir, the majority (> 98%) of radioactivity in plasma was parent drug.
Po enkratnem 100-miligramskem odmerku [14C]-velpatasvirja je večina (> 98 %) radioaktivnosti v plazmi posledica izhodiščne spojine.
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.
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.
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.
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.
Table 6: SVR12 in patients with or without baseline NS5A RAVs by HCV genotype (studies ASTRAL-1, ASTRAL-2 and ASTRAL-3)
Preglednica 6: SVR12 pri bolnikih z izhodiščnimi RAV NS5A ali brez njih po genotipu HCV (študije ASTRAL-1, ASTRAL-2 in ASTRAL-3)
• If it's 18 hours or more after the time you usually take Epclusa, wait and take the next dose at your usual time.
• Če se tega spomnite več kot 18 ur od takrat, ko običajno vzamete zdravilo Epclusa, počakajte in vzemite naslednji odmerek ob običajnem času.
No teratogenic effects were observed in the rat and rabbit developmental toxicity studies with sofosbuvir.
V študijah razvojne toksičnosti s sofosbuvirjem pri podganah in kuncih niso opazili teratogenih učinkov.
Table 15 presents the virologic outcome for patients with genotype 1 or 3 HCV infection in the ASTRAL-4 study.
V preglednici 15 je predstavljen virološki izid za bolnike z okužbo s HCV genotipa 1 ali 3 v študiji ASTRAL-4.
Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
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.
Epclusa 12 weeks (277) SOF+RBV 24 weeks (275)
Zdravilo Epclusa 12 tednov (277) SOF + RBV 24 tednov (275)
SOF+RBV 24 weeks (n = 275)
SOF + RBV 24 tednov (n = 275)
Talk to your doctor if you:
Opozorila in previdnostni ukrepi S svojim zdravnikom se posvetujte, če:
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).
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).
For ribavirin dose modifications, refer to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Smernice za prilagajanje odmerka ribavirina si oglejte v povzetku glavnih značilnosti zdravila, ki vsebuje ribavirin.
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.
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
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.
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.
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).
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).
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.
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
Refer to the tenofovir disoproxil fumarate-containing product's Summary of Product Characteristics for recommendations on renal monitoring (see section 4.4).
Za priporočila o spremljanju ledvic glejte povzetke glavnih značilnosti zdravila za zdravila, ki vsebujejo dizoproksiltenofovirijev fumarat (glejte poglavje 4.4).
SOF+RBV 12 weeks (n = 132)
SOF + RBV 12 tednov (n = 132)
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).
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).
c Administered as Epclusa.
c. Uporabljeno kot zdravilo Epclusa.
Safety and efficacy of Epclusa has not been assessed in patients with CPT Class C cirrhosis (see sections 4.8 and 5.1).
Varnost in učinkovitost zdravila Epclusa pri bolnikih s cirozo jeter stopnje C po CPT nista bili ocenjeni (glejte poglavji 4.8 in 5.1).
As Epclusa contains sofosbuvir and velpatasvir, any interactions that have been identified with these active substances individually may occur with Epclusa.
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.
ANTICOAGULANTS Dabigatran etexilate
ANTIKOAGULANTI Dabigatran eteksilat
Co-administration with proton pump inhibitors is not recommended.
Hkratno dajanje z zaviralci protonske črpalke ni priporočljivo.
Some medicines should not be taken with Epclusa.
Nekaterih zdravil ne smete uporabljati sočasno z zdravilom Epclusa.
The highest documented doses of sofosbuvir and velpatasvir were a single dose of 1,200 mg and a single dose of 500 mg, respectively.
Najvišja dokumentirana odmerka sta bila enkratni odmerek 1.200 mg sofosbuvirja in enkratni odmerek 500 mg velpatasvirja.