FrancophonIA/ELRC3.0 huggingface dataset:
English: Elevations in direct and indirect bilirubin have been reported in patients treated with simeprevir and were mostly of mild or moderate severity.
Danish: Der er indberettet stigninger i direkte og indirekte bilirubin hos patienter, der blev behandlet med simeprevir, primært lette eller moderate i sværhedsgrad.
English: No emerging NS5B amino acid substitutions associated with sofosbuvir resistance were observed in patients who did not achieve SVR following treatment of simeprevir in combination with sofosbuvir (with or without ribavirin) for 12 or 24 weeks.
Danish: Der blev ikke observeret nogen opståede NS5B-aminosyresubstitutioner relateret til resistens over for sofosbuvir hos patienter, som ikke opnåede SVR, efter behandling med simeprevir i kombination med sofosbuvir (med eller uden ribavirin) i 12 eller 24 uger.
English: No serious adverse reactions
Danish: Der blev ikke indberettet nogen alvorlige bivirkninger.
English: Additionally, resistance to simeprevir was evaluated in HCV genotype 1a and 1b replicon assays using site-directed mutants and chimeric replicons carrying NS3 sequences derived from clinical isolates.
Danish: Resistens over for simeprevir blev desuden undersøgt i analyser af HCVgenotype 1a- og 1b-replikoner med anvendelse af målrettede mutanter og kimære replikoner, der bærer NS-sekvenser fra kliniske isolater.
English: No dose adjustment of OLYSIO is required in patients with mild or moderate renal impairment.
Danish: Det er ikke nødvendigt at justere dosis af OLYSIO hos patienter med let eller moderat nyreinsufficiens.
English: In vitro experiments show that simeprevir is a substrate for the drug transporters P-glycoprotein (P-gp), MRP2, OATP1B1/3 and OATP2B1.
Danish: Eksperimenter in vitro viser, at simeprevir er substrat for lægemiddeltransportørerne P-gp, MRP2, OATP1B1/3 og OATP2B1.
English: Some of the treatment-emergent NS3 amino acid substitutions detected in simeprevir-treated patients who did not achieve SVR in clinical studies (e.g., R155K) have been shown to reduce anti-HCV activity of telaprevir, boceprevir, and other NS3/4A PIs.
Danish: Nogle af de behandlingsrelaterede NS3-aminosyresubstitutioner, der blev påvist hos de simeprevir-behandlede patienter, som ikke opnåede SVR i de kliniske studier (fx R155K), er vist at reducere anti-HCV-aktiviteten af telaprevir, boceprevir og andre NS3/4A-PI'er.
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
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: Study HPC3007
Danish: Studie HPC3007
English: It is not recommended to co-administer OLYSIO with clarithromycin or telithromycin.
Danish: Det anbefales ikke at administrere OLYSIO sammen med clarithromycin eller telithromycin.
English: Amino acid substitutions at NS3 positions 80, 122, 155, and/or 168, associated with in vitro low level resistance to simeprevir when occurring alone, reduced simeprevir activity by more than 50-fold when present in combination.
Danish: Aminosyresubstitutioner ved NS3-positionerne 80, 122, 155 og/eller 168, der var forbundet med et lavt resistensniveau over for simeprevir in vitro, når de forekom alene, reducerede aktiviteten af simeprevir mere end 50 gange, når de forekom i kombination.
English: The presence of Q80K at baseline was associated with lower SVR rates in HCV genotype 1a patients treated with simeprevir in combination with peginterferon alfa and ribavirin (tables 19, 21, 22).
Danish: Forekomsten af Q80K ved baseline var forbundet med lavere SVR-rater hos patienter med HCVgenotype 1a, der blev behandlet med simeprevir i kombination med peginterferon alfa og ribavirin (tabel 19, 21, 22).
English: Caution is warranted and therapeutic drug monitoring for amiodarone and/or clinical monitoring (ECG etc.) when orally administered are recommended.
Danish: Der skal udvises forsigtighed, og terapeutisk monitorering af amiodaron og/eller klinisk monitorering (ekg osv.) anbefales, hvis det indgives oralt.
English: The effect of simeprevir 150 mg once daily and 350 mg once daily for 7 days on the QT interval was evaluated in a randomised, double-blind, placebo- and positive-controlled (moxifloxacin 400 mg once daily), 4-way cross-over study in 60 healthy subjects.
Danish: Effekten af simeprevir 150 mg én gang dagligt og 350 mg én gang dagligt i 7 dage på QT-intervallet blev undersøgt hos 60 raske studiedeltagere i et randomiseret, dobbeltblindt 4-vejs cross-over-studie med placebo og positiv kontrol (moxifloxacin 400 mg én gang dagligt).
English: When OLYSIO is used with ribavirin, please read the package leaflet for ribavirin for information regarding pregnancy.
Danish: Hvis OLYSIO bruges sammen med ribavirin, skal du læse indlægssedlen for ribavirin angående information om graviditet.
English: OLYSIO has not been studied in HCV infected patients with severe renal impairment (creatinine clearance below 30 ml/min) or end stage renal disease, including patients requiring haemodialysis.
Danish: OLYSIOs sikkerhed og virkning er ikke undersøgt hos HCV-inficerede patienter med alvorlig nyreinsufficiens (kreatinin-clearance under 30 ml/min) eller med nyresygdom i terminalstadiet, herunder patienter, der har behov for hæmodialyse.
English: No dose adjustment of OLYSIO is required in patients with mild hepatic impairment (Child-Pugh A).
Danish: Det er ikke nødvendigt at justere dosis af OLYSIO hos patienter med let leverinsufficiens (Child-Pugh A).
English: Combination treatment of OLYSIO with other medicines used for treating your chronic hepatitis C infection may affect your ability to drive and use machines.
Danish: Kombinationsbehandling med OLYSIO og andre lægemidler, der bruges til behandling af kronisk hepatitis C-infektion, kan påvirke din evne til at køre motorkøretøj og arbejde med maskiner.
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
Danish: Når du tager OLYSIO i kombinationsbehandling, skal du fortælle det til din læge, hvis du får følgende symptomer, da de kan være tegn på forværrede leverproblemer.
English: Increase in sofosbuvir exposure observed in the pharmacokinetic substudy is not clinically relevant.
Danish: En ikke klinisk relevant øget eksponering af sofosbuvir blev observeret i det farmakokinetiske delstudie.
English: When administered to lactating rats, simeprevir was detected in plasma of suckling rats likely due to excretion of simeprevir via milk.
Danish: Efter administration til lakterende rotter blev simeprevir påvist i plasma hos diende rotter, hvilket sandsynligvis skyldes udskillelse af simeprevir til mælk.
English: These increases in bilirubin levels were not associated with any adverse liver safety finding.
Danish: Denne stigning i bilirubin-koncentrationen var ikke forbundet med nogen leverrelaterede bivirkninger.
English: Unchanged simeprevir in faeces accounted for on average 31% of the administered dose.
Danish: Uomdannet simeprevir i fæces udgjorde gennemsnitligt 31% af
English: Grade 1
Danish: Grad 3
English: The terminal elimination half-life of simeprevir was 10 to 13 hours in healthy subjects and 41 hours in HCV infected patients receiving 200 mg simeprevir.
Danish: Den terminale halveringstid efter administration af 200 mg simeprevir var 10 til 13 timer hos raske personer og 41 timer hos HCV-inficerede patienter.
English: Action
Danish: Foranstaltning
English: There are limited data on the safety and efficacy of OLYSIO in patients older than 65 years.
Danish: Der foreligger kun begrænsede data vedrørende OLYSIOs sikkerhed og virkning hos patienter over 65 år.
English: When OLYSIO is used with ribavirin, read the package leaflet for ribavirin for information regarding contraception requirements.
Danish: Hvis OLYSIO bruges sammen med ribavirin, skal du læse indlægssedlen for ribavirin angående information om kravene til prævention.
English: Serious adverse reactions were reported in 0.3% of simeprevir-treated patients (2 photosensitivity events requiring hospitalisation) and in none of the patients receiving placebo with peginterferon alfa and ribavirin.
Danish: Der blev indberettet alvorlige bivirkninger for 0,3% af de simeprevir-behandlede patienter (2 lysfølsomhedsreaktioner, der nødvendiggjorde hospitalsindlæggelse) og for ingen af de patienter, der fik placebo sammen med peginterferon alfa og ribavirin.
English: Amino acid substitutions at NS3 positions 43, 80, 122, 155, 156, and 168 reduced in vitro simeprevir activity.
Danish: Aminosyresubstitutioner ved NS3-positionerne 43, 80, 122, 155, 156 og 168 reducerede aktiviteten af simeprevir in vitro.
English: Table 3: Treatment stopping rules in patients receiving OLYSIO in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response
Danish: Tabel 3: Regler for seponering hos patienter, der får OLYSIO i kombination med peginterferon alfa og ribavirin, og som har utilstrækkeligt virologisk respons under behandling
English: The days of the week are printed on
Danish: Ugedagene er trykt på blisterkortet.
English: Close monitoring is recommended if this medicinal product is administered with OLYSIO in combination with sofosbuvir (see section 4.4).
Danish: Nøje monitorering anbefales, hvis lægemidlet indgives sammen med OLYSIO i kombination med sofosbuvir (se pkt.
English: Co-administration of OLYSIO with medicinal products that are substrates for OATP1B1/3, P-gp and BCRP transport may result in increased plasma concentrations of such medicinal products (see table 4).
Danish: Samtidig administration af OLYSIO og lægemidler, der er substrater for OATP1B1/3-, P-gp- og BCRP-transport, kan medføre forhøjede plasmakoncentrationer af sådanne lægemidler (se tabel 4).
English: SVR12 rates were statistically significantly higher for patients receiving simeprevir with peginterferon alfa-2a or peginterferon alfa-2b and ribavirin (88% and 78%, respectively) compared to patients receiving placebo with peginterferon alfa-2a or peginterferon alfa-2b and ribavirin (62% and 42%, respectively) (study C216).
Danish: SVR12-raterne var statistisk signifikant højere for patienter, der fik simeprevir sammen med peginterferon alfa-2a eller peginterferon alfa-2b og ribavirin (henholdsvis 88% og 78%), sammenlignet med patienter, der fik placebo sammen med peginterferon alfa-2a eller peginterferon alfa-2b og ribavirin (henholdsvis 62% og 42%) (studie C216).
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 Antal inkluderede patienter
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
English: Then continue taking OLYSIO at the usual scheduled time.
Danish: Tag derefter den næste dosis OLYSIO på det sædvanlige tidspunkt.
English: Grade 3 rash or pruritus occurred in 0.5% and 0.1% of simeprevir-treated patients, respectively.
Danish: Der opstod udslæt eller kløe grad 3 hos henholdsvis 0,5% og 0,1% af de simeprevir-behandlede patienter.
English: Table 14 shows the response rates for patients without cirrhosis (METAVIR scores F0-3) receiving 12 weeks of simeprevir +sofosbuvir with or without ribavirin; extending treatment to 24 weeks did not increase response rates in comparison with 12 weeks treatment.
Danish: Tabel 14 viser responsraterne for patienter uden cirrose (METAVIR-score F0-3), der fik 12 ugers behandling med simeprevir + sofosbuvir med eller uden ribavirin; forlængelse af behandlingen til 24 uger øgede ikke responsraterne sammenlignet med 12 ugers behandling.
English: Genotype 1a and 1b isolates with a baseline Q80K polymorphism resulted in median FC in simeprevir EC50 of 11 (N = 33) and 8.4 (N = 2), respectively.
Danish: Genotype 1a- og 1b-isolater med en Q80Kpolymorfisme ved baseline medførte en median FC for simeprevir-EC50 på henholdsvis 11 (N = 33) og 8,4 (N = 2).
English: - If you are a man, your female partner must not become pregnant during your treatment and
Danish: - Hvis du er mand, må din kvindelige partner ikke blive gravid, så længe du er i behandling og i flere måneder efter, behandlingen er stoppet.
English: Elimination of simeprevir occurs via biliary excretion.
Danish: Simeprevir elimineres gennem biliær udskillelse.
English: Grade 2 ‘blood bilirubin increased' was reported in one patient (0.3%) receiving 12 weeks of treatment.
Danish: Forhøjet bilirubin i blodet af grad 2 blev indberettet for en enkelt patient (0,3%), der fik 12 ugers behandling.
English: Pharmacokinetic parameters of simeprevir were comparable between patients with HCV genotype 1 infection with or without HIV-1 co-infection.
Danish: De farmakokinetiske parametre for simeprevir var sammenlignelige hos patienter med HCVgenotype 1-infektion med og uden samtidig HIV-1-infektion.
English: Treatment week 12: ≥ 25 IU/ml
Danish: Behandlingsuge 12: ≥ 25 IE/ml
English: During administration of simeprevir with peginterferon alfa and ribavirin, the elevations in direct and indirect bilirubin were generally not associated with elevations in liver transaminases and normalised
Danish: Under administration af simeprevir sammen med peginterferon alfa og ribavirin var stigningerne i direkte og indirekte bilirubin generelt ikke forbundet med stigninger i leveraminotransferaser og blev normaliseret efter afslutning af behandlingen.
English: Plasma concentrations of midazolam were not affected when administered intravenously as simeprevir does not inhibit hepatic CYP3A4.
Danish: Plasmakoncentrationen af midazolam blev ikke påvirket efter intravenøs administration, da simeprevir ikke hæmmer CYP3A4 i leveren.
English: Read the package leaflets for these medicines for their dosage and directions on ‘how to take' them.
Danish: Læs indlægssedlerne til disse lægemidler med information om doseringen af dem samt instruktioner til anvendelsen.
English: UAB "JOHNSON & JOHNSON" filiāle Latvijā Mūkusalas iela 101
Danish: UAB "JOHNSON & JOHNSON" filiāle Latvijā
English: Moderate or strong inhibitors of CYP3A4 significantly increase the plasma exposure of simeprevir, and moderate or strong inducers of CYP3A4 significantly reduce plasma exposure of simeprevir.
Danish: Moderate og potente CYP3A4hæmmere øger plasmaeksponeringen af simeprevir markant, og moderate og potente CYP3A4induktorer reducerer plasmaeksponeringen af simeprevir markant.
English: Treatment week 4: ≥ 25 IU/ml
Danish: Behandlingsuge 4: ≥ 25 IE/ml
English: The capsule should be
Danish: Kapslen skal sluges hel.
English: Female patients of childbearing potential must use an effective form of contraception (see section 4.6).
Danish: Kvindelige patienter i den fertile alder skal anvende sikker kontraception (se pkt.
English: The MAH shall complete, within the stated timeframe, the below measures:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende
English: Patients with HCV genotype 1a predominantly had emerging R155K alone or in combination with amino acid substitutions at NS3 positions 80, 122 and/or 168, while patients with HCV genotype 1b had most often an emerging D168V substitution (table 10).
Danish: Hos patienter med HCV-genotype 1a opstod R155K hovedsagelig alene eller i kombination med aminosyresubstitutioner ved NS3-positionerne 80, 122 og/eller 168, mens patienter med HCV-genotype 1b oftest havde en opstået D168V-substitution (tabel 10).
English: Simeprevir inhibits the uptake transporters OATP1B1/3 and NTCP and the efflux transporters P-gp/MDR1, MRP2, BCRP and BSEP.
Danish: Simeprevir hæmmer optagelsestransportørerne OATP1B1/3 og NTCP samt effluxtransportørerne P-gp/MDR1, MRP2, BCRP og BSEP.
English: Refer to the Summary of Product Characteristics of peginterferon alfa and ribavirin for pre-treatment, on-treatment and post-treatment laboratory testing requirements including haematology, biochemistry (including hepatic enzymes and bilirubin), and pregnancy testing requirements.
Danish: Der henvises til produktresumeerne for peginterferon alfa og ribavirin for information om krav til laboratorietest før, under og efter behandlingen, herunder krav til hæmatologiske og biokemiske test (inklusive leverenzymer og bilirubin) samt graviditetstest.
English: Data from a 3-year follow-up study in patients who did not achieve SVR with simeprevir in combination with peginterferon alfa and ribavirin in a previous phase 2 or phase 3 study showed that in 86% (37/43) of these patients the emerging mutations at time of failure in the previous study were no longer detected after a median follow-up of 180 weeks (range 47-230 weeks) (study HPC3002).
Danish: Data fra et 3-årigt opfølgningsstudie med patienter, der ikke opnåede SVR med simeprevir i kombination med peginterferon alfa og ribavirin i et tidligere fase 2- eller fase 3-studie, viste, at hos 86% (37/43) af disse patienter kunne de opståede mutationer på tidspunktet for svigt i det tidligere studie ikke længere påvises efter en median opfølgningtid på 180 uger (intervallet 47-230 uger) (studie
English: Seventy-one percent (37/52), 93% (14/15), 80% (8/10) and 36% (10/28) of simeprevir-treated treatment-naïve patients, prior relapsers, prior partial responders and prior null responders had undetectable HCV RNA at week 4.
Danish: Henholdsvis 71% (37/52), 93% (14/15), 80% (8/10) og 36% (10/28) af de simeprevir-behandlede, behandlingsnaive patienter, patienter med tidligere recidiv, tidligere delvist respons og tidligere nul respons havde udetekterbart HCV-RNA ved uge 4.
English: Grade 3 or 4 adverse reactions were reported in 3.1% of patients receiving simeprevir with peginterferon alfa and ribavirin versus 0.5% of patients receiving placebo with peginterferon alfa and ribavirin.
Danish: Bivirkninger af grad 3 eller 4 blev indberettet for 3,1% af de patienter, der fik simeprevir sammen med peginterferon alfa og ribavirin, versus 0,5% af de patienter, der fik placebo sammen med peginterferon alfa og ribavirin.
English: The emerging NS3 amino acid substitutions were similar to those observed in patients who did not achieve SVR following treatment with simeprevir in combination with peginterferon alfa and ribavirin.
Danish: De opståede NS3-aminosyresubstitutioner svarede til dem, der observeres hos patienter, som ikke opnåede SVR efter behandling med simeprevir i kombination med peginterferon alfa og ribavirin.
English: rash*, pruritus*
Danish: udslæt*, kløe*
English: It is not recommended to co-administer OLYSIO with systemic fluconazole or voriconazole.
Danish: Det anbefales ikke at administrere OLYSIO sammen med systemisk fluconazol eller voriconazol.
English: Gastrointestinal disorders: very common nausea constipation common blood bilirubin increased* blood bilirubin increased* blood bilirubin increased* Skin and subcutaneous tissue disorders:
Danish: kvalme obstipation almindelig forhøjet blodbilirubin* forhøjet blodbilirubin* forhøjet blodbilirubin*
English: No dose adjustment is necessary based on body weight or body mass index.
Danish: Dosisjustering på baggrund af legemsvægt eller BMI er ikke nødvendig.
English: Table 9: Antiviral activity of simeprevir 200 mg monotherapy (studies C201 and C202) Mean (SE) change in HCV RNA at day 7/8 (log10 IU/mL)
Danish: Tabel 9: Antiviral aktivitet af monoterapi med simeprevir 200 mg (studie C201 og C202) Gennemsnitlig (SE) ændring i HCV-RNA på dag 7/8 (log10 IE/ml)
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
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
English: Chimeric replicons carrying NS3 sequences derived from HCV PI treatment-naïve genotype 1a and genotype 1b patients displayed median fold change (FC) in simeprevir EC50 values of 1.4 (N = 78) and 0.4 (N = 59) compared to reference genotype 1b replicon, respectively.
Danish: Kimære replikoner, der bærer NS3sekvenser fra HCV-PI-behandlingsnaive patienter med genotype 1a og genotype 1b, viste en median fold-ændring (FC) i simeprevirs EC50-værdier på henholdsvis 1,4 (N = 78) og 0,4 (N = 59) sammenlignet med reference-genotype 1b-replikonet.
English: Adverse reactions of simeprevir in combination with sofosbuvir or in combination with peginterferon alfa and ribavirin reported in adult patients with HCV genotype 1 infection are listed in table 5.
Danish: Bivirkninger af simeprevir i kombination med sofosbuvir eller i kombination med peginterferon alfa og ribavirin, der er indberettet for voksne patienter med HCV-genotype 1-infektion, vises i tabel 5.
English: Compared to healthy subjects with normal renal function (classified using the Modification of Diet in Renal Disease [MDRD] eGFR formula; eGFR ≥ 80 ml/min), the mean steady-state AUC of simeprevir was 1.62-fold higher (90% confidence interval: 0.73-3.6) in subjects with severe renal impairment (eGFR below 30 ml/min).
Danish: til Modification of Diet in Renal Disease [MDRD] eGFR-formlen; eGFR ≥ 80 ml/min) var det gennemsnitlige AUC for simeprevir ved steady state 1,62 gange højere (90% konfidensinterval: 0,73-3,6) hos personer med svær nyreinsufficiens (eGFR under 30 ml/min).
English: It is not recommended to co-administer OLYSIO with darunavir/ritonavir.
Danish: Det anbefales ikke at administrere OLYSIO sammen med darunavir/ritonavir.
English: OLYSIO in combination with peginterferon alfa and ribavrin It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR), therefore discontinuation of treatment is recommended in these patients.
Danish: OLYSIO i kombination med peginterferon alfa og ribavirin Det er usandsynligt, at patienter med utilstrækkeligt virologisk respons under behandlingen vil opnå et vedvarende virologisk respons (SVR).
English: Hepatic decompensation and hepatic failure, including fatal cases, have been reported post-marketing in patients treated with OLYSIO in combination with peginterferon alfa and ribavirin and in combination with sofosbuvir.
Danish: Der er efter markedsføring indberettet leverdekompensation og leverinsufficiens, herunder fatale tilfælde, hos patienter, der blev behandlet med OLYSIO i kombination med peginterferon alfa og ribavirin og i kombination med sofosbuvir.
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
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
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.