FrancophonIA/ELRC3.0 huggingface dataset:
English: The proportion of patients who permanently discontinued treatment due to adverse events was 0%, < 1% and 1% for patients receiving ledipasvir/sofosbuvir for 8, 12 and 24 weeks, respectively; and < 1%, 0%, and 2% for patients receiving ledipasvir/sofosbuvir + ribavirin combination therapy for 8, 12 and 24 weeks, respectively.
Danish: Andelen af patienter, som seponerede behandlingen permanent på grund af uønskede hændelser, var 0 %, <1 % og 1 % for patienter, som fik ledipasvir/sofosbuvir i hhv. 8, 12 og 24 uger, og <1 %, 0 % og 2 % for patienter, som fik kombinationsbehandling med ledipasvir/sofosbuvir + ribavirin i hhv. 8, 12 og 24 uger.
English: Copovidone, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate
Danish: Copovidon, lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, kolloid, kolloid vandfri silica, magnesiumstearat
English: No Yes a. One patient was excluded from the LDV/SOF 12-week treatment arm and one patient was excluded from the LDV/SOF+RBV 24-week treatment arm as both patients were infected with genotype 4 CHC.
Danish: Nej Ja a. En patient blev ekskluderet fra behandlingsarmen med 12 ugers LDV/SOF, og en patient blev ekskluderet fra behandlingsarmen med 24 ugers LDV/SOF+RBV, da begge patienter var inficeret med genotype 4 CHC.
English: The three Phase 3 studies included one study conducted in non-cirrhotic treatment-naïve patients (ION-3); one study in cirrhotic and non-cirrhotic treatment-naïve patients (ION-1); and one study in cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2).
Danish: De tre fase 3-studier omfattede et studie udført hos behandlingsnaive patienter uden cirrose (ION-3), et studie med behandlingsnaive patienter med og uden cirrose (ION-1) og et studie med patienter med og uden cirrose, hvor tidligere behandling med et interferon-baseret regime har svigtet, herunder regimer, der indeholder en HCV-proteasehæmmer (ION-2).
English: The pharmacokinetics of sofosbuvir were studied in HCV negative patients 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 patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir.
Danish: Sofosbuvirs farmakokinetik blev undersøgt hos HCV-negative patienter 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 patienter med ESRD, der krævede hæmodialyse efter en enkelt 400 mg dosis sofosbuvir.
English: Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Danish: Derfor bør det ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
English: d. Lack of pharmacokinetics interaction bounds 70-143%.
Danish: d. Interval på 70-143 %, hvor der ikke opstår farmakokinetisk interaktion.
English: The clinical data to support the use of Harvoni in patients infected with HCV genotype 3 are limited (see section 5.1).
Danish: De kliniske data, der støtter brug af Harvoni hos patienter inficeret med HCV-genotype 3 er begrænsede (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Harvoni 90 mg/400 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Harvoni 90 mg/400 mg filmovertrukne tabletter
English: In vitro ledipasvir inhibits intestinal CYP3A4 and UGT1A1.
Danish: In vitro hæmmer ledipasvir CYP3A4 og UGT1A1 i tarmen.
English: - Harvoni + ribavirin for 12 weeks or Harvoni (without ribavirin) for 24 weeks should be considered for previously treated patients with uncertain subsequent retreatment options (see section 4.4).
Danish: - Harvoni + ribavirin i 12 uger eller Harvoni (uden ribavirin) i 24 uger skal overvejes for tidligere behandlede patienter med usikre efterfølgende muligheder for genbehandling (se pkt.
English: Treatment-naïve Patients without cirrhosis Patients with cirrhosis Treatment-experienced
Danish: Behandlingsnaive Patienter uden cirrose Patienter med cirrose Behandlingserfarne
English: • tenofovir disoproxil fumarate or any medicine containing tenofovir disoproxil fumarate, used to treat HIV infection;
Danish: • tenofovirdisoproxilfumarat eller andre lægemidler, der indeholder tenofovirdisoproxilfumarat,
English: Nizatidinee Ranitidine e
Danish: Nizatidine Ranitidin e
English: 24% (4/17)e a. These 4 non-cirrhotic relapsers all had baseline NS5A resistance-associated polymorphisms.
Danish: a. Disse 4 patienter uden cirrose med recidiv havde alle NS5A-polymorfisme forbundet med resistens ved baseline.
English: • If you are allergic to ledipasvir, sofosbuvir or any of the other ingredients of this medicine
Danish: • Hvis du er allergisk over for ledipasvir, sofosbuvir eller et af de øvrige indholdsstoffer i Harvoni (angivet i punkt 6 i denne indlægsseddel).
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: Harvoni has been shown to increase tenofovir exposure, especially when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).
Danish: Samtidig brug med visse hiv-antiretrovirale regimer Harvoni har vist sig at øge tenofovireksponeringen, især når det bruges sammen med et hiv-regimen, der indeholder tenofovirdisoproxilfumarat og en farmakokinetisk forstærker (ritonavir eller cobicistat).
English: What Harvoni looks like and contents of the pack The film-coated tablets are orange, diamond-shaped tablets debossed with “GSI” on one side and “7985” on the other side.
Danish: De filmovertrukne tabletter er orange, diamantformede tabletter, præget med ”GSI” på den ene side og med ”7985” på den anden side.
English: HMG-CoA REDUCTASE INHIBITORS Rosuvastating
Danish: HMG-CoA REDUCTASEHÆMMERE Rosuvastatin g
English: Elimination Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in faeces and urine was 87%, with most of the radioactive dose recovered from faeces (86%).
Danish: Efter en enkelt 90 mg oral dosis af [14C]-ledipasvir, var den gennemsnitlige totale genfinding af [14C]-radioaktivitet i fæces og urin 87 %, hvoraf størstedelen af den radioaktive dosis blev genfundet i fæces (86 %).
English: Not interpretable a. Two patients in the LDV/SOF 12-week treatment arm, one patient in the LDV/SOF+RBV 12-week treatment arm, two patients in the LDV/SOF 24-week treatment arm, and two patients in the LDV/SOF+RBV 24-week treatment arm did not have a confirmed genotype 1 subtype.
Danish: Kan ikke fortolkes a. To patienter i behandlingsarmen med 12-ugers LDV/SOF, en patient i behandlingsarmen med 12-ugers LDV/SOV + RBV, to patienter i behandlingsarmen med 24-ugers LDV/SOF og to patienter i behandlingsarmen med 24-ugers LDV/SOF+RBV havde ikke en bekræftet genotype 1-undertype.
English: Table 8: Relapse rates by baseline characteristics in the ION-3 study, virological failure population* LDV/SOF
Danish: Tabel 8: Recidivrater pr. baselinekarakteristika i ION-3-studiet, population med virologisk svigt* LDV/SOF
English: Do not breast-feed during treatment with Harvoni.
Danish: Du må ikke amme under behandlingen med Harvoni.
English: In the SOLAR-1 study (see “Clinical efficacy and safety”, below) 13 patients with genotype 1 infection relapsed after treatment with ledipasvir/sofosbuvir with ribavirin.
Danish: I SOLAR-1-studiet (se ”Klinisk virkning og sikkerhed” nedenfor) recidiverede 13 patienter med genotype 1-infektion efter behandling med ledipasvir/sofosbuvir sammen med ribavirin.
English: NS5A transient replicons
Danish: Stabile replikoner NS5A transitoriske replikoner
English: • St. John's wort (Hypericum perforatum - herbal medicine used to treat depression);
Danish: • prikbladet perikon (Hypericum perforatum - et naturlægemiddel, der anvendes til at behandle depression)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 90 mg ledipasvir og 400 mg sofosbuvir.
English: c/ sofosbuvir (400 mg single dose)c, d Famotidine dosed simultaneously with Harvonid
Danish: c/ sofosbuvir (400 mg enkeltdosis)c Omeprazol doseret sammen med Harvoni
English: Other b
Danish: Andet b
English: HCV PRODUCTS Simeprevir (150 mg once daily)/ ledipasvir (30 mg once daily)
Danish: HCV-PRÆPARATER Simeprevir (150 mg én gang dagligt)/ ledipasvir (30 mg én gang dagligt)
English: - Harvoni (without ribavirin) for 24 weeks may be considered in patients who are ineligible for or intolerant to ribavirin.
Danish: - Harvoni (uden ribavirin) i 24 uger kan overvejes for patienter, der ikke er egnede til eller er intolerante over for ribavirin.
English: c. Analysis (by deep sequencing) included NS5A resistance-associated polymorphisms that conferred > 2.5-fold change in EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T, and Y93C/F/H/N/S for genotype 1a and L31I/F/M/V, P32L, P58D, A92K, and Y93C/H/N/S for genotype 1b HCV infection).
Danish: c. Analysen (ved dyb sekventering) omfattede NS5A-polymorfismer forbundet med resistens, der gav >2,5 gange ændring i EC50 (K24G/N/R, M28A/G/T, Q30E/G/H/L/K/R/T, L31I/F/M/V, P32L, S38F, H58D, A92K/T og Y93C/F/H/N/S for genotype 1a HCV-infektion og L31I/F/M/V, P32L, P58D, A92K og Y93C/H/N/S for genotype 1b HCV-infektion).
English: Table 13 presents relapse rates with the 12-week regimens (with or without ribavirin) for selected subgroups (see also previous section “Effect of baseline HCV resistance-associated variants on treatment outcome”).
Danish: Tabel 13 viser recidivrater med det 12-ugers regime (med eller uden ribavirin) for udvalgte undergrupper (se også tidligere pkt.
English: The safety of Harvoni has not been assessed 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.
Danish: Sikkerheden af Harvoni er ikke blevet undersøgt hos patienter med svært nedsat nyrefunktion (estimeret glomulær filtrationshastighed [eGFR] <30 ml/min/1,73 m2) eller nyresygdom i slutstadiet (ESRD), der kræver hæmodialyse.
English: Table 9: Demographics and baseline characteristics in study ION-1 Patient disposition
Danish: Tabel 9: Demografi og baselinekarakteristika i studie ION-1 Patientdisposition
English: and L31M substitution in genotype 1a conferred high levels of reduced susceptibility to ledipasvir (fold-change in EC50 ranging from 544-fold to 1,677-fold).
Danish: Site-directed mutagenese af Y93H-substitutionen i både genotype 1a og 1b samt Q30R- og L31M-substitutionen i genotype 1a tildelte høje niveauer af nedsat følsomhed over for ledipasvir (interval på 544 til 1.677 gange større ændring i EC50).
English: NS5A RAVs were seen at the time of relapse in 11/13 patients (for genotype 1a: Q30R alone [n = 2], Y93C [n = 1], Y93H/C [n = 2], Q30R + H58D [n = 1], M28T + Q30H [n = 1]; for genotype 1b: Y93H [n = 3], Y93H/C [n = 1]).
Danish: NS5A-RAVs blev set på tidspunktet for recidiv hos 11/13 patienter (for genotype 1a: Q30R alene [n = 2], Y93C [n = 1], Y93H/C [n = 2], Q30R + H58D [n = 1], M28T + Q30H [n = 1]; for genotype 1b: Y93H [n = 3], Y93H/C [n = 1]).
English: In vitro potential for ledipasvir/sofosbuvir to affect other medicinal products At concentrations achieved in the clinic, ledipasvir is not an inhibitor of hepatic transporters including the OATP 1B1 or 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug and toxic compound extrusion (MATE) 1 transporter, multidrug resistance protein (MRP) 2 or MRP4.
Danish: Ledipasvir/sofosbuvirs potentiale in vitro for at påvirke andre lægemidler Ved koncentrationer, der blev opnået i klinikken, er ledipasvir ikke en hæmmer af levertransportere, herunder OATP 1B1 eller 1B3, BSEP, OCT1, OCT2, OAT1, OAT3, multidrug- og toksisk stofekstrusion (MATE) 1-transporter, multidrug resistance protein (MRP) 2 eller MRP4.Sofosbuvir og GS-331007 er ikke hæmmere af lægemiddeltransporterne P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3, OCT1 og GS-331007 er ikke en hæmmer af OAT1, OCT2 og MATE1.
English: What Harvoni contains
Danish: Harvoni indeholder:
English: Marketing Authorisation Holder Gilead Sciences International Ltd. Cambridge
Danish: Indehaver af markedsføringstilladelsen Gilead Sciences International Ltd. Cambridge
English: Treatment-experienced patients had failed prior treatment with PEG-IFN + ribavirin ± an HCV protease inhibitor or sofosbuvir +
Danish: Hos behandlingserfarne patienter havde tidligere behandling med PEG-IFN + ribavirin ± en HCV-proteasehæmmer eller sofosbuvir + ribavirin ± PEG-IFN svigtet.
English: Harvoni + ribavirin for 12 weeks (see section 5.1).
Danish: Harvoni + ribavirin i 12 uger (se pkt.
English: Patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant The safety profile of ledipasvir/sofosbuvir with ribavirin for 12 or 24 weeks in patients with decompensated liver disease and/or those post-liver transplant was assessed in an open-label study (SOLAR-1).
Danish: Sikkerhedsprofilen for ledipasvir/sofosbuvir sammen med ribavirin i 12 eller 24 uger hos patienter med dekompenseret leversygdom og/eller patienter efter levertransplantation blev vurderet i et åbent studie (SOLAR-1).
English: Cases of severe bradycardia and heart block have been observed when Harvoni is used with concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Danish: Der er iagttaget tilfælde af svær bradykardi og hjerteblok ved anvendelse af Harvoni samtidig med amiodaron og/eller andre hjertefrekvenssænkende lægemidler (se pkt.
English: ORAL CONTRACEPTIVES Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ ledipasvir (90 mg once daily)
Danish: ORALE ANTIKONTRACEPTIVA Norgestimat/ ethinylestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ ethinylestradiol 0,025 mg)/ ledipasvir (90 mg én gang dagligt)d
English: Table 6: Demographics and baseline characteristics in study ION-3 Patient disposition
Danish: Tabel 6: Demografi og baselinekarakteristika i studie ION-3 Patientdisposition
English: No dose adjustment of Harvoni or ciclosporin is required.
Danish: Ingen dosisjustering af Harvoni eller ciclosporin er nødvendig.
English: Simeprevir h
Danish: Simeprevirh
English: Co-administration is not recommended.
Danish: Samtidig administration bør ikke anvendes.
English: NAME OF THE MEDICINAL PRODUCT Harvoni 90 mg/400 mg film-coated tablets ledipasvir/sofosbuvir
Danish: LÆGEMIDLETS NAVN Harvoni 90 mg/400 mg filmovertrukne tabletter ledipasvir/sofosbuvir
English: Harvoni is contraindicated with carbamazepine, phenobarbital and phenytoin, potent intestinal P-gp inducers (see section 4.3).
Danish: Harvoni er kontraindiceret sammen med carbamazepin, phenobarbital og phenytoin, potente P-gp-inducere i tarmen (se pkt.
English: Use with certain HIV antiretroviral regimens
Danish: anvendes til at behandle hiv-infektion
English: No dose adjustment of Harvoni or tacrolimus is required.
Danish: Ingen dosisjustering af Harvoni eller tacrolimus er nødvendig.
English: c/ sofosbuvir (400 mg once daily)c, d
Danish: c/ sofosbuvir (400 mg enkeltdosis)c,d
English: c. Patients with missing cirrhosis status were excluded from this subgroup analysis.
Danish: c. Patienter med manglende cirrose-status blev ekskluderet fra denne undergruppeanalyse.
English: d. Patients with missing cirrhosis status were excluded from this subgroup analysis.
Danish: d. Patienter med manglende cirrose-status blev ekskluderet fra denne undergruppeanalyse.
English: b. Patients with missing cirrhosis status were excluded from this subgroup analysis.
Danish: b. Patienter med manglende cirrose-status blev ekskluderet fra denne undergruppeanalyse.
English: The safety of ledipasvir/sofosbuvir has not been assessed 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 af ledipasvir/sofosbuvir er ikke blevet undersøgt hos patienter med svært nedsat nyrefunktion (estimeret glomulær filtrationshastighed [eGFR] <30 ml/min/1,73 m2) eller nyresygdom i slutstadiet (ESRD, end stage renal disease), der kræver hæmodialyse (se pkt.
English: c. Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
Danish: c. Andet omfatter patienter, der ikke opnåede SVR og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up).
English: Patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant The efficacy of ledipasvir/sofosbuvir in genotype 5 and genotype 6 HCV-infected patients with decompensated cirrhosis and/or who are awaiting liver transplant or post-liver transplant has not been investigated.
Danish: Ledipasvir/sofosbuvirs virkning er ikke blevet undersøgt hos HCV-genotype 5- og 6-inficerede patienter med dekompenseret cirrose, og/eller som venter på levertransplantation eller har gennemgået en levertransplantation.
English: before taking this medicine.
Danish: også kaldet ”E110”, før du tager denne medicin.
English: What you need to know before you take Harvoni
Danish: Det skal du vide, før du begynder at tage Harvoni Tag ikke Harvoni
English: • Tell your doctor if you are allergic to sunset yellow FCF aluminium lake, also called “E110”
Danish: • Fortæl det til lægen, hvis du er overfølsom over for sunset yellow FCF aluminiumpigment,
English: Outcome for patients without SVR On-treatment virologic failure Relapse b
Danish: Resultat for patienter uden SVR Virologisk svigt under behandling Recidiv b
English: ANTIMYCOBACTERIALS Rifampicin (600 mg once daily)/ ledipasvir (90 mg single dose)
Danish: ANTIMYKOBAKTERIELLE MIDLER Rifampicin (600 mg én gang dagligt)/ ledipasvir (90 mg enkeltdosis)d
English: a. One patient in the LDV/SOF 24-week treatment arms and one patient in the LDV/SOF+RBV 24-week treatment arm were prior treatment failures of a non-pegylated interferon based regimen.
Danish: Kan ikke fortolkes a. En patient i behandlingsarmen med 24 ugers LDV/SOF og en patient i behandlingsarmen med 24 ugers LDV/SOV+RBV havde oplevet svigt af en tidligere behandling med et non-pegyleret interferonbaseret regimen.
English: b. Other includes patients who did not achieve SVR and did not meet virologic failure criteria (e.g. lost to follow-up).
Danish: b. Andet omfatter patienter, der ikke opnåede SVR og ikke opfyldte kriterierne for virologisk svigt (f.eks. lost to follow-up).
English: Tacrolimus (5 mg single dose)/ sofosbuvir (400 mg single dose)
Danish: Tacrolimus (5 mg enkeltdosis)/ sofosbuvir (400 mg enkeltdosis)
English: Norgestimate/ ethinyl estradiol (norgestimate 0.180 mg/ 0.215 mg/ 0.25 mg/ ethinyl estradiol 0.025 mg)/ sofosbuvir (400 mg once daily)d
Danish: Norgestimat/ ethinylestradiol (norgestimat 0,180 mg/ 0,215 mg/ 0,25 mg/ ethinylestradiol 0,025 mg)/ sofosbuvir (400 mg én gang dagligt)
English: Outcome for patients without SVR On-treatment virologic failure
Danish: Resultat for patienter uden SVR Virologisk svigt under behandling
English: Medicinal products that are potent P-gp inducers (rifampicin, rifabutin, St. John's wort, carbamazepine, phenobarbital and phenytoin) may significantly decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of ledipasvir/sofosbuvir and thus are contraindicated with Harvoni (see section 4.3).
Danish: Lægemidler, der er potente P-gp-inducere (rifampicin, rifabutin, prikbladet perikon, carbamazepin, phenobarbital og phenytoin), kan nedsætte plasmakoncentrationerne af ledipasvir og sofosbuvir signifikant og føre til en reduceret terapeutisk virkning af ledipasvir/sofosbuvir.
English: Following treatment with ledipasvir/sofosbuvir with ribavirin for 12 weeks in patients with decompensated disease (irrespective of liver transplantation status), 3/7 patients with baseline NS5A RAVs conferring > 100-fold reduced susceptibility to ledipasvir relapsed, as compared to 4/68 in those without any baseline RAVs or RAVs conferring ≤ 100-fold reduced susceptibility to ledipasvir.
Danish: Efter behandling med ledipasvir/sofosbuvir sammen med ribavirin i 12 uger hos patienter med dekompenseret sygdom (uanset levertransplantationsstatus) var der 3/7 patienter med NS5A-RAV ved baseline, der gav >100 gange nedsat følsomhed for ledipasvir, som recidiverede, sammenlignet med 4/68 af patienterne uden baseline-RAVs eller -RAVs, der gav ≤100 gange nedsat følsomhed for ledipasvir.
English: SOLAR-1 is an open-label, multicentre study evaluating 12 and 24 weeks of treatment with ledipasvir/sofosbuvir + ribavirin in patients with genotype 1 or 4 CHC who have advanced liver disease and/or who have undergone liver transplantation.
Danish: Patienter, der venter på levertransplantation og efter levertransplantation - SOLAR-1 SOLAR-1 er et åbent, multicenterstudie, der evaluerer 12 og 24 ugers behandling med ledipasvir/sofosbuvir + ribavirin hos patienter med genotype 1 eller 4 CHC, der har fremskreden leversygdom og/eller som har gennemgået en levertransplantation.
English: Table 13: Relapse rates for selected subgroups in study ION-2 LDV/SOF
Danish: Tabel 13: Recidivrater for udvalgte undergrupper i studie ION-2 LDV/SOF
English: Raltegravir (400 mg twice daily)/ sofosbuvir (400 mg once daily)
Danish: Raltegravir (400 mg to gange dagligt)/ sofosbuvir (400 mg én gang dagligt)d
English: HIV ANTIVIRAL AGENTS: INTEGRASE INHIBITORS Raltegravir (400 mg twice daily)/ ledipasvir (90 mg once daily)
Danish: HIV ANTIVIRALE STOFFER: INTEGRASEHÆMMERE Raltegravir (400 mg to gange dagligt)/ ledipasvir (90 mg én gang dagligt)d
English: Harvoni contains sunset yellow FCF aluminium lake (E110)
Danish: Harvoni indeholder sunset yellow FCF aluminiumpigment (E110)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 90 mg ledipasvir og 400 mg sofosbuvir.
English: Ciclosporin (600 mg single dose)/ sofosbuvir (400 mg single dose)
Danish: Ciclosporin (600 mg enkeltdosis)/ sofosbuvir (400 mg enkeltdosis)
English: LIST OF EXCIPIENTS Contains lactose and sunset yellow FCF aluminium lake (E110).
Danish: Indeholder lactose og sunset yellow FCF aluminiumpigment (E110).
English: Following a single dose of 90 mg [14C]-ledipasvir, systemic exposure was almost exclusively due to the parent drug (> 98%).
Danish: skyldtes den systemiske eksponering næsten udelukkende udgangsstoffet (>98 %).
English: b. The denominator for relapse is the number of patients with HCV RNA < LLOQ at their last on-treatment assessment.
Danish: b. Benævnelsen for recidiv er antallet af patienter med HCV-rna < LLOQ ved deres seneste vurdering under behandling.
English: Change in MELD score: 53% (72/135) and 21% (28/135) had an improvement or no change of MELD score from baseline to post-treatment week 4, respectively; of the 35 patients whose MELD score was ≥ 15 at baseline, 63% (22/35) had a MELD score < 15 at post-treatment week 12.
Danish: Ændring i MELD-score (model for end stage liver disease): 53 % (72/135) og 21 % (28/135) havde hhv. en forbedring eller ingen ændring i MELD-score fra baseline til uge 4 efter behandlingen.
English: 24 weeks (n = 217)
Danish: 24 uger (n = 217)
English: Table 10: Response rates in study ION-1 LDV/SOF
Danish: Tabel 10: Responsrater i ION-1-studiet LDV/SOF
English: Harvoni + ribavirin for 24 weeks (see sections 4.4 and 5.1).
Danish: Harvoni + ribavirin i 24 uger (se pkt.