FrancophonIA/ELRC3.0 huggingface dataset:
English: Mild increases in concentrations of these antihistamines may be expected.
Danish: Let forhøjede koncentrationer af disse antihistaminer kan forventes.
English: Hepatobiliary disorders: common blood bilirubin increased* blood bilirubin increased* blood bilirubin increased* Skin and subcutaneous tissue disorders: very common rash*
Danish: Lever- og galdeveje: almindelig forhøjet blodbilirubin* forhøjet blodbilirubin* forhøjet blodbilirubin* Hud og subkutane væv: meget almindelig udslæt*
English: Table 21: SVR12 rates for selected subgroups (study HPC3007) Subgroup simeprevir + peginterferon + ribavirin % (n/N)
Danish: Tabel 21: SVR12-raterne for udvalgte undergrupper (studie HPC3007) Undergruppe simeprevir + peginterferon + ribavirin % (n/N)
English: HPC2014 (OSIRIS; Phase 2)
Danish: HPC2014 (OSIRIS; fase
English: 12 or 24 weeks SMV + sofosbuvir, with or without ribavirin4
Danish: 12 eller 24 ugers SMV + sofosbuvir med eller uden ribavirin4
English: CALCIUM CHANNEL BLOCKERS (oral administration) Amlodipine
Danish: CALCIUMANTAGONISTER (oral administration) Amlodipin
English: This effect was observed at higher systemic exposures (11-fold) than those in humans at the recommended dose of 150 mg once daily.
Danish: Denne effekt blev observeret ved højere systemisk eksponering (11 gange) end hos mennesker ved den anbefalede dosis på 150 mg én gang dagligt.
English: OLYSIO contains lactose
Danish: OLYSIO indeholder lactose
English: In case of severe rash, OLYSIO and other co-administered medicinal products for the treatment of CHC should be discontinued and the patients should be monitored until the symptoms have resolved.
Danish: I tilfælde af alvorligt udslæt skal OLYSIO og anden samtidig medicin til behandling af CHC seponeres, og patienten skal monitoreres, indtil symptomerne er forsvundet.
English: Co-administration of OLYSIO with ciclosporin is not recommended as this leads to significantly higher exposure of simeprevir based on interim data from an ongoing phase 2 study in HCV infected post-liver transplant patients (see section 4.5).
Danish: Samtidig administration af OLYSIO og ciclosporin anbefales ikke, da dette giver signifikant højere eksponering for simeprevir baseret på foreløbige data fra et igangværende fase 2-studie med HCVinficerede levertransplanterede patienter (se pkt.
English: Tacrolimus 2 mg patient individualised dose4
Danish: Tacrolimus 2 mg individuelt tilpasset dosis4
English: 7 The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic study in opioid-dependent adults on stable methadone maintenance therapy.
Danish: 7 Interaktionen mellem simeprevir og lægemidlet blev undersøgt i et farmakokinetisk studie med opioidafhængige voksne i stabil vedligeholdelsesbehandling med methadon.
English: 1 Re-evaluation of HCV RNA is recommended in case of HCV RNA ≥ 25 IU/ml after previous undetectable HCV RNA to confirm HCV RNA levels prior to discontinuing HCV treatment.
Danish: 1 Reevaluering af HCV-RNA anbefales, hvis HCV-RNA ≥ 25 IE/ml efter tidligere udetekterbart HCV-RNA for at bekræfte HCV-RNA-niveauet inden seponering af HCV-behandlingen.
English: - The other ingredients are sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, gelatin, titanium dioxide (E171), iron oxide black (E172) and shellac (E904).
Danish: - Øvrige indholdsstoffer: natriumlaurilsulphat, magnesiumstearat, kolloid vandfri silica, croscarmellosenatrium, lactosemonohydrat, gelatine, titandioxid (E 171), sort jernoxid (E 172) og shellac (E 904).
English: Study HPC2014 N = 43 % (n/N)
Danish: Studie HPC2014 N = 43 % (n/N)
English: 1 WHO worst toxicity grades 1 to 4.
Danish: 1 Sværeste toksicitetsgrader 1 til 4 iht.
English: Very common: may affect more than 1 in 10 people: - feeling sick (nausea) - itching of the skin - skin rash - being short of breath.
Danish: Meget almindelig: Kan ramme flere end 1 ud af 10 personer: - kvalme - hudkløe - hududslæt - stakåndethed
English: Table 11: Studies conducted with simeprevir + sofosbuvir: population and summary of study design
Danish: Tabel 11: Studier udført med simeprevir + sofosbuvir: population og resumé af studiedesign Studie1
English: Other NRTIs (Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Zidovudine)
Danish: Andre NRTI'er (abacavir, didanosin, emtricitabin, lamivudin, stavudin, zidovudin)
English: Most of the rash and pruritus events in simeprevir-treated patients were of mild or moderate severity (grade 1 or 2).
Danish: De fleste tilfælde af udslæt og kløe hos simeprevir-behandlede patienter var lette eller moderate i styrke (grad 1 eller 2).
English: Antiretroviral - protease inhibitors (PIs) Darunavir/ritonavir3
Danish: Antiretrovirale midler - proteasehæmmere (PI'er) Darunavir/ritonavir3
English: (inhibition of P-gp transporter)
Danish: (Hæmning af P-gp-transportør.)
English: Cobicistat-containing medicinal products
Danish: Cobicistat-holdige lægemidler
English: 1 The one patient with on-treatment failure discontinued treatment early due to an adverse event.
Danish: 1 Den ene patient med manglende effekt under behandlingen afbrød behandlingen før det planlagte tidspunkt på grund af en bivirkning.
English: WHO worst toxicity grades 1 to 4.
Danish: Sværeste toksicitetsgrader 1 til 4 iht.
English: Compared to healthy subjects with normal hepatic function, the mean steady-state AUC of simeprevir was 2.4-fold higher in non-HCV infected subjects with moderate hepatic impairment (Child-Pugh class B) and 5.2-fold higher in non-HCV infected subjects with severe hepatic impairment (Child-Pugh class C).
Danish: Sammenlignet med raske personer med normal leverfunktion var den gennemsnitlige AUC for simeprevir ved steady state 2,4 gange højere hos ikke-HCV-inficerede personer med moderat leverinsufficiens (Child-Pugh-klasse B) og 5,2 gange højere hos ikke-HCV-inficerede personer med svær leverinsufficiens (Child-Pugh-klasse C).
English: The safety and efficacy of simeprevir have not been established in HCV infected patients with moderate or severe hepatic impairment (Child-Pugh class B or C).
Danish: Simeprevirs sikkerhed og virkning er ikke blevet fastlagt hos HCV-inficerede patienter med moderat eller svær leverinsufficiens (Child-Pugh klasse B eller C).
English: Other ritonavir-boosted or unboosted HIV PIs (Atazanavir, (Fos)amprenavir, Lopinavir, Indinavir, Nelfinavir, Saquinavir, Tipranavir)
Danish: Andre ritonavir-forstærkede eller uforstærkede HIV-PI'er (atazanavir, (fos)amprenavir, lopinavir, indinavir, nelfinavir, saquinavir, tipranavir)
English: HPC3011 (RESTORE; Phase 3)
Danish: HPC3011 (RESTORE; fase 3)
English: The following side effects may happen with OLYSIO when used in combination with sofosbuvir: Common: may affect up to 1 in 10 people: - itching of the skin - skin rash* - constipation - being sensitive to sunlight (photosensitivity) - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver).
Danish: Følgende bivirkninger kan optræde, når du tager OLYSIO sammen med sofosbuvir: Almindelig: Kan ramme op til 1 ud af 10 personer: - hudkløe - hududslæt* - forstoppelse - øget følsomhed for sollys (fotosensibilitet) - for meget bilirubin i blodet (bilirubin er et farvestof, der dannes i leveren) * Hududslæt kan ramme flere end 1 ud af 10 personer (meget almindelig bivirkning), hvis
English: 4 simeprevir-treated patients who experienced relapse after SVR12.
Danish: Inkluderer 4 simeprevir-behandlede patienter, der fik recidiv efter SVR12.
English: 2 The daily dose of ribavirin is weight based (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg) and administered orally in two divided doses with food; also refer to the Summary of Product Characteristics of ribavirin.
Danish: 2 Den daglige dosis af ribavirin er vægtbaseret (< 75 kg: 1.000 mg; ≥ 75 kg: 1.200 mg) og administreres oralt fordelt på to doser sammen med mad.
English: What OLYSIO is - OLYSIO contains the active substance ‘simeprevir'.
Danish: Det er OLYSIO - OLYSIO indeholder det aktive stof simeprevir.
English: Capsule content Sodium lauryl sulfate Magnesium stearate Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate
Danish: Kapselindhold Natriumlaurilsulfat Magnesiumstearat Kolloid vandfri silica Croscarmellosenatrium Lactosemonohydrat
English: Mild increases in concentrations of these antiarrhythmics may be expected when these medicinal products are administered orally.
Danish: Mindre stigninger i koncentrationerne af disse antiarytmika kan forventes, hvis disse lægemidler indgives oralt.
English: treatment was 24 weeks if the following on-treatment protocol-defined response-guided therapy criteria were met: HCV RNA < 25 IU/ml detectable or undetectable at week 4 AND undetectable HCV RNA at week 12.
Danish: Den planlagte samlede varighed af HCV-behandling var 24 uger, hvis følgende protokoldefinerede kriterier for responsafhængig behandling var opfyldt under behandlingen: HCV-RNA < 25 IE/ml detekterbart eller ikke-detekterbart i uge 4 OG ikke-detekterbart HCVRNA i uge 12.
English: In vitro experiments with human Caco-2 cells indicated that simeprevir is a substrate of P-gp.
Danish: Eksperimenter in vitro med humane Caco-2-celler indikerede, at simeprevir er substrat for P-glykoprotein (P-gp).
English: If a dose of OLYSIO is missed by more than 12 hours after the usual dosing time, the patient should not take the missed dose of OLYSIO and should resume dosing of OLYSIO with food at the regularly scheduled time.
Danish: Hvis en dosis af OLYSIO glemmes i mere end 12 timer efter det sædvanlige doseringstidspunkt, må patienten ikke tage den manglende dosis, men skal genoptage doseringen af OLYSIO sammen med mad på det sædvanlige, planlagte tidspunkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/924/001 (7 capsules)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/924/001 (7 kapsler)
English: (study C212)
Danish: infektion (studie C212)
English: Table 9: Antiviral activity of simeprevir 200 mg monotherapy (studies C201 and C202) Genotype
Danish: Tabel 9: Antiviral aktivitet af monoterapi med simeprevir 200 mg (studie C201 og C202) Genotype
English: ANTIHISTAMINES Astemizole Terfenadine
Danish: ANTIHISTAMINER Astemizol
English: HPC3007 (PROMISE; Phase 3)
Danish: HPC3007 (PROMISE; fase 3)
English: Female patients of childbearing potential and male patients with female partners of childbearing potential must use an effective form of contraception during treatment with ribavirin and after completion of ribavirin treatment for a duration as specified in the Summary of Product Characteristics for ribavirin.
Danish: Kvindelige, fertile patienter samt mandlige patienter og deres kvindelige fertile partnere skal bruge en sikker antikonceptionsmetode under behandlingen med ribavirin, og efter behandlingen med ribavirin er afsluttet i den periode, der er angivet i produktresumeet for ribavirin.
English: Most photosensitivity reactions in simeprevir-treated patients were of mild or moderate severity (grade 1 or 2); 0.3% of the simeprevir-treated patients experienced serious reactions leading to hospitalisation (see section 4.4).
Danish: De fleste lysfølsomhedsreaktioner hos simeprevir-behandlede patienter var af let eller moderat sværhedsgrad (grad 1 eller grad 2); 0,3% af de simeprevir-behandlede patienter havde alvorlige reaktioner førende til hospitalisering (se pkt.
English: In patients aged > 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patients compared to 9.1% in placebo-treated patients (all grades; pooled phase 3).
Danish: Hos patienter > 45 år blev der indberettet dyspnø hos 16,4% af de simeprevir-behandlede patienter sammenlignet med hos 9,1% i placebo-gruppen (alle grader; puljede fase 3-studier).
English: Mild increased or decreased plasma concentrations of sirolimus may occur.
Danish: Der kan forekomme let forhøjet eller reduceret plasmakoncentration af sirolimus.
English: Co-administration of OLYSIO with substances that moderately or strongly induce or inhibit cytochrome P450 3A (CYP3A4) is not recommended as this may lead to significantly lower or higher exposure of simeprevir, respectively.
Danish: Samtidig administration af OLYSIO og stoffer, der i moderat eller kraftig grad inducerer eller hæmmer cytokrom P450 3 A (CYP3A4), anbefales ikke, da dette i signifikant grad kan henholdsvis reducere eller øge eksponeringen af simeprevir.
English: R(-) methadone AUC 0.99 (0.91-1.09) ↔ R(-) methadone Cmax 1.03 (0.97-1.09) ↔ R(-) methadone Cmin 1.02 (0.93-1.12) ↔
Danish: R(-) methadon AUC 0,99 (0,91-1,09) ↔ R(-) methadon Cmax 1,03 (0,97-1,09) ↔ R(-) methadon Cmin 1,02 (0,93-1,12) ↔
English: In a biochemical assay, simeprevir inhibited the proteolytic activity of recombinant genotype 1a and 1b HCV NS3/4A proteases, with median Ki values of 0.5 nM and 1.4 nM, respectively.
Danish: I en biokemisk analyse hæmmede simeprevir den proteolytiske aktivitet af rekombinant genotype 1a og 1b HCV NS3/4A-proteaser med mediane Ki -værdier på henholdsvis 0,5 nM og 1,4 nM.
English: (CYP3A4 enzyme induction [etravirine or nevirapine] or inhibition [delavirdine])
Danish: (Induktion af CYP3A4 [etravirin eller nevirapin] eller hæmning [delavirdin])
English: 12, 24 or 48 weeks SMV in combination with 48 weeks peg-IFN-alfa + RBV; control group: 48 weeks placebo + peg-IFN-alfa + RBV
Danish: 12, 24 eller 48 ugers SMV i kombination med 48 ugers peg-IFN-alfa + RBV; kontrolgruppe: 48 ugers placebo + peg-IFN-alfa + RBV
English: Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment.
Danish: Plasmaproteinbindingen gennemgår ingen ændring af betydning hos patienter med nyre- eller leverinsufficiens.
English: Read the package leaflets for these other medicines for information regarding driving and using machines.
Danish: Læs indlægssedlerne til de andre lægemidler for information om at køre motorkøretøj og arbejde med maskiner.
English: HMG CO-A REDUCTASE INHIBITORS Rosuvastatin
Danish: HMG-CO-A-REDUKTASEHÆMMERE Rosuvastatin
English: Antiretroviral - non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz
Danish: Antiretrovirale midler - non-nukleosid reverse transkriptasehæmmere (NNRTI'er) Efavirenz
English: All patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir achieved SVR12 (table 16).
Danish: Alle patienter med eller uden cirrose, der fik 12 ugers behandling med simeprevir + sofosbuvir, opnåede SVR12 (tabel 16).
English: (OATP1B1 inhibition by tacrolimus)
Danish: (OATP1B1 hæmmes af tacrolimus)
English: How to take - The recommended dose of OLYSIO is one capsule (150 milligrams) once a day.
Danish: Sådan skal du tage OLYSIO - Den anbefalede dosis af OLYSIO er én kapsel (150 mg) én gang om dagen.
English: 1 Superior versus historical control rate (historical SVR rates of approved combination treatments of direct acting antivirals with peginterferon alfa and ribavirin).
Danish: 1 Superioritet vs. historisk kontrolrate (historiske SVR-rater for godkendte kombinationsbehandlinger med direkte virkende antivirale midler plus peginterferon alfa og ribavirin).
English: Antiretroviral - nucleoside or nucleotide reverse transcriptase inhibitors (N(t)RTIs) Tenofovir disoproxil fumarate
Danish: Antiretrovirale midler - nukleosid eller nukleotid revers transkriptasehæmmere (N(t)RTI'er) Tenofovirdisoproxilfu marat
English: Antiretroviral - integrase inhibitor Raltegravir
Danish: Antiretrovirale midler - integrasehæmmer Raltegravir
English: No dose adjustment of OLYSIO is required in patients with mild hepatic impairment (Child-Pugh class A).
Danish: Det er ikke nødvendigt at justere dosis af OLYSIO hos patienter med let leverinsufficiens (Child-Pugh klasse A).
English: 1 p < 0.001 compared to historical control of peginterferon alfa and ribavirin.
Danish: 1 p < 0,001 sammenlignet med en tidligere kontrol med peginterferon alfa og ribavirin.
English: 24 weeks OLYSIO + sofosbuvir or 12 weeks OLYSIO + sofosbuvir + ribavirin2
Danish: 24 ugers OLYSIO + sofosbuvir eller 12 ugers OLYSIO + sofosbuvir + ribavirin2
English: PHOSPHODIESTERASE TYPE 5 INHIBITORS Sildenafil
Danish: FOSFODIESTERASE 5-HÆMMERE Sildenafil
English: Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with OLYSIO.
Danish: Se også produktresumeet for de lægemidler, der anvendes i kombination med OLYSIO.
English: Refer to the Summary of Product Characteristics for these co-administered medicinal products regarding their potential effect on the ability to drive and use machines.
Danish: Der henvises til produktresumeerne for disse samtidigt administrerede lægemidler for information om deres potentielle virkning på evnen til at føre motorkøretøj og betjene maskiner.
English: Table 18: Studies conducted with simeprevir + peginterferon alfa + ribavirin: demographics and baseline characteristics Pooled C208 and C216 N = 785
Danish: Tabel 18: Studier udført med simeprevir + peginterferon alfa + ribavirin: Demografiske karakteristika og baselinekarakteristika Puljet C208 og C216 N = 785
English: No dose adjustment is required for either drug when OLYSIO is co-administered with maraviroc.
Danish: Der er ikke behov for justering af dosis af nogen af præparaterne, hvis OLYSIO administreres sammen med maraviroc.
English: Table 23: Treatment outcome in HCV genotype 4 infected patients (study HPC3011) Treatment outcome
Danish: Tabel 23: Behandlingsresultat hos HCV-genotype 4-inficerede patienter (studie HPC3011) Behandlingsresultat
English: Table 17: Studies conducted with simeprevir + peginterferon alfa + ribavirin: population and summary of study design
Danish: Tabel 17: Studier udført med simeprevir + peginterferon alfa + ribavirin: population og resumé af studiedesign
English: ANTICOAGULANTS Warfarin and other vitamin K antagonists warfarin 10 mg:
Danish: ANTIKOAGULANTIA Warfarin og andre vitamin K-antagonister
English: This can damage or break open the capsule.
Danish: Kapslen kan blive ødelagt eller gå i stykker.
English: - Swallow the capsule whole.
Danish: - Kapslen skal sluges hel.
English: The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 14% (70/509); 67% achieved SVR12.
Danish: Andelen af OLYSIO-behandlede patienter med HCV-RNA < 25 IE/ml detekterbart ved uge 4 var 14% (70/509); 67% opnåede SVR12.
English: HERBAL PRODUCTS Milk thistle (Silybum marianum)
Danish: NATURLÆGEMIDLER Marietidsel (Silybum marianum)
English: Mild increases in concentrations of amiodarone may be expected when amiodarone is administered orally.
Danish: Let stigning i koncentrationen af amiodaron kan forventes, når amiodaron indgives oralt.
English: Table 12: Demographics and baseline characteristics (studies HPC3017 and HPC3018) HPC3017 N = 310
Danish: Tabel 12: Demografiske karakteristika og baseline-karakteristika (studie HPC3017 og HPC3018)
English: Increased plasma concentrations of orally administered calcium channel blockers may be expeced.
Danish: Der kan forventes forhøjede plasmakoncentrationer af oralt administrerede calciumantagonister.
English: nelfinavir, nevirapine, ritonavir, saquinavir or tipranavir to treat HIV infection - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin to lower cholesterol levels - ciclosporin, sirolimus or tacrolimus to lower immune response or prevent organ transplant failures - sildenafil or tadalafil to treat ‘pulmonary arterial hypertension' - midazolam or triazolam (when taken by mouth) to help you sleep or for anxiety
Danish: nelfinavir, nevirapin, ritonavir, saquinavir eller tipranavir til behandling af HIV-infektion - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin eller simvastatin til sænkning af kolesterolindholdet i blodet - ciclosporin, sirolimus eller tacrolimus til hæmning af immunforsvaret eller forebyggelese af svigt af transplanterede organer - sildenafil eller tadalafil til behandling af ‘pulmonal arteriel hypertension' - midazolam eller triazolam (når det tages gennem munden) behandling af søvnproblemer eller angst
English: Black printing ink Shellac (E904) Iron oxide black (E172)
Danish: Sort prægeblæk Shellac (E 904) Jernoxid, sort (E 172)
English: What OLYSIO contains - The active substance is simeprevir.
Danish: OLYSIO indeholder: - Aktivt stof: simeprevir.
English: 48 weeks3
Danish: 48 uger3
English: R155Q3, D168A, D168F3, D168H, D168T, I170T5
Danish: Q80K3, S122A/G/I/T3, S122R, R155Q3, D168A, D168F3, D168H, D168T, I170T5
English: How to take OLYSIO
Danish: Sådan skal du tage OLYSIO
English: Interim data from a phase 2 study in 9 HCV infected post-liver transplant patients.
Danish: Foreløbige data fra et fase 2-studie med 9 HCV-inficerede levertransplanterede patienter.
English: Supernumerary ribs and delayed ossification were reported in mice at 4-fold higher exposures than those observed in humans at the recommended dose of 150 mg once daily.
Danish: Der blev rapporteret for mange ribben og forsinket ossifikation hos mus ved eksponeringer, der var 4 gange højere end den observede humane eksponering ved den anbefalede dosis på 150 mg én gang dagligt.
English: 2 Relapsers after prior interferon-based therapy.
Danish: 2 Patienter med recidiv efter tidligere interferon-baseret behandling.
English: HPC3021 (PLUTO; Phase 3)
Danish: HPC3021 (PLUTO; fase
English: The safety profile of simeprevir is comparable in patients with HCV genotype 4 infection and HCV genotype 1 infection, when given either in combination with sofosbuvir or in combination with peginterferon alfa and ribavirin.
Danish: Simeprevirs sikkerhedsprofil er sammenlignelig hos patienter med HCV-genotype 4-infektion og HCV-genotype 1-infektion, når det enten gives i kombination med sofosbuvir eller i kombination med peginterferon alfa og ribavirin.
English: Interim data from a phase 2 study in 11 HCV infected post-liver transplant patients.
Danish: Foreløbige data fra et fase 2-studie med 11 HCV-inficerede levertransplanterede patienter.
English: (OATP1B1/3, P-gp and CYP3A inhibition by ciclosporin)
Danish: (OATP1B1/3, P-gp og CYP3A hæmmes af ciclosporin)
English: The following side effects may happen with OLYSIO when used in combination with peginterferon alfa and ribavirin:
Danish: Følgende bivirkninger kan opstå, når du tager OLYSIO sammen med peginterferon alfa og ribavirin:
English: Prior relapsers Prior partial responders Prior null responders
Danish: med tidligere recidiv med tidligere delvist respons med tidligere nul respons
English: Nisoldipine
Danish: Nisoldipin
English: 4 Body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin.
Danish: 4 Dosis af ribavirin baseret på legemsvægt og fordelt på to daglige doser i henhold til produktresumeet for ribavirin.
English: 100 mg patient individualised dose4
Danish: 100 mg individuelt tilpasset dosis4
English: HPC3018 (OPTIMIST-2; Phase 3)
Danish: HPC3018 (OPTIMIST-2; fase 3)
English: These HCV protease inhibitors are anticipated to be cross-resistant, and co-administration is not recommended (see also section 4.5).
Danish: Man kan forudse krydsresistens med disse HCV-proteasehæmmere, og samtidig administration kan ikke anbefales (se også pkt.
English: Plasma exposure of simeprevir in HCV infected patients was about 2- to 3-fold higher compared to that observed in healthy subjects.
Danish: Plasmaeksponeringen af simeprevir hos HCV-inficerede patienter var cirka 2-3 gange højere end den, der er observeret hos raske personer.
English: Study1
Danish: Studie1
English: Mild increases in concentrations of PDE-5 inhibitors may be expected.
Danish: Let forhøjede koncentrationer af PDE-5- hæmmere kan forventes.
English: LIST OF EXCIPIENTS Contains lactose monohydrate
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactosemonohydrat
English: Treatment-emergent laboratory abnormalities that were observed at a higher incidence in simeprevir-treated patients than in patients treated with placebo, peginterferon alfa and ribavirin are given in table 7.
Danish: Behandlingsrelaterede laboratorieanomalier, der blev observeret med en højere incidens hos de simeprevir-behandlede patienter end hos de patienter, som fik placebo, peginterferon alfa og ribavirin, er vist i tabel 7.