FrancophonIA/ELRC3.0 huggingface dataset:
English: A summary of the effect of varying degrees of renal impairment (RI) on the exposures of sofosbuvir and GS-331007 compared to subjects with normal renal function, as described in the text below, are provided in Table 24.
Danish: Et resumé af virkningen af forskellige grader af nedsat nyrefunktion (RI) på eksponeringen for indholdsstofferne i sofosbuvir og GS-331007 sammenlignet med forsøgspersoner med normal nyrefunktion, som beskrevet nedenfor, vises i tabel 24.
English: 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: Farmakokinetikken hos lægemidler, der metaboliseres i leveren (f.eks. immunsuppressive midler såsom calcineurinhæmmere), kan påvirkes af ændringer i leverfunktionen under DAA-behandling, relateret til clearance af hepatitis C-virus.
English: Treatment duration was 12 weeks in treatment-naïve patients with genotype 2 or 3 HCV infection, and 24 weeks in treatment-experienced patients with genotype 3 HCV infection, as well as patients with genotype 1 HCV infection.
Danish: Behandlingsvarigheden var 12 uger hos behandlingsnaive patienter med HCV-genotype 2 eller 3-infektion, og 24 uger hos behandlingserfarne patienter med HCV-genotype 3-infektion, samt hos patienter med genotype 1 HCV-infektion.
English: An interim analysis was conducted on 61 patients who received sofosbuvir and ribavirin; the majority of patients had HCV genotype 1, 44 patients were CPT class A and 17 patients were CPT class B. Of these 61 patients, 44 patients underwent liver transplantation following up to 48 weeks of treatment with sofosbuvir and ribavirin; 41 had HCV RNA <LLOQ at the time of transplantation.
Danish: Hovedparten af patienterne havde HCV-genotype 1, 44 patienter havde CPT klasse A og 17 patienter havde CPT klasse B. Ud af disse 61 patienter gennemgik 44 patienter levertransplantation efter op til 48 ugers behandling med sofosbuvir og ribavirin, 41 havde HCV-rna < LLOQ på tidspunktet for transplantationen.
English: When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, refer also to the Summary of Product Characteristics for ribavirin for patients with creatinine clearance (CrCl) <50 mL/min (see also section 5.2).
Danish: Når Sovaldi anvendes i kombination med ribavirin eller peginterferon alfa/ribavirin, henvises der også til produktresuméet for ribavirin for patienter med kreatininclearance (CrCl) < 50 ml/min (se også pkt.
English: Patients should be informed that fatigue and disturbance in attention, dizziness and blurred vision have been reported during treatment with sofosbuvir in combination with peginterferon alfa and ribavirin (see section 4.8).
Danish: Patienterne bør informeres om, at der er blevet rapporteret om træthed og koncentrationsbesvær, svimmelhed og sløret syn under behandling med sofosbuvir i kombination med peginterferon alfa og ribavirin (se pkt.
English: Sovaldi should always be taken in combination with other medicinal products for use against hepatitis C.
Danish: Sovaldi bør altid tages i kombination med andre lægemidler, der anvendes mod hepatitis C.
English: The safety and efficacy of Sovaldi in adolescents aged 12 to <18 years are based on data from 50 patients who were treated with Sovaldi and ribavirin for 12 weeks (genotype 2 patients) and 24 weeks (genotype 3 patients) in a Phase 2, open-label clinical trial.
Danish: Sovaldis sikkerhed og virkning hos børn og unge i alderen 12 til <18 år er baseret på data fra 50 patienter, som blev behandlet med Sovaldi og ribavirin i 12 uger (genotype 2-patienter) og 24 uger (genotype 3-patienter) i et fase II, ublindet klinisk studie.
English: c. Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
Danish: c. Andet omfatter patienter, der ikke opnåede SVR12 og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up).
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 ikke substrater for eller hæmmere af UGT1A1 eller CYP3A4, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 og CYP2D6.
English: The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV infected patients with moderate and severe hepatic impairment (CPT class B and C).
Danish: Sofosbuvirs farmakokinetik blev undersøgt efter 7 dages dosering med 400 mg sofosbuvir hos HCVinficerede patienter med moderat og svært nedsat leverfunktion (CPT klasse B og C).
English: Patients should be instructed that if vomiting occurs within 2 hours of dosing an additional tablet should be taken.
Danish: Patienterne skal instrueres i at tage en ekstra tablet, hvis de kaster op inden for 2 timer efter dosering.
English: Emtricitabinef (200 mg once daily)d
Danish: Emtricitabinf (200 mg én gang dagligt)d
English: After a single 400 mg oral dose of [14C]-sofosbuvir, sofosbuvir and GS-331007 accounted for approximately 4% and >90% of drug-related material (sum of molecular weight-adjusted AUC of sofosbuvir and its metabolites) systemic exposure, respectively.
Danish: Efter en enkelt 400 mg oral dosis af [14C]-sofosbuvir udgjorde sofosbuvir og GS-331007 ca. hhv. 4 % og > 90 % af det lægemiddelrelaterede materiale (summen af molekylvægt-justeret AUC for sofosbuvir og metabolitterne herfra) systemisk eksponering.
English: Table 17: Response rates in study PHOTON-1
Danish: Tabel 17: Responsrater i PHOTON-1-studiet
English: Sovaldi + ribavirina for 12 weeks b
Danish: Sovaldi + ribavirina i 12 uger b
English: Concerning co-administration with other direct-acting antivirals against HCV, see section 4.4.
Danish: Angående samtidig administration af andre direkte virkende antivirale midler mod HCV, se pkt.
English: The pharmacokinetics of sofosbuvir and GS-331007 have not been established in paediatric patients < 12 years of age.
Danish: Farmakokinetikken af sofosbuvir og GS-331007 hos pædiatriske patienter <12 år er ikke klarlagt.
English: Intracellular hydrolytic prodrug cleavage catalysed by enzymes including carboxylesterase 1 and sequential phosphorylation steps catalysed by nucleotide kinases result in formation of the pharmacologically active uridine nucleoside analogue triphosphate.
Danish: Intracellulær hydrolytisk prodrugkløvning katalyseret af enzymer, herunder carboxylesterase 1 og sekventiel fosforyleringstrinkatalyseret af nukleotidkinaser fører til dannelsen af det farmakologisk aktive uridinnukleosidanalog-triphosphat.
English: Table 4: Recommended dosing for ribavirin in combination therapy with Sovaldi in adolescents aged 12 to < 18 years
Danish: Tabel 4: Anbefalet dosering af ribavirin i kombinationsbehandling med Sovaldi hos unge i alderen 12 til <18 år
English: Common anaemia
Danish: Almindelig anæmi
English: IMMUNOSUPPRESSANTS Ciclosporine (600 mg single dose)
Danish: IMMUNOSUPPRIMERENDE MIDLER Ciclosporine (600 mg enkeltdosis)
English: b. Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
Danish: b. Andet omfatter patienter, der ikke opnåede SVR12 og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up).
English: While subject to active tubular secretion, GS-331007 is not a substrate for renal transporters including organic anion transporter (OAT) 1 or 3, OCT2, MRP2, P-gp, BCRP or MATE1.
Danish: Selvom det gennemgår aktiv tubulær sekretion er GS-331007 ikke et substrat for renale transportere, herunder organisk aniontransporter (OAT) 1 eller 3, OCT 2, MRP2, P-gp, BCRP og MATE1.
English: When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and for a period of time after the treatment as recommended in the Summary of Product Characteristics for ribavirin.
Danish: Når Sovaldi anvendes i kombination med ribavirin eller peginterferon alfa/ribavirin, skal kvinder i den fertile alder eller deres mandlige partnere anvende en sikker kontraceptionsmetode i løbet af behandlingen og i en tidsperiode efter behandlingen, som anbefalet i produktresuméet for ribavirin.
English: Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Danish: Sofosbuvir er et nukleotid prodrug, der gennemgår intracellulær metabolisme og danner farmakologisk aktivt uridin-analog triphosphat (GS-461203), som kan indbygges i HCV-rna af NS5B-polymerasen og virke som en kædeterminator.
English: The mean ± SD EC50 of sofosbuvir against chimeric replicons encoding NS5B sequences from clinical isolates was 0.068 ± 0.024 μM for genotype 1a (n = 67), 0.11 ± 0.029 μM for genotype 1b (n = 29), 0.035 ± 0.018 μM for genotype 2 (n = 15) and 0.085 ± 0.034 μM for genotype 3a (n = 106).
Danish: Den gennemsnitlige ± SD EC50 af sofosbuvir mod kimære replikoner, der koder NS5B-sekvenser fra kliniske isolater var 0,068 ± 0,024 μM for genotype 1a (n = 67), 0,11 ± 0,029 μM for genotype 1b (n = 29), 0,035 ± 0,018 μM for genotype 2 (n = 15) og 0,085 ± 0,034 μM for genotype 3a (n = 106).
English: However, it is not recommended that ribavirin be increased to the original assigned dose (1,000 mg to 1,200 mg daily).
Danish: Det anbefales dog ikke, at ribavirin øges til den oprindeligt tildelte dosis (1.000 mg til 1.200 mg dagligt) til unge i alderen 12 til <18 år.
English: In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with a 50% inhibitory concentration (IC50) value ranging from 0.7 to 2.6 μM.
Danish: I en biokemisk analyse hæmmede GS-461203 polymeraseaktiviteten af rekombinant NS5B fra HCV-genotype 1b, 2a, 3a og 4a, med en 50 % inhibitorisk koncentration (IC50)-værdi fra 0,7 til 2,6 μM.
English: Efficacy, in terms of rapid virologic response, has been shown to correlate with exposure to sofosbuvir as well as GS 331007.
Danish: Virkning, udtrykt som et hurtigt virologisk respons, har vist sig at korrelere med eksponering for sofosbuvir såvel som for GS-331007.
English: Population pharmacokinetic analysis in HCV infected patients showed that within the age range (19 to 75 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter viste, at inden for det analyserede aldersinterval (19 til 75 år), havde alder ingen klinisk relevant virkning på eksponeringen for sofosbuvir og GS-331007.
English: SVR12 was achieved in 100 % (18/18) of patients treated with ledipasvir/sofosbuvir.
Danish: 100 % (18/18) af patienter, som blev behandlet med ledipasvir/sofosbuvir, opnåede SVR12.
English: Consult the Summary of Product Characteristics for co-prescribed medicinal products before starting therapy with Sovaldi.
Danish: Se produktresuméet for samtidigt ordinerede lægemidler, før behandlingen med Sovaldi startes.
English: Patients were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence) and HCV genotype (2 versus 3).
Danish: Patienterne blev randomiseret i forholdet 1:1, og stratificeret efter cirrose (til stede versus ikke til stede) og HCV-genotype (2 versus 3).
English: Tenofovir disoproxilf (245 mg once daily)d
Danish: Tenofovirdisoproxilf (245 mg én gang dagligt)d
English: Sofosbuvir was studied in HCV infected patients prior to undergoing liver transplantation in an open-label clinical study evaluating the safety and efficacy of sofosbuvir and ribavirin administered pre-transplant to prevent post-transplant HCV reinfection.
Danish: Sofosbuvir blev undersøgt hos HCV-inficerede patienter før de gennemgik levertransplantation i et open-label klinisk studie, der evaluerede sikkerheden og virkningen af sofosbuvir og ribavirin, der blev administreret før transplantationen for at undgå HCV-reinfektion efter transplantationen.
English: b. pTVR: post-transplant virologic response (HCV RNA <LLOQ at 12 weeks post-procedure).
Danish: b. pTVR: virologisk respons efter transplantation (HCV-rna < LLOQ 12 uger efter proceduren).
English: a. For previously treated patients with genotype 1 HCV infection, no data exists with the combination of sofosbuvir, peginterferon alfa and ribavirin.
Danish: a. For tidligere behandlede patienter med HCV-infektion af genotype 1, eksisterer der ingen data med kombinationen af sofosbuvir, peginterferon alfa og ribavirin.
English: The S282T substitution in NS5B was detected in a single subject receiving Sovaldi monotherapy in a Phase 2 study.
Danish: S282T-substitutionen i NS5B blev detekteret hos en enkelt patient, der fik monoterapi med Sovaldi i et fase II-studie.
English: The primary endpoint of the study was post-transplant virologic response (pTVR, HCV RNA <LLOQ at 12 weeks post-transplant).
Danish: Det primære endepunkt i studiet var virologisk respons efter transplantationen (pTVR, HCV-rna < LLOQ 12 uger efter transplantationen).
English: and <80 mL/min/1.73 m2)
Danish: < 80 ml/min/ 1,73 m2)
English: Table 2: Ribavirin dose modification guideline for co-administration with Sovaldi in adults
Danish: Tabel 2: Retningslinjer for dosismodifikation af ribavirin ved samtidig administration af Sovaldi hos voksne
English: Treatment of patients with genotype 5 or 6 HCV infection
Danish: Behandling af patienter med HCV-genotype 5 eller 6-infektion
English: Patients received 400 mg sofosbuvir and weight-based ribavirin (1,000 mg for patients weighing <75 kg or 1,200 mg for patients weighing ≥75 kg).
Danish: Patienterne fik 400 mg sofosbuvir og vægtbaseret ribavirin (1.000 mg til patienter, der vejede < 75 kg eller 1.200 mg for patienter, der vejede ≥ 75 kg).
English: A starting ribavirin dose of 400 mg administered orally in two divided doses with food is recommended.
Danish: En startdosis på 400 mg ribavirin oralt fordelt på 2 doser sammen med mad anbefales.
English: Sovaldi is contraindicated with phenobarbital and phenytoin (see section 4.3).
Danish: Sovaldi er kontraindiceret sammen med phenobarbital og phenytoin (se pkt.
English: Population pharmacokinetics analysis in HCV infected patients indicated that cirrhosis had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede patienter indikerer, at cirrose ikke havde nogen klinisk relevant virkning på eksponeringen for sofosbuvir og GS-331007.
English: The efficacy of sofosbuvir in HCV-infected patients aged 12 to <18 years was evaluated in a Phase 2, open label clinical trial that enrolled 50 patients with genotype 2 (n = 13) or genotype 3 (n = 37) chronic HCV infection.
Danish: Sofosbuvirs virkning hos HCV-inficerede patienter i alderen 12 til <18 år blev evalueret i et fase II, ublindet klinisk studie, der inkluderede 50 patienter med genotype 2 (n = 13) eller genotype 3 (n = 37) kronisk HCV-infektion.
English: Sofosbuvir in a fixed dose combination with ledipasvir was administered for 12 weeks to 18 patients with genotype 1 CHC and severe renal impairment in an open-label study (Study 0154).
Danish: Sofosbuvir blev administreret i 12 uger i en fast dosiskombination med ledipasvir hos 18 patienter med genotype 1 CHC og svært nedsat nyrefunktion i et åbent studie (Studie 0154).
English: ANTIMYCOBACTERIALS Rifampicinf (600 mg single dose)
Danish: ANTIMYKOBAKTERIELLE MIDLER Rifampicinf (600 mg enkeltdosis)
English: In this setting, exposure of sofosbuvir metabolite GS-331007 is 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: Sovaldi in combination with ribavirin is recommended for 24 weeks in liver transplant recipients.
Danish: Patienter, der har gemmengået en levertransplantation Sovaldi i kombination med ribavirin anbefales i 24 uger hos patienter, der har gennemgået en levertransplantation.
English: In HCV replicon assays, the effective concentration (EC50) values of sofosbuvir against full-length replicons from genotype 1a, 1b, 2a, 3a and 4a were 0.04, 0.11, 0.05, 0.05 and 0.04 μM, respectively, and EC50 values of sofosbuvir against chimeric 1b replicons encoding NS5B from genotype 2b, 5a or 6a were 0.014 to 0.015 μM.
Danish: I HCV replikon-analyser var effektive koncentrationsværdier (EC50) af sofosbuvir i forhold til replikoner i fuld længe fra genotype 1a, 1b, 2a, 3a og 4a var hhv. 0,04, 0,11, 0,05, 0,05 og 0,04 µM, og EC50-værdier af sofosbuvir mod kimære 1b-replikoner, der koder NS5B fra genotype 2b, 5a eller 6a var fra 0,014 til 0,015 μM.
English: Treatment-experienced (VALENCE)
Danish: Behandlingserfarne (VALENCE)
English: • Peginterferon alfa and ribavirin
Danish: • Ribavirin eller • Peginterferon alfa og ribavirin
English: The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 6).
Danish: De følgende bivirkninger er identificeret med sofosbuvir i kombination med ribavirin eller i kombination med peginterferon alfa og ribavirin (tabel 6).
English: Nervous system disorders: Very common headache dizziness, headache
Danish: Nervesystemet: Meget almindelig hovedpine svimmelhed, hovedpine
English: Eye disorders: Common vision blurred
Danish: Øjne: Almindelig sløret syn
English: Treatment-naïve and previously treated adults - VALENCE (study 133) VALENCE was a Phase 3 study that evaluated sofosbuvir in combination with weight-based ribavirin for the treatment of genotype 2 or 3 HCV infection in treatment-naïve patients or patients who did not achieve SVR with prior interferon-based treatment, including patients with compensated cirrhosis.
Danish: Behandlingsnaive og tidligere behandlede voksne - VALENCE (studie 133) VALENCE var et fase III-studie, der evaluerede sofosbuvir i kombination med vægtbaseret ribavirin til behandlingen af HCV-genotype 2 eller 3-infektion hos behandlingsnaive patienter eller patienter, der ikke opnåede SVR med tidligere interferon-baseret behandling, herunder patienter med kompenseret cirrose.
English: Treatment-naïve (VALENCE)
Danish: Behandlingsnaive (VALENCE)
English: The following pack sizes are available: outer cartons containing 1 bottle of 28 film-coated tablets and 84 (3 bottles of 28) film-coated tablets.
Danish: De følgende pakningsstørrelser er tilgængelige: ydre kartoner indeholdende 1 tabletbeholder med 28 filmovertrukne tabletter, og 84 (3 tabletbeholdere med 28) filmovertrukne tabletter.
English: Table 15: Response rates in study VALENCE
Danish: Tabel 15: Responsrater i VALENCE-studiet
English: If patients maintained haemoglobin levels ≥12 g/dL, ribavirin dose was increased at weeks 2, 4, and up to every 4 weeks until the appropriate weight-based dose was reached (1,000 mg daily in patients <75 kg, 1,200 mg daily in patients ≥75 kg).
Danish: Hvis patienterne opretholdt hæmoglobinniveau ≥ 12 g/dl, blev ribavirindosis øget ved uge 2, 4 og op til hver 4. uge, indtil den passende vægtbaserede dosis (1.000 mg dagligt hos patienter < 75 kg, 1.200 mg dagligt hos patienter ≥ 75 kg) blev nået.
English: Sovaldi 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: Sovaldi kan anvendes hos disse patienter uden dosisjustering, når ingen andre relevante behandlingsmuligheder er tilgængelige (se pkt.
English: Interferon intolerant, ineligible or unwilling adults - POSITRON (study 107) POSITRON was a randomised, double-blinded, placebo-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin (n = 207) compared to placebo (n = 71) in patients who are interferon intolerant, ineligible or unwilling.
Danish: Voksne, som var interferon-intolerante, -uegnede eller -uvillige - POSITRON (studie 107) POSITRON var et randomiseret, dobbeltblindet, placebokontrolleret studie, der evaluerede 12 ugers behandling med sofosbuvir og ribavirin (n = 207), sammenlignet med placebo (n = 71) hos patienter, som var interferon-intolerante, -uegnede eller -uvillige.
English: Monotherapy of Sovaldi is not recommended.
Danish: Monoterapi med Sovaldi frarådes.
English: The starting dose of ribavirin was 400 mg given in a divided daily dose.
Danish: Startdosis af ribavirin var 400 mg daglig fordelt på flere doser.
English: Adults The recommended dose is one 400 mg tablet, taken orally, once daily with food (see section 5.2).
Danish: Den anbefalede dosis er en 400 mg tablet, der tages oralt, én gang dagligt sammen med mad (se pkt.
English: Table 12 presents the subgroup analysis by genotype for cirrhosis and interferon classification.
Danish: Tabel 12 viser analyse af undergrupperne efter genotype for cirrose og interferon klassifikation.
English: • chest pain, feeling weak
Danish: • brystsmerter, svaghedsfølelse
English: HIV/HCV co-infection
Danish: Samtidig infektion med hiv/HCV
English: NA = not available/not applicable a. Mean ratio (90% CI) of co-administered drug pharmacokinetics with/without sofosbuvir and mean ratio of sofosbuvir and GS-331007 with/without co-administered drug.
Danish: NA = ikke tilgængelig/ikke relevant a. Det gennemsnitlige forhold (90 % CI) af farmakokinetikken for det samtidigt administrerede lægemiddel, i tilfælde af administration med/uden sofosbuvir, og det gennemsnitlige forhold af farmakokinetikken for sofosbuvir og GS-331007 med/uden samtidigt administreret lægemiddel.
English: Skin and subcutaneous tissue disorders: Very common rash, pruritus
Danish: Hud og subkutane væv: Meget almindelig udslæt, pruritus
English: If the starting dose of ribavirin is well-tolerated, the dose can be titrated up to a maximum of 1,000-1,200 mg daily (1,000 mg for patients weighing <75 kg and 1,200 mg for patients weighing ≥75 kg).
Danish: Hvis startdosis af ribavirin er veltolereret, kan dosis titreres op til maksimalt 1.000-1.200 mg dagligt (1.000 mg til patienter, der vejer < 75 kg, og 1.200 mg til patienter, der vejer ≥ 75 kg).
English: Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to <18 years (see sections 4.2, 4.4 and 5.1).
Danish: Sovaldi er indiceret i kombination med andre lægemidler til behandling af kronisk hepatitis C (CHC) hos voksne og unge i alderen 12 til < 18 år (se pkt.
English: No drug-drug interaction data exists regarding the co-administration of Sovaldi with boceprevir or telaprevir.
Danish: Der foreligger ingen lægemiddelinteraktionsdata vedrørende samtidig administration af Sovaldi og boceprevir eller telaprevir.
English: HIV ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS Efavirenzf (600 mg once daily)d
Danish: HIV-ANTIVIRALE STOFFER: REVERS TRANSKRIPTASEHÆMMERE Efavirenzf (600 mg én gang dagligt)d
English: Table 1: Recommended co-administered medicinal product(s) and treatment duration for adults treated with Sovaldi combination therapy
Danish: Tabel 1: Anbefalet samtidigt administreret lægemiddel/anbefalede samtidigt administrerede lægemidler og behandlingsvarighed for voksne behandlet med Sovaldi kombinationsbehandling
English: Sustained virologic response (SVR) was the primary endpoint to determine the HCV cure rate for all studies which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12).
Danish: Vedvarende virologisk respons (sustained virologic response, SVR) var det primære endepunkt til bestemmelse af helbredelsesraten for HCV, og det vedvarende virologiske respons blev defineret som HCV-rna under LLOQ 12 uger efter behandlingens afslutning (SVR12).
English: Such co-administration is not recommended (see also section 4.5).
Danish: Sådan en samtidig administration anbefales ikke (se også pkt.
English: Dose modification in adults Dose reduction of Sovaldi is not recommended.
Danish: Dosismodifikation hos voksne Dosisreduktion af Sovaldi bør ikke anvendes.