FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment of Epclusa is required for patients with mild, moderate, or severe hepatic impairment (CPT Class A, B, or C) (see section 5.2).
Slovenian: Pri bolnikih z blago, zmerno ali hudo jetrno okvaro (stopnja A, B ali C po Child-Pugh-Turcotteu [CPT]) odmerka zdravila Epclusa ni treba prilagajati (glejte poglavje 5.2).
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone with or without other medicinal products that lower heart rate.
Slovenian: Pri uporabi režimov, ki vključujejo sofosbuvir, v kombinaciji z amiodaronom, skupaj z drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, so opazili primere hude bradikardije in srčnega bloka.
English: Body weight did not have a clinically significant effect on sofosbuvir or velpatasvir exposure according to a population pharmacokinetic analysis.
Slovenian: Glede na analizo populacijske farmakokinetike telesna masa ni klinično pomembno vplivala na izpostavljenost sofosbuvirju ali velpatasvirju.
English: No dose adjustment of Epclusa or tacrolimus is required at initiation of co-administration.
Slovenian: Odmerka zdravila Epclusa ali takrolimusa ob uvedbi sočasnega dajanja ni treba prilagajati.
English: No NS5B NI RAVs were observed at failure in the 10 patients.
Slovenian: Ob neuspehu pri teh 10 bolnikih niso zabeležili nobenih RAV NI NS5B.
English: Epclusa for 12 weeks
Slovenian: Zdravilo Epclusa 12 tednov
English: 63.9% to 95.5% 6.8% to 93.2% 69.6% to 98.8%
Slovenian: (izboljšanje) Brez sprememb 60,3 % (138/229) 76,4 % (175/229) 96,5 % (221/229) 89,1 % (204/229) 91,3 % (209/229)
English: No dose adjustment of Epclusa or ciclosporin is required at initiation of co-administration.
Slovenian: Odmerka zdravila Epclusa ali ciklosporina ob uvedbi sočasnega dajanja ni treba prilagajati.
English: Epclusa is contraindicated with carbamazepine (see section 4.3).
Slovenian: Zdravilo Epclusa je kontraindicirano v kombinaciji s karbamazepinom (glejte poglavje 4.3).
English: No dose adjustment of Epclusa or pravastatin is required.
Slovenian: Odmerka zdravila Epclusa ali pravastatina ni treba prilagajati.
English: In vitro potential for sofosbuvir/velpatasvir drug-drug interactions Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP while GS-331007 is not.
Slovenian: Sofosbuvir in velpatasvir sta substrata prenašalcev P-gp in BCRP, GS-331007 pa ni. Velpatasvir je prav tako substrat prenašalca OATP1B.
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate (150/ 150/ 200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Slovenian: Elvitegravir/kobicistat/ emtricitabin/ dizoproksiltenofovirijev fumarat (150/150/200 mg/300 mg enkrat na dan)/sofosbuvir/ velpatasvir (400/100 mg enkrat na dan)c, d
English: Table 17 presents the SVR12 for the ASTRAL-5 study by HCV genotype.
Slovenian: V preglednici 17 je predstavljen SVR12 za študijo ASTRAL-5 po genotipu HCV.
English: Patients with decompensated cirrhosis
Slovenian: Bolniki z dekompenzirano cirozo
English: Sofosbuvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study.
Slovenian: V razvojni študiji pri podganah pred kotitvijo in po njej sofosbuvir ni povzročil nobenih neželenih učinkov na vedenje, razmnoževanje ali razvoj potomcev.
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Ribavirin Dose
Slovenian: Odmerek ribavirina
English: e These are medicinal products within class where similar interactions could be predicted.
Slovenian: d. Območje 70-143 %, znotraj katerega ni farmakokinetičnih interakcij e. To so zdravila v skupini, kjer je bilo mogoče predvideti podobne interakcije.
English: No patients with genotype 2 or 4 HCV infection in the Epclusa + RBV 12 weeks group experienced virologic failure.
Slovenian: V skupini, ki je prejemala zdravilo Epclusa + RBV 12 tednov, ni noben bolnik z okužbo s HCV genotipa 2 ali 4 doživel virološkega neuspeha.
English: Dosed 1 hr Before Dialysis
Slovenian: Odmerjen o 1 uro pred dializo
English: No patients with genotype 2, 4 or 6 HCV infection experienced virologic failure.
Slovenian: Virološkega neuspeha ni doživel noben bolnik z okužbo s HCV genotipa 2, 4 ali 6.
English: Rilpivirine ↔ ↔ ↔ No dose adjustment of Epclusa or emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate is required.
Slovenian: Rilpivirin ↔ ↔ ↔ Odmerka zdravila Epclusa ali emtricitabina/rilpivirina/dizoprok siltenofovirijev fumarata ni treba prilagajati.
English: Patient populationa
Slovenian: Starejši bolniki
English: Treatment-naïve (n = 201)
Slovenian: (n = 201)
English: If you have any questions about your medicines, please ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja glede zdravil, se posvetujte z zdravnikom ali farmacevtom.
English: Table 3: Interactions between Epclusa and other medicinal products
Slovenian: Preglednica 3: Interakcije med zdravilom Epclusa in drugimi zdravili Zdravila po terapevtskih področjih/možni mehanizem interakcije
English: (20 mg once daily)/
Slovenian: (400/100 mg enkrat na dan)
English: ANTIARRHYTHMICS Amiodarone
Slovenian: NARKOTIČNI ANALGETIKI
English: Table 14 presents the SVR12 for the ASTRAL-4 study by HCV genotype.
Slovenian: V preglednici 14 je predstavljen SVR12 za študijo ASTRAL-4 po genotipih HCV.
English: Epclusa 12 weeks (n = 90)
Slovenian: 12 tednov (n = 90)
English: Epclusa is contraindicated with rifabutin (see section 4.3).
Slovenian: Zdravilo Epclusa je kontraindicirano v kombinaciji z rifabutinom (glejte poglavje 4.3).
English: Table 10 presents the SVR12 for the ASTRAL-1 study by HCV genotypes.
Slovenian: V preglednici 10 je predstavljen SVR12 za študijo ASTRAL-1 po genotipih HCV.
English: Co-administration of such medicinal products with Epclusa is not recommended (see section 4.5).
Slovenian: Sočasna uporaba teh zdravil z zdravilom Epclusa ni priporočljiva (glejte poglavje 4.5).
English: Renal impairment No dose adjustment of Epclusa is required for patients with mild or moderate renal impairment.
Slovenian: Ledvična okvara Pri bolnikih z blago ali zmerno ledvično okvaro prilagajanje odmerka zdravila Epclusa ni potrebno.
English: Table 11: SVR12 in study ASTRAL-2 (HCV genotype 2)
Slovenian: Preglednica 11: SVR12 v študiji ASTRAL-2 (HCV genotipa 2) Zdravilo Epclusa
English: The proportions of patients with genotype 1, 2, 3, 4 or 6 HCV were 78%, 4%, 15%, 3%, and < 1% (1 patient), respectively.
Slovenian: Delež bolnikov z okužbo s HCV genotipa 1 je bil 78 %, genotipa 2 4 %, genotipa 3 15 %, genotipa 4 3 % in genotipa 6 < 1 % (1 bolnik).
English: No dose adjustment of Epclusa or atorvastatin is required.
Slovenian: Odmerka zdravila Epclusa ali atorvastatina ni treba prilagajati.
English: Treatment-naïve (n = 206)
Slovenian: (n = 206)
English: Outcome for patients without SVR12 Ontreatment virologic failure
Slovenian: Izid za osebe brez SVR12
English: Breast-feeding Do not breast-feed during treatment with Epclusa.
Slovenian: Med zdravljenjem z zdravilom Epclusa ne smete dojiti.
English: ↔ ↔ ↔ No dose adjustment of Epclusa, darunavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Slovenian: ↔ ↔ ↔ Odmerka zdravila Epclusa, darunavirja (okrepljenega z ritonavirjem) ali emtricitabina/dizoproksiltenofovi rat fumarata ni treba prilagajati.
English: 76% of the patients had non-CC IL28B alleles (CT or TT); 56% had baseline HCV RNA levels of at least 800,000 IU/mL, 55% were treatment-experienced; 90% and 95% of patients had CPT Class B
Slovenian: Vključenih ni bilo nobenih bolnikov z okužbo s HCV genotipa 5. 76 % bolnikov je imelo alele IL28B ne-CC (CT ali TT); 56 % je imelo izhodiščne ravni HCV RNK najmanj 800.000 i.e./ml, 55 % se je predhodno že zdravilo; 90 % bolnikov je imelo cirozo stopnje B po CPT in 95 % jih je imelo rezultat ≤ 15 na lestvici za oceno jetrne odpovedi (MELD, Model for End Stage Liver Disease) ob izhodišču.
English: Clinical studies in patients without cirrhosis and patients with compensated cirrhosis Genotype 1, 2, 4, 5 and 6 HCV-infected adults - ASTRAL-1 (study 1138) ASTRAL-1 was a randomised, double-blind, placebo-controlled study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of placebo in patients with genotype 1, 2, 4, 5, or 6 HCV infection.
Slovenian: Klinične študije pri bolnikih brez ciroze in pri bolnikih s kompenzirano cirozo Odrasli bolniki z okužbo s HCV genotipa 1, 2, 4, 5 in 6 HCV - ASTRAL-1 (študija 1138) ASTRAL-1 je bila randomizirana, dvojno slepa s placebom nadzorovana študija, v kateri so ocenili
English: ANTIFUNGALS Ketoconazole
Slovenian: Ketokonazol
English: Table 12: SVR12 in study ASTRAL-3 (HCV genotype 3)
Slovenian: Preglednica 12: SVR12 v študiji ASTRAL-3 (HCV genotipa 3) Zdravilo Epclusa
English: Elvitegravir ↔ ↔ ↔ No dose adjustment of Epclusa or elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate is required.
Slovenian: ↔ ↔ ↔ Odmerka zdravila Epclusa ali elvitegravirja/kobicistata/ emtricitabina/ dizoproksiltenofovirijevega fumarata ni treba prilagajati.
English: HMG-CoA REDUCTASE INHIBITORS Atorvastatin (40 mg single dose) + sofosbuvir / velpatasvir (400/ 100 mg once daily)d
Slovenian: ZAVIRALCI REDUKTAZE HMG-CoA Atorvastatin (40 mg enkratni odmerek) + sofosbuvir/velpatasvir
English: Epclusa is contraindicated with rifampicin (see section 4.3).
Slovenian: Zdravilo Epclusa je kontraindicirano v kombinaciji z rifampicinom (glejte poglavje 4.3).
English: Epclusa [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Epclusa [samo zunanja ovojnina]
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ sofosbuvir (400 mg single dose)d
Slovenian: ZDRAVILA ZA ZDRAVLJENJE OKUŽB Z MIKOBAKTERIJAMI Rifampicin (600 mg enkrat na dan)/sofosbuvir (400 mg enkratni odmerek)d (indukcija P-gp in citokromov CYP)
English: Dolutegravir (50 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)
Slovenian: Dolutegravir (50 mg enkrat na dan)/sofosbuvir/velpatasvir
English: No NS5B nucleoside inhibitor (NI) RAVs were observed at failure in the 2 patients.
Slovenian: Pri teh dveh bolnikih niso zabeležili nobene različice, povezane z odpornostjo na nukleozidne zaviralce NS5B (RAV NI NS5B; NI - nucleoside inhibitor) ob neuspehu.
English: NARCOTIC ANALGESICS Methadone (Methadone maintenance therapy [30 to 130 mg daily])/ sofosbuvir (400 mg once daily)d
Slovenian: (vzdrževalna terapija z metadonom [30 do 130 mg/dan])/sofosbuvir
English: Velpatasvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 5-fold higher than the human exposure at the recommended clinical dose.
Slovenian: V študiji razvoja pri podganah pred kotitvijo in po njej pri izpostavljenosti vrednostim na podlagi AUC, ki so bile približno 5-krat večje od izpostavljenosti pri človeku pri priporočenem kliničnem odmerku, velpatasvir ni povzročil nobenih neželenih učinkov na vedenje, razmnoževanje ali razvoj potomcev.
English: tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/
Slovenian: -siltenofovirijev fumarat (600/200/300 mg enkrat na dan)/sofosbuvir/velpatasvir
English: TN and TE with or without cirrhosis, with ESRD requiring dialysis
Slovenian: GS-US-342-4062 PN in PZ s cirozo ali brez nje, z ESRD, zaradi katere je potrebna dializa
English: Lopinavir boosted with ritonavir (4x200 mg/ 50 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Slovenian: Z ritonavirjem okrepljeni lopinavir (4 × 200 mg/50 mg enkrat na dan) + emtricitabin/ dizoproksil-tenofovirijev fumarat (200/300 mg enkrat na dan)/sofosbuvir/velpatasvir
English: Epclusa should be taken with food 4 hours before using a proton pump inhibitor.
Slovenian: Če uporabljate zaviralec protonske črpalke, je treba zdravilo Epclusa vzeti s hrano 4 ure pred zaviralcem protonske črpalke;
English: Clinical monitoring, looking for signs of bleeding and anaemia, is recommended when dabigatran etexilate is co-administered with Epclusa.
Slovenian: Ko se dabigatran eteksilat daje sočasno z zdravilom Epclusa, se priporoča klinično spremljanje glede znakov krvavitve in anemije.
English: Genotypes 2, 4, 5 or 6 Total
Slovenian: Genotip 2, 4, 5 ali 6 Skupaj
English: No patients with genotype 5 HCV infection were enrolled.
Slovenian: Virološkega neuspeha ni doživel noben bolnik z okužbo s HCV
English: Darunavir boosted with ritonavir (800/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Slovenian: Z ritonavirjem okrepljeni darunavir (800 mg/100 mg enkrat na dan) + emtricitabin/ dizoproksil-tenofovirijev fumarat (200/300 mg enkrat na dan)/sofosbuvir/velpatasvir
English: Table 4: Activity of sofosbuvir and velpatasvir against full-length or chimeric laboratory replicons
Slovenian: Preglednica 4: Aktivnost sofosbuvirja in velpatasvirja proti laboratorijskim replikonom polne dolžine ali himeričnim laboratorijskim replikonom Genotip replikona Sofosbuvir EC50, nMa Velpatasvir EC50, nMa
English: No dose adjustment of Epclusa, raltegravir or emtricitabine/ tenofovir disoproxil fumarate is required.
Slovenian: Odmerka zdravila Epclusa, raltegravirja ali emtricitabina/dizoproksiltenofovi rat fumarata ni treba prilagajati.
English: Observed: Atorvastatin
Slovenian: Atorvas tatin
English: Table 14: SVR12 in study ASTRAL-4 by HCV genotype
Slovenian: Preglednica 14: SVR12 v študiji ASTRAL-4 po genotipu HCV Zdravilo Epclusa
English: Of the 266 treated patients, the median age was 58 years (range: 23 to 81); 59% of the patients were male; 88% were White, 7% were Black; 33% had a baseline body mass index of at least 30 kg/m2; 62% had non-CC IL28B alleles (CT or TT); 80% had baseline HCV RNA levels of at least 800,000 IU/mL; 14% had compensated cirrhosis and 15% were treatment-experienced.
Slovenian: 88 % je bilo belcev, 7 % je bilo črncev; 33 % jih je imelo izhodiščni indeks telesne mase najmanj 30 kg/m2; 62 % bolnikov je imelo alele IL28B ne-CC (CT ali TT); 80 % bolnikov je imelo izhodiščne ravni HCV RNK najmanj 800.000 i.e./ml; 14 % jih je imelo kompenzirano cirozo in 15 % bolnikov se je predhodno že zdravilo.
English: GT-2 (n = 104)
Slovenian: (n = 104)
English: Otherd a No patients with genotype 1 HCV had on-treatment virologic failure.
Slovenian: Drugod a. Virološkega neuspeha med zdravljenjem ni doživel noben bolnik z okužbo s HCV genotipa 1.
English: Refer to tenofovir disoproxil fumarate, emtricitabine/tenofovir disoproxil fumarate, or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate Summary of Product Characteristics for recommendations on renal monitoring.
Slovenian: Za priporočila o spremljanju ledvic glejte povzetke glavnih značilnosti zdravila za dizoproksiltenofovirijev fumarat, emtricitabin/dizoproksiltenofovirijev fumarat ali elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirijev fumarat.
English: Ketoconazole (200 mg twice daily)/ velpatasvir (100 mg single dose)d
Slovenian: Ketokonazol (200 mg enkrat na dan)/velpatasvir (100 mg enkratni odmerek)d (zaviranje P-gp in citokromov CYP)
English: GT-5 (n = 35)
Slovenian: (n = 35)
English: No dose adjustment of Epclusa, atazanavir (ritonavir boosted) or emtricitabine/ tenofovir disoproxil fumarate is required.
Slovenian: atazanavirja (okrepljenega z ritonavirjem) ali emtricitabina/dizoproksiltenofovi rat fumarata ni treba prilagajati.
English: Co-administration with such medicinal products is not recommended with Epclusa (see section 4.4).
Slovenian: Sočasna uporaba teh zdravil z zdravilom Epclusa ni priporočljiva (glejte poglavje 4.4).
English: Medicinal products that increase gastric pH are expected to decrease the concentration of velpatasvir.
Slovenian: Pričakuje se, da bodo zdravila, ki povečujejo vrednost pH v želodcu,
English: Of the 740 treated patients, the median age was 56 years (range: 18 to 82); 60% of the patients were male; 79% were White, 9% were Black; 21% had a baseline body mass index of at least 30 kg/m2; the proportions of patients with genotype 1, 2, 4, 5, or 6 HCV infection were 53%, 17%, 19%, 5% and 7%, respectively; 69% had non-CC IL28B alleles (CT or TT); 74% had baseline HCV RNA levels of at least 800,000 IU/mL; 19% had compensated cirrhosis; and 32% were treatment-experienced.
Slovenian: HCV genotipa 1, 17 % genotipa 2, 19 % genotipa 4, 5 % genotipa 5 in 7 % genotipa 6; 69 % bolnikov je imelo alele IL28B ne-CC (CT ali TT); 74 % bolnikov je imelo izhodiščne ravni RNK HCV najmanj 800.000 i.e./ml; 19 % jih je imelo kompenzirano cirozo in 32 % bolnikov se je predhodno že zdravilo.
English: Epclusa 12 weeks (n = 624)
Slovenian: Zdravilo Epclusa 12 tednov (624)
English: What Epclusa is and what it is used for What you need to know before you take Epclusa How to take Epclusa
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Epclusa
English: Cobicistat
Slovenian: Kobicistat
English: 92.9% to 98.0% 82.8% to 96.4% 92.8% to 98.6%
Slovenian: Brez sprememb 54,0 % (115/213) 80,8 % (172/213) 94,8 % (202/213) 81,2 % (173/213) 88,3 % (188/213) Višji rezultat
English: BOTTLE AND CARTON LABELLING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAČEVANJE NA NALEPKI PLASTENKE IN ŠKATLI
English: The single genotype 3 patient who had baseline NS5A RAVs and failed to achieve SVR12 had NS5A substitution Y93H at baseline; pharmacokinetic data from this patient was consistent with non-adherence to treatment.
Slovenian: Pri bolniku z okužbo s HCV genotipa 3 z izhodiščnimi RAV NS5A, ki ni dosegel SVR12, je prišlo do substitucije NS5A Y93H ob izhodišču.
English: Baseline RAVs had no relevant impact on SVR12 rates in patients infected with genotype 1, 2, 4, 5 and 6 HCV, as summarised in Table 6.
Slovenian: Izhodiščni RAV niso imeli pomembnega učinka na stopnje SVR12 pri bolnikih z okužbo s HCV
English: Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 12 weeks.
Slovenian: Epclusa ali za 12-tedensko zdravljenje s SOF + RBV.
English: 3a 4a
Slovenian: 4a
English: Iron oxide red
Slovenian: Zaviralci protonske črpalke
English: SVR12 95% Outcome for patients without SVR Ontreatment virologic failure
Slovenian: SVR12 Izid za osebe brez SVR12
English: Genotype 2, 4 and 6
Slovenian: genotipa 2, 4, 5 ali 6.
English: GT-4 (n = 116)
Slovenian: (n = 116)
English: Dosed 1
Slovenian: PRILOGA II
English: HIV ANTIVIRAL AGENTS: HIV PROTEASE INHIBITORS Atazanavir boosted with ritonavir (300/ 100 mg once daily) + emtricitabine/ tenofovir disoproxil fumarate (200/ 300 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Slovenian: Z ritonavirjem okrepljeni atazanavir (300/100 mg enkrat na dan) + emtricitabin/ dizoproksil-tenofovirijev fumarat (200/300 mg enkrat na dan)/sofosbuvir/velpatasvir
English: Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 24 weeks.
Slovenian: Epclusa ali za 24-tedensko zdravljenje s SOF + RBV.
English: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide fumarate (150/ 150/ 200/ 10 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)c, d
Slovenian: alafenamidtenofovirijev fumarat (150/150/200/10 mg enkrat na dan)/sofosbuvir/velpatasvir
English: Of the 552 treated patients, the median age was 52 years (range: 19 to 76); 62% of the patients were male; 89% were White, 9% were Asian; 1% were Black; 20% had a baseline body mass index of at least 30 kg/m2; 61% had non-CC IL28B alleles (CT or TT); 70% had baseline HCV RNA levels of at least 800,000 IU/mL, 30% had compensated cirrhosis and 26% were treatment-experienced.
Slovenian: 89 % je bilo belcev, 9 % je bilo Azijcev; 1 % je bilo črncev; 20 % jih je imelo izhodiščni indeks telesne mase najmanj 30 kg/m2; 61 % bolnikov je imelo alele IL28B ne-CC (CT ali TT); 70 % bolnikov je imelo izhodiščne ravni RNK HCV najmanj 800.000 i.e./ml; 30 % jih je imelo kompenzirano cirozo in 26 % bolnikov se je predhodno že zdravilo.
English: Increased score (Worsening)
Slovenian: Višji rezultat
English: Pravastatin (40 mg single dose)/ velpatasvir (100 mg once daily)d
Slovenian: Pravastatin (40 mg enkratni odmerek)/velpatasvir (100 mg enkrat na dan)d (zaviranje prenašalca OATP1B)
English: IMMUNOSUPPRESSANTS Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)f
Slovenian: Ciklosporin (600 mg enkratni odmerek)f/
English: • Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers,
Slovenian: • Če jemljete zdravila, ki se uporabljajo za zdravljenje želodčnih razjed, zgage ali refluksa kisline, se posvetujte z zdravnikom ali farmacevtom, saj lahko znižajo količino velpatasvirja v krvi.
English: Ethinyl estradiol
Slovenian: Norgestimat/etinilestradiol
English: Posology
Slovenian: Albumin
English: Do not stop the treatment.
Slovenian: Ne prekinite zdravljenja.
English: • if you are taking another type of medicine (see ‘Taking other medicines').
Slovenian: • če jemljete druge vrste zdravil (glejte “Jemanje drugih zdravil”)
English: White (n=1356) Black (n=966) Chinese (n=573)
Slovenian: Belci (n = 1356) Črnci (n = 966) Kitajci (n = 573)
English: EU/1/08/464/001 - Cartons of 14 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/002 - Cartons of 14 film-coated tablets in all aluminium blisters EU/1/08/464/003 - Cartons of 28 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/004 - Cartons of 28 film-coated tablets in all aluminium blisters EU/1/08/464/005 - Cartons of 30 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/006 - Cartons of 30 film-coated tablets in all aluminium blisters EU/1/08/464/007 - Cartons of 50x1 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/008 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/1/08/464/009 - Cartons of 84 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/010 - Cartons of 84 film-coated tablets in all aluminium blisters EU/1/08/464/011 - Cartons of 90 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/012 - Cartons of 90 film-coated tablets in all aluminium blisters EU/1/08/464/013 - Cartons of 100 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/014 - Cartons of 100 film-coated tablets in all aluminium blisters EU/1/08/464/018 - Cartons of 7 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/464/019 - Cartons of 7 film-coated tablets in all aluminium blisters
Slovenian: EU/1/08/464/001 - škatle s 14 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/002- škatle s 14 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/003 - škatle z 28 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/004 - škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/005 - škatle s 30 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/006 - škatle s 30 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/007 - škatle s 50x1 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/008 - škatle s 50x1 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/009 - škatle z 84 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/010 - škatle z 84 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/011 - škatle z 90 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/012 - škatle z 90 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/464/013 - škatle s 100 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/014 - škatle s 100 filmsko obloženimi tabletam v aluminijastih pretisnih omotih EU/1/08/464/018 - škatle s 7 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/464/019 - škatle s 7 filmsko obloženimi tabletami v aluminijastih pretisnih omotih
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 July 2008
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 16. julij 2008