FrancophonIA/ELRC3.0 huggingface dataset:
English: Study 111 was a Phase 3, randomised, open label study conducted in treatment-naïve patients.
Danish: Studie 111 var et randomiseret, åbent fase 3-studie med behandlingsnaive patienter.
English: In Phase 3 studies, a sensitive real-time PCR assay with a limit of quantification of 25 IU/ml and a limit of detection of 10-15 IU/ml was used to determine whether HCV RNA levels were undetectable (target not detected) (see section 5.1).
Danish: I fase 3studier anvendtes en sensitiv real-time PCR-analyse med en kvantificeringsgrænse på 25 IE/ml og en detektionsgrænse på 10-15 IE/ml til at bestemme, om HCV-RNA-niveauer var ikke-detekterbare (HCV-RNA ikke påvist) (se pkt.
English: Efavirenz: with this combination the telaprevir dose must be increased to 1,125 mg three times per day (q8h).
Danish: Efavirenz: Med denne kombination skal telaprevir-dosis øges til 1.125 mg tre gange dagligt (hver 8.
English: Mild and moderate CYP3A inducers should be avoided, particularly in patients who are prior non-responders (partial or null responders for peginterferon alfa/ribavirin), unless specific dose recommendations are given (refer to table 2).
Danish: Svage og moderate CYP3A-induktorer bør undgås - især hos patienter, som er tidligere non-responders (med partial response eller null response på pegyleret interferon-alfa/ribavirin), med mindre der gives specifikke dosisrekommandationer (se tabel 2).
English: INCIVO must not be administered concurrently with Class Ia or III antiarrhythmics, except for
Danish: INCIVO må ikke anvendes samtidig med klasse Ia- eller III-antiarytmika med undtagelse af
English: C - telaprevir and VRT-127394 towards total radioactivity recovered in faeces was 31.8% and 18.7%, respectively.
Danish: C-telaprevir og VRT-127394 bidrog med henholdsvis 31,8% og 18,7% til den totale radioaktivitet genfundet i fæces.
English: • Pictures of rash according to different grades
Danish: • Billeder af udslæt inddelt efter sværhedsgrad
English: The in vitro replication capacity of telaprevir-resistant variants was lower than that of wild-type virus.
Danish: In vitro replikationskapaciteten var lavere hos telaprevir-resistente varianter end hos vildtype-virus.
English: Concomitant use may lead to adverse events such as nausea, dizziness, hypotension and syncope.
Danish: Samtidig brug kan føre til bivirkninger i form af kvalme, svimmelhed, hypotension og synkope.
English: Signs and symptoms of dehydration include increased thirst, dry mouth, decreased urine frequency or volume, and dark coloured urine.
Danish: Symptomer på dehydrering omfatter øget tørst, mundtørhed, mindre hyppig vandladning eller nedsat urinmængde og mørkfarvet urin.
English: In patients with normal renal and hepatic function, an interruption of colchicine treatment is recommended, or only a limited colchicine treatment course at a reduced colchicine dose should be used.
Danish: Hos patienter med normal nyreog leverfunktion anbefales det at indstille colchicinbehandlingen midlertidigt eller kun gennemføre et begrænset behandlingsforløb med colchicin med en reduceret colchicindosis.
English: Swallow the tablets whole.
Danish: Tabletterne skal synkes hele.
English: Co-administration of atorvastatin and telaprevir is contraindicated (see section 4.3).
Danish: Co-administration af atorvastatin og telaprevir er kontraindiceret (se pkt.
English: A lower ribavirin dose (600 mg/day) at initiation of INCIVO treatment is recommended (see section 5.1).
Danish: Det anbefales at give en lavere dosis ribavirin (600 mg/dag) ved indledning af behandling med INCIVO (se pkt.
English: Tacrolimus may prolong the QT interval (see section 4.4).
Danish: Tacrolimus kan forlænge QT-intervallet (se pkt.
English: These may be symptoms of anaemia.
Danish: Det kan være symptomer på blodmangel (anæmi).
English: In clinical trials, the majority of patients were administered antihistamines and topical corticosteroids.
Danish: I kliniske studier fik de fleste patienter antihistaminer og lokalbehandling med kortikosteroider.
English: The total duration of treatment of peginterferon alfa and ribavirin varies from 24 to 48 weeks depending on treatment response and whether you have been treated before.
Danish: Den samlede behandlingsvarighed for pegyleret interferon-alfa og ribavirin kan vare fra 24 til 48 uger afhængigt af, hvordan du reagerer på behandlingen, og om du tidligere har været i behandling.
English: In both rats and dogs, AST/ALT elevations were observed in most studies, of which the increase in ALT in rats was not normalised after recovery.
Danish: I de fleste studier sås forhøjet ASAT og ALAT hos både rotter og hunde, hvor stigningen i ALAT i rotter ikke normaliseredes i observationsperioden.
English: INCIVO acts against the virus that causes hepatitis C infection and is used to treat chronic hepatitis C infection in adult patients (aged 18-65 years) in combination with peginterferon alfa and ribavirin.
Danish: INCIVO virker mod den virus, der giver hepatitis C-leverbetændelse, og det bruges til at behandle kronisk hepatitis C hos voksne patienter (i alderen 18-65 år) i kombination med pegyleret interferonalfa og ribavirin.
English: The primary assessment was an evaluation of non-inferiority, using a margin of -10.5% of the 24-week regimen compared to the 48-week regimen in patients with undetectable HCV RNA (target not detected) at weeks 4 and 12.
Danish: Den primære vurdering var en evaluering af non-inferiority med en margin på -10,5% for 24-ugers regimet sammenlignet med 48-ugers regimet hos patienter med ikke-detekterbart HCV-RNA (HCV-RNA ikke
English: Variants V36A/M, T54A/S, R155K/T, and A156S conferred lower levels of in vitro resistance to telaprevir (3- to 25-fold increase in telaprevir IC50), and the A156V/T and V36M+R155K variants conferred higher levels of in vitro resistance to telaprevir (> 25-fold increase in telaprevir IC50).
Danish: Varianterne V36A/M, T54A/S, R155K/T og A156S medførte lavere niveauer af in vitro-resistens mod telaprevir (en stigning på faktor 3-25 i telaprevirs IC50-værdi), og varianterne A156V/T og V36M+R155K medførte højere niveauer af in vitro-resistens mod telaprevir (en stigning på > faktor 25 i telaprevirs IC50-værdi).
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia (see section 4.4).
Danish: Denne kombination kan resultere i en øget risiko for de kardiovaskulære hændelser, der er forbundet med salmeterol, inklusive QTforlængelse, palpitationer og sinustakykardi (se pkt.
English: Patients with HCV genotype 1a predominately had V36M and R155K single and combination variants, while patients with HCV genotype 1b predominately had V36A, T54A/S, and A156S/T/V variants.
Danish: Patienter med HCV-genotype 1a havde overvejende V36M- og R155K-enkelt- og kombinationsvarianter, mens patienter med HCV-genotype 1b overvejende havde V36A-, T54A/S- og A156S/T/V-varianter.
English: Improvement of rash occurs after INCIVO dosing completion or discontinuation; however, rashes may take several weeks to
Danish: Der ses bedring af udslæt efter gennemførelse eller seponering af behandling med INCIVO, men udslættene kan være flere uger om
English: Rare side effects (affects less than 1 in 1,000 people): - a wide-spread severe rash with peeling skin which may be accompanied by fever, flu-like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens-Johnson syndrome).
Danish: Sjældne bivirkninger (forekommer hos færre end 1 ud af 1.000 behandlede): - et udbredt, alvorligt udslæt med afskallende hud, der kan være ledsaget af feber, influenza lignende symptomer, blærer i mund, øjne og/eller på kønsdelene (Stevens-Johnsons syndrom).
English: Permanently discontinue INCIVO immediately.
Danish: Omgående og permanent seponering af INCIVO.
English: Based on population sequencing analyses of HCV in these 215 patients, the emergence of telaprevir-resistant HCV variants was detected in 105 (84%) virologic failures and in 55 (61%) relapsers, and wild-type virus was detected in 15 (12%) virologic failures and in 24 (27%) relapsers.
Danish: Ud fra populationssekventeringsanalyser af HCV hos disse 215 patienter blev der påvist telaprevir-resistente HCV-varianter hos 105 patienter (84%) med virologisk svigt og hos 55 patienter (61%) med relapse, og vildtype-virus blev påvist hos 15 patienter (12%) med virologisk svigt og hos 24 patienter (27%) med relapse.
English: Taking INCIVO without food or without regard to the dosing interval may result in decreased plasma concentrations of telaprevir which could reduce the
Danish: Indtagelse af INCIVO uden føde eller uden at overholde doseringsintervallet kan føre til nedsat plasmakoncentration af telaprevir, hvilket kan reducere INCIVOs terapeutiske virkning.
English: In placebo-controlled Phase 2 and 3 trials, 0.4% of patients had suspected Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).
Danish: I placebokontrollerede fase 2- og 3-studier fik 0,4% af patienterne mistænkt DRESS (Drug Rash with Eosinophilia and Systemic Symptoms).
English: HCV RNA levels should be monitored at weeks 4 and 12.
Danish: HCV-RNA-niveauerne bør kontrolleres i uge 4 og 12.
English: Available data suggest that peginterferon alfa, and perhaps also ribavirin, may contribute to the frequency and severity of rash associated with INCIVO combination treatment.
Danish: Data indikerer, at pegyleret interferon-alfa og muligvis også ribavirin kan påvirke hyppigheden og sværhedsgraden af udslæt, der associeres med INCIVO-kombinationsbehandling.
English: T12(DS)/PR % (n/N) ≥ 1 log10 reduction in HCV RNA at week 4
Danish: T12(DS)/PR % (n/N) < 1 log10 reduktion i HCVRNA i uge 4
English: The mean elimination half-life after single-dose oral administration of telaprevir 750 mg typically ranged from about 4.0 to 4.7 hours.
Danish: Det gennemsnitlige eliminationshalveringstid efter en enkelt dosis telaprevir på 750 mg indgivet per os lå typisk i intervallet ca. 4,0 til 4,7 timer.
English: An effect of telaprevir on UDP-glucuronyltransferases cannot be ruled out and may affect the plasma concentrations of abacavir or zidovudine.
Danish: Det kan ikke udelukkes, at telaprevir indvirker på UDP-glucuronyltransferaser, hvilket kan påvirke plasmakoncentrationen af abacavir eller zidovudin.
English: Interruption of ribavirin may be required sooner if the rash worsens despite discontinuation of telaprevir.
Danish: Der kan opstå behov for tidligere indstilling af behandlingen med ribavirin, hvis udslættet forværres til trods for seponering af telaprevir.
English: Due to the combined treatment with peginterferon alfa and ribavirin, female patients of childbearing potential and their male partners as well as male patients and their female partners must use 2 effective contraceptive methods during INCIVO treatment.
Danish: På grund af kombinationsbehandling med pegyleret interferon-alfa og ribavirin skal kvindelige patienter i den fertile alder og deres mandlige partnere samt mandlige patienter og deres kvindelige partnere anvende 2 sikre kontraceptionsmetoder under INCIVO-behandling.
English: In a follow-up study of 98 treatment-naïve and prior treatment-failure patients who were treated with a INCIVO regimen in a Phase 2 or Phase 3study and did not achieve SVR, telaprevir-resistant variants were no longer detected in 85% (83/98) of patients (median follow-up of 27.5 months).
Danish: I et opfølgningsstudie med 98 patienter der var behandlingsnaive eller med tidligere behandlingssvigt, som blev behandlet med et INCIVO-regime i et fase 2- eller et fase 3-studie, og som ikke opnåede SVR, kunne telaprevir-resistente varianter ikke længere påvises hos 85% (83/98) af patienterne (median opfølgning 27,5 måneder).
English: Telaprevir-resistant variants were tested for cross-resistance against representative protease inhibitors in the HCV replicon system.
Danish: Telaprevir-resistente varianter blev testet for krydsresistens mod repræsentive proteasehæmmere i HCV-replicon-systemet.
English: In the Pbo/PR arm, 2 (9%) patients had baseline bridging fibrosis and no patients had baseline cirrhosis.
Danish: I Pbo/PR-gruppen havde 2 forsøgspersoner (9%) brofibrose ved baseline, og ingen havde cirrose ved baseline.
English: Concomitant administration with Class Ia or III antiarrhythmics, except for intravenous lidocaine (see section 4.5).
Danish: Samtidig anvendelse af klasse Ia- eller III-antiarytmika med undtagelse af intravenøst lidocain (se pkt.
English: There are limited clinical data on the use of INCIVO in HCV patients aged ≥ 65 years.
Danish: Der foreligger begrænsede kliniske data om anvendelse af INCIVO til HCV-patienter ≥ 65 år.
English: Telaprevir and its major metabolite are excreted in rat milk (see section 5.3).
Danish: Telaprevir og dets hovedmetabolit udskilles i rottemælk (se pkt.
English: Refer to sections 4.4 and 4.6.
Danish: 4.4 og 4.6.
English: The incidence of adverse drug reactions (ADRs) of at least moderate intensity (≥ Grade 2) was higher in the INCIVO group than in the placebo group.
Danish: Incidensen af bivirkninger af mindst moderat intensitet (≥ grad 2) var højere i INCIVO-gruppen end i
English: In HCV negative patients with moderate hepatic impairment, reduced exposure to telaprevir was observed.
Danish: Hos HCV-negative patienter med moderat nedsat leverfunktion blev der observeret nedsat eksponering for telaprevir.
English: Caution is warranted and clinical monitoring is recommended for itraconazole, posaconazole, and voriconazole.
Danish: Forsigtighed tilrådes, og klinisk monitorering af itraconazol, posaconazol og voriconazol anbefales.
English: Of the 393 resistant variants detected in the 255 patients, 68% of NS3-36, 84% of NS3-54, 59% of NS3-155, 86% of NS3-156, and 52% of NS3-36M+NS3-155K variants were no longer detected.
Danish: Ud af de 393 resistente varianter påvist hos de 255 patienter kunne 68% ud af NS3-36, 84% ud af NS3-54, 59% ud af NS3-155, 86% ud af NS3-156 og 52% ud af NS3-36M+NS3-155K varianter ikke
English: In the analysis of an additional study, Study C211, the safety profile of combination therapy with INCIVO 1,125 mg twice daily was similar to the safety profile for patients receiving combination therapy with INCIVO 750 mg every 8 hours.
Danish: I analysen af et supplerende studie, Studie C211, svarede sikkerhedsprofilen af kombinationsbehandling med INCIVO 1.125 mg to gange dagligt til sikkerhedsprofilen hos patienter, der fik kombinationsbehandling med INCIVO 750 mg hver 8. time.
English: Proton pump inhibitors can be used without dose modification.
Danish: Syrepumpehæmmere kan anvendes uden dosisændring.
English: Table 6 shows SVR rates by IL28B genotype and the stage of liver fibrosis at baseline.
Danish: Tabel 6 viser SVR-rater fordelt på IL28B-genotype og stadiet af leverfibrose ved baseline.
English: The efficacy and safety of INCIVO in patients with genotype 1 chronic hepatitis C were evaluated in four Phase 3 studies: 3 in treatment-naïve patients and 1 in previously treated patients (relapsers, partial responders, and null responders).
Danish: Virkning og sikkerhed af INCIVO blev evalueret hos patienter med kronisk hepatitis C af genotype 1 i fire fase 3-studier: 3 med behandlingsnaive og 1 med tidligere behandlede patienter (med relapse, partial response eller null response).
English: You must always take INCIVO with food as this is important to get the right levels of medicine in your body.
Danish: Du skal altid tage INCIVO sammen med mad, så kroppen kan optage den rette mængde af medicinen.
English: INCIVO is available in packs containing one bottle or 4 bottles per carton.
Danish: INCIVO fås i pakninger med 1 beholder eller 4 beholdere pr. æske.
English: Careful monitoring of therapeutic and adverse effects (including respiratory depression) is recommended when telaprevir is co-administered with alfentanil or fentanyl, including oral, buccal, nasal and extended-release transdermal or transmucosal preparations of fentanyl, especially at initiation of treatment.
Danish: Omhyggelig monitorering af den terapeutiske virkning og bivirkninger (herunder respirationsdepression) anbefales ved samtidig anvendelse af telaprevir og alfentanil eller fentanyl, inklusive orale, bukkale og nasale formuleringer samt transdermale eller transmukosale depotformuleringer af fentanyl, specielt ved behandlingsstart.
English: P < 0.001, T12/PR compared to Pbo/PR48.
Danish: P < 0,001, T12/PR sammenlignet med Pbo/PR48.
English: The clinical implications of this finding are currently unknown.
Danish: Den kliniske betydning af dette fund er endnu ikke klarlagt.
English: For moderate rash that progresses, permanent discontinuation of INCIVO should be considered.
Danish: Ved progression af et moderat udslæt bør permanent seponering af behandlingen med INCIVO overvejes.
English: Patients were randomised to 12 weeks of INCIVO (750 mg every 8 hours if taken in combination with atazanavir/ritonavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine OR 1,125 mg every 8 hours if taken in combination with efavirenz, tenofovir disoproxil fumarate, and emtricitabine) or placebo.
Danish: Patienterne blev randomiseret til 12 ugers behandling med INCIVO (750 mg hver 8. time, hvis de fik det i kombination med atazanavir/ritonavir, tenofovirdisoproxilfumarat og emtricitabin eller lamivudin, ELLER 1.125 mg hver 8. time, hvis de fik det i kombination med efavirenz, tenofovirdisoproxilfumarat og emtricitabin) eller placebo.
English: The assay had a lower limit of quantification of 25 IU/ml.
Danish: Denne analyse havde en laveste kvantificeringsgrænse på 25 IE/ml.
English: Of a combined 255 treatment-naïve and previously treated patients from Phase 3 studies 108, 111, and C216 in whom telaprevir-resistant variants had emerged during treatment, 152 (60%) patients no longer had resistant variants detected by population sequencing (median follow-up of 10 months).
Danish: Ud af i alt 255 behandlingsnaive og tidligere behandlede patienter fra fase 3-studie 108, 111 og C216, hos hvem der var opstået telaprevir-resistente varianter under behandlingen, havde 152 patienter (60%) ikke længere resistente varianter påvist ved populationssekvensering (median opfølgningstid 10 måneder).
English: HCV RNA levels should be monitored at weeks 4 and 12 to determine treatment duration.
Danish: HCV-RNA-niveauer skal kontrolleres i uge 4 og 12 for at fastsætte behandlingsvarighed.
English: an herbal product to relieve anxiety to lower cholesterol levels (HMG CoA reductase inhibitors)
Danish: et plantelægemiddel mod angst til at sænke kolesteroltallet (HMG-COAreduktasehæmmere)
English: Potent CYP3A inducers, such as carbamazepine, phenytoin and phenobarbital, are contraindicated
Danish: Potente CYP3A-induktorer såsom carbamazepin, phenytoin og phenobarbital er
English: Study C211 was a randomised, open-label, Phase 3 study conducted in treatment-naïve patients who were randomised to one of two treatment groups: INCIVO 750 mg every 8 hours [T12(q8h)/PR] or INCIVO 1,125 mg twice daily [T12(b.i.d.
Danish: Studie C211 var et randomiseret, åbent fase 3-studie, der omfattede behandlingsnaive patienter, som blev randomiseret til en af de to behandlingsgrupper: INCIVO 750 mg hver 8. time [T12(q8h)/PR] eller INCIVO 1.125 mg to gange dagligt [T12(b.i.d.
English: Close monitoring of immunosuppressant blood levels, renal function and immunosuppressant related side effects are recommended when co-administered with telaprevir.
Danish: Nøje monitorering af det immunsupprimerende middels blodkoncentration, nyrefunktion og bivirkninger af det immunsupprimerende middel anbefales ved samtidig brug af telaprevir.
English: • The Patient Information Leaflet
Danish: • Information til læger
English: Patients received INCIVO at a dosage of 750 mg every 8 hours, except for patients on an efavirenz-based regimen who received INCIVO at a dosage of 1,125 mg every 8 hours.
Danish: Patienterne fik INCIVO i doser på 750 mg hver 8. time med undtagelse af patienter på et efavirenz-baseret regime, som fik INCIVO i doser på 1.125 mg hver 8. time.
English: Yellow caplet-shaped tablets of approximately 20 mm in length, marked with ‘T375' on one side.
Danish: Gule, kapselformede tabletter, der er ca. 20 mm lange og mærket “T375” på den ene side.
English: The exposure (AUC) to telaprevir increased slightly greater than proportionally to the dose after single-dose administration of 375 up to 1,875 mg with food, possibly due to saturation of metabolic
Danish: Eksponeringen (AUC) for telaprevir steg lidt mere end proportionalt med dosis efter indgift af en enkelt dosis fra 375 og op til 1.875 mg samtidig med fødeindtagelse, hvilket muligvis skyldes mætning af metaboliske processer eller effluks-transportører.
English: The serum digoxin concentrations should be monitored and used for titration of digoxin dose to obtain the desired clinical effect.
Danish: Serumkoncentrationen af digoxin bør kontrolleres og anvendes til dosistitrering af digoxin mhp.
English: Patients on an efavirenz-based regimen must receive INCIVO 1,125 mg every 8 hours.
Danish: Til patienter på et efavirenz-baseret regime gives INCIVO 1.125 mg hver 8. time.
English: If improvement is not observed within 7 days of INCIVO discontinuation, sequential or simultaneous interruption or discontinuation of ribavirin and/or peginterferon alfa should be considered.
Danish: Hvis der ikke ses bedring inden for 7 dage efter seponering af INCIVO, bør det overvejes sekventielt eller samtidigt at indstille eller seponere behandling med ribavirin og/eller pegyleret interferon-alfa.
English: Contact your doctor immediately if you get a skin rash.
Danish: Kontakt straks lægen, hvis du får hududslæt.
English: The active substance is telaprevir.
Danish: INCIVO indeholder Aktivt stof: telaprevir.
English: INCIVO is a strong, time-dependent inhibitor of CYP3A4 and also markedly inhibits P-gp.
Danish: INCIVO er en stærk, tidsafhængig CYP3A4-hæmmer, der også hæmmer P-gp markant.
English: It is not known whether telaprevir, the active ingredient in INCIVO, is found in human breast milk.
Danish: Det vides ikke, om telaprevir, det aktive stof i INCIVO, går over i modermælken.
English: Patients taking INCIVO frequently get an itchy skin rash.
Danish: Patienter, der tager INCIVO, får hyppigt et kløende hududslæt.
English: TSH levels should be determined before and during the course of INCIVO combination treatment and treated as clinically appropriate, including potential adjustment of thyroid replacement therapy in patients with pre-existing hypothyroidism (see section 4.4,
Danish: TSH-niveauer bør bestemmes før og under INCIVO-kombinationsbehandlingen, og behandles som klinisk indiceret, inklusiv potentiel justering af thyroideahormon-substitutionsbehandlingen hos patienter med eksisterende hypothyroidisme (se pkt.
English: Therefore, INCIVO is not recommended in these patients (see sections 4.2 and 5.2).
Danish: INCIVO anbefales derfor ikke til disse patienter (se pkt.
English: All patients received ribavirin at a fixed dose of 800 mg/day.
Danish: Alle patienter fik en fast dosis ribavirin på 800 mg/dag.
English: Exposure to telaprevir is higher during co-administration of peginterferon alfa and ribavirin than after administration of telaprevir alone.
Danish: Eksponeringen for telaprevir er højere under samtidig behandling med pegyleret interferon-alfa og ribavirin end efter administration af telaprevir alene.
English: Ribavirin dose reduction is the preferred strategy for managing treatment-emergent anaemia.
Danish: Reduktion af ribavirin-dosis er den foretrukne strategi ved behandling af anæmi, som opstår under behandlingen.
English: The overall safety profile of INCIVO is based on Phase 2 and 3 clinical trial data (both controlled and uncontrolled) containing 3,441 patients who received INCIVO combination treatment and on
Danish: Den samlede sikkerhedsprofil af INCIVO er baseret på data fra kliniske fase 2- og 3-studier (såvel kontrollerede som ukontrollerede), der omfatter 3.441 patienter, som fik INCIVOkombinationsbehandling, samt på spontane indberetninger efter markedsføring.
English: Table 4: Selected laboratory abnormalities (DAIDS
Danish: Tabel 4: Selekterede anormale laboratoriefund (DAIDS-grad ≥ 2