FrancophonIA/ELRC3.0 huggingface dataset:
English: Site-directed mutagenesis of known NS5A RAVs showed that substitutions conferring a > 100-fold reduction in velpatasvir susceptibility are M28G, A92K and Y93H/N/R/W in genotype 1a, A92K in genotype 1b, C92T and Y93H/N in genotype 2b, Y93H in genotype 3, and L31V and P32A/L/Q/R in genotype 6.
Danish: Site-directed mutagenese af kendte NS5A-RAV'er viste, at substitutioner, der gav > 100 gange nedsat følsomhed for velpatasvir, er M28G, A92K og Y93H/N/R/W i genotype 1a, A92K i genotype 1b, C92T og Y93H/N i genotype 2b, Y93H i genotype 3 samt L31V og P32A/L/Q/R i genotype 6.
English: Velpatasvir was fully active against the sofosbuvir resistance-associated substitution S282T in NS5B while all velpatasvir resistance-associated substitutions in NS5A were fully susceptible to sofosbuvir.
Danish: Velpatasvir var fuldt aktivt mod den sofosbuvirresistensassocierede substitution S282T i NS5B, mens alle substitutioner i NS5A, der er forbundet med resistens over for velpatasvir, var fuldt følsomme for sofosbuvir.
English: Randomisation was stratified by HCV genotype (1, 2, 4, 6, and indeterminate) and the presence or absence of cirrhosis.
Danish: Randomisering blev stratificeret efter HCV-genotype (1, 2, 4, 6 og ubestemt) og tilstedeværelse eller fravær af cirrose.
English: • rifapentine (antibiotic used to treat infections, including tuberculosis);
Danish: • rifapentin (antibiotikum, der anvendes til behandling af infektioner, herunder tuberkulose)
English: (n = 331), velpatasvir AUC0-24 and Cmax were 37% lower and 41% lower, respectively in HCV-infected patients.
Danish: I forhold til raske personer (n = 331) var AUC0-24 og Cmax for velpatasvir hhv. 37 % lavere og 41 % lavere hos HCV-inficerede patienter.
English: In this setting, exposure of sofosbuvir metabolite GS331007 was 20-fold increased, exceeding levels where adverse reactions have been observed in preclinical trials.
Danish: Eksponeringen for sofosbuvirs metabolit GS-331007 var i dette studie 20 gange højere, hvilket oversteg de niveauer, hvor der blev set bivirkninger i prækliniske forsøg.
English: Velpatasvir was not carcinogenic in the 6-month rasH2 transgenic mouse and 2-year rat carcinogenicity studies at exposures at least 50-times and 5-times higher than human exposure, respectively.
Danish: Velpatasvir var ikke karcinogen i det 6 måneder lange rasH2-studie med transgene mus og i de 2-årige karcinogenicitetsstudier med rotter ved eksponeringer hhv. mindst 50 gange og 5 gange højere end den humane eksponering.
English: In vitro resistance selection and cross-resistance studies indicate velpatasvir targets NS5A as its mode of action.
Danish: In vitro studier af resistensudvælgelse og krydsresistens indikerer, at velpatasvirs virkningsmåde er målrettet mod NS5A.
English: Unchanged velpatasvir is the major species present in faeces.
Danish: Uomdannet velpatasvir er den primære form, der er til stede i fæces.
English: Mean ratio (90% confidence interval)a,b
Danish: Middelratio (90 % konfidensinterval)a, b Anbefaling vedrørende administration sammen med Epclusa
English: Child-Pugh-Turcotte (CPT) Class B cirrhosis pre-transplant
Danish: CPT- (Child-Pugh-Turcotte) klasse Bcirrose før transplantation
English: Genotype 3 infected patients with the NS5A RAV Y93H at baseline had a lower SVR12 rate than patients without Y93H after treatment with Epclusa for 12 weeks, as summarised in Table 7.
Danish: Genotype 3-inficerede patienter med NS5A-RAV Y93H ved baseline havde en lavere SVR12-rate end patienter uden Y93H efter behandling med Epclusa i 12 uger, som opsummeret i tabel 7.
English: In clinical studies, headache, fatigue and nausea were the most common (incidence ≥ 10%) treatment emergent adverse events reported in patients treated with 12 weeks of Epclusa.
Danish: I kliniske studier var hovedpine, træthed og kvalme de hyppigst rapporterede bivirkninger (forekomst ≥ 10 %), der opstod under behandlingen hos patienter, der blev behandlet med Epclusa i 12 uger.
English: • If you are sick (vomit) more than 3 hours after taking Epclusa, you do not need to take another tablet until your next scheduled tablet.
Danish: • Hvis du kaster op mere end 3 timer efter, du har taget Epclusa, skal du ikke tage en anden tablet før din næste skemalagte tablet.
English: Table 9: Studies conducted with Epclusa in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection
Danish: Tabel 9: Studier udført med Epclusa hos patienter med genotype 1-, 2-, 3-, 4-, 5- eller 6-HCVinfektion
English: Do not stop taking Epclusa
Danish: Du må ikke holde op med at tage Epclusa
English: SVR12 in patients with or without baseline NS5A RAVs in the Epclusa + RBV 12 week group for this study is shown in Table 8.
Danish: SVR12 hos patienter med eller uden NS5A-RAV'er ved baseline i gruppen, der fik Epclusa + RBV i 12 uger i dette studie, er vist i tabel 8.
English: Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on Epclusa.
Danish: På grund af amiodarons lange halveringstid skal patienter, som inden for de seneste par måneder har stoppet behandling med amiodaron, og som skal sættes i behandling med Epclusa, monitoreres på passende vis.
English: Total (n = 78)
Danish: I alt (n = 78)
English: Epclusa 400 mg/100 mg film-coated tablets sofosbuvir/velpatasvir
Danish: Epclusa 400 mg/100 mg filmovertrukne tabletter sofosbuvir/velpatasvir
English: At clinically relevant plasma concentration, velpatasvir is not an inhibitor of hepatic transporters bile salt export pump (BSEP), sodium taurocholate cotransporter protein (NTCP), OATP2B1, OATP1A2 or organic cation transporter (OCT) 1, renal transporters OCT2, OAT1, OAT3, multidrug resistance-associated protein 2 (MRP2) or multidrug and toxin extrusion protein (MATE) 1, or CYP or uridine glucuronosyltransferase (UGT) 1A1 enzymes.
Danish: Ved en klinisk relevant plasmakoncentration hæmmer velpatasvir ikke levertransportørerne galdesalteksportpumpe (BSEP), natriumtaurocholat-cotransporterprotein (NTCP), OATP2B1, OATP1A2 eller organisk kation-transporter (OCT) 1, de renale transportører OCT2, OAT1, OAT3, multidrug resistensassocieret protein 2 (MRP2) eller multidrug og toksisk ekstrusionsprotein (MATE) 1, CYP-enzymer eller uridinglukuronosyltransferase (UGT) 1A1enzymet.
English: GT = genotype a The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Danish: GT = genotype a. Nævneren for recidiv er antallet af patienter med HCV-RNA < LLOQ ved deres seneste vurdering under behandling.
English: Interaction only studied with velpatasvir Expected:
Danish: Interaktion kun undersøgt med velpatasvir Forventet:
English: Study 4062 was an open-label clinical trial that evaluated 12 weeks of treatment with Epclusa in 59 HCV-infected patients with ESRD requiring dialysis.
Danish: Studie 4062 var et åbent klinisk forsøg, som evaluerede 12 ugers behandling med Epclusa hos 59 HCV-inficerede patienter med ESRD, der krævede dialyse.
English: Available pharmacokinetic data in animals have shown excretion of velpatasvir and metabolites of sofosbuvir in milk.
Danish: De tilgængelige farmakokinetiske data fra dyrestudier viser, at velpatasvir og sofosbuvirs metabolitter udskilles i mælk.
English: At baseline, 29% of patients had cirrhosis, 22% were treatment experienced, 32% had received a kidney transplant, 92% were on haemodialysis, and 8% were on peritoneal dialysis; mean duration on dialysis was 7.3 years (range: 0 to 40 years).
Danish: Ved baseline havde 29 % af patienterne cirrose, 22 % var behandlingserfarne, 32 % havde fået foretaget en nyretransplantation, 92 % var i hæmodialyse og 8 % var i peritoneal dialyse; den gennemsnitlige varighed i dialyse var 7,3 år (interval: 0 til 40 år).
English: Sofosbuvir and GS-331007 are not substrates or inhibitors of UGT1A1 or CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6 enzymes.
Danish: Sofosbuvir og GS-331007 er hverken substrater for eller hæmmere af UGT1A1 eller enzymerne CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 og CYP2D6.
English: 92.9% to 98.0% 82.8% to 96.4% 92.8% to 98.6%
Danish: 92,9 % til 98,0 % 82,8 % til 96,4 % 92,8 % til 98,6 %
English: 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.
Danish: Patienter, hvor tidligere behandling med et NS5A-indeholdende regime er mislykket Der er ingen kliniske data, der understøtter virkningen af sofosbuvir/velpatasvir hos patienter, hvor behandling med et regime indeholdende en anden NS5A-hæmmer er mislykket.
English: The following pack sizes are available: • outer cartons containing 1 bottle of 28 film-coated tablets
Danish: Følgende pakningsstørrelse er tilgængelige: • kartonæske indeholdende 1 tabletbeholder med 28 filmovertrukne tabletter
English: ↔ ↔ ↔ No dose adjustment of oral contraceptives is required.
Danish: Norelgestromin ↔ ↔ ↔ Dosisjustering af orale kontraceptiva er ikke nødvendig.
English: • rifampicin and rifabutin (antibiotics used to treat infections, including tuberculosis);
Danish: • rifampicin og rifabutin (antibiotika, der anvendes til behandling af infektioner, herunder tuberkulose)
English: b n = 4 for genotype 2 and n = 2 for genotype 4.
Danish: b. n = 4 for genotype 2 og n = 2 for genotype 4
English: Epclusa has been shown to increase tenofovir exposure (P-gp-inhibition).
Danish: Det er vist, at Epclusa øger tenofovireksponering (P-gp-hæmning).
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.
Danish: Baseret på NS5Aresistensforbundne varianter (RAV'er), der typisk ses hos patienter, hvor behandling med andre regimer indeholdende NS5A-hæmmere er mislykket, på farmakologien af velpatasvir in vitro og på resultaterne af sofosbuvir/velpatasvir-behandling hos NS5A-naive patienter med NS5A-RAV'er ved baseline i ASTRAL-studierne, kan behandling med Epclusa + RBV i 24 uger imidlertid overvejes hos patienter, hvor behandling med et NS5A-indeholdende regime er mislykket, og som skønnes at have en høj risiko for sygdomsprogression, og hvor der ikke er alternative behandlingsmuligheder.
English: Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
Danish: Sofosbuvir er en pan-genotypisk hæmmer af HCV-NS5B-RNA-afhængig RNA-polymerase, som er essentiel for viral replikation.
English: Omeprazole dosed 4 hours after Epclusad
Danish: Omeprazol doseret 4 timer efter Epclusad
English: The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets.
Danish: Følgende pakningsstørrelse er tilgængelig: kartonæske indeholdende 1 beholder med 28 filmovertrukne tabletter.
English: Tablet core: Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Danish: Tabletkerne: Copovidon, mikrokrystallinsk cellulose, croscarmellosenatrium, magnesiumstearat
English: Epclusa + ribavirin for 12 weeks a Includes patients co-infected with human immunodeficiency virus (HIV) and patients with recurrent HCV post-liver transplant (see section 4.4.
Danish: Epclusa + ribavirin i 12 uger a. Inklusive patienter med samtidig infektion med humant immundefektvirus (hiv) og patienter med recidiverende HCV efter levertransplantation (se pkt.
English: The proportion of patients who permanently discontinued treatment due to adverse events was 0.2% and the proportion of patients who experienced any severe adverse events was 3.2% for patients receiving Epclusa for 12 weeks.
Danish: 0,2 % af patienterne seponerede behandlingen permanent pga. bivirkninger, og 3,2 % af de patienter, der fik Epclusa i 12 uger, oplevede alvorlige bivirkninger.
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS
Danish: ANTIVIRALE MIDLER MOD HIV: INTEGRASEHÆMMERE
English: 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.
Danish: Patienterne var i stabil hiv 1-antiretroviral behandling, der omfattede emtricitabin/tenofovirdisoproxilfumarat eller abacavir/lamivudin administreret sammen med en hiv-proteasehæmmer boostet med ritonavir (atazanavir, darunavir eller lopinavir), rilpivirin, raltegravir eller emtricitabin/tenofovirdisoproxilfumarat/elvitegravir/cobicistat.
English: Medicinal products that inhibit OATP, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentration of velpatasvir.
Danish: Lægemidler, der hæmmer OATP, CYP2B6, CYP2C8 eller CYP3A4, kan øge plasmakoncentrationen af velpatasvir.
English: Film-coating: Polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red
Danish: Filmovertræk: Polyvinylalkohol, titandioxid, polyethylenglycol, talcum, rød jernoxid.
English: • oxcarbazepine (medicine used to treat epilepsy and prevent seizures);
Danish: • oxcarbazepin (anvendes til at behandle epilepsi og forebygge krampeanfald)
English: The EC50 values of sofosbuvir and velpatasvir against clinical isolates are presented in Table 5.
Danish: EC50-værdierne for sofosbuvir og velpatasvir i forhold til kliniske isolater er vist i tabel 5.
English: Replicons containing NS5A from clinical isolates
Danish: Replikoner, der indeholder NS5A fra kliniske isolater
English: Another patient had virus with Y93H at baseline and virologic failure and also developed low levels (< 5%) of NS5B NI RAVs N142T and E237G at failure.
Danish: Den anden patient med virologisk svigt havde virus med Y93H ved baseline og udviklede også lave niveauer (< 5 %) af NS5B-NI-RAV'er N142T og E237G på tidspunktet for svigt.
English: The 50% effective concentration (EC50) values of sofosbuvir and velpatasvir against full-length or chimeric replicons encoding NS5B and NS5A sequences from the laboratory strains are presented in Table 4.
Danish: 50 % effektive koncentrationsværdier (EC50) for sofosbuvir og velpatasvir mod replikoner af fuld længde eller kimære replikoner, der koder for NS5B- og NS5A-sekvenser, fra laboratoriestammer er vist i tabel 4.
English: Velpatasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions.
Danish: Velpatasvir er en HCV-hæmmer, der er målrettet mod HCV-NS5A-protein, som er essentielt for både RNA-replikation og samlingen af HCV-virioner.
English: 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%).
Danish: Behandling med Epclusa i 12 uger viste statistisk superioritet (p = 0,018) i forhold til behandling med SOF+RBV i 12 uger (behandlingsdifferens +5,2 %; 95 % konfidensinterval: +0,2 % til +10,3 %).
English: Patients without cirrhosis and patients with compensated cirrhosis
Danish: Patienter uden cirrose og patienter med kompenseret cirrose.
English: What you need to know before you take Epclusa Do not take Epclusa
Danish: Det skal du vide, før du begynder at tage Epclusa Tag ikke Epclusa
English: Non-Cirrhotic (n = 197)
Danish: Uden cirrose (n = 197)
English: The pharmacokinetics of sofosbuvir, GS-331007 and velpatasvir in paediatric patients have not been established (see section 4.2).
Danish: Farmakokinetikken af sofosbuvir, GS-331007 og velpatasvir hos pædiatriske patienter er ikke klarlagt (se pkt.
English: Demographics and baseline characteristics were balanced across the treatment groups.
Danish: De demografiske karakteristika og baseline-karakteristika var afbalanceret mellem behandlingsgrupperne.
English: The safety assessment of Epclusa was based on pooled Phase 3 clinical study data from patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection (with or without compensated cirrhosis) including 1,035 patients who received Epclusa for 12 weeks.
Danish: Sikkerhedsvurderingen af Epclusa blev baseret på de samlede data fra kliniske fase III-studier hos patienter med genotype 1-, 2-, 3-, 4-, 5- eller 6-HCV-infektion (med eller uden kompenseret cirrose), herunder 1.035 patienter, der fik Epclusa i 12 uger.
English: Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 82 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir, GS-331007, or velpatasvir.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter viste, at inden for det analyserede aldersinterval (18 til 82 år) havde alder ingen klinisk relevant indvirkning på eksponeringen for sofosbuvir, GS-331007 eller velpatasvir.
English: TN and TE, without cirrhosis or with compensated cirrhosis
Danish: TN og TE uden cirrose eller med kompenseret cirrose
English: Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 for sofosbuvir (n = 982), GS-331007 (n = 1,428) and velpatasvir (n = 1,425) were 1,260, 13,970 and 2,970 ng•h/mL, respectively.
Danish: Baseret på den populationsfarmakokinetiske analyse hos HCV-inficerede patienter var middelAUC0-24 for sofosbuvir (n = 982), GS-331007 (n = 1.428) og velpatasvir (n = 1,425) hhv. 1.260, 13.970 og 2.970 ng•t/ml ved steady state.
English: In HCV-infected patients with severe renal impairment treated with sofosbuvir 200 mg with ribavirin (n=10) or sofosbuvir 400 mg with ribavirin (n=10) for 24 weeks or ledipasvir/sofosbuvir 90/400 mg (n=18) for 12 weeks, the pharmacokinetics of sofosbuvir and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Danish: Hos HCV-inficerede patienter med svært nedsat nyrefunktion, som blev behandlet med sofosbuvir 200 mg med ribavirin (n=10) eller sofosbuvir 400 mg med ribavirin (n=10) i 24 uger eller ledipasvir/sofosbuvir 90/400 mg (n=18) i 12 uger, var farmakokinetikken af sofosbuvir og GS-331007 overensstemmende med farmakokinetikken, som blev set hos HCV-negative patienter med svært nedsat nyrefunktion.
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.
Danish: De mulige risici og fordele forbundet med administration af Epclusa sammen med fastdosis-kombinationstabletter, der indeholder elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxilfumarat eller tenofovirdisoproxilfumarat, givet sammen med en boostet hiv-proteasehæmmer (f.eks. atazanavir eller darunavir) bør overvejes, især hos patienter med øget risiko for renal dysfunktion.
English: If vomiting occurs more than 3 hours after dosing, no further dose of Epclusa is needed (see section 5.1).
Danish: Hvis de kaster op senere end 3 timer efter dosering af Epclusa, er en yderligere dosis ikke nødvendig (se pkt.
English: Therefore, Epclusa should not be used during breast-feeding.
Danish: Derfor bør Epclusa ikke anvendes under amning.
English: Table 7: SVR12 in patients with and without baseline Y93H, 1% Cut-off (Resistance Analysis Population Set) ASTRAL 3
Danish: Tabel 7: SVR12 hos patienter med og uden Y93H ved baseline, 1 % cut-off (resistensanalysepopulationsgruppe) ASTRAL 3
English: c One patient had on-treatment virologic failure.
Danish: c. En patient havde virologisk svigt under behandlingen.
English: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
Danish: Sofosbuvir og GS-331007 hæmmer ikke lægemiddeltransportørerne P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 og OCT1.
English: Among the 87 patients who were treated with Epclusa + RBV for 12 weeks, decreases in haemoglobin to less than 10 g/dL and 8.5 g/dL during treatment were experienced by 23% and 7% patients, respectively.
Danish: Henholdsvis 23 % og 7 % af de 87 patienter, der blev behandlet med Epclusa + RBV i 12 uger, oplevede fald i hæmoglobin til under 10 g/dl og 8,5 g/dl under behandlingen.
English: Treatment-naïve (n = 206)
Danish: Behandlingsnaive (n = 206)
English: No teratogenic effects were observed in the mouse and rat developmental toxicity studies with velpatasvir at AUC exposures approximately 31- and 6-fold higher, respectively, than the human exposure at the recommended clinical dose.
Danish: Der blev ikke observeret nogen teratogene virkninger i studier af udviklingstoksicitet hos mus og rotter med velpatasvir ved AUCeksponeringer ca. hhv. 31 og 6 gange højere end den humane eksponering ved den anbefalede kliniske dosis.
English: The proportions of patients with genotype 1, 2, 3, 4, 6 or indeterminate HCV infection were 42%, 12%, 27%, 7% , 3%, and 9%, respectively.
Danish: Andelene af patienter med genotype 1-, 2-, 3-, 4-, 6- eller ubestemt HCV-infektion var henholdsvis 42 %, 12 %, 27 %, 7 % , 3 % og 9 %.
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.
Danish: Blandt de patienter, der fik behandling med Epclusa + RBV i 12 uger, havde 29 % (25/85) af patienterne virus med NS5A-RAV'er ved baseline: 29 % (19/66), 75 % (3/4), 15 % (2/13) og 50 % (1/2) for patienter med henholdsvis genotype 1-, 2-, 3- og 4-HCV.
English: Three patients in the Epclusa + RBV 12 week group had baseline NS5B NI RAVs (N142T and L159F) and all three patients achieved SVR12.
Danish: Tre patienter i gruppen, der fik Epclusa + RBV i 12 uger, havde NS5B-NI-RAV'er ved baseline (N142T og L159F), og alle tre patienter opnåede SVR12.
English: Following a single dose of 100 mg [14C]-velpatasvir, the majority (> 98%) of radioactivity in plasma was parent drug.
Danish: Efter en enkelt dosis på 100 mg [14C]-velpatasvir var størstedelen (> 98 %) af radioaktiviteten i plasma moderstof.
English: Effect on rifampicin exposure not studied.
Danish: Virkning på rifampicineksponering ikke undersøgt.
English: Interactions between Epclusa and other medicinal products Table 3 provides a listing of established or potentially clinically significant medicinal product interactions (where 90% confidence interval [CI] of the geometric least-squares mean [GLSM] ratio were within “↔”, extended above “↑”, or extended below “↓” the predetermined interaction boundaries).
Danish: Interaktioner mellem Epclusa og andre lægemidler Tabel 3 viser en liste over påviste eller potentielt klinisk signifikante lægemiddelinteraktioner (hvor 90 % konfidensintervallet [KI] for middelratio beregnet ved mindste kvadraters metode var inden for
English: 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%).
Danish: Behandling med Epclusa i 12 uger viste statistisk superioritet (p < 0,001) i forhold til behandling med SOF+RBV i 24 uger (behandlingsdifferens +14,8 %, 95 % konfidensinterval: +9,6 % til +20,0 %).
English: Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Danish: F.eks. aluminium- eller magnesiumhydroxid, calciumcarbonat
English: Ribavirin was discontinued in 15% of patients treated with Epclusa + RBV for 12 weeks due to adverse events.
Danish: Ribavirin blev seponeret hos 15 % af patienterne, der blev behandlet med Epclusa + RBV i 12 uger, pga. bivirkninger.