FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetic properties of sofosbuvir and the predominant circulating metabolite GS-331007 have been evaluated in healthy adult subjects and in subjects with chronic hepatitis C. Following oral administration, sofosbuvir was absorbed quickly and the peak plasma concentration was observed ~0.5-2 hour post-dose, regardless of dose level.
Danish: De farmakokinetiske egenskaber for sofosbuvir og den primære cirkulerende metabolit, GS-331007, er blevet evalueret hos raske voksne personer, og hos patienter med kronisk hepatitis C. Efter oral administration blev sofosbuvir absorberet hurtigt, og den maksimale plasmakoncentration blev observeret ~0,5-2 timer efter dosering, uanset dosisniveau.
English: Effect of baseline HCV polymorphisms on treatment outcome Baseline NS5B sequences were obtained for 1,292 subjects from Phase 3 studies by population sequencing and the S282T substitution was not detected in any subject with available baseline sequence.
Danish: Virkning af baseline HCV-polymorfismer på behandlingsresultatet Der blev indhentet baseline NS5B-sekvenser for 1.292 personer fra fase III-studier ved populationssekventering, og S282T-substitutionen blev ikke detekteret hos nogen personer med en tilgængelig baselinesekvens.
English: In a pooled analysis of 991 subjects who received sofosbuvir in Phase 3 studies, 226 subjects qualified for resistance analysis due to virologic failure or early study drug discontinuation and having HCV RNA >1,000 IU/mL.
Danish: I en samlet analyse med 991 patienter, som fik sofosbuvir i fase III-studier, kvalificerede 226 patienter sig til resistensanalyse på grund af virologisk svigt eller tidlig seponering af studielægemidlet, samt at de havde HCV-rna > 1.000 IE/ml.
English: Subjects were either not on antiretroviral therapy with a CD4+ cell count >500 cells/mm3 or had virologically suppressed HIV-1
Danish: Patienterne fik enten ikke antiretroviral behandling med et CD4+ celletal på > 500 celler/mm3, eller de havde virologisk supprimeret hiv-1 med et CD4+ celletal > 200 celler/mm3.
English: Response rates for subjects with cirrhosis at baseline are presented in Table 8 by HCV genotype.
Danish: Responsraterne for patienter med cirrose ved baseline er vist i tabel 8 efter HCV-genotype.
English: As liver function may change during treatment with Sovaldi, 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 Sovaldi, anbefales tæt monitorering af INR (international normaliseret ratio).
English: Forty subjects (33 with HCV genotype 1 infection, 6 with HCV genotype 3 infection, and 1 with HCV genotype 4 infection) were enrolled, 35 of whom had previously failed interferon-based treatment, and 16 of whom had cirrhosis.
Danish: 40 personer (33 med HCV-genotype 1-infektion, 6 med HCV-genotype 3-infektion og 1 med HCVgenotype 4-infektion) indgik, hvoraf 35 havde tidligere svigt af interferonbaseret behandling, og 16 havde cirrose.
English: Table 2: Ribavirin dose modification guideline for co-administration with Sovaldi Laboratory values
Danish: Tabel 2: Retningslinjer for dosismodifikation af ribavirin ved samtidig administration af Sovaldi Laboratorieværdier
English: Women of childbearing potential / contraception in males and females When Sovaldi is used in combination with ribavirin or peginterferon alfa/ribavirin, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Danish: Kvinder i den fertile alder/kontraception hos mænd og kvinder Når Sovaldi anvendes i kombination med ribavirin eller peginterferon alfa/ribavirin, skal der udvises ekstrem forsigtighed, så graviditet undgås hos kvindelige patienter og hos mandlige patienters kvindelige partnere.
English: Only for use in patients ineligible or intolerant to peginterferon alfa (see section 4.4)
Danish: Bør kun anvendes til patienter, der er uegnede eller intolerante over for peginterferon alfa (se pkt.
English: Sovaldi is always taken with other medicines.
Danish: Sovaldi tages altid sammen med andre lægemidler.
English: The sofosbuvir-associated resistance substitution S282T was not detected in any of these subjects by deep sequencing or population sequencing.
Danish: Substitutionen S282T, som er forbundet med resistens over for sofosbuvir, blev ikke detekteret hos nogen af disse patienter ved dyb sekventering eller populationssekventering.
English: Subjects with genotype 2 or 3 HCV were enrolled in an approximately 1:3 ratio.
Danish: Patienter med HCV af genotype 2 eller 3 blev inkluderet i et forhold på ca. 1:3.
English: Treatment of patients with genotype 5 or 6 HCV infection The clinical data to support the use of Sovaldi in patients with genotype 5 and 6 HCV infection is very limited (see section 5.1).
Danish: Behandling af patienter med HCV-genotype 5 eller 6-infektion De kliniske data til at støtte anvendelsen af Sovaldi hos patienter med HCV-genotype 5 og 6-infektion er meget begrænset (se pkt.
English: Two NS5B substitutions, L159F and V321A, were detected in post-treatment relapse samples from multiple genotype 3 HCV infected subjects in the Phase 3 clinical studies.
Danish: To NS5B-substitutioner, L159F og V321A, blev detekteret i recidivprøver efter behandlingen fra flere patienter med HCV-genotype 3-infektion i de kliniske fase III-studier.
English: post-transplant (pTVR)b
Danish: Uge 12 efter transplantation (pTVR)b
English: Genotype 1bc No cirrhosisc Cirrhosisc n = number of subjects with SVR12 response; N = total number of subjects per group.
Danish: Samletc Genotype 1ac Genotype 1bc Uden cirrosec Cirrosec n = antal patienter med SVR12-respons; N = totalt antal patienter pr. gruppe.
English: Relative to healthy subjects (n = 284), the sofosbuvir and GS-331007 AUC0-24 was 57% higher and 39% lower, respectively in HCV infected subjects.
Danish: I forhold til raske personer (n = 284) var sofosbuvir og GS-331007 AUC0-24 hhv. 57 % højere og 39 % lavere hos HCV-inficerede patienter.
English: Subjects were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence), HCV genotype (2 versus 3) and baseline HCV RNA level (<6 log10 IU/mL versus ≥6 log10 IU/mL).
Danish: Patienterne blev randomiseret i forholdet 1:1 og stratificeret efter cirrose (til stede versus ikke til stede), HCV-genotype (2 versus 3) og baseline HCV-rna-niveau (< 6 log10 IE/ml versus ≥ 6 log10 IE/ml).
English: The pharmacokinetics of sofosbuvir were studied following 7-day dosing of 400 mg sofosbuvir in HCV infected subjects 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 personer med moderat og svært nedsat leverfunktion (CPT klasse B og C).
English: The safety of Sovaldi has not been assessed in patients with severe renal impairment or ESRD (see section 4.4).
Danish: Sikkerheden af Sovaldi er ikke blevet vurderet hos patienter med svært nedsat nyrefunktion eller ESRD (se pkt.
English: Based on population pharmacokinetic analysis in subjects with genotypes 1 to 6 HCV infection (n = 986), steady-state AUC0-24 for sofosbuvir and GS-331007 was 1,010 ng•h/mL and 7,200 ng•h/mL, respectively.
Danish: Baseret på populationsfarmakokinetisk analyse hos patienter med HCV-infektion af genotype 1 til 6 (n = 986) var steady-state AUC0-24 for sofosbuvir og GS-331007 hhv. 1.010 ng•t/ml og 7.200 ng•t/ml.
English: Relative to subjects with normal renal function (eGFR >80 mL/min/1.73 m2), the sofosbuvir AUC0-inf was 61%, 107% and 171% higher in mild, moderate and severe renal impairment, while the GS-331007 AUC0-inf was 55%, 88% and 451% higher, respectively.
Danish: I forhold til personer med normal nyrefunktion (eGFR > 80 ml/min/1,73 m2) var sofosbuvir AUC0-inf 61 %, 107 % og 171 % højere ved let, moderat og svært nedsat nyrefunktion, mens GS-331007 AUC0-inf var hhv. 55 %, 88 % og 451 % højere.
English: During treatment with sofosbuvir in combination with ribavirin or with peginterferon alfa and ribavirin, the most frequently reported adverse drug reactions were consistent with the expected safety profile of ribavirin and peginterferon alfa treatment, without increasing the frequency or severity of the expected adverse drug reactions.
Danish: Under behandlingen med sofosbuvir i kombination med ribavirin eller sammen med peginterferon alfa og ribavirin, var de hyppigst rapporterede bivirkninger i overensstemmelse med den forventede sikkerhedsprofil for behandling med ribavirin og peginterferon alfa, uden at øge hyppigheden og sværhedsgraden af de forventede bivirkninger.
English: Table 17: Virologic response post-transplant in subjects with HCV RNA <LLOQ at the time of liver transplantation
Danish: Tabel 17: Virologisk respons efter transplantation hos patienter med HCV-rna < LLOQ på tidspunktet for levertransplantationen
English: No dose adjustment of Sovaldi is required for patients with mild or moderate renal impairment.
Danish: Ingen dosisjustering af Sovaldi er påkrævet for patienter med let eller moderat nedsat nyrefunktion.
English: The most common adverse drug reactions occurring in subjects receiving sofosbuvir and ribavirin or sofosbuvir, ribavirin and peginterferon alfa were fatigue, headache, nausea and insomnia.
Danish: De mest almindelige bivirkninger, der forekom hos personer, som fik sofosbuvir og ribavirin, eller sofosbuvir, ribavirin og peginterferon alfa var træthed, hovedpine, kvalme og søvnløshed.
English: Genotype 1a 92% (206/225) Genotype 1b 83% (55/66) No cirrhosis
Danish: Genotype 1a 92 % (206/225) Genotype 1b 83 % (55/66) Uden cirrose 93 % (253/273) Cirrose
English: Hepatobiliary disorders: Very common blood bilirubin increased blood bilirubin increased
Danish: Meget almindelig forhøjet bilirubin i blodet forhøjet bilirubin i blodet
English: Close monitoring is recommended if this medicinal product is administered with Sovaldi and another DAA (see sections 4.4 and 4.8).
Danish: Tæt overvågning anbefales, hvis dette lægemiddel administreres med Sovaldi og et andet DAA (se pkt.
English: The pharmacokinetics of sofosbuvir were studied in HCV negative subjects with mild (eGFR ≥50 and <80 mL/min/1.73 m2), moderate (eGFR ≥30 and <50 mL/min/1.73 m2), severe renal impairment (eGFR <30 mL/min/1.73 m2) and subjects with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
Danish: Sofosbuvirs farmakokinetik blev undersøgt hos HCV-negative personer med let (eGFR ≥ 50 og < 80 ml/min/1,73m2), moderat (eGFR ≥ 30 og < 50 ml/min/1,73m2), svært nedsat nyrefunktion (eGFR < 30 ml/min/1,73 m2) og personer med ESRD, der krævede hæmodialyse efter en enkelt 400 mg dosis sofosbuvir.
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravirf
Danish: HIV-ANTIVIRALE STOFFER: INTEGRASEHÆMMERE Raltegravirf
English: Population pharmacokinetic analysis in HCV infected subjects 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 personer 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: 12 weeks (n = 256)a
Danish: 12 uger (n = 256)a
English: Genotype 1a 82% (74/90) Genotype 1b 54% (13/24) No cirrhosis
Danish: Genotype 1a 82 % (74/90) Genotype 1b 54 % (13/24) Uden cirrose 77 % (84/109) Cirrose
English: Subjects were randomised in 3:1 ratio and stratified by cirrhosis (presence versus absence).
Danish: Patienterne blev randomiseret i forholdet 3:1, og stratificeret efter cirrose (til stede versus ikke til stede).
English: Subjects 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: • Oxcarbazepine (a medicine used to treat epilepsy and prevent seizures);
Danish: • Oxcarbamazepin (medicin, der anvendes til at behandle epilepsi og forebygge krampeanfald)
English: An interim analysis was conducted on 61 subjects who received sofosbuvir and ribavirin; the majority of subjects had HCV genotype 1, 44 subjects were CPT class A and 17 subjects were CPT class B. Of these 61 subjects, 44 subjects 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 personer 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: Treatment duration was 12 weeks in treatment-naïve subjects with genotype 2 or 3 HCV infection, and 24 weeks in treatment-experienced subjects with genotype 3 HCV infection, as well as subjects 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: Patients with genotype 3 CHC
Danish: Patienter med CHC af genotype 3
English: Sofosbuvir was studied in HCV infected subjects 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. Other includes subjects who did not achieve SVR12 and did not meet virologic failure criteria (e.g., lost to follow-up).
Danish: b. Andet omfatter personer, der ikke opnåede SVR12 og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up).
English: What Sovaldi contains
Danish: Sovaldi indeholder:
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 subjects 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: Table 13: Response rates in study VALENCE Genotype 2
Danish: Tabel 13: Responsrater i VALENCE-studiet Genotype 2
English: Population pharmacokinetics analysis in HCV infected subjects indicated that cirrhosis had no clinically relevant effect on the exposure to sofosbuvir and GS-331007.
Danish: Populationsfarmakokinetisk analyse hos HCV-inficerede personer indikerer, at cirrose ikke havde nogen klinisk relevant virkning på eksponeringen for sofosbuvir og GS-331007.
English: Overall SVR12 Outcome for subjects without SVR12 On-treatment virologic failure Relapsea Otherb a. The denominator for relapse is the number of subjects with HCV RNA <LLOQ at their last on-treatment assessment.
Danish: Samlet SVR12 Resultat for patienter uden SVR12 Virologisk svigt under behandling Recidiva Andetb a. Benævnelsen for recidiv er antallet af patienter med HCV-rna < LLOQ ved deres seneste vurdering under behandling.
English: Drug interaction information for Sovaldi with potential concomitant medicinal products is summarised in Table 3 below (where 90% confidence interval (CI) of the geometric least-squares mean (GLSM)
Danish: Information om lægemiddelinteraktion for Sovaldi med mulige samtidige lægemidler er opsummeret i tabel 3 nedenfor (hvor 90 % konfidensintervallet (CI) af forholdet af det geometriske mindste kvadraters gennemsnit (GLSM) var inden for ”↔”, strakte sig over ”↑” eller strakte sig under ”↓” de ækvivalensgrænser, der var bestemt på forhånd).
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 subjects or subjects who did not achieve SVR with prior interferon-based treatment, including subjects 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: The following adverse drug reactions have been identified with sofosbuvir in combination with ribavirin or in combination with peginterferon alfa and ribavirin (Table 4).
Danish: De følgende bivirkninger er identificeret med sofosbuvir i kombination med ribavirin eller i kombination med peginterferon alfa og ribavirin (tabel 4).
English: c. Other includes subjects 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: 12 weeks (n = 103)a
Danish: 12 uger (n = 103)a
English: Relative to subjects 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 personer med normal leverfunktion var sofosbuvir AUC0-24 126 % og 143 % højere ved moderat og svært nedsat leverfunktion, mens GS-331007 AUC0-24 var hhv. 18 % og 9 % højere.
English: NAME OF THE MEDICINAL PRODUCT Sovaldi 400 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Sovaldi 400 mg filmovertrukne tabletter
English: The safety of Sovaldi has not been assessed in subjects with severe renal impairment (eGFR <30 mL/min/1.73 m2) or ESRD requiring haemodialysis.
Danish: Sikkerheden af Sovaldi er ikke blevet vurderet hos personer med svært nedsat nyrefunktion (eGFR < 30 ml/min/1,73 m2) eller ESRD, der kræver hæmodialyse.
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
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: Treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection Sovaldi has not been studied in a Phase 3 study in treatment-experienced patients with genotype 1, 4, 5 and 6 HCV infection.
Danish: Behandlingserfarne patienter med HCV-genotype 1, 4, 5 og 6-infektion Sovaldi er ikke blevet undersøgt i et fase III-studie hos behandlingserfarne patienter med HCV-genotype 1, 4, 5 og 6-infektion.
English: Table 10 presents the subgroup analysis by genotype for cirrhosis and interferon classification.
Danish: Tabel 10 viser analyse af undergrupperne efter genotype for cirrose og interferon klassifikation.
English: Frequency SOFa + RBVb
Danish: Hyppighed SOFa + RBVb
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of sofosbuvir.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 400 mg sofosbuvir.
English: Overall No cirrhosis Cirrhosis TN = treatment-naïve; TE = treatment-experienced.
Danish: Samlet Uden cirrose Cirrose TN = behandlingsnaive, TE = behandlingserfarne.
English: 12 weeks (n = 68)
Danish: 12 uger (n = 68)
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir is used in combination with another direct-acting antiviral (DAAs, including daclatasvir, simeprevir and ledipasvir) and concomitant amiodarone with or without other drugs that lower heart rate.
Danish: Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af sofosbuvir i kombination med et andet direkte virkende antiviralt middel (DAA (direct acting antiviral), herunder daclatasvir, simeprevir og ledispavir) samtidig med amiodaron med eller uden andre hjertefrekvenssænkende lægemidler.
English: Table 10: SVR12 rates for selected subgroups by genotype in POSITRON SOF+RBV 12 weeks
Danish: Tabel 10: SVR12-rater for udvalgte undergrupper efter genotype i POSITRON SOF+RBV 12 uger
English: Interferon-free therapy for genotype 1, 4, 5 and 6 HCV infection Interferon-free regimens for patients with genotype 1, 4, 5 and 6 HCV infection with Sovaldi have not been investigated in Phase 3 studies (see section 5.1).
Danish: Interferonfri behandling af HCV-genotype 1, 4, 5 og 6-infektion Interferonfrie behandlingsprogrammer for patienter med HCV-genotype 1, 4, 5 og 6-infektion med Sovaldi er ikke blevet undersøgt i fase III-studier (se pkt.
English: If you are not sure, talk to your doctor or pharmacist.
Danish: Er du i tvivl, så tal med lægen eller apotekspersonalet.
English: FISSION was a randomised, open-label, active-controlled study that evaluated 12 weeks of treatment with sofosbuvir and ribavirin compared to 24 weeks of treatment with peginterferon alfa 2a and ribavirin in treatment-naïve subjects with genotype 2 or 3 HCV infection.
Danish: FISSION var et randomiseret, open-label, aktivt kontrolleret studie, der evaluerede 12 ugers behandling med sofosbuvir og ribavirin, sammenlignet med 24 ugers behandling med peginterferon alfa 2a og ribavirin hos behandlingsnaive patienter med HCV-infektion af genotype 2 eller 3.
English: What Sovaldi looks like and contents of the pack The film-coated tablets are yellow, capsule-shaped tablets, debossed on one side with “GSI” and “7977” on the other side.
Danish: De filmovertrukne tabletter er gule, kapselformede tabletter, præget på den ene side med ”GSI” og med ”7977” på den anden side.
English: The safety and appropriate dose of Sovaldi have not been established in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
Danish: Sikkerheden og den passende dosis af Sovaldi er ikke blevet klarlagt hos patienter med svært nedsat nyrefunktion (estimeret glomulær filtrationshastighed [eGFR] < 30 ml/min/1,73 m2) eller nyresygdom i slutstadiet (ESRD), der kræver hæmodialyse (se pkt.
English: Table 1: Recommended co-administered medicinal product(s) and treatment duration for Sovaldi combination therapy
Danish: Tabel 1: Anbefalet samtidigt administreret lægemiddel/anbefalede samtidigt administrerede lægemidler og behandlingsvarighed for Sovaldi kombinationsbehandling Patientpopulation
English: Subjects had HCV RNA ≥104 IU/mL at screening and documented evidence of chronic
Danish: Personerne havde HCV-rna ≥ 104 IE/ml ved screening og dokumenteret evidens for kronisk HCV-infektion inden transplantationen.
English: Cmin (NA) Ethinyl estradiol ↔ Cmax 1.14 (0.96,
Danish: Cmin (NA) Ethinylestradiol ↔ Cmax 1,14 (0,96;
English: level was 6.4 log10 IU/mL; 21% had cirrhosis; 78% had HCV genotype 3; 65% were prior relapsers.
Danish: gennemsnitlige baseline HCV-rna-niveau var 6,4 log10 IE/ml, 21 % havde cirrose, 78 % havde HCVgenotype 3, 65 % havde tidligere recidiv.
English: 12 weeks (n = 327)
Danish: 12 uger (n = 327)
English: 12 weeks (n = 207)
Danish: 12 uger (n = 207)