FrancophonIA/ELRC3.0 huggingface dataset:
English: Telaprevir is partly metabolised in the liver by CYP3A and is a P-glycoprotein (P-gp) substrate.
Danish: Telaprevir metaboliseres delvist i leveren af CYP3A, og det er et substrat for P-glykoprotein (P-gp).
English: INCIVO has no or negligible influence on the ability to drive and use machines.
Danish: INCIVO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The direction of the arrow (↑ = increase, ↓ = decrease, ↔ = no change) for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Danish: Pilens retning (↑ = stigning, ↓ = fald, ↔ = ingen ændring) for de enkelte farmakokinetiske parametre er baseret på, at 90%-konfidensintervallet for den geometriske gennemsnitsratio ligger inden for (↔), under (↓) eller over (↑) 80-125%-intervallet.
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin, therefore, extreme care must be taken to avoid pregnancy in female patients and
Danish: Der er påvist signifikant teratogenicitet og/eller fosterdød hos alle dyrearter efter eksponering for ribavirin, hvorfor det er yderst vigtigt at undgå graviditet hos kvindelige patienter samt hos mandlige
English: Tell your doctor if you have heart failure, irregular heartbeat, slow heart rate, an abnormality shown in your heart tracing (ECG) called 'long QT syndrome', or a family history of a heart condition called 'congenital QT syndrome'.
Danish: Fortæl det til lægen, hvis du lider af hjertesvigt, uregelmæssig puls, langsom puls, en unormal visning på hjertediagrammet (ekg), der kaldes “langt QT-syndrom”, eller en hjertesygdom i familien, der kaldes “medfødt QT-syndrom”.
English: If you are breast-feeding, you must stop breast-feeding before starting to take INCIVO.
Danish: Hvis du ammer, skal du holde op med at amme, før du begynder at tage INCIVO.
English: Concomitant administration with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Danish: Samtidig anvendelse af aktive stoffer, hvis clearance er stærkt afhængig af CYP3A, og som ved forhøjet plasmakoncentration sættes i forbindelse med alvorlige og/eller livstruende hændelser.
English: INCIVO tablets should be stored in the original bottle.
Danish: Opbevar INCIVO tabletter i den originale beholder.
English: The impact of predominant telaprevir-resistant variants at baseline is likely greatest in patients with a poor interferon response,
Danish: Påvirkningen fra overvejende telaprevir-resistente varianter ved baseline er sandsynligvis størst hos patienter med dårligt respons på interferon såsom tidligere null responders.
English: Caution is warranted and clinical monitoring is recommended when intravenous lidocaine is administered for the treatment of acute ventricular arrhythmia.
Danish: Forsigtighed tilrådes, og klinisk monitorering anbefales, når intravenøst lidocain administreres til behandling af akut ventrikulær arytmi.
English: The pharmacokinetic properties of telaprevir have been evaluated in healthy adult volunteers and in subjects with chronic HCV infection.
Danish: Telaprevirs farmakokinetiske egenskaber blev evalueret hos voksne raske forsøgspersoner og hos forsøgspersoner med kronisk HCV-infektion.
English: Telaprevir is primarily metabolised in the liver.
Danish: Telaprevir metaboliseres fortrinsvis i leveren.
English: Decisions related to your treatment may be made based on the results of these tests.
Danish: Din behandling kan så planlægges ud fra resultaterne af disse blodprøver.
English: Hormonal contraceptives may be continued but may not be reliable during INCIVO dosing and for up to two months following cessation of INCIVO (see section 4.5).
Danish: Hormonale kontraceptiva kan fortsat anvendes, men er muligvis ikke pålidelige under INCIVO-behandling og i op til to måneder efter seponering af INCIVO-behandlingen (se pkt.
English: break, or dissolve the tablets before you swallow them.
Danish: Du må ikke tygge, dele eller opløse tabletterne, før du synker dem.
English: Table 5 shows the response rates for the T12(b.i.d.
Danish: Tabel 5 viser responsraterne for T12(b.i.d.
English: However, sufficiently high concentrations were not tested for intestinal inhibition to be excluded.
Danish: Der blev dog ikke undersøgt tilstrækkeligt høje koncentrationer til, at hæmning i tarmsystemet kan
English: The mean telaprevir Cmax and AUC were 10% and 21% greater, respectively, compared to healthy subjects (see section 4.2).
Danish: Telaprevirs gennemsnitsværdier for Cmax og AUC var henholdsvis 10% og 21% større end hos raske forsøgspersoner (se pkt.
English: Talk to your doctor or pharmacist before taking INCIVO.
Danish: Kontakt lægen eller apotekspersonalet, før du tager INCIVO.
English: Concomitant use may result in loss of therapeutic effect of telaprevir.
Danish: Samtidig brug kan medføre nedsat terapeutisk virkning af telaprevir.
English: )/PR group was 74% (274/369) compared to 73% (270/371) in the T12(q8h)/PR group with 95% confidence interval of the difference: -4.9%, 12.0%.
Danish: )/PR-gruppen var 74% (274/369) sammenlignet med 73% (270/371) i T12(q8h)/PR-gruppen med et 95% konfidensinterval for forskellen: -4,9%; 12,0%.
English: High density polyethylene (HDPE) bottle containing 42 film-coated tablets and fitted with polypropylene (PP) child resistant closure and induction seal liner.
Danish: Beholder af højdensitetspolyethylen (HDPE), der indeholder 42 filmovertrukne tabletter og er forsynet med børnesikret lukke af polypropylen (PP) med forsegling.
English: Your doctor may evaluate how severe your liver disease is before deciding if you can take INCIVO.
Danish: Lægen vil eventuelt vurdere alvoren af din leversygdom, før det besluttes, om du
English: NA = not applicable
Danish: IR - ikke relevant.
English: Do not remove this desiccant from the bottle.
Danish: Fjern ikke tørremidlet fra beholderen.
English: • Rash and Severe Cutaneous Adverse Reactions safety data from Phases 2 and 3
Danish: • Sikkerhedsdata om udslæt og alvorlige kutane bivirkninger fra fase 2- og 3-studier
English: Tell your doctor if you have had other problems with your liver such as liver failure.
Danish: Fortæl det til lægen, hvis du har haft andre problemer med leveren såsom nedsat leverfunktion.
English: Liver transplant patients without cirrhosis
Danish: Levertransplanterede patienter uden cirrose
English: Refer to section 4.3 for a listing of medicinal products that are contraindicated for use with INCIVO due to potentially life-threatening adverse events or potential loss of therapeutic effect to INCIVO.
Danish: 4.3 over lægemidler, som er kontraindiceret sammen med INCIVO på grund af potentielt livstruende bivirkninger eller potentiel manglende terapeutisk virkning af INCIVO.
English: Please see section ‘Other medicines and INCIVO'.
Danish: Se afsnittet "Brug af anden medicin sammen med INCIVO"
English: The SVR rate for the T8/PR group was 72% (261/364) (P < 0.0001 compared to Pbo/PR48 group).
Danish: SVR-raten for T8/PR-gruppen var 72% (261/364) (P < 0,0001 sammenlignet med Pbo/PR48gruppen).
English: All telaprevir-resistant variants studied remained fully sensitive to interferon-alfa, ribavirin, and representative HCV nucleoside and non-nucleoside polymerase inhibitors in the replicon system.
Danish: Alle de undersøgte telaprevir-resistente varianter bevarede deres følsomhed over for interferon-alfa, ribavirin og repræsentative HCV-nukleoside og non-nukleoside polymerasehæmmere i replicon-systemet.
English: Moderate rash: Diffuse rash ≤ 50% of body surface area
Danish: Moderat udslæt: Diffust udslæt ≤ 50% af
English: All patients N = 74 % (n/N)
Danish: Alle patienter N = 74 % (n/N)
English: atazanavir/ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir to treat HIV infections (HIV-protease inhibitors)
Danish: atazanavir/ritonavir, darunavir/ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir til at behandle hiv-infektioner (hivproteasehæmmere)
English: Prescribers should ensure that patients are fully informed about the risk of severe rashes, and to consult with their prescriber immediately if they develop a new rash or worsening of an existing rash.
Danish: Ved ordination bør lægen sørge for, at patienten er velinformeret om risikoen for alvorlige udslæt og ved, at lægen skal kontaktes i tilfælde af et nyt udslæt eller forværring af et eksisterende udslæt.
English: No clinical studies have been performed in paediatric patients.
Danish: Pædiatrisk population Der er ikke udført kliniske studier med pædiatriske patienter.
English: A 3-year follow-up study of patients who achieved SVR with an INCIVO-based regimen showed that > 99% (122/123) of patients maintained their SVR status through the available follow-up period
Danish: Et 3-års opfølgningsstudie med patienter, som opnåede SVR med et INCIVO-baseret regime, viste, at > 99% (122/123) af patienterne opretholdt deres SVR-status under den foreliggende opfølgningsperiode (median varighed 22 måneder).
English: There is limited pharmacokinetic data on the use of INCIVO in HCV patients aged ≥ 65 years and no data in subjects > 70 years of age.
Danish: Der foreligger begrænsede farmakokinetiske data om anvendelse af INCIVO til HCV-patienter i aldersgruppen ≥ 65 år og ingen data om personer > 70 år.
English: Upon completion of INCIVO, doses of tacrolimus or cyclosporine A need to be increased, and the dosing interval for tacrolimus will need to be reduced.
Danish: Når behandlingen med INCIVO er fuldført, skal doserne af tacrolimus eller ciclosporin øges, og doseringsintervallet for tacrolimus skal afkortes.
English: A total of 215 of 1,169 patients treated with a T12/PR regimen in a Phase 3 clinical trial had on-treatment virologic failure (n = 125) or relapse (n = 90).
Danish: I alt 215 ud af 1.169 patienter, der fik et T12/PR-regime i et klinisk fase 3-studier, oplevede virologisk svigt under behandlingen (n = 125) eller relapse (n = 90).
English: Marked immunosuppressant dose reductions with or without prolongation of the dosing intervals will be required.
Danish: Markant dosisreduktion med eller uden forlængelse af doseringsintervallet er nødvendig for immunsupprimerende midler.
English: The Marketing Authorisation Holder shall agree to the format and content of the healthcare professional educational pack with the National Competent Authority prior to launch in the Member State.
Danish: • Yderligere risikominimeringsforanstaltninger Indehaveren af markedsføringstilladelsen skal blive enig med den relevante nationale myndighed om format og indhold af uddannelsespakken for sundhedsprofessionelle før lancering i medlemslandet.
English: The rash reported during INCIVO combination treatment was assessed as a typically pruritic, eczematous rash, and involved less than 30% of body surface area.
Danish: Udslæt rapporteret under INCIVO-kombinationsbehandling bedømtes til typisk udslæt med pruritus og eksem, som omfattede mindre end 30% af legemsoverfladen.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web
Danish: Yderligere oplysninger om INCIVO findes på Det Europæiske Lægemiddelagenturs hjemmeside
English: Study 108 was a randomised, double-blind, parallel-group, placebo-controlled, Phase 3 study conducted in treatment-naïve patients.
Danish: Studie 108 var et randomiseret, dobbeltblindt, parallelgruppe, placebokontrolleret fase 3-studie med behandlingsnaive patienter.
English: Peginterferon alfa may be continued unless interruption is medically indicated.
Danish: Pegyleret interferon-alfa kan fortsættes, med mindre der er medicinsk indikation for at indstille denne behandling.
English: Figure 2: Duration of treatment for previously treated patients with prior partial or prior
Danish: Figur 2: Behandlingsvarighed for tidligere behandlede patienter med tidligere partial
English: Severe, potentially life-threatening and fatal skin reactions have been reported with INCIVO combination treatment.
Danish: Der er indberettet alvorlige, potentielt livstruende og fatale hudreaktioner i forbindelse med INCIVOkombinationsbehandling.
English: Clinical drug-drug interaction studies with substrates of CYP2B6, CYP2C8, CYP2D6, CYP2C19 and UGT1A1, UGT2B7 and UGT1A3 indicate no clinically relevant impact of the suppression observed in vitro.
Danish: Kliniske studier af lægemiddelinteraktion med substrater af CYP2B6, CYP2C8, CYP2D6 og CYP2C19 samt UGT1A1, UGT2B7 og UGT1A3 indikerer ingen klinisk relevant effekt af suppressionen observeret in vitro.
English: - if you have a wide-spread rash with peeling skin which may be accompanied by fever, flu-like symptoms, painful skin blisters, and blisters in the mouth, eyes, and/or genitals.
Danish: - hvis du har et udbredt udslæt med skællende hud, som kan være ledsaget af feber, influenzalignende symptomer, smertefulde blærer i huden eller blærer i mund, øjne og/eller på
English: In that study, the following common adverse events were reported more frequently with the 1,875 mg every 8 hours regimen compared to the 750 mg every 8 hours regimen: nausea, headache, diarrhoea, decreased appetite, dysgeusia and vomiting.
Danish: I det studie sås følgende almindelige bivirkninger hyppigere med regimet på 1.875 mg hver 8 time sammenlignet med regimet med 750 mg hver 8 time: kvalme, hovedpine, diarré, nedsat appetit, dysgeusi og opkastning.
English: The exposure to telaprevir was increased by 20% when taken following a high-fat caloric meal (56 g fat, 928 kcal) compared to an intake following a standard normal caloric meal (21 g fat, 533 kcal).
Danish: Eksponeringen for telaprevir øgedes med 20%, når lægemidlet blev indtaget efter et måltid med højt fedt- og kalorieindhold (56 g fedt, 928 kcal) sammenlignet med indtagelse efter et standardmåltid med normalt kalorieindhold (21 g fedt, 533 kcal).
English: Patients with renal or hepatic impairment should not be given colchicine with INCIVO, due to the risk of colchicine toxicity.
Danish: Patienter med nedsat nyre- eller leverfunktion bør ikke ordineres colchicin sammen med INCIVO på grund af risikoen for colchicintoksicitet.
English: In case of overdose you may experience nausea, headache, diarrhoea, decreased appetite, abnormal
Danish: I tilfælde af en overdosis kan du få kvalme, hovedpine, diarré, nedsat appetit, smagsforstyrrelser og
English: You must carefully read the information under Rash in section 4 Possible Side Effects.
Danish: Det er vigtigt, at du læser oplysningerne under "Udslæt" i afsnit 4: Bivirkninger.
English: When compared to administration following a standard normal caloric meal, exposure (AUC) decreased by 73% when telaprevir was taken on an empty stomach, by 26% following a low-calorie high-protein meal (9 g fat, 260 kcal), and by 39% following a low-calorie low-fat meal (3.6 g fat, 249 kcal).
Danish: Ved sammenligning med indtagelse efter et standardmåltid med normalt kalorieindhold faldt eksponeringen (AUC) med 73%, når telaprevir blev indtaget på tom mave, med 26% efter et måltid med lavt kalorieindhold og højt proteinindhold (9 g fedt, 260 kcal), og med 39% efter et måltid med lavt kalorie- og fedtindhold (3,6 g fedt, 249 kcal).
English: The following laboratory evaluations (complete blood count with white blood cell differential counts, electrolytes, serum creatinine, liver function tests, TSH, uric acid) must be conducted in all patients prior to initiating INCIVO combination treatment.
Danish: Følgende laboratorieundersøgelser (komplet blodstatus inklusive differentialtælling af leukocyttyper, elektrolytter, serumkreatinin, leverfunktionsprøver, TSH, urat) skal udføres hos alle patienter før indledning af kombinationsbehandling med INCIVO.
English: Increase in thyroid stimulating hormone (TSH) may occur during INCIVO combination treatment, which may indicate worsening or recurrence of pre-existing or previous hypothyroidism, or new-onset hypothyroidism (see section 4.8).
Danish: Der kan forekomme stigning i thyroidea-stimulerende hormon (TSH) under INCIVO kombinationsbehandling, hvilket kan indikere forværring eller recidiv af eksisterende eller tidligere hypothyroidisme eller debut af hypothyroidisme (se pkt.
English: Table 6: SVR rates for patient subgroups: Study C211 T12(b.i.d.
Danish: Tabel 6: SVR-rater i patientundergrupper: Studie C211 T12(b.i.d.
English: In the event that treatment with INCIVO in such patients is judged strictly necessary, patients should be closely monitored, including ECG assessments.
Danish: I de tilfælde, hvor behandling med INCIVO hos sådanne patienter skønnes absolut nødvendig, skal patienterne kontrolleres nøje inklusive ekg-vurderinger.
English: Other enzymes are also involved in the metabolism such as aldo-ketoreductases and other proteolytic enzymes.
Danish: Andre enzymer såsom aldo-ketoreduktaser og andre proteolytiske enzymer er også involveret i metabolismen.
English: The median time for telaprevir-resistant variants to become undetectable by population sequencing was longer for variants NS3-36 (6 months), NS3-155 (9 months) and NS3-36M+NS3-155K (12 months) predominantly observed in patients with genotype 1a than for variants NS3-54 (2 months) and NS3-156 (3 months) predominantly observed in patients with genotype 1b.
Danish: Median tid, før telaprevir-resistente varianter blev ikke-påviselige ved populationssekvensering, var længere for varianterne NS3-36 (6 måneder), NS3-155 (9 måneder) og NS3-36M+NS3-155K (12 måneder), der overvejende observeredes hos patienter med genotype 1a, end for varianterne NS3-54 (2 måneder) og NS3-156 (3 måneder), der overvejende observeredes hos patienter med genotype 1b.
English: (e.g., CYP1A1, CYP1A2, BCRP, OATPs) regulated by the same nuclear receptors, the potential clinical impact is unknown.
Danish: For andre enzymer og transportører (f.eks. CYP1A1, CYP1A2, BCRP, OATP-er), der reguleres af de samme nukleære receptorer, er den potentielle kliniske effekt ukendt.
English: Contact your doctor immediately also if you develop any of the following symptoms: - tiredness, weakness, shortness of breath, light-headedness, and/or feeling of heart racing.
Danish: Kontakt også straks lægen, hvis du får et af følgende symptomer: - træthed, svaghed, kortåndethed, svimmelhed og/eller galopperende hjerte.
English: The highest documented INCIVO dose administered is 1,875 mg every 8 hours for 4 days in healthy volunteers.
Danish: Den højeste dokumenterede dosis INCIVO er 1.875 mg givet hver 8. time i 4 dage i raske forsøgspersoner.
English: Telaprevir is a weak in vitro inhibitor of the transporters multidrug and toxin extrusion (MATE) MATE1 and MATE2-K with an IC50 of 28.3 μM and 32.5 μM, respectively.
Danish: Telaprevir er en svag in vitro-hæmmer af MATE1- og MATE2-K-transportørerne med en IC50 på henholdsvis 28,3 μM og 32,5 μM.
English: In clinical trials, the majority of these events (e.g., haemorrhoids, anorectal discomfort, anal pruritus, and rectal burning) were mild to moderate, very few led to treatment discontinuation and resolved after completion of INCIVO dosing.
Danish: I kliniske studier var de fleste af disse hændelser (f.eks. hæmorider, anorektale gener, anal pruritus og svie i rektum) lette til moderate, yderst få førte til seponering af behandlingen, og de forsvandt efter gennemførelse af behandlingen med INCIVO.
English: When administered to lactating rats, levels of telaprevir and its major metabolite were higher in milk compared to those observed in plasma.
Danish: Når telaprevir gives til diegivende rotter, er de observerede koncentrationer af stoffet og dets hovedmetabolit højere i mælk end i plasma.
English: The safety and efficacy have not been established in patients with moderate or severe renal impairment (CrCl < 50 ml/min) or in patients on haemodialysis.
Danish: Sikkerhed og virkning er ikke klarlagt hos patienter med moderat eller svært nedsat nyrefunktion (CrCl < 50 ml/min) eller hos patienter i hæmodialyse.
English: An increase in dose from 750 mg every 8 hours to 1,875 mg every 8 hours in a multiple-dose study resulted in a less than proportional increase (i.e., about 40%) in telaprevir exposure.
Danish: En dosisøgning fra 750 mg hver 8. time til 1.875 mg hver 8. time i et studie med gentagne doser resulterede i en mindre end proportional stigning (dvs. ca. 40%) i eksponering for telaprevir.
English: Neither telaprevir nor its major metabolite caused damage to DNA when tested in the standard battery of mutagenesis assays, in the presence and absence of metabolic activation.
Danish: Hverken telaprevir eller dets hovedmetabolit førte til DNA-skade, da det blev afprøvet i standardanalyserne for mutagenese med og
English: It is not known whether telaprevir is excreted in human breast milk.
Danish: Det er ukendt, om telaprevir udskilles i human mælk.
English: If the rash does not improve within 7 days following INCIVO discontinuation, ribavirin should be interrupted.
Danish: Hvis udslættet ikke bedres i løbet af 7 dage efter seponering af INCIVO, bør behandling med ribavirin indstilles.
English: INCIVO may increase concentrations of the co-administered medicinal product and this may result in an increased risk of their associated cardiac adverse reactions.
Danish: INCIVO kan øge koncentrationerne af det samtidigt administrerede lægemiddel, hvilket kan resultere i en øget risiko for kardielle bivirkninger associeret med disse lægemidler.
English: Treatment with INCIVO should be initiated and monitored by a physician experienced in the
Danish: Behandling med INCIVO bør indledes og overvåges af en læge med erfaring i behandling af kronisk
English: Mild rash: localised skin eruption and/or a skin eruption with a limited distribution (up to several isolated sites on the body)
Danish: Mildt udslæt: lokalt udbrud af hududslæt og/eller hududslæt med begrænset udbredelse (op til flere isolerede steder på kroppen)
English: Rarely patients may have other symptoms with the rash that may be a sign of a severe skin reaction.
Danish: I sjældne tilfælde kan patienter få andre symptomer sammen med udslættet, hvilket kan være tegn på en alvorlig
English: Therefore, the use of INCIVO in patients with non-genotype-1 HCV is not recommended.
Danish: INCIVO anbefales derfor ikke til patienter med non-genotype 1 HCV.
English: These may be symptoms of anaemia (decrease in your red blood cells);
Danish: Det kan være symptomer på blodmangel (anæmi - fald i de røde blodlegemer).
English: If you are taking INCIVO twice daily (morning and evening) If you notice the missed dose within 6 hours, you must take three tablets immediately.
Danish: Hvis du tager INCIVO to gange dagligt (morgen og aften) Hvis du inden for 6 timer opdager, at du har glemt en dosis, skal du straks tage tre tabletter.
English: The median recovery of the administered radioactive dose was approximately 82% in the faeces, 9% in exhaled air and 1% in urine.
Danish: Median genfinding af den indgivne radioaktive dosis var ca. 82% i fæces, 9% i eksspirationsluft og
English: There is no data using INCIVO in combination with peginterferon alfa-2b in treatment-experienced patients and limited data in treatment-naïve patients.
Danish: Der foreligger ingen data baseret på INCIVO i kombination med pegyleret interferon-alfa-2b hos tidligere behandlede patienter og kun begrænsede data fra behandlingsnaive patienter.
English: QT interval prolongation and Torsade de Pointes have been reported with clarithromycin and erythromycin.
Danish: Forlænget QT-interval og torsades de pointes er rapporteret i forbindelse med clarithromycin og erythromycin.
English: Sequence analyses of the telaprevir-resistant variants identified substitutions at 4 positions in the NS3-4A protease region, consistent with the mechanism of action for telaprevir (V36A/M, T54A/S, R155K/T, and A156S/T/V).
Danish: Sekvensanalyser af telaprevir-resistente varianter identificerede substitutioner på 4 positioner i NS3-4A-proteaseregionen, hvilket svarer til virkningsmekanismen for telaprevir (V36A/M, T54A/S, R155K/T og A156S/T/V).
English: In vitro studies demonstrated that telaprevir is not an inhibitor of UGT1A9 or UGT2B7.
Danish: In vitro-studier har vist, at telaprevir ikke hæmmer UGT1A9 eller UGT2B7.