FrancophonIA/ELRC3.0 huggingface dataset:
English: If a dose of Epclusa is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time.
Danish: Patienterne skal informeres om, at hvis de glemmer at tage en dosis Epclusa, og der er gået mindre end 18 timer fra det normale tidspunkt, skal de tage tabletten så hurtigt som muligt, hvorefter de skal tage den næste dosis til sædvanlig tid.
English: No teratogenic effects were observed in the rat and rabbit developmental toxicity studies with sofosbuvir.
Danish: Der blev ikke observeret nogen teratogen virkning af sofosbuvir i studier af udviklingstoksicitet hos rotter og kaniner.
English: In vitro, slow metabolic turnover of velpatasvir by CYP2B6, CYP2C8 and CYP3A4 was observed.
Danish: In vitro blev der set langsom metabolisk omsætning af velpatasvir via CYP2B6, CYP2C8 og CYP3A4.
English: Median sofosbuvir EC50, nM (range)
Danish: Middel sofosbuvir EC50, nM (interval)
English: Epclusa 12 weeks (59)
Danish: Epclusa i 12 uger (59)
English: SVR12 95% Outcome for patients without SVR Ontreatment virologic failure
Danish: SVR12 95 % Resultat for patienter, der ikke opnåede SVR Virologisk svigt under behandling Recidiva Andetb
English: No NS5B nucleoside inhibitor (NI) RAVs were observed at failure in the 2 patients.
Danish: Der blev ikke set nogen NS5B-nukleosidhæmmer- (NI) RAV'er på tidspunktet for svigt hos de 2 patienter.
English: ↔ ↔ ↔ Co-administration of Epclusa with efavirenz/ emtricitabine/ tenofovir disoproxil fumarate is expected to decrease the concentration of velpatasvir.
Danish: ↔ ↔ ↔ Samtidig administration af Epclusa og efavirenz/emtricitabin/ tenofovirdisoproxilfumarat forventes at nedsætte koncentrationen af velpatasvir.
English: Epclusa 24 weeks
Danish: Epclusa 24 uger
English: Effect on velpatasvir exposure not studied.
Danish: Virkning på velpatasvir-eksponering er ikke undersøgt
English: Epclusa can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2).
Danish: Epclusa kan anvendes hos disse patienter uden dosisjustering, når ingen andre relevante behandlingsmuligheder er tilgængelige (se pkt.
English: Of the 2 genotype 3 virologic failure patients, one had NS5A RAV Y93H emerge at failure.
Danish: Af de 2 genotype 3-patienter med virologisk svigt, udviklede den ene patient NS5A-RAV Y93H på tidspunktet for svigt.
English: Of the 106 treated patients, the median age was 57 years (range: 25 to 72); 86% of the patients were male; 51% were white; 45% were black; 22% had a baseline body mass index ≥ 30 kg/m2; 19 patients (18%) had compensated cirrhosis; and 29% were treatment experienced.
Danish: Medianalderen for de 106 behandlede patienter var 57 år (25-72 år); 86 % af patienterne var mænd, 51 % var hvide, 45 % var sorte, 22 % havde baseline-BMI ≥ 30 kg/m2, 19 patienter (18 %) havde kompenseret cirrose, og 29 % var behandlingserfarne.
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.
Danish: Kliniske studier hos patienter uden cirrose og patienter med kompenseret cirrose Voksne inficeret med genotype 1-, 2-, 4-, 5- og 6-HCV - ASTRAL-1 (studie 1138) ASTRAL-1 var et randomiseret, dobbeltblindt, placebokontrolleret studie, der evaluerede 12 ugers behandling med Epclusa versus med 12 uger med placebo hos patienter med genotype 1-, 2-, 4-, 5eller 6-HCV-infektion.
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).
Danish: Kliniske studier hos patienter med samtidig infektion med HCV/hiv 1 - ASTRAL-5 (studie 1202) ASTRAL-5 evaluerede 12 ugers behandling med Epclusa hos patienter med genotype 1-, 2-, 3- eller 4HCV-infektion med samtidig infektion med hiv 1 (patienter med genotype 5 og 6 HCV kunne deltage, men sådanne patienter blev ikke inkluderet).
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.
Danish: Der foreligger begrænsede sikkerhedsdata hos patienter med svært nedsat nyrefunktion (estimeret glomerulær filtrationshastighed [eGFR] < 30 ml/min/1,73 m2) og nyresygdom i slutstadiet (ESRD), der kræver hæmodialyse.
English: If you are not sure talk to your doctor or pharmacist.
Danish: Er du i tvivl, så tal med lægen eller apotekspersonalet.
English: TN and TE with or without cirrhosis, with ESRD requiring dialysis
Danish: GS-US-342-4062 TN og TE med eller uden cirrose, med ESRD, der krævede dialyse
English: After a single 100 mg dose of [14C]-velpatasvir in healthy subjects, the blood to plasma ratio of [14C]-radioactivity ranged between 0.52 and 0.67.
Danish: Efter en enkelt 100 mg-dosis af [14C]-velpatasvir hos raske personer var forholdet af [14C]-radioaktivitet mellem blod og plasma fra 0,52 til 0,67.
English: Gilead Sciences Ireland UC
Danish: Gilead Sciences Ireland UC Тел.
English: Of the 87 patients treated with Epclusa + RBV, 85 patients were included in the analysis of NS5A RAVs; 2 patients were excluded as they neither achieved SVR12 nor had virologic failure.
Danish: Ud af de 87 patienter, der blev behandlet med Epclusa + RBV, blev 85 patienter inkluderet i analysen af NS5A-RAV'er.
English: Other medicines and Epclusa
Danish: Brug af anden medicin sammen med Epclusa
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
Danish: ORALE KONTRACEPTIVA Norgestimat/ ethinylestradiol (norgestimat 0,180 mg/0,215 mg/0,25 mg/ ethinylestradiol 0,025 mg)/sofosbuvir (400 mg én gang dagligt)d
English: SOF+RBV 24 weeks (n = 275)
Danish: SOF+RBV 24 uger (n = 275)
English: Genotype 1, 2, 3, 4, 5 and 6
Danish: Genotype 1, 2, 3, 4, 5 og 6
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.
Danish: Velpatasvir var ikke genotoksisk i et arsenal af in vitro- eller in vivo-analyser, herunder bakteriel mutagenicitet, kromosomafvigelse ved brug af humane lymfocytter fra perifert blod og in vivomikronukleus-analyser hos rotter.
English: Co-administration of Epclusa with rifapentine is expected to decrease the concentration of sofosbuvir and velpatasvir, leading to reduced therapeutic effect of
Danish: Administration af Epclusa sammen med rifapentin forventes at nedsætte koncentrationen af sofosbuvir og velpatasvir, hvilket medfører nedsat terapeutisk virkning af Epclusa.
English: Breast-feeding Do not breast-feed during treatment with Epclusa.
Danish: Amning Du må ikke amme under behandlingen med Epclusa.
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.
Danish: Klinisk signifikante lægemiddelinteraktioner med Epclusa medieret af P-gp, BCRP, OATP eller CYP-hæmmere forventes ikke.
English: Total (all GTs) (n = 106)
Danish: I alt (alle GT'er) (n = 106)
English: CPT Class C cirrhosis pre-transplant CPT Class B or C post-transplant
Danish: CPT-klasse B- eller C-cirrose efter transplantation
English: Safety and efficacy of Epclusa has not been assessed in patients with CPT Class C cirrhosis (see sections 4.8 and 5.1).
Danish: Epclusas sikkerhed og virkning er ikke blevet vurderet hos patienter med CPT-klasse C-cirrose (se pkt.
English: NARCOTIC ANALGESICS Methadone (Methadone maintenance therapy [30 to 130 mg daily])/ sofosbuvir (400 mg once daily)d
Danish: OPIOID-ANALGETIKA Methadon (Methadon vedligeholdelsesbehandling [30-130 mg dagligt])/ sofosbuvir (400 mg én gang dagligt)d
English: Co-administration is not recommended (see section 4.4).
Danish: Samtidig administration frarådes (se pkt.
English: Epclusa + RBV 12 weeks (n = 87)
Danish: Epclusa + RBV 12 uger (n = 87)
English: Median velpatasvir EC50, nM (range)
Danish: Middel velpatasvir EC50, nM (interval)
English: No patients with genotype 2, 4, 5, or 6 HCV infection experienced virologic failure.
Danish: Ingen patienter med genotype 2-, 4-, 5- eller 6-HVC-infektion oplevede virologisk svigt.
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone and/or other medicinal products that lower heart rate (see sections 4.4 and 4.5).
Danish: Der er set tilfælde af svær bradykardi og hjerteblok ved anvendelse af regimer, der indeholder sofosbuvir, i kombination med amiodaron og/eller andre lægemidler, der nedsætter hjertefrekvensen (se pkt.
English: Patients with decompensated cirrhosis
Danish: Patienter med dekompenseret cirrose
English: Safety data are limited in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Danish: Der foreligger begrænsede sikkerhedsdata hos patienter med svært nedsat nyrefunktion (estimeret glomerulær filtrationshastighed [eGFR] < 30 ml/min/1,73 m2) og ESRD, der kræver hæmodialyse.
English: SOF+RBV 12 weeks (n = 132)
Danish: SOF+RBV i 12 uger (n = 132)
English: Table 8: SVR12 in patients with or without baseline NS5A RAVs by HCV genotype (study ASTRAL-4)
Danish: Tabel 8: SVR12 hos patienter med eller uden NS5A-RAV'er ved baseline efter HVC-genotype (ASTRAL-4-studiet).
English: Medicinal products that are strong inducers of P-gp and/or strong inducers of CYP2B6, CYP2C8, or CYP3A4 (e.g. carbamazepine, phenobarbital and phenytoin, rifampicin, rifabutin and St. John's wort) may decrease plasma concentrations of sofosbuvir or velpatasvir leading to reduced therapeutic effect of sofosbuvir/velpatasvir.
Danish: Lægemidler, der er stærke induktorer af P-gp og/eller CYP2B6, CYP2C8 eller CYP3A4 (f.eks. carbamazepin, phenobarbital og phenytoin, rifampicin, rifabutin og perikon) kan nedsætte plasmakoncentrationen af sofosbuvir og velpatasvir, hvilket fører til en nedsat terapeutisk virkning af sofosbuvir/velpatasvir.
English: Co-administration of Epclusa with efavirenz-containing regimens is not recommended (see section 4.4).
Danish: Det frarådes at administrere Epclusa samtidig med efavirenz-holdige regimer (se pkt.
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).
Danish: Epclusas sikkerhed og virkning er blevet vurderet hos patienter med CPT-klasse B-cirrose, men ikke hos patienter med CPT-klasse C-cirrose (se pkt.
English: Total (all GTs) (n = 624)
Danish: I alt (alle GT'er) (n = 624)
English: Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Danish: Epclusa er indiceret til behandling af kronisk hepatitis C-virus- (HCV-) infektion hos voksne (se pkt.
English: Genotype 1, 2, 4, 5 and 6
Danish: Genotype 1, 2, 4, 5 og 6
English: No dose adjustment of Epclusa or atorvastatin is required.
Danish: Dosisjustering af Epclusa eller atorvastatin er ikke nødvendig.
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.
Danish: Efter en enkelt 400 mg-dosis af [14C]-sofosbuvir hos raske personer var forholdet af [14C]-radioaktivitet mellem blod og plasma ca. 0,7.
English: The pharmacokinetics of velpatasvir was studied with a single dose of 100 mg velpatasvir in HCV negative patients with moderate and severe hepatic impairment (CPT Class B and C).
Danish: Velpatasvirs farmakokinetik efter en enkelt dosis på 100 mg velpatasvir blev undersøgt hos HCV-negative patienter med moderat og svært nedsat leverfunktion (CPT-klasse B og C).
English: In biochemical assays, the ability of the active triphosphate of sofosbuvir (GS-461203) to inhibit recombinant NS5B polymerase from genotypes 1b, 2a, 3a and 4a expressing the S282T substitution was reduced compared to its ability to inhibit wild-type recombinant NS5B polymerase, as indicated by a 8.5- to 24-fold increase in the 50% inhibitory concentration (IC50).
Danish: 1b, 2a, 3a og 4a, der udtrykker S282T-substitutionen, reduceret, sammenlignet med dets evne til at hæmme rekombinant NS5B-polymerase fra vildtypen, som angivet af en 8,5 til 24 gange øgning i 50 % hæmningskoncentrationen (IC50).
English: Dolutegravir ↔ ↔ ↔ No dose adjustment of Epclusa or dolutegravir is required.
Danish: ↔ ↔ ↔ Dosisjustering af Epclusa eller dolutegravir er ikke nødvendig.
English: Epclusa 12 weeks (106)
Danish: Epclusa i 12 uger (106)
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.
Danish: Se produktresuméerne for tenofovirdisoproxilfumarat, emtricitabin/tenofovirdisoproxilfumarat eller elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat for anbefalinger vedrørende monitorering af nyrefunktionen.
English: No patients with genotype 2, 4 or 6 HCV infection experienced virologic failure.
Danish: Ingen patienter med genotype 2-, 4- eller 6-HVC-infektion oplevede virologisk svigt.
English: Medicinal products that are strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP) inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin and St. John's wort).
Danish: Brug sammen med stærke P-gp-induktorer og stærke CYP-induktorer Lægemidler, der er stærke induktorer af P-glykoprotein (P-gp) og/eller af CYP (carbamazepin, phenobarbital, phenytoin, rifampicin, rifabutin og perikon).
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.
Danish: Lægemidler, der er moderate P-gpinduktorer og/eller moderate CYP-induktorer (f.eks. efavirenz, modafinil, oxcarbazepin eller rifapentin), kan nedsætte plasmakoncentrationen af sofosbuvir og velpatasvir og medføre reduceret terapeutisk virkning af Epclusa.
English: SOF+RBV 24 weeksa
Danish: SOF+RBV 24 ugera
English: Famotidine dosed simultaneously with Epclusad
Danish: Famotidin doseret samtidig med Epclusad
English: • a wide spread severe rash with peeling skin which may be accompanied by fever, flu like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens Johnson syndrome).
Danish: influenzalignende symptomer, blærer i munden, øjnene og/eller på kønsorganerne
English: Table 11 presents the SVR12 for the ASTRAL-2 study.
Danish: Tabel 11 viser SVR12 for ASTRAL-2-studiet.
English: Table 12 presents the SVR12 for the ASTRAL-3 study.
Danish: Tabel 12 viser SVR12 for ASTRAL-3-studiet.
English: Tacrolimus (5 mg single dose)f/ sofosbuvir (400 mg single dose)d
Danish: Tacrolimus (5 mg enkeltdosis)f/ sofosbuvir (400 mg enkeltdosis)d
English: Without cirrhosis 98% (160/163) With cirrhosis a Five patients with missing cirrhosis status in the SOF+RBV 24 week group were excluded from this subgroup analysis.
Danish: Uden cirrose Med cirrose a. Fem patienter med manglende cirrosestatus i gruppen, der fik SOF+RBV i 24 uger, blev ekskluderet fra denne undergruppeanalyse.
English: Severe RI (eGFR <30 mL/min/1.7 3m2)
Danish: Svært RI (eGFR < 30 ml/min/ 1,73m2)
English: g Lack of pharmacokinetics interaction bounds 50-200%.
Danish: g. Interval på 50-200 %, hvor der ikke er farmakokinetisk interaktion.
English: Omeprazole dosed simultaneously with Epclusad
Danish: Omeprazol doseret samtidig med Epclusad
English: Genotype 3 HCV-infected adults - ASTRAL-3 (study 1140) ASTRAL-3 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 24 weeks of treatment with SOF+RBV in patients with genotype 3 HCV infection.
Danish: Voksne med genotype 3-HCV-infektion - ASTRAL-3 (studie 1140) ASTRAL-3 var et randomiseret åbent studie, der evaluerede 12 ugers behandling med Epclusa versus 24 ugers behandling med SOF+RBV hos patienter med genotype 3-HCV-infektion.
English: Use with moderate P-gp inducers and/or moderate CYP inducers Medicinal products that are moderate P-gp and/or moderate CYP inducers (e.g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir or velpatasvir plasma concentrations leading to reduced therapeutic effect of Epclusa.
Danish: Brug sammen med moderate P-gp-induktorer og/eller moderate CYP-induktorer Lægemidler, der er moderate P-gp- og/eller moderate CYP-induktorer (f.eks. efavirenz, modafinil, oxcarbazepin eller rifapentin), kan nedsætte plasmakoncentrationen af sofosbuvir og velpatasvir og medføre reduceret terapeutisk virkning af Epclusa.
English: If it is considered necessary to co-administer, then Epclusa should be administered with food and taken 4 hours before proton pump inhibitor at max doses comparable to omeprazole 20 mg.
Danish: Hvis samtidig administration anses for nødvendig, skal Epclusa administreres sammen med mad og tages 4 timer før protonpumpehæmmeren.
English: Dolutegravir (50 mg once daily)/ sofosbuvir/ velpatasvir (400/ 100 mg once daily)
Danish: Dolutegravir (50 mg én gang dagligt)/sofosbuvir/ velpatasvir (400/100 mg én gang dagligt)
English: Digoxin (0.25 mg single dose)f/ velpatasvir (100 mg single dose)
Danish: Digoxin (0,25 mg enkeltdosis)f/velpatasvir (100 mg enkeltdosis)
English: IMMUNOSUPPRESSANTS Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)f
Danish: IMMUNOSUPPRESSIVA Ciclosporin (600 mg enkeltdosis)/ sofosbuvir (400 mg enkeltdosis)f
English: Epclusa 12 weeks (90)
Danish: Epclusa i 12 uger (90)
English: With any baseline NS5A RAVs Without baseline NS5A RAVs
Danish: Med enhver NS5A-RAV'er ved baseline
English: Genotype 2 HCV-infected adults - ASTRAL-2 (study 1139) ASTRAL-2 was a randomised, open-label study that evaluated 12 weeks of treatment with Epclusa compared with 12 weeks of treatment with SOF+RBV in patients with genotype 2 HCV infection.
Danish: Voksne med genotype 2-HCV-infektion - ASTRAL-2 (studie 1139) ASTRAL-2 var et randomiseret åbent studie, der evaluerede 12 ugers behandling med Epclusa versus 12 ugers behandling med SOF+RBV hos patienter med genotype 2-HCV-infektion.
English: Observed: Velpatasvir
Danish: Observeret: Velpatasvir
English: Otherd a No patients with genotype 1 HCV had on-treatment virologic failure.
Danish: Andetd a. Der var ingen patienter med genotype 1-HCV, der havde virologisk svigt under behandlingen.
English: Epclusa 24 weeks (n = 90)
Danish: Epclusa 24 uger (n = 90)
English: ↔ ↔ ↔ No dose adjustment of Epclusa or methadone is required.
Danish: R-methadon ↔ ↔ ↔ Dosisjustering af Epclusa eller methadon er ikke nødvendig.
English: • shortness of breath;
Danish: • åndenød
English: (Inhibition of P-gp and CYPs)
Danish: (Hæmning af P-gp og CYP'er)
English: Ethinyl estradiol
Danish: Ethinylestradiol ↑
English: The overall mean CD4+ count was 598 cells/µL (range: 183−1513 cells/µL).
Danish: 598 celler/μl (183-1.513 celler/μl).
English: Epclusa is contraindicated with rifabutin (see section 4.3).
Danish: Epclusa er kontraindiceret sammen med rifabutin (se pkt.
English: Co-administration of such medicinal products with Epclusa is not recommended (see section 4.5).
Danish: Samtidig administration af sådanne lægemidler og Epclusa frarådes (se pkt.
English: Rifampicin (600 mg once daily)/ velpatasvir (100 mg single dose)
Danish: Rifampicin (600 mg én gang dagligt)/velpatasvir (100 mg enkeltdosis)
English: Observed: Sofosbuvir
Danish: Observeret: Sofosbuvir
English: H2-receptor antagonists Famotidine (40 mg single dose)/ sofosbuvir/ velpatasvir (400/ 100 mg single dose)c
Danish: H2-receptorantagonister Famotidin (40 mg enkeltdosis)/ sofosbuvir/velpatasvir (400/100 mg enkeltdosis)c
English: Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 24 weeks.
Danish: Patienterne blev randomiseret i et 1:1-forhold til behandling med Epclusa i 12 uger eller SOF+RBV i 24 uger.
English: Table 13: SVR12 for selected subgroups in study ASTRAL-3 (HCV genotype 3)
Danish: Tabel 13: SVR12 i udvalgte undergrupper i studie ASTRAL-3 (HCV-genotype 3)
English: Ciclosporin (600 mg single dose)f/ velpatasvir (100 mg single dose)d
Danish: Ciclosporin (600 mg enkeltdosis)f/ velpatasvir (100 mg enkeltdosis)d
English: Ketoconazole (200 mg twice daily)/ velpatasvir (100 mg single dose)d
Danish: Ketoconazol (200 mg to gange dagligt)/velpatasvir (100 mg enkeltdosis)d
English: Outcome for patients without SVR12 Ontreatment virologic failure
Danish: Resultat for patienter, der ikke opnåede SVR12 Virologisk svigt under behandling
English: Pravastatin (40 mg single dose)/ velpatasvir (100 mg once daily)d
Danish: Pravastatin (40 mg enkeltdosis)/velpatasvir (100 mg én gang dagligt)d
English: Of the 1,035 patients treated with sofosbuvir/velpatasvir in the three Phase 3 clinical studies, 1,023 patients were included in the analysis of NS5A RAVs; 7 patients were excluded as they neither achieved sustained virologic response (SVR12) nor had virologic failure and 5 additional patients were excluded as NS5A gene sequencing failed.
Danish: Af de 1.035 patienter, der blev behandlet med sofosbuvir/velpatasvir i de tre kliniske fase III-studier, blev 1.023 patienter inkluderet i analysen af NS5A-RAV'er.
English: Patients were randomised in a 1:1 ratio to treatment with Epclusa for 12 weeks or SOF+RBV for 12 weeks.
Danish: Patienterne blev randomiseret i et 1:1-forhold til behandling med Epclusa i 12 uger eller SOF+RBV i 12 uger.
English: Epclusa is contraindicated with rifampicin (see section 4.3).
Danish: Epclusa er kontraindiceret sammen med rifampicin (se pkt.
English: No dose adjustment of Epclusa or pravastatin is required.
Danish: Dosisjustering af Epclusa eller pravastatin er ikke nødvendig.
English: How to take Epclusa
Danish: Sådan skal du tage Epclusa
English: Genotypes 2 or 4
Danish: Genotype 2 eller 4 I alt
English: Epclusa 12 weeks (n = 277)
Danish: Epclusa i 12 uger (n = 277)
English: Epclusa is contraindicated with carbamazepine (see section 4.3).
Danish: Epclusa er kontraindiceret sammen med carbamazepin (se pkt.
English: • Get advice from a doctor or pharmacist if you take medicines used to treat stomach ulcers,
Danish: • Få rådgivning fra en læge eller apotekspersonalet, hvis du tager lægemidler, der anvendes til at behandle mavesår, halsbrand eller sure opstød, da disse kan nedsætte mængden af velpatasvir i blodet.
English: Genotypes 2, 4, 5 or 6 Total
Danish: Genotype 2, 4, 5 eller 6 I alt
English: (400/ 100 mg single dose fed)c
Danish: (40 mg enkeltdosis)/
English: • fainting.
Danish: • svimmelhed
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.
Danish: Den ene genotype 3-patient, der havde NS5A-RAV'er ved baseline og ikke opnåede SVR12, havde NS5A-substitution Y93H ved baseline.
English: Epclusa 12 weeks (n = 106)
Danish: Epclusa i 12 uger (n = 106)
English: HMG-CoA REDUCTASE INHIBITORS Atorvastatin (40 mg single dose) + sofosbuvir / velpatasvir (400/ 100 mg once daily)d
Danish: HMG-CoA-REDUKTASEHÆMMERE Atorvastatin (40 mg enkelt dosis) + sofosbuvir/velpatasvir (400/100 mg én gang dagligt)d
English: Epclusa 12 weeks (n = 624)
Danish: Epclusa i 12 uger (n = 624)
English: Epclusa 12 weeks (n = 134)
Danish: Epclusa i 12 uger (n = 134)
English: Epclusa 12 weeks
Danish: Epclusa 12 uger
English: Epclusa 12 weeks (n = 90)
Danish: Epclusa 12 uger (n = 90)