FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Epclusa in one or more subsets of the paediatric population in the treatment of chronic hepatitis C (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Epclusa i en eller flere undergrupper af den pædiatriske population ved behandling af kronisk hepatitis C (se pkt.
English: SVR with Y93H 95% CI
Danish: SVR med Y93H 95 % KI
English: Serum HCV RNA values were measured during the clinical studies using the COBAS AmpliPrep/COBAS Taqman HCV test (version 2.0) with a lower limit of quantification (LLOQ) of 15 IU/mL.
Danish: Serum-HCV-RNA blev målt i løbet af de kliniske studier vha. COBAS AmpliPrep/COBAS Taqman HCV-test (version 2.0) med en nedre kvantificeringsgrænse (LLOQ) på 15 IE/ml.
English: One additional patient with genotype 3 HCV infection at baseline was reinfected with genotype 1a HCV at virologic failure and was excluded from the virological analysis.
Danish: Yderligere en patient med genotype 3-HCV-infektion ved baseline blev reinficeret med genotype 1a-HCV ved virologisk svigt og blev ekskluderet fra den virologiske analyse.
English: Pink, diamond-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with “GSI” and “7916” on the other side.
Danish: Lyserød, rombeformet, filmovertrukket tablet med dimensionerne 20 mm x 10 mm, præget med ”GSI” på den ene side og med ”7916” på den anden side.
English: It has not been possible to fully estimate exposure margins achieved for sofosbuvir in the rat relative to the exposure in humans at the recommended clinical dose (see section 5.3).
Danish: Det har ikke været muligt klart at estimere eksponeringsmarginer, som blev opnået for sofosbuvir hos rotter, i forhold til eksponeringen hos mennesker ved den anbefalede kliniske dosis (se pkt.
English: Co-administration with proton pump inhibitors is not recommended.
Danish: Administration samtidig med protonpumpehæmmere frarådes.
English: • dabigatran used to thin the blood;
Danish: • dabigatran (anvendes til at fortynde blodet)
English: Elderly No dose adjustment is warranted for elderly patients (see section 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: Ribavirin dose adjustments were performed according to the ribavirin prescribing information.
Danish: Dosisjustering af ribavirin blev udført i henhold til ordinationsoplysningerne for ribavirin.
English: Package leaflet: Information for the user Epclusa 400 mg/100 mg film-coated tablets sofosbuvir/velpatasvir This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren Epclusa 400 mg/100 mg filmovertrukne tabletter sofosbuvir/velpatasvir Dette lægemiddel er underlagt supplerende overvågning.
English: The safety of Epclusa has been evaluated in a 12-week non-controlled study including 59 subjects with ESRD requiring dialysis (Study 4062).
Danish: Epclusas sikkerhed blev vurderet i et 12-ugers, ikke-kontrolleret studie hos 59 forsøgspersoner med ESRD, som krævede dialyse (Studie 4062).
English: Effect on amiodarone, velpatasvir, and sofosbuvir concentrations unknown.
Danish: Virkning på amiodaron-, velpatasvir- og sofosbuvirkoncentrationer ukendt.
English: Median peak plasma concentration of GS-331007 was observed 3 hours post-dose.
Danish: Median maksimal plasmakoncentration af GS-331007 blev observeret 3 timer efter dosering.
English: TN and TE, without cirrhosis or with compensated cirrhosis, with HCV/HIV-1 co-infection
Danish: TN og TE uden cirrose eller med kompenseret cirrose og med samtidig infektion med HCV/hiv 1
English: No clinically relevant pharmacokinetic differences due to race or gender have been identified for sofosbuvir, GS-331007 or velpatasvir.
Danish: Der blev ikke identificeret nogen klinisk relevante farmakokinetiske forskelle, der skyldes race eller køn, for sofosbuvir, GS-331007 eller velpatasvir.
English: • modafinil used to treat sleep disorders;
Danish: • modafinil (anvendes til at behandle søvnforstyrrelser)
English: • carbamazepine, phenobarbital and phenytoin (medicines used to treat epilepsy and prevent seizures).
Danish: • carbamazepin, phenobarbital og phenytoin (medicin, der anvendes til at behandle epilepsi og forebygge krampeanfald).
English: Epclusa 400 mg/100 mg film-coated tablets.
Danish: Epclusa 400 mg/100 mg filmovertrukne tabletter.
English: The metabolic activation pathway involves sequential hydrolysis of the carboxyl ester moiety catalysed by human cathepsin A (CatA) or carboxylesterase 1 (CES1) and phosphoramidate cleavage by histidine triad nucleotide-binding protein 1 (HINT1) followed by phosphorylation by the pyrimidine nucleotide biosynthesis pathway.
Danish: Den metaboliske aktiveringsvej omfatter sekventiel hydrolyse af carboxylesterdelen, hvilket katalyseres af humant cathepsin A (CatA) eller carboxylesterase 1 (CES1) og phosphoramidat-kløvning via histidin-triad nukleotid-bindende protein 1 (HINT1), efterfulgt af fosforylering via pyrimidin-nukleotid-biosyntesevejen.
English: Taking Epclusa with any of these may stop your medicines from working properly, or make any side effects worse.
Danish: Hvis du tager Epclusa sammen med nogle af disse lægemidler, kan det forhindre, at lægemidlerne virker korrekt, eller det kan gøre bivirkninger mere udtalte.
English: b Stable chimeric 1b replicons carrying NS5B genes from genotype 2b, 5a or 6a were used for testing.
Danish: b. Der blev anvendt stabile kimære 1b-replikoner, der bærer NS5B-gener fra genotype 2b, 5a eller 6a, til testningen.
English: Contents of the pack and other information What Epclusa contains
Danish: Pakningsstørrelser og yderligere oplysninger Epclusa indeholder:
English: 86% (6/7)c a n = 4 for genotype 2 and n = 4 for genotype 4.
Danish: 86 % (6/7)c a. n = 4 for genotype 2 og n = 4 for genotype 4
English: 1,000 mg per day for patients < 75 kg and 1,200 mg for those weighing ≥ 75 kg
Danish: 1.000 mg dagligt for patienter < 75 kg og 1.200 mg for patienter ≥ 75 kg
English: However, a possible teratogenic effect was indicated in rabbits where an increase in total visceral malformations was seen in exposed animals at AUC exposures up to 0.7 fold the human exposure at recommended clinical dose.
Danish: Der sås dog en mulig teratogen virkning hos kaniner, hvor der sås en stigning i samlede viscerale misdannelser hos dyr, der blev udsat for AUC-eksponeringer på op til 0,7 gange den humane eksponering ved den anbefalede kliniske dosis.
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).
Danish: Dosisjustering af Epclusa er ikke nødvendig hos patienter med let, moderat eller svært nedsat leverfunktion (CPT-klasse A, B eller C) (se pkt.
English: Renal impairment No dose adjustment of Epclusa is required for patients with mild or moderate renal impairment.
Danish: Nedsat nyrefunktion Dosisjustering af Epclusa er ikke nødvendig hos patienter med let eller moderat nedsat nyrefunktion.
English: • antacids (such as aluminium/magnesium hydroxide or calcium carbonate).
Danish: • syreneutraliserede midler (såsom aluminium/magnesiumhydroxid eller calciumcarbonat).
English: Medicinal products that increase gastric pH are expected to decrease the concentration of velpatasvir.
Danish: Lægemidler, der øger gastrisk pH, forventes at nedsætte koncentrationen af velpatasvir.
English: Compared to subjects with normal hepatic function velpatasvir total plasma exposure (AUCinf) was similar in patients with moderate or severe hepatic impairment.
Danish: Sammenlignet med personer med normal leverfunktion var velpatasvirs samlede plasmaeksponering (AUCinf) sammenlignelig hos patienter med moderat eller svært nedsat leverfunktion.
English: The median terminal half-lives of sofosbuvir and GS-331007 following administration of Epclusa were 0.5 and 25 hours, respectively.
Danish: De mediane terminale halveringstider for sofosbuvir og GS-331007 efter administration af Epclusa var hhv. 0,5 og 25 timer.
English: Both sofosbuvir and velpatasvir were fully active against substitutions associated with resistance to other classes of direct-acting antivirals with different mechanisms of actions, such as NS5B non-nucleoside inhibitors and NS3 protease inhibitors.
Danish: Både sofosbuvir og velpatasvir var fuldt aktive mod substitutioner, der var forbundet med resistens over for andre klasser af direkte virkende antivirale midler med forskellige virkningsmekanismer, såsom NS5Bnon-nukleosidhæmmere og NS3-proteasehæmmere.
English: Famotidine dosed 12 hours prior to Epclusad
Danish: Famotidin doseret 12 timer før Epclusad
English: If you forget to take Epclusa
Danish: Hvis du har glemt at tage Epclusa
English: Steady-state Cmax for sofosbuvir, GS-331007 and velpatasvir were 566, 868 and 259 ng/mL, respectively.
Danish: Steady state-Cmax for sofosbuvir, GS-331007 og velpatasvir var hhv. 566, 868 og 259 ng/ml.
English: The moderate or high fat meal did not alter GS-331007 AUC0-inf, but resulted in a 25% and 37% decrease in its Cmax, respectively.
Danish: Måltidet med moderat eller højt fedtindhold ændrede ikke AUC0-inf for GS-331007, men resulterede i hhv. en 25 % og 37 % stigning i Cmax.
English: • efavirenz used to treat HIV infection;
Danish: • efavirenz (anvendes til at behandle hiv-infektion)
English: Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1.)
Danish: Tillæg af ribavirin kan overvejes hos genotype 3-inficerede patienter med kompenseret cirrose (se pkt.
English: As liver function may change during treatment with Epclusa, a close monitoring of International Normalised Ratio (INR) values is recommended.
Danish: Patienter i behandling med vitamin K-antagonister Da leverfunktionen kan ændre sig under behandling med Epclusa, anbefales tæt monitorering af INR (international normaliseret ratio).
English: Sofosbuvir was not a carcinogen in the 2-year mouse and rat carcinogenicity studies at GS-331007 exposures up to 15 and 9 times, respectively, higher than human exposure.
Danish: Sofosbuvir var ikke et karcinogen i de 2-årige karcinogenicitetsstudier hos mus og rotter ved GS-331007-eksponeringer op til hhv. 15 og 9 gange højere end den humane eksponering.
English: GS-461203 (the active metabolite of sofosbuvir) is neither an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
Danish: GS-461203 (den aktive metabolit af sofosbuvir) hæmmer hverken humane DNA- og RNA-polymeraser eller mitokondriel RNA-polymerase.
English: It is unknown whether sofosbuvir, metabolites of sofosbuvir or velpatasvir are excreted in human milk.
Danish: Det er ukendt, om sofosbuvir, sofosbuvirs metabolitter eller velpatasvir udskilles i human mælk.
English: You may need closer monitoring of your blood glucose levels and/or adjustment of your diabetes medication after starting Epclusa.
Danish: Det kan være, at dit blodsukker skal overvåges tættere, og/eller at din diabetesmedicin skal justeres efter påbegyndelse af behandling med Epclusa.
English: In this study, 2 patients treated with Epclusa for 12 or 24 weeks without ribavirin had emergent NS5B S282T at low levels (< 5%) along with L159F.
Danish: I dette studie udviklede 2 patienter, der blev behandlet med Epclusa i 12 eller 24 uger uden ribavirin, NS5B S282T ved lave niveauer (< 5 %) sammen med L159F.
English: Velpatasvir is also a substrate of drug transporter OATP1B.
Danish: Velpatasvir er også substrat for lægemiddeltransportøren OATP1B.
English: Epclusa 12 weeks (624) Placebo 12 weeks (116)
Danish: Epclusa i 12 uger (624) Placebo i 12 uger (116)
English: Raltegravir (400 mg twice daily)g + emtricitabine/
Danish: Raltegravir (400 mg to gange dagligt)g + emtricitabin/
English: The safety profile of Epclusa has been evaluated in one open-label study in which patients with CPT Class B cirrhosis received Epclusa for 12 weeks (n = 90), Epclusa + RBV for 12 weeks (n = 87) or Epclusa for 24 weeks (n = 90).
Danish: Epclusas sikkerhedsprofil er blevet evalueret i ét åbent studie, i hvilket patienter med CPT-klasse B-cirrose fik Epclusa i 12 uger (n = 90), Epclusa + RBV i 12 uger (n = 87) eller Epclusa i 24 uger (n = 90).
English: Patients with genotype 5 HCV infection were enrolled to the Epclusa group.
Danish: Patienter med genotype 5HCV-infektion blev tilmeldt Epclusa-gruppen.
English: Epclusa tablets are supplied in high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 28 film-coated tablets with polyester coil.
Danish: Epclusatabletter leveres i en beholder af højdensitetspolyethylen (HDPE) med et børnesikret lukke af polypropylen, som indeholder 28 filmovertrukne tabletter med en polyesterspiral.
English: • If you notice within 18 hours of the time you usually take Epclusa, you must take the tablet as soon as possible.
Danish: • Hvis du opdager det inden for 18 timer efter det tidspunkt, du normalt tager Epclusa, skal du tage tabletten snarest muligt.
English: Of the 10 genotype 3 virologic failure patients, Y93H was observed in all 10 patients at failure (6 had Y93H emerge post-treatment and 4 patients had Y93H at baseline and post-treatment).
Danish: Blandt de 10 genotype 3-patienter med virologisk svigt blev der set Y93H hos alle 10 patienter på tidspunktet for svigt (6 udviklede Y93H efter behandling, og 4 patienter havde Y93H ved baseline og efter behandling).
English: Demographics and baseline characteristics were balanced across the two treatment groups.
Danish: De demografiske karakteristika og baseline-karakteristika var afbalancerede mellem de to behandlingsgrupper.
English: The efficacy of Epclusa has not been assessed in patients who have previously failed treatment with other regimens that include an NS5A inhibitor.
Danish: Virkningen af Epclusa er ikke blevet vurderet hos patienter, hvor tidligere behandling med andre regimer, der omfatter en NS5A-hæmmer, er mislykket.
English: Relative to fasting conditions, the administration of a single dose of Epclusa with a moderate fat (~600 kcal, 30% fat) or high fat (~800 kcal, 50% fat) meal resulted in a 34% and 21% increase in velpatasvir AUC0-inf, respectively, and a 31% and 5% increase in velpatasvir Cmax, respectively.
Danish: I forhold til fastende tilstand resulterede administration af en enkelt dosis Epclusa sammen med et måltid med moderat fedtindhold (~600 kcal, 30 % fedt) eller højt fedtindhold (~800 kcal, 50 % fedt) i en stigning på henholdsvis 34 % og 21 % i AUC0-inf for velpatasvir og henholdsvis 31 % og 5 % i Cmax for velpatasvir.
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.
Danish: RAV'er ved baseline havde ingen relevant indvirkning på SVR12-raten hos patienter, der var inficeret med HCV-genotype 1, 2, 4, 5 eller 6, som opsummeret i tabel 6.
English: The NS5B NI RAV S282T was not detected in the baseline NS5B sequence of any patient in Phase 3 studies.
Danish: NS5B-NI-RAV S282T blev ikke detekteret i baseline-NS5B-sekvensen hos nogen af patienterne i fase III-studier.
English: Relative to patients with normal hepatic function, the sofosbuvir AUC0-24 was 126% and 143% higher in moderate and severe hepatic impairment, while the GS-331007 AUC0-24 was 18% and 9% higher, respectively.
Danish: I forhold til patienter med normal leverfunktion var sofosbuvirs AUC0-24 126 % og 143 % højere ved moderat og svært nedsat leverfunktion, mens AUC0-24 af GS-331007 var hhv. 18 % og 9 % højere.
English: Epclusa is sometimes taken with another medicine, ribavirin.
Danish: Epclusa tages nogle gange sammen med et andet lægemiddel, der hedder ribavirin.
English: SVR12 was achieved in all 77 patients who had baseline NS5B NI RAVs including N142T, L159F, E/N237G, C/M289L/I, L320F/I/V, V321A/I, and S282G+V321I.
Danish: SVR12 blev opnået hos alle 77 patienter, der har NS5B-NI-RAV'er ved baseline, herunder N142T, L159F, E/N237G, C/M289L/I, L320F/I/V, V321A/I og S282G+V321I.
English: Patients who have previously failed therapy with an NS5A-containing regimen Epclusa + ribavirin for 24 weeks may be considered (see section 4.4).
Danish: Patienter, hvor tidligere behandling med et NS5A-indeholdende regime er mislykket Epclusa + ribavirin i 24 uger kan overvejes (se pkt.
English: Randomisation was stratified by HCV genotype (1, 2, 3, 4, 5, 6 and indeterminate).
Danish: Randomisering blev stratificeret efter HCV-genotype (1, 2, 3, 4, 5, 6 og ubestemt).
English: 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.
Danish: Indvirkning af DAA-behandling på lægemidler, der metaboliseres af leveren Farmakokinetikken for lægemidler, der metaboliseres af leveren (f.eks. immunosuppressiva såsom calcineurinhæmmere) kan blive påvirket af ændringer i leverfunktionen under DAA-behandling, relateret til clearance af HCV.
English: c n = 4 for genotype 2, n = 2 for genotype 4 and n = 1 for genotype 6.
Danish: c. n = 4 for genotype 2, n = 2 for genotype 4 og n = 1 for genotype 6.
English: Both patients had virus at baseline harboring NS5A RAVs.
Danish: Begge patienter havde virus ved baseline, der havde NS5A-RAV'er.
English: The ribavirin dose was weight-based (1,000 mg daily administered in two divided doses for patients < 75 kg and 1,200 mg for those ≥ 75 kg) and administered in two divided doses when used in combination with sofosbuvir in the ASTRAL-2 and ASTRAL-3 studies or in combination with Epclusa in the ASTRAL-4 study.
Danish: Ribavirin-dosis var vægtbaseret (1.000 mg dagligt til patienter < 75 kg og 1.200 mg til patienter ≥ 75 kg) og fordelt på 2 doser, når det blev anvendt i kombination med sofosbuvir i ASTRAL-2- og ASTRAL-3-studierne eller i kombination med Epclusa i ASTRAL-4-studiet.
English: The safety of tenofovir disoproxil fumarate in the setting of Epclusa and a pharmacokinetic enhancer has not been established.
Danish: Tenofovirdisoproxilfumarats sikkerhed ved anvendelse sammen med Epclusa og en farmakokinetisk forstærker er ikke klarlagt.
English: ANTICONVULSANTS Phenytoin
Danish: ANTIKONVULSIVA Phenytoin
English: Velpatasvir median peak concentrations were observed at 3 hours post-dose.
Danish: Velpatasvirs mediane maksimale koncentration blev observeret 3 timer efter dosering.
English: Unchanged velpatasvir was the major species in faeces accounting for a mean of 77% of the administered dose, followed by monohydroxylated velpatasvir (5.9%) and desmethylated velpatasvir (3.0%).
Danish: Uomdannet velpatasvir var den form, der primært var til stede i fæces, hvor den i gennemsnit udgjorde 77 % af den administrerede dosis, efterfulgt af monohydroxyleret velpatasvir (5,9 %) og desmethyleret velpatasvir (3,0 %).
English: Potential for other medicinal products to affect Epclusa Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP.
Danish: Potentialet for andre lægemidlers påvirkning af Epclusa Sofosbuvir og velpatasvir er substrater for lægemiddeltransportørerne P-gp og BCRP.
English: Film-coating Polyvinyl alcohol Titanium dioxide Polyethylene glycol Talc
Danish: Filmovertræk Polyvinylalkohol Titandioxid Polyethylenglycol Talcum
English: Clinical monitoring, looking for signs of bleeding and anaemia, is recommended when dabigatran etexilate is co-administered with Epclusa.
Danish: Klinisk overvågning for tegn på blødning og anæmi anbefales, når dabigatranetexilat administreres sammen med Epclusa.
English: • If it's 18 hours or more after the time you usually take Epclusa, wait and take the next dose at your usual time.
Danish: • Hvis det er 18 timer eller længere efter det tidspunkt, du normalt tager Epclusa, skal du vente og tage den næste dosis på det sædvanlige tidspunkt.
English: Ethinyl estradiol a Mean ratio (90% CI) of co-administered drug pharmacokinetics of study medicinal products alone or in combination.
Danish: a. Middelratio (90 % CI) af farmakokinetikken af samtidigt administreret forsøgsmedicin alene eller i kombination.
English: Tell your doctor or pharmacist if you are taking any of the medicines below:
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager nogle af følgende lægemidler:
English: If you are taking an antacid, take it at least 4 hours before or at least 4 hours after Epclusa.
Danish: Hvis du tager et syreneutraliserende middel, skal du tage det mindst 4 timer før eller mindst 4 timer efter Epclusa.
English: Table 5: Activity of sofosbuvir and velpatasvir against transient replicons containing NS5A or NS5B from clinical isolates
Danish: Tabel 5: Aktivitet af sofosbuvir og velpatasvir mod transiente replikoner, der indeholder NS5A eller NS5B fra kliniske isolater
English: Patients receiving tenofovir disoproxil fumarate and Epclusa concomitantly should be monitored for adverse reactions associated with tenofovir disoproxil fumarate.
Danish: Patienter, der får tenofovirdisoproxilfumarat og Epclusa samtidig, skal overvåges for bivirkninger forbundet med tenofovirdisoproxilfumarat.
English: 63.9% to 95.5% 6.8% to 93.2% 69.6% to 98.8%
Danish: 63,9 % til 95,5 % 6,8 % til 93,2 % 69,6 % til 98,8 %
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.
Danish: Der er set tilfælde af svær bradykardi og hjerteblok ved anvendelse af regimer, der indeholder sofosbuvir, i kombination med amiodaron med eller uden andre lægemidler, der nedsætter hjertefrekvensen.
English: 94.3% to 98.9% 85.3% to 97.8% 95.9% to 99.9%
Danish: 94,3 % til 98,9 % 85,3 % til 97,8 % 95,9 % til 99,9 %
English: Starting dose of 600 mg, which can be titrated up to a maximum of 1,000/1,200 mg (1,000 mg for patients weighing < 75 kg and 1,200 mg for patients weighing ≥ 75 kg) if well tolerated.
Danish: Startdosis på 600 mg, som kan titreres op til maksimalt 1.000/1.200 mg (1.000 mg til patienter, der vejer < 75 kg, og 1.200 mg til patienter, der vejer ≥ 75 kg), hvis dosis er veltolereret.
English: TN and TE, with CPT Class B decompensated cirrhosis
Danish: TN og TE med dekompenseret CPTklasse B-cirrose
English: Total (n = 328)
Danish: I alt (n = 328)
English: Patient populationa
Danish: Patientpopulationa
English: • tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
Danish: • tenofovirdisoproxilfumarat eller et hvilket som helst lægemiddel, der indeholder tenofovirdisoproxilfumarat (anvendes til at behandle hiv-infektion)
English: The pharmacokinetic properties of sofosbuvir, GS-331007 and velpatasvir have been evaluated in healthy adult subjects and in patients with chronic hepatitis C. Following oral administration of Epclusa, sofosbuvir was absorbed quickly and the peak median plasma concentration was observed 1 hour post-dose.
Danish: De farmakokinetiske egenskaber for sofosbuvir, GS-331007 og velpatasvir er blevet evalueret hos raske voksne personer og hos patienter med kronisk hepatitis C. Efter oral administration af Epclusa blev sofosbuvir absorberet hurtigt, og median maksimal plasmakoncentration blev observeret 1 time efter dosering.
English: CPT Class C cirrhosis
Danish: CPT-klasse C-cirrose
English: Haemodialysis can efficiently remove the predominant circulating metabolite of sofosbuvir, GS-331007, with an extraction ratio of 53%.
Danish: Hæmodialyse er effektivt til at fjerne den dominerende cirkulerende metabolit af sofosbuvir, GS-331007, med en ekstraktionsratio på 53 %.