FrancophonIA/ELRC3.0 huggingface dataset:
English: A risk to the newborn/infant cannot be excluded.
Danish: En risiko for bivirkninger hos de ammede nyfødte/spædbørn kan ikke udelukkes.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: - Do not use this medicine after the expiry date which is stated on the carton and blister packaging after EXP.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisterpakningen efter
English: Do not stop taking OLYSIO unless your doctor tells you to.
Danish: Du må ikke holde op med at tage OLYSIO, medmindre din læge har sagt, at du skal.
English: Read all of this leaflet carefully before you start taking this medicine because it contains
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den
English: Do not stop taking OLYSIO
Danish: Hvis du holder op med at tage OLYSIO
English: Antibiotics - macrolides (systemic administration) Azithromycin
Danish: Antibiotika - makrolider (systemisk administration) Azithromycin
English: May include few patients with HCV non-genotype 1a/1b.
Danish: Kan omfatte nogle få patienter med HCV-non-genotype 1a/1b.
English: You may be more sensitive to sunlight (photosensitivity) when taking OLYSIO (see section 4 for
Danish: Du vil muligvis blive mere følsom for sollys (fotosensibilitet), når du tager OLYSIO (se afsnit 4 for
English: It is therefore important that you also read the package leaflets that are provided with these other medicines before you start taking OLYSIO.
Danish: Det er derfor vigtigt, at du også læser de indlægssedler, der følger med disse andre lægemidler, inden du begynder at tage OLYSIO.
English: Simeprevir is extensively bound to plasma proteins ( 99.9%), primarily to albumin and, to a lesser extent, alfa-1-acid glycoprotein.
Danish: Simeprevir er i omfattende grad bundet til plasmaproteiner (> 99,9%), fortrinsvis til albumin og i mindre udstrækning til surt alfa-1-glykoprotein.
English: Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.
Danish: Der skal udvises særdeles stor forsigtighed for at undgå graviditet hos kvindelige patienter og kvindelige partnere til mandlige patienter.
English: Pregnant women should not take OLYSIO unless specifically directed by the doctor.
Danish: Gravide kvinder må ikke tage OLYSIO, medmindre lægen specifikt har ordineret det.
English: Concentrations of digoxin should be monitored and used for titration of digoxin dose to obtain the desired clinical effect.
Danish: Digoxinkoncentrationen bør monitoreres og bruges til titrering af digoxindosis, så den ønskede kliniske effekt opnås.
English: The adverse reactions are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very
Danish: Bivirkningerne er inddelt efter systemorganklasse (SOC) og hyppighed: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000).
English: There are no data on the effect of simeprevir on human fertility.
Danish: Der foreligger ingen data vedrørende effekten af simeprevir på human fertilitet.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of
Danish: Du kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Disposal: Read the package leaflet.
Danish: Bortskaffelse: Læs indlægssedlen.
English: In the event of an overdose with OLYSIO, it is recommended to employ the usual supportive measures and observe the patient's clinical status.
Danish: I tilfælde af overdosering af OLYSIO anbefales det at benytte sædvanlige understøttende foranstaltninger og observere patientens kliniske status.
English: Therefore, it is not expected that renal impairment will have a clinically relevant effect on the exposure to simeprevir.
Danish: Det forventes derfor ikke, at nyreinsufficiens vil have en klinisk relevant virkning på eksponeringen af simeprevir.
English: This is particularly significant if these are accompanied by either of the following symptoms: - feel sick (nauseous), are sick (vomit) or lose your appetite
Danish: Dette er især vigtigt, hvis disse symptomer opstår samtidig med nogen af de følgende symptomer: - hvis du får kvalme, kaster op eller mister appetitten
English: - Store in the original package in order to protect from light.
Danish: - Opbevares i den originale pakning for at beskytte mod lys.
English: Treatment regimen not containing sofosbuvir:
Danish: Behandlingsregime,der ikke indeholder sofosbuvir:
English: Study HPC3007: includes 5 simeprevir-treated patients who experienced relapse
Danish: Studie HPC3007: Inkluderer 5 simeprevir-behandlede patienter, der fik
English: The presence of 50% human serum reduced simeprevir replicon activity by 2.4-fold.
Danish: Tilstedeværelse af 50% human serum reducerede simeprevirs replikon-aktivitet 2,4 gange.
English: Tell your doctor immediately if you are taking OLYSIO with sofosbuvir and any medicines for heart problems, and during treatment you experience:
Danish: Fortæl det straks til din læge, hvis du tager OLYSIO sammen med sofosbuvir og et hvilket som helst lægemiddel mod hjerteproblemer, og du under behandlingen oplever:
English: In pregnant rats, simeprevir concentrations in placenta, fetal liver and foetus were lower compared to those observed in blood.
Danish: Hos drægtige rotter var koncentrationerne af simeprevir i placenta, fosterlever og foster lavere end dem, der blev set i blod.
English: This interaction study has been performed with a dose higher than the recommended dose for simeprevir assessing the maximal effect on the co-administered drug.
Danish: Dette interaktionsstudie er blevet gennemført med en højere dosis end den anbefalede dosis af simeprevir for at vurdere den maksimale virkning på det samtidigt administrerede lægemiddel.
English: There were no grade 3 events reported.
Danish: Der blev ikke indberettet grad 3-tilfælde.
English: While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Danish: Der forventes ingen ændringer i warfarins farmakokinetik, men tæt monitorering af INR anbefales ved alle vitamin K-antagonister.
English: (studies HPC3007 and C206) Treatment Outcome
Danish: (studie HPC3007 og C206) Behandlingsresultat
English: Study C206
Danish: Studie C206
English: - If you are a woman, you must not become pregnant during treatment and for several
Danish: - Hvis du er kvinde, må du ikke blive gravid under behandlingen og i flere måneder efter,
English: Like all medicines, OLYSIO can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Patients should be informed of the risk of photosensitivity reactions and on the importance of applying appropriate sun protective measures during treatment with OLYSIO.
Danish: Patienterne skal informeres om risikoen for lysfølsomhedsreaktioner og om vigtigheden af at bruge relevante foranstaltninger til beskyttelse mod solen under behandling med OLYSIO.
English: There is no specific antidote for overdose with OLYSIO.
Danish: Der findes ingen specifik antidot ved overdosering af OLYSIO.
English: The HCV RNA thresholds that trigger discontinuation of treatment (i.e., treatment stopping rules) are presented in table 3.
Danish: De HCV-RNA-tærskler, der udløser seponering af behandlingen (dvs. reglerne for behandlingsophør), vises i tabel 3.
English: Only grade 1 and 2 events were reported and there were no events leading to discontinuation of any of the study drugs.
Danish: Der blev kun indberettet tilfælde af grad 1 og 2, og ingen førte til seponering af nogen af studiespræparaterne.
English: It is not known whether simeprevir or its metabolites are excreted in human milk.
Danish: Det er ukendt, om simeprevir eller dets metabolitter udskilles i human mælk.
English: Recommended duration of treatment provided that patient does not meet a stopping rule (see table 3).
Danish: Anbefalet behandlingsvarighed, hvis patienten ikke er omfattet af regler for behandlingsophør (se tabel 3).
English: OLYSIO must be taken orally once a day with food (see section 5.2).
Danish: OLYSIO skal tages oralt én gang dagligt sammen med mad (se pkt.
English: Involvement of CYP2C8 and CYP2C19 cannot be excluded.
Danish: Det kan ikke udelukkes, at CYP2C8 og CYP2C19 er involveret.
English: C-simeprevir to healthy subjects, the majority of the radioactivity in plasma (up to 98%) was accounted for by unchanged drug and a small part of the radioactivity in plasma was related to metabolites (none being major metabolites).
Danish: C-simeprevir til raske personer kunne størstedelen af radioaktiviteten i plasma (op til 98%) tilskrives uomdannet lægemiddel, og en lille del af radioaktiviteten i plasma var bundet til metabolitter (hvoraf ingen er vigtige metabolitter).
English: Treatment with OLYSIO should be initiated and monitored by a physician experienced in the
Danish: Behandling med OLYSIO skal iværksættes og superviseres af en læge med erfaring i behandling af
English: Tell your doctor if any of the following applies: - you currently take, or have taken in the last few months, the medicine amiodarone (your doctor may consider alternative treatments if you have taken this medicine) - you take other medicines to treat irregular heart beat or high blood pressure.
Danish: Fortæl det til din læge, hvis et eller flere af følgende udsagn gør sig gældende for dig: - du tager aktuelt lægemidlet amiodaron eller har gjort det inden for de seneste få måneder (din læge vil muligvis overveje andre behandlinger, hvis du har taget dette lægemiddel) - du tager anden medicin til behandling af en uregelmæssig hjerterytme eller forhøjet blodtryk.
English: The following side effects may happen with OLYSIO when used in combination with sofosbuvir: Common: may affect up to 1 in 10 people:
Danish: Følgende bivirkninger kan optræde, når du tager OLYSIO sammen med sofosbuvir: Almindelig: Kan ramme op til 1 ud af 10 personer:
English: OLYSIO contains lactose (a type of sugar).
Danish: OLYSIO indeholder lactose (mælkesukker).
English: OLYSIO is available in packs containing 7 capsules (1 blister) or 28 capsules (4 blisters).
Danish: OLYSIO fås i pakninger med 7 kapsler (1 blister) eller 28 kapsler (4 blistere).
English: Includes 4 simeprevir-treated patients who experienced relapse after SVR12.
Danish: Inkluderer 4 simeprevir-behandlede patienter, der fik recidiv efter SVR12.
English: Opaque polyvinylchloride/polyethylene/polyvinylidenechloride (PVC/PE/PVDC) aluminium push-through blister strips of 7 capsules.
Danish: Uigennemsigtige blisterpakninger af polyvinylchlorid/polyethylen/polyvinylidenchlorid (PVC/PE/PVDC) -aluminium med 7 kapsler.
English: Rash may become severe.
Danish: Udslættet kan blive alvorligt.
English: SVR: SVR12 for study HPC3007 and SVR24 for study C206.
Danish: SVR: SVR12 for studie HPC3007 og SVR24 for studie C206.
English: Simeprevir in vitro was very mildly irritating to the eyes.
Danish: Simeprevir in vitro forårsagede let irritation i øjnene.
English: As simeprevir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by
Danish: Da simeprevir er kraftigt bundet til plasmaproteiner, er det usandsynligt, at det vil blive fjernet i
English: * darunavir/ritonavir + 50 mg simeprevir compared to
Danish: * darunavir/ritonavir + 50 mg simeprevir sammenlignet
English: Patient individualised dose at the discretion of the physician, according to local clinical practice.
Danish: Individuelt tilpasset dosis efter lægens skøn i henhold til lokal praksis.
English: Substitutions D168V and R155K alone or in combinations with other mutations at these positions emerged most frequently (table 10).
Danish: Substitutionerne D168V og R155K alene eller i kombination med andre mutationer på disse positioner dukkede hyppigst op (tabel 10).
English: It acts against the virus that causes hepatitis C infection, called ‘hepatitis C virus' (HCV).
Danish: Det virker mod den virus, der forårsager hepatitis C-infektion, og som kaldes for hepatitis C-virus (HCV).
English: This is due to potential liver function changes during treatment with OLYSIO.
Danish: Dette skyldes, at leverfunktionen potentielt kan ændre sig under behandling med OLYSIO.
English: OLYSIO has no or negligible influence on the ability to drive and use machines.
Danish: OLYSIO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Patients with mild to moderate rashes should be monitored for possible progression of rash, including the development of mucosal signs or systemic symptoms.
Danish: Patienter med let til moderat udslæt skal monitoreres for eventuel progression af udslættet, herunder udvikling af symptomer på slimhinder eller systemiske symptomer.
English: Monitoring of blood concentrations of tacrolimus is recommended.
Danish: Monitorering af blodkoncentrationen af tacrolimus anbefales.
English: Special populations
Danish: Andre specielle populationer
English: In order to evaluate the recurrence of hepatocellular carcinoma associated with OLYSIO, the MAH shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol.
Danish: For at vurdere recidiv af hepatocellulært karcinom associeret med OLYSIO skal indehaveren af markedsføringstilladelsen udføre og indsende resultaterne fra et prospektivt sikkerhedsstudie baseret på en vedtagen protokol med brug af data fra en kohorte af en veldefineret gruppe patienter.
English: Ribavirin use and prior treatment status (treatment-naïve and prior null responders) did not impact treatment outcome.
Danish: Tillæg af ribavirin og tidligere behandlingsstatus (behandlingsnaive og tidligere nul respons) påvirkede ikke behandlingsresultatet.
English: In rodents, simeprevir elicited toxic effects in the liver, pancreas and gastrointestinal systems.
Danish: Hos gnavere udløste simeprevir toksiske virkninger på lever, pancreas og gastrointestinal-systemet.
English: Dosage adjustment or interruption of OLYSIO treatment To prevent treatment failure, the dose of OLYSIO must not be reduced or interrupted.
Danish: Justering af dosis eller afbrydelse af behandling med OLYSIO For at forhindre at behandlingen ikke virker, må doseringen af OLYSIO ikke nedsættes eller afbrydes.
English: Metabolites identified in faeces were formed via oxidation at the macrocyclic moiety or aromatic moiety or both and by O-demethylation followed by oxidation.
Danish: Metabolitter, der blev påvist i fæces, blev dannet gennem oxidering ved den makrocykliske del eller aromatiske del eller begge dele og ved O-demetylering efterfulgt af oxidation.
English: There is limited data on the use of simeprevir in patients older than 65 years.
Danish: Der foreligger kun begrænsede data vedrørende anvendelse af simeprevir til patienter over 65 år.
English: Bilirubin elevations were generally not associated with elevations in liver transaminases and bilirubin levels normalised after end of treatment.
Danish: Stigningerne i bilirubin var generelt ikke forbundet med stigninger i levertransaminaser, og bilirubinniveauerne normaliseredes efter afslutning af behandlingen.
English: * In a clinical study in Asian patients from China and South-Korea, increased blood ‘bilirubin' levels were reported in more than 1 in 10 people (very common).
Danish: * I et kliniske studie med asiatiske patienter fra Kina og Sydkorea blev der indberettet forhøjede niveauer af bilirubin i blodet hos flere end 1 ud af 10 personer (meget almindelig bivirkning).
English: This is important because it is not known whether simeprevir can pass into breast milk.
Danish: Dette er vigtigt, da det ikke vides, om simeprevir udskilles i mælk.
English: Most of these emerging substitutions have been shown to reduce simeprevir anti-HCV activity in cell culture replicon assays.
Danish: De fleste af disse opståede substitutioner er vist at reducere simeprevirs anti-HCV-aktivitet i analyser af replikoner fra cellekultur.
English: The mean absolute bioavailability of simeprevir following a single oral 150 mg dose of simeprevir in fed conditions is 62%.
Danish: Simeprevirs gennemsnitlige absolutte biotilgængelighed efter en enkelt oral dosis på 150 mg efter indtagelse af føde er 62%.
English: Eighty-eight percent (n = 93) of the patients were on HIV therapy, most commonly with 2 NRTIs + raltegravir.
Danish: 88% (n = 93) af patienterne var i HIV-behandling, hyppigst med 2 NRTI'er + raltegravir.
English: Viral breakthrough rates were 24% (11/45), 20% (5/25) and 11% (4/36) in patients with genotype 4a, 4d and 4/other, respectively.
Danish: Raterne for viralt gennembrud var henholdsvis 24% (11/45), 20% (5/25) og 11% (4/36) hos patienter med genotype 4a, 4d og 4/andre.
English: The efficacy of OLYSIO has not been studied in patients with HCV genotypes 2, 3, 5 or 6; therefore OLYSIO should not be used in these patients (see section 5.1).
Danish: Effekten af OLYSIO er ikke undersøgt hos patienter med HCV-genotyperne 2, 3, 5 og 6; derfor bør OYSIO ikke anvendes til disse patienter (se pkt.
English: Plasma Cmax and the area under the plasma concentration time curve (AUC) increased more than dose proportional after multiple doses between 75 mg and 200 mg once daily, with accumulation occurring following repeated dosing.
Danish: Plasma Cmax og arealet under plasmakoncentration/tids-kurven (AUC) steg mere end dosisproportionalt efter flere doser på mellem 75 mg og 200 mg én gang dagligt med akkumulering efter gentagen dosering.
English: Table 21 shows the SVR rates for selected subgroups for study HPC3007.
Danish: Tabel 21 viser SVR-raterne for udvalgte undergrupper i studie HPC3007.
English: C-simeprevir to healthy subjects, on average 91% of the total radioactivity was recovered in faeces.
Danish: C-simeprevir til raske personer blev gennemsnitligt 91% af den samlede radioaktivitet påvist i fæces.
English: Co-administration with other direct acting antivirals against HCV OLYSIO should only be co-administered with other direct acting antiviral medicinal products if the benefits are considered to outweigh the risks based upon available data.
Danish: Samtidig administration af andre direkte virkende antivirale midler mod HCV OLYSIO bør kun indgives samtidig med andre direkte virkende antivirale lægemidler, hvis fordelene på baggrund af de tilgængelige data anses for at opveje risiciene.
English: Dosage adjustment or interruption of medicinal products used in combination with OLYSIO for the
Danish: Justering af dosis eller seponering af lægemidler, der bruges i kombination med OLYSIO til
English: Table 4: Interactions and dose recommendation with other medicinal products Recommendation for co-administration
Danish: Tabel 4: Interaktioner med andre lægemidler og anbefalinger til dosering Anbefaling ved samtidig administration
English: The Q80K polymorphism was not observed in patients with genotype 4 infection.
Danish: Q80K-polymorfisme blev ikke observeret hos patienter med genotype 4-infektion.
English: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Danish: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgien
English: Simeprevir is a specific inhibitor of the HCV NS3/4A serine protease, which is essential for viral replication.
Danish: Simeprevir er en specifik hæmmer af HCV NS3/4A-serinproteasen, som er afgørende for den virale replikation.
English: - ciclosporin, sirolimus or tacrolimus to lower immune response or prevent organ transplant
Danish: - ciclosporin, sirolimus eller tacrolimus til hæmning af immunforsvaret eller forebyggelese af
English: OLYSIO should only be used during pregnancy or in women of childbearing potential if the benefit justifies the risk.
Danish: OLYSIO bør kun anvendes under graviditet eller til kvinder i den fertile alder, hvis fordelen opvejer risikoen.
English: Simeprevir is classified as a PBT (persistent, bioaccumulative and toxic) substance (see section 6.6).
Danish: Simeprevir er klassificeret som PBT-stof (persistent, bioakkumulerbart og toksisk) (se pkt.
English: Other substitutions such as Q80G or L, S122G, N or T did not reduce simeprevir activity (FC in EC50 ≤ 2).
Danish: Andre substitutioner såsom Q80G eller L samt S122G, N eller T reducerede ikke aktiviteten af simeprevir (FC i EC50 ≤ 2).
English: Simeprevir was not genotoxic in a series of in vitro and in vivo tests.
Danish: Simeprevir var ikke genotoksisk i en række test in vitro og in vivo.
English: All patients receiving OLYSIO combination treatment with sofosbuvir in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they
Danish: Alle patienter, der får kombinationsbehandling med OLYSIO og sofosbuvir i kombination med amiodaron med eller uden andre lægemidler, der sænker hjertefrekvensen, skal desuden advares om symptomerne på bradykardi og hjerteblok og skal tilrådes straks at søge læge, hvis de får disse
English: The doctor will advise you to stop breast-feeding or to stop taking OLYSIO while breast-feeding.
Danish: Lægen vil bede dig om at holde op med at amme eller stoppe med at tage OLYSIO, mens du ammer.
English: Number of patients enrolled
Danish: Antal inkludere de patienter
English: The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
Danish: Dosis af simeprevir i dette interaktionsstudie var 50 mg, når det blev administreret i kombination med darunavir/ritonavir, og sammenlignet med 150 mg i behandlingsgruppen på simeprevir alene.
English: If photosensitivity reactions occur, discontinuation of OLYSIO should be considered and patients should be monitored until the
Danish: Hvis der opstår lysfølsomhedsreaktioner, bør seponering af OLYSIO overvejes, og patienten skal monitoreres, indtil
English: - If it is less than 12 hours until your next dose, skip the missed dose.
Danish: - Hvis der er mindre end 12 timer til din næste dosis, skal du springe den glemte dosis over.
English: Table 10: Treatment-emergent amino-acid substitutions in pooled phase 2 and phase 3 studies: patients who did not achieve SVR with 150 mg simeprevir in combination
Danish: Tabel 10: Behandlingsrelaterede aminosyresubstitutioner i puljede fase 2- og fase 3-studier: Patienter, der ikke opnåede SVR med 150 mg simeprevir i kombination med
English: The pharmacokinetics of simeprevir in children aged below 18 years have not been investigated.
Danish: Simeprevirs farmakokinetik er ikke blevet undersøgt hos børn under 18 år.
English: Caution is warranted and clinical monitoring of patients is recommended when these calcium channel blockers are given orally.
Danish: Der skal udvises forsigtighed, og klinisk monitorering af patienterne anbefales, når disse calciumantagonister gives oralt.
English: For any information about this medicine, please contact the local representative of the Marketing
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Excipient with known effect: each capsule contains 78.4 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver kapsel indeholder 78,4 mg lactose (som
English: Renal elimination of simeprevir is negligible.
Danish: Den renale elimination af simeprevir er ubetydelig.