FrancophonIA/ELRC3.0 huggingface dataset:
English: S-warfarin AUC 1.04 (1.00-1.07) ↔ S-warfarin Cmax 1.00 (0.94-1.06) ↔ S-warfarin Cmin not studied
Danish: S-warfarin AUC 1,04 (1,00-1,07) ↔ S-warfarin Cmax 1,00 (0,94-1,06) ↔ S-warfarin Cmin ikke undersøgt
English: Sustained virologic response (SVR) was the primary endpoint in all studies and was defined as HCV RNA less than the lower limit of quantification (LLOQ) detectable or undetectable 12 weeks (SVR12) or 24 weeks (SVR24) after the planned end of treatment (studies C206, C208, C212, C216, HPC2002, HPC3007 and HPC3011) or after the actual end of treatment (studies HPC2014, HPC3017, HPC3018 and HPC3021) (LLOQ of 25 IU/ml and limit of detection of 15 IU/ml, except in studies HPC2014 and HPC3021 where LLOQ and limit of detection were 15 IU/ml).
Danish: Vedvarende virologisk respons (SVR) var det primære endemål i alle studier og blev defineret som detekterbart eller ikke-detekterbart HCV-RNA < nedre kvantificeringsgrænse (LLOQ) 12 uger (SVR12) eller 24 uger (SVR24) efter den planlagte behandlingsafslutning (studierne C206, C208, C212, C216, HPC2002, HPC3007 og HPC3011) eller efter den faktiske behandlingsafslutning (studierne HPC2014, HPC3017, HPC3018 og HPC3021) (LLOQ på 25 IE/ml og en detektionsgrænse på 15 IE/ml, bortset fra studierne HPC2014 og HPC3021, hvor LLOQ og detektionsgrænsen var 15 IE/ml).
English: Frequency Category simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781
Danish: Frekvens simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781
English: HPC3017 (OPTIMIST-1; Phase 3)
Danish: HPC3017 (OPTIMIST-1; fase 3)
English: When taking OLYSIO combination treatment, tell your doctor if you have the following symptoms as they may be a sign of worsening liver problems: - notice yellowing of your skin or eyes - your urine is darker than normal - notice swelling of your stomach area.
Danish: Kontakt læge: - hvis du bemærker gulfarvning af huden eller øjnene - hvis din urin er mørkere end normalt - hvis du bemærker, at din mave svulmer op.
English: 10 mg rosuvastatin AUC 2.81 (2.34-3.37) ↑ rosuvastatin Cmax 3.17 (2.57-3.91) ↑ rosuvastatin Cmin not studied
Danish: 10 mg rosuvastatin AUC 2,81 (2,34-3,37) ↑ rosuvastatin Cmax 3,17 (2,57-3,91) ↑ rosuvastatin Cmin ikke undersøgt
English: pruritus*, photosensitivity reaction*
Danish: kløe*, lysfølsomhedsreaktion*
English: Treatment week 12: ≥ 25 IU/ml1
Danish: Behandlingsuge 12: ≥ 25 IE/ml1
English: Increased simeprevir concentrations may occur due to mild inhibition of CYP3A4 by amlodipine and moderate inhibition of CYP3A4 by diltiazem and verapamil.
Danish: Koncentration af simeprevir kan øges på grund af amlodipins svage hæmning af CYP3A4 og diltiazems og verapamils moderate hæmning af CYP3A4.
English: Treatment week 24: ≥ 25 IU/ml1
Danish: Behandlingsuge 24: ≥ 25 IE/ml1
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains simeprevir sodium equivalent to 150 mg of simeprevir.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hård kapsel indeholder simeprevirnatrium svarende til 150 mg simeprevir.
English: In HCV genotype 1a infected patients without cirrhosis, simeprevir efficacy in combination with sofosbuvir at the recommended 12-week treatment duration was not impacted by the presence of the NS3 Q80K polymorphism (see section 5.1).
Danish: Hos HCV-genotype 1a-inficerede patienter uden cirrose blev effekten af simeprevir i kombination med sofosbuvir ved den anbefalede 12-ugers behandlingsvarighed ikke påvirket af forekomst af NS3 Q80K-polymorfismen (se pkt.
English: OLYSIO in combination with peginterferon alfa and ribavirin: HCV/HIV-1 co-infected patients should be treated for the same duration as HCV mono-infected patients, except for co-infected patients with cirrhosis who should receive 36 weeks of treatment with peginterferon alfa and ribavirin after completing 12 weeks of treatment with OLYSIO, peginterferon alfa and ribavirin (total treatment duration of 48 weeks).
Danish: OLYSIO i kombination med peginterferon alfa og ribavirin: Hos HCV/HIV-1-coinficerede patienter er behandlingsvarigheden den samme som for HCV-monoinficerede patienter; dog skal coinficerede patienter med cirrose have 36 ugers behandling med peginterferon alfa og ribavirin efter at have fuldført 12 ugers behandling med OLYSIO, peginterferon alfa og ribavirin (total behandlingsvarighed 48 uger).
English: 1 Open-label, randomised, except for studies HPC3018 and HPC3021 which were single arm, and study HPC2014 which was partly randomised.
Danish: 1 Åbent, randomiseret, bortset fra studierne HPC3018 og HPC3021, der havde en enkelt behandlingsarm, og studie
English: 2 Following prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin (see section 5.1).
Danish: 2 Efter tidligere behandling med interferon (pegyleret eller ikke-pegyleret) med eller uden ribavirin (se pkt.
English: Baseline HCV RNA levels > 800,000 IU/ml
Danish: HCV-RNA > 800.000 IE/ml ved baseline
English: When used together with other medicines to treat chronic hepatitis C infection, OLYSIO helps to clear HCV from your body.
Danish: Når OLYSIO anvendes sammen med andre lægemidler til behandling af kronisk hepatitis C-infektion, er det med til at fjerne HCV fra kroppen.
English: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV3; control group: 48 weeks placebo + peg-IFN-alfa + RBV
Danish: 12 ugers SMV + peg-IFN-alfa + RBV efterfulgt af 12 eller 36 ugers peg-IFN-alfa + RBV3; kontrolgruppe: 48 ugers placebo + peg-IFN-alfa + RBV
English: photosensitivity reaction*
Danish: lysfølsomhedsreaktion*
English: common rash*, pruritus*, photosensitivity reaction*
Danish: almindelig udslæt*, kløe*, lysfølsomhedsreaktion*
English: Discontinue peginterferon alfa and ribavirin
Danish: Seponér peginterferon alfa og ribavirin
English: Pre-treatment testing for NS3 Q80K polymorphism in patients infected with HCV genotype 1a OLYSIO in combination with sofosbuvir
Danish: Test for NS3 Q80K-polymorfisme hos patienter inficeret med HCV-genotype 1a inden behandling OLYSIO i kombination med sofosbuvir
English: 40 mg omeprazole AUC 1.21 (1.00-1.46) ↑ omeprazole Cmax 1.14 (0.93-1.39) ↑ omeprazole Cmin not studied
Danish: 40 mg omeprazol AUC 1,21 (1,00-1,46) ↑ omeprazol Cmax 1,14 (0,93-1,39) ↑ omeprazol Cmin ikke undersøgt
English: Table 2: Recommended treatment duration for OLYSIO combination therapy with peginterferon alfa and ribavirin1 in HCV genotype 1 or 4
Danish: Tabel 2: Anbefalet varighed af kombinationsbehandling med OLYSIO og peginterferon alfa og ribavirin1 hos patienter med HCV-genotype 1 eller 4
English: Increased plasma concentrations of pitavastatin and pravastatin are expected.
Danish: Der forventes forhøjede plasmakoncentrationer af pitavastatin og pravastatin.
English: R155K Q80X+D168X4
Danish: Q80X+D168X4 R155X+ D168X4
English: NAME OF THE MEDICINAL PRODUCT OLYSIO 150 mg hard capsules
Danish: LÆGEMIDLETS NAVN OLYSIO 150 mg hårde kapsler
English: 1 Simeprevir in combination with sofosbuvir: pooled studies HPC2002, HPC3017 and HPC3018 (12 weeks) or study HPC2002 (24 weeks); simeprevir in combination with peginterferon alfa and ribavirin: pooled phase 3 studies C208, C216 and HPC3007 (first 12 weeks of treatments).
Danish: 1 Simeprevir i kombination med sofosbuvir: Puljede studier HPC2002, HPC3017 og HPC3018 (12 uger) og studie HPC2002 (24 uger); simeprevir i kombination med peginterferon alfa og ribavirin: Puljede fase 3-studier C208, C216 og HPC3007 (første 12 behandlingsuger).
English: Magnesium hydroxide Calcium carbonate
Danish: Aluminium- eller magnesiumhydroxid
English: Chemistry Amylase
Danish: Kemi Amylase
English: Intravenous: midazolam AUC 1.10 (0.95-1.26) ↑ midazolam Cmax 0.78 (0.52-1.17) ↓ midazolam Cmin not studied
Danish: Intravenøst: midazolam AUC 1,10 (0,95-1,26) ↑ midazolam Cmax 0,78 (0,52-1,17) ↓ midazolam Cmin ikke undersøgt
English: - Take this medicine by mouth.
Danish: Det er ligegyldigt, hvilken type mad det er. - Denne medicin skal tages gennem munden.
English: SVR12 rates for selected subgroups METAVIR fibrosis score F0-2 F3-4 F4 IL28B genotype CC CT TT HCV geno/subtype and presence of Q80K polymorphism in HCV genotype 1a Genotype 1a with Q80K without Q80K Genotype 1b
Danish: SVR12-rater for udvalgte undergrupper METAVIR-fibrose-score F0-2 F3-4 F4 IL28B-genotype CC CT TT HCV-geno-/undertype og forekomst af Q80K-polymorfisme i HCV-genotype 1a Genotype 1a med Q80K uden Q80K Genotype 1b
English: Table 5: Adverse reactions identified with simeprevir in combination with sofosbuvir or simeprevir in combination with peginterferon alfa and ribavirin1
Danish: Tabel 5: Identificerede bivirkninger af simeprevir i kombination med sofosbuvir eller simeprevir i kombination med peginterferon alfa og ribavirin1 Systemorgan klasse
English: Check with your doctor or pharmacist if you are not sure.
Danish: Kontakt din læge eller apotekspersonalet, hvis du er i tvivl om, hvad du skal gøre.
English: Table 7: Treatment-emergent laboratory abnormalities observed at a higher incidence in patients receiving simeprevir in combination with peginterferon alfa and ribavirin (pooled phase 3 studies C208, C216 and HPC3007; first 12 weeks of treatments)
Danish: Tabel 7: Behandlingsrelaterede laboratorieanomalier , som blev observeret med en højere incidens hos patienter, der fik simeprevir i kombination med peginterferon alfa og ribavirin (puljede fase 3-studier C208, C216 og HPC3007; de første 12 ugers behandling)
English: HCV/Human immunodeficiency virus type 1 (HIV-1) co-infection No dose adjustment of OLYSIO is required in HCV/HIV-1 co-infected patients (see sections 4.8, 5.1 and 5.2).
Danish: Samtidig infektion med HCV/human immundefektvirus type 1 (HIV-1) Dosisjustering af OLYSIO er ikke nødvendig til patienter med samtidig HCV- og HIV-1-infektion (se pkt.
English: > 1.5 to ≤ 3.0 x ULN 22 (7.7%)
Danish: > 1,5 til ≤ 3,0 x ULN 22 (7,7%)
English: 0.25 mg digoxin AUC 1.39 (1.16-1.67) ↑ digoxin Cmax 1.31 (1.14-1.51) ↑ digoxin Cmin not studied
Danish: 0,25 mg digoxin AUC 1,39 (1,16-1,67) ↑ digoxin Cmax 1,31 (1,14-1,51) ↑ digoxin Cmin ikke undersøgt
English: 2 Comparison based on historic controls.
Danish: 2 Sammenligning baseret på tidligere kontroller.
English: Medicinal products that affect simeprevir exposure
Danish: Lægemidler, der påvirkes af simeprevir
English: Simeprevir in combination with peginterferon alfa and ribavirin The safety profile of simeprevir in combination with peginterferon alfa and ribavirin in patients with HCV genotype 1 infection is based on the pooled data from the phase 2 studies and phase 3 studies C205, C206, C208, C216 and HPC3007 which included 924 patients who received simeprevir 150 mg once daily for 12 weeks and 540 patients who received placebo with peginterferon alfa and ribavirin.
Danish: Simeprevir i kombination med peginterferon alfa og ribavirin Sikkerhedsprofilen for simeprevir i kombination med peginterferon alfa og ribavirin hos patienter med HCV-genotype 1-infektion er baseret på de puljede data fra fase 2-studierne og fase 3-studierne C205, C206, C208, C216 og HPC3007 med 924 patienter, der fik simeprevir 150 mg én gang dagligt i 12 uger, og 540 patienter, der fik placebo sammen med peginterferon alfa og ribavirin.
English: Table 14: Treatment outcome in HCV genotype 1 infected patients without cirrhosis receiving 12 weeks simeprevir + sofosbuvir, with or without ribavirin (study HPC2002) Treatment outcome simeprevir + sofosbuvir N = 21 % (n/N)
Danish: Tabel 14: Behandlingsresultat hos HCV-genotype 1-inficerede patienter uden cirrose, der fik 12 ugers behandling med simeprevir + sofosbuvir med eller uden ribavirin (studie HPC2002) Behandlingsresultat simeprevir + sofosbuvir N = 21 % (n/N)
English: Patients without cirrhosis N = 155 % (n/N)
Danish: Patienter uden cirrose N = 155 % (n/N)
English: What OLYSIO is used for OLYSIO is used with other medicines to treat chronic (long-term) hepatitis C infection in adults.
Danish: OLYSIO anvendes sammen med andre lægemidler til behandling af kronisk (langvarig) hepatitis Cinfektion hos voksne.
English: Baseline polymorphisms at NS3 positions 43, 80, 122, 155, 156, and/or 168, associated with reduced simeprevir activity in vitro were generally uncommon (1.3%) in patients with HCV genotype 1 infection (n = 2,007; pooled phase 2 and phase 3 studies with simeprevir in combination with peginterferon alfa and ribavirin), with exception of the substitution Q80K in HCV genotype 1a patients which was seen 30% in patients with HCV genotype 1a and 0.5% in patients with HCV genotype 1b.
Danish: Baseline-polymorfisme ved NS3-positionerne 43, 80, 122, 155, 156 og/eller 168, forbundet med nedsat aktivitet af simeprevir in vitro, var generelt ikke almindelige (1,3%) hos patienter med HCVgenotype 1-infektion (n = 2.007; puljede fase 2- og fase 3-studier med simeprevir i kombination med peginterferon alfa og ribavirin), bortset fra substitutionen Q80K hos patienter med HCV-genotype 1a, som blev observeret hos 30% af patienterne med HCV-genotype 1a og hos 0,5% af patienterne med HCV-genotype 1b. I Europa var prævalensen lavere; 19% (73/377) hos patienter med HCVgenotype 1a og 0,3% (3/877) hos patienter med HCV-genotype 1b.
English: OLYSIO is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh class B or C) (see sections 4.4 and 5.2).
Danish: OLYSIO anbefales ikke til patienter med moderat eller svær leverinsufficiens (Child-Pugh klasse B eller C) (se pkt.
English: No dose adjustment of simeprevir is required in elderly patients (see section 4.2).
Danish: Justering af simeprevirdosis er ikke nødvendig hos ældre patienter (se pkt.
English: Each capsule contains simeprevir sodium equivalent to 150 milligrams of simeprevir.
Danish: Hver kapsel indeholder simeprevir-natrium svarende til 150 mg (milligram) simeprevir.
English: without cirrhosis, who are co-infected with HIV
Danish: uden cirrose med HIVcoinfektion med cirrose med HIV-coinfektion
English: DXM AUC 1.08 (0.87-1.35) ↑ DXM Cmax 1.21 (0.93-1.57) ↑ DXM Cmin not studied dextrorphan AUC 1.09 (1.03-1.15) ↔ dextrorphan Cmax 1.03 (0.93-1.15) ↔ dextrorphan Cmin not studied
Danish: DXM AUC 1,08 (0,87-1,35) ↑ DXM Cmax 1,21 (0,93-1,57) ↑ DXM Cmin ikke undersøgt dextrorphan AUC 1,09 (1,03-1,15) ↔ dextrorphan Cmax 1,03 (0,93-1,15) ↔ dextrorphan Cmin ikke undersøgt
English: ≥ 1.1 to ≤ 1.5 x ULN 34 (11.9%)
Danish: ≥ 1,1 til ≤ 1,5 x ULN 34 (11,9%)
English: The safety profile of simeprevir in combination with sofosbuvir in patients with HCV genotype 1 infection with or without cirrhosis is based on pooled data from the phase 2 study HPC2002 and the phase 3 studies HPC3017 and HPC3018 which included 472 patients who received simeprevir with sofosbuvir without ribavirin (155, 286 and 31 patients received 8, 12 or 24 weeks of treatment, respectively) and 108 patients who received simeprevir with sofosbuvir and ribavirin (54 patients each received 12 or 24 weeks of treatment).
Danish: Sikkerhedsprofilen af simeprevir i kombination med sofosbuvir hos patienter med HCV-genotype 1infektion med eller uden cirrose er baseret på puljede data fra fase 2-studiet HPC2002 og fase 3studierne HPC3017 og HPC3018 med 472 patienter inkluderet, der fik simeprevir sammen med sofosbuvir uden ribavirin (155, 286 og 31 patienter fik henholdsvis 8, 12 eller 24 ugers behandling), og 108 patienter, der fik simeprevir sammen med sofosbuvir og ribavirin (54 patienter fik 12 og 54 fik 24 ugers behandling).
English: - you have ever taken any medicines to treat hepatitis C; - you have any other liver problems in addition to hepatitis C; - you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely; - you have had or are going to have an organ transplant.
Danish: du har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere - du har eller skal gennemgå en organtransplantation Tal med din læge eller apotekspersonalet, inden du tager OLYSIO, hvis noget af ovenstående gør sig gældende for dig, eller hvis du er i tvivl.
English: If you forget to take OLYSIO - If it is more than 12 hours until your next dose, take the missed dose as soon as possible with food.
Danish: Hvis du har glemt at tage OLYSIO - Hvis der er mere end 12 timer til din næste dosis, skal du tage den glemte dosis sammen med mad, så snart du kommer i tanke om det. Fortsæt derefter med at tage OLYSIO på det sædvanlige tidspunkt.
English: Posology The recommended dosage of OLYSIO is one capsule of 150 mg once daily, taken with food.
Danish: Den anbefalede dosis af OLYSIO er én kapsel på 150 mg én gang dagligt.
English: Median baseline HCV RNA levels (log10 IU/ml) Presence of cirrhosis no cirrhosis with cirrhosis Prior treatment history treatment-naïve treatment-experienced1 IL28B genotype CC non-CC HCV geno/subtype and presence of baseline Q80K polymorphism in HCV genotype 1a HCV genotype 1a with Q80K HCV genotype 1b
Danish: Median HCV-RNA ved baseline (log10 IE/ml) Forekomst af cirrose ingen cirrose cirrose Tidligere behandling behandlingsnaiv behandlingserfaren IL28B-genotype CC ikke-CC HCV-geno-/undertype og forekomst af Q80K-polymorfisme i HCV-genotype 1a ved baseline HCV-genotype 1a med Q80K HCV-genotype 1b
English: ≥ 1.1 to ≤ 1.5 x ULN
Danish: ≥ 1,1 til ≤ 1,5 x ULN
English: HCV PRODUCTS Antiviral
Danish: HCV-PRÆPARATER Antivirale midler Daclatasvir
English: Treatment with OLYSIO must be initiated in combination with peginterferon alfa + ribavirin and administered for 12 weeks and then followed by an additional 12 weeks of peginterferon alfa + ribavirin.
Danish: Behandling med OLYSIO skal initieres i kombination med peginterferon alfa + ribavirin og administreres i 12 uger efterfulgt af yderligere 12 uger med peginterferon alfa + ribavirin.
English: Oral: midazolam AUC 1.45 (1.35-1.57) ↑ midazolam Cmax 1.31 (1.19-1.45) ↑ midazolam Cmin not studied
Danish: Oralt: midazolam AUC 1,45 (1,35-1,57) ↑ midazolam Cmax 1,31 (1,19-1,45) ↑ midazolam Cmin ikke undersøgt
English: Treatment-naïve patients N = 53 % (n/N)
Danish: Behandlingsnaiv e patienter N = 53 % (n/N)
English: Increased plasma concentrations of lovastatin are expected.
Danish: Der forventes forhøjet plasmakoncentration af lovastatin.
English: Mild increases in simeprevir concentrations may occur due to mild inhibition of OATP1B1 by sildenafil.
Danish: Let forhøjet koncentration af simeprevir kan opstå på grund af sildenafils svage hæmning af OATP1B1.
English: Treatment with OLYSIO must be initiated in combination with peginterferon alfa + ribavirin and administered for 12 weeks and then followed by an additional 36 weeks of peginterferon alfa + ribavirin.
Danish: Behandling med OLYSIO skal initieres i kombination med peginterferon alfa + ribavirin og administreres i 12 uger efterfulgt af yderligere 36 uger med peginterferon alfa + ribavirin.
English: ≥ 1.25 to ≤ 2.50 x ULN
Danish: ≥ 1,25 til ≤ 2,50 x ULN
English: Photosensitivity reactions have been observed with OLYSIO combination treatment (see section 4.8).
Danish: Der er observeret reaktioner i form af fotosensibilitet efter anvendelse af OLYSIOkombinationsbehandling (se pkt.
English: Table 6: Treatment-emergent laboratory abnormalities in amylase and lipase in patients receiving 12 or 24 weeks of simeprevir in combination with sofosbuvir (12 weeks: pooled studies HPC2002, HPC3017 and HPC3018; 24 weeks: study HPC2002) Laboratory parameter WHO toxicity range1 12 weeks simeprevir +
Danish: Tabel 6: Behandlingsrelaterede laboratorieanomalier i amylase og lipase hos patienter, der fik 12 eller 24 ugers behandling med simeprevir i kombination med sofosbuvir (12 uger: de puljede studier HPC2002, HPC3017 og HPC3018; 24 uger: studie HPC2002)
English: 24 weeks3
Danish: 24 uger3
English: Gender had no clinically relevant effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis of HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Danish: Køn havde ingen klinisk relevant virkning på simeprevirs farmakokinetik, baseret på en farmakokinetisk populationsanalyse af HCVinficerede patienter, der blev behandlet med simeprevir i kombination med peginterferon alfa og ribavirin.
English: ANALEPTIC Caffeine 150 mg caffeine AUC 1.26 (1.21-1.32) ↑ caffeine Cmax 1.12 (1.06-1.19) ↔ caffeine Cmin not studied
Danish: Koffein AUC 1,26 (1,21-1,32) ↑ Koffein Cmax 1,12 (1,06-1,19) ↔ Koffein Cmin ikke undersøgt
English: These characteristics have no clinically relevant effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis of HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Danish: Disse parametre havde ingen klinisk relevant virkning på simeprevirs farmakokinetik, baseret på en farmakokinetisk populationsanalyse af HCV-inficerede patienter, der blev behandlet med simeprevir i kombination med peginterferon alfa og ribavirin.
English: 3 To prior treatment with peginterferon alfa and ribavirin.
Danish: 3 På tidligere behandling med peginterferon alfa og ribavirin.
English: 4 Includes relapsers, partial and null responders to prior treatment with peginterferon and ribavirin.
Danish: 4 Inkluderer patienter med recidiv og patienter med delvist eller nul respons inden behandling med peginterferon og ribavirin.
English: Table 13: Treatment outcome in HCV genotype 1 infected patients receiving 12 weeks simeprevir + sofosbuvir (studies HPC3017 and HPC3018) Treatment outcome
Danish: Tabel 13: Behandlingsresultat hos HCV-genotype 1-inficerede patienter, der fik 12 ugers behandling med simeprevir + sofosbuvir (studie HPC3017 og HPC3018) Behandlingsresultat
English: > 3.0 to ≤ 5.0 x ULN 1 (0.3%)
Danish: > 3,0 til ≤ 5,0 x ULN 1 (0,3%)
English: Treatment-naïve patients N = 35 % (n/N)
Danish: Behandlingsnaiv e patienter N = 35 % (n/N)
English: > 1.5 to ≤ 2.0 x ULN 15 (5.2%)
Danish: > 1,5 til ≤ 2,0 x ULN 15 (5,2%)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains simeprevir sodium equivalent to 150 mg simeprevir.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder simeprevirnatrium svarende til 150 mg simeprevir.
English: tacrolimus AUC 0.83 (0.59-1.16) ↓ tacrolimus Cmax 0.76 (0.65-0.90) ↓ tacrolimus Cmin not studied simeprevir AUC 1.85 (1.18-2.91) ↑6 simeprevir Cmax 1.79 (1.22-2.62) ↑6 simeprevir Cmin not studied6
Danish: tacrolimus AUC 0,83 (0,59-1,16) ↓ tacrolimus Cmax 0,76 (0,65-0,90) ↓ tacrolimus Cmin ikke undersøgt simeprevir AUC 1,85 (1,18-2,91) ↑6 simeprevir Cmax 1,79 (1,22-2,62) ↑6 simeprevir Cmin ikke undersøgt6
English: ciclosporin AUC 1.19 (1.13-1.26) ↑ ciclosporin Cmax 1.16 (1.07-1.26) ↑ ciclosporin Cmin not studied simeprevir AUC 5.81 (3.56-9.48) ↑5 simeprevir Cmax 4.74 (3.12-7.18) ↑5 simeprevir Cmin not studied5
Danish: ciclosporin AUC 1,19 (1,13-1,26) ↑ ciclosporin Cmax 1,16 (1,07-1,26) ↑ ciclosporin Cmin ikke undersøgt simeprevir AUC 5,81 (3,56-9,48) ↑5 simeprevir Cmax 4,74 (3,12-7,18) ↑5 simeprevir Cmin ikke undersøgt
English: Increased simeprevir concentrations may occur due to inhibition of OATP1B1 by atorvastatin.
Danish: Simeprevirkoncentrationen kan øges på grund af atorvastatins hæmning af OATP1B1.
English: The response rates for patients with cirrhosis (METAVIR score F4) receiving 12 or 24 weeks of simeprevir + sofosbuvir are shown in table 15.
Danish: Tabel 15 viser responsraterne for patienter med cirrose (METAVIRscore F4), der fik 12 eller 24 ugers behandling med simeprevir + sofosbuvir.
English: 1 Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin, and interferon-intolerant patients.
Danish: 1 Inkluderer patienter med recidiv og patienter med delvist eller nul respons inden behandling med interferon (pegyleret eller ikke-pegyleret) med eller uden ribavirin samt interferon-intolerante patienter.