FrancophonIA/ELRC3.0 huggingface dataset:
English: - Adequately controlled thyroid function (TSH) - Calculated creatinine clearance ≥ 50 ml/min
Danish: - Velkontrolleret thyroideafunktion (TSH) - Beregnet kreatininclearance ≥ 50 ml/min
English: More than 90% of rashes were of mild or moderate severity.
Danish: Over 90% af alle udslæt var lette til moderate.
English: In prior null responders, consideration should be given to conduct an additional HCV RNA test between weeks 4 and 12.
Danish: Hos tidligere null responders bør det overvejes at udføre en yderligere HCV-RNA-test mellem uge 4 og uge 12.
English: Tell your doctor if you have an hepatitis B infection so that your doctor can decide if INCIVO
Danish: Fortæl det til lægen, hvis du har en hepatitis B-leverbetændelse, så lægen kan afgøre, om INCIVO er den rette behandling til dig.
English: In addition, the limit of quantification of 25 IU/ml was used to determine SVR.
Danish: Desuden anvendtes kvantificeringsgrænsen på 25 IE/ml til at bestemme SVR.
English: Dosage adjustment of fentanyl or alfentanil may be necessary.
Danish: Dosisjustering af fentanyl eller alfentanil kan være nødvendig.
English: C-telaprevir in healthy subjects, 90% of total radioactivity was recovered in faeces, urine and expired air within 96 hours post-dose.
Danish: C-telaprevir hos raske forsøgspersoner blev 90% af den totale radioaktivitet genfundet i fæces, urin og eksspirationsluft inden for 96 timer efter indgift.
English: After oral administration, the apparent total clearance (Cl/F) was estimated to be 32.4 l/h with an inter-individual variability of 27.2%.
Danish: Efter oral anvendelse estimeredes tilsyneladende total clearance (Cl/F) til 32,4 l/time med en interindividuel variabilitet på 27,2%.
English: In rats and dogs, telaprevir was associated with a reversible reduction of red blood cell parameters accompanied by a regenerative response.
Danish: I rotter og hunde blev telaprevir associeret med et reversibelt fald i erytrocytparametre ledsaget af et regenerativt respons.
English: Multiple metabolites were detected in faeces, plasma, and urine.
Danish: Der blev påvist flere metabolitter i fæces, plasma og urin.
English: Your doctor will measure blood levels of your virus at weeks 4 and 12 to determine your treatment duration.
Danish: Lægen vil kontrollere blodets indhold af virus i 4. og 12. uge for at fastsætte, hvor længe din behandling skal vare.
English: Ribavirin may be restarted per the dosing modification guidelines for ribavirin.
Danish: Ribavirin kan genoptages i henhold til vejledningen for dosisændringer for ribavirin.
English: - to check if you have anaemia (decrease in your red blood cells).
Danish: - for at kontrollere, om du har anæmi (fald i de røde blodlegemer).
English: Similar proportions of patients in both treatment groups had telaprevir-resistant variants at the time of failure.
Danish: Samme andel af patienter i de 2 behandlingsgrupper havde varianter, der var resistente over for telaprevir, på tidspunktet for svigt.
English: In vitro studies with recombinant UGT1A3 suggested that telaprevir may inhibit this enzyme.
Danish: In vitro-studier med rekombinant UGT1A3 tyder på, at telaprevir kan hæmme dette enzym.
English: Table 2 provides dosing recommendations as a result of drug interactions with INCIVO.
Danish: Tabel 2 viser dosisrekommandationer som følge af lægemiddelinteraktioner med INCIVO.
English: These changes should be based on frequent monitoring of tacrolimus or cyclosporine A plasma concentrations during INCIVO treatment.
Danish: Disse ændringer skal baseres på hyppig monitorering af plasmakoncentrationen af tacrolimus eller ciclosporin under behandlingen med INCIVO.
English: For moderate rash that progresses to severe (≥ 50% body surface area), permanently discontinue INCIVO (see below).
Danish: Ved moderat udslæt, der progredierer til alvorligt udslæt (≥ 50% legemsoverflade) skal INCIVO seponeres permanent (se nedenfor).
English: Other enzymes are also involved in the metabolism (see section 5.2).
Danish: Andre enzymer er også involveret i metaboliseringen (se pkt.
English: (7.0-8.9 g/dl or any decrease ≥ 4.5 g/dl)
Danish: (7,0-8,9 g/dl eller ethvert fald ≥ 4,5 g/dl)
English: Use of INCIVO in treatment of other HCV genotypes There are not sufficient clinical data to support the treatment of patients with HCV genotypes other than genotype 1.
Danish: Anvendelse af INCIVO til behandling af andre HCV-genotyper Der foreligger ikke tilstrækkelige kliniske data til at forsvare behandling af patienter med andre HCV-genotyper end genotype1.
English: Any birth control method can fail, and, therefore, you and your partner must use at least two effective birth control methods during INCIVO therapy and afterwards.
Danish: Enhver form for prævention kan svigte, og derfor er det vigtigt, at du og din partner anvender mindst to sikre former for prævention under og efter behandling med INCIVO.
English: Replicons with single substitutions at position 155 or 156 and double variants with substitutions at residues 36 and 155 showed cross-resistance to all protease inhibitors tested with a wide range of sensitivities.
Danish: Replika med enkeltsubstitutioner ved position 155 eller 156 og dobbeltvarianter med substitutioner ved position 36 og 155 viste krydsresistens over for alle proteasehæmmere testet med et bredt interval af følsomhed.
English: Use of INCIVO should be avoided in patients with congenital QT prolongation, or a family history of congenital QT prolongation or sudden death.
Danish: Anvendelse af INCIVO bør undgås hos patienter med medfødt QT-forlængelse eller familiær anamnese med medfødt QT-forlængelse eller pludselig død.
English: Tadalafil for treatment of erectile dysfunction can be used with caution at a single dose not exceeding 10 mg dose in 72 hours and with increased monitoring for tadalafil associated adverse events.
Danish: Tadalafil til behandling af erektil dysfunktion kan anvendes med forsigtighed som en enkelt dosis, der ikke overstiger 10 mg i løbet af 72 timer, og ved øget samtidig kontrol for bivirkninger associeret med tadalafil.
English: ANTIFUNGALS ketoconazole* itraconazole posaconazole voriconazole
Danish: ANTIMYKOTIKA ketoconazol* itraconazol posaconazol voriconazol
English: If your treatment is not working, your doctor may stop your medicines.
Danish: Hvis behandlingen ikke virker på dig, kan lægen vælge at stoppe medicinen.
English: Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVO combination treatment after a serious skin reaction was identified.
Danish: Der foreligger indberetninger af tilfælde med dødeligt forløb hos patienter med progredierende udslæt og systemiske symptomer, der fortsatte med INCIVOkombinationsbehandling efter konstatering af en alvorlig hudreaktion.
English: Monitor for progression or systemic symptoms until the rash is resolved.
Danish: Overvåges for progression eller systemiske symptomer, indtil udslættet forsvinder.
English: No relevant effect of gender was identified.
Danish: Der sås ingen relevant effekt
English: Detectable HCV RNA below the lower limit of assay quantification should not be used as a substitute for “undetectable” (target not detected), for making decisions on treatment duration, as this may lead to an insufficient duration of therapy and higher relapse rates.
Danish: Detekterbart HCV-RNA under den nedre kvantificeringsgrænse bør ikke anvendes som erstatning for ”ikke-detekterbart” (HCV-RNA ikke påvist) til at træffe afgørelser om behandlingsvarighed, da det ville kunne føre til en utilstrækkelig varighed af behandlingen og højere relapse-rater.
English: Note that the virologic stopping rules taken into account in this treatment outcome analysis are actual stopping rules, i.e., those derived from disposition and exposure data, as opposed to mathematical stopping rules, i.e., derived from the
Danish: Bemærk, at de virologiske stopregler, der er taget højde for i denne analyse af behandlingsresultater, er faktiske stopregler, dvs. afledt af dispositions- og eksponeringsdata til forskel fra matematiske stopregler, dvs. afledt
English: Rifampicin reduces the telaprevir plasma AUC by approximately 92%.
Danish: Rifampicin reducerer telaprevirs plasma-AUC med ca. 92%, og INCIVO må derfor ikke anvendes
English: Fifty-five out of 60 patients received ribavirin at a fixed dose of 800 mg/day and the remaining 5 patients received a weight-based ribavirin dose.
Danish: 55 ud af 60 patienter fik ribavirin i en fast dosis på 800 mg/dag, og de resterende 5 patienter fik en vægtbaseret dosis ribavirin.
English: In general, exposure levels in relation to human values were low in animal pharmacology and toxicology studies.
Danish: Generelt var eksponeringsniveauet lavere i farmakologiske og toksikologiske dyrestudier i forhold til værdier hos mennesker.
English: Table 8 shows SVR rates for patient subgroups.
Danish: I tabel 8 vises SVR-rater for patienterne i de enkelte undergrupper.
English: Telaprevir did not have any teratogenic potential in rat or mouse.
Danish: Telaprevir udviste ikke teratogent potentiale hos rotter eller mus.
English: INCIVO is not for use in children or adolescents, because it has not been sufficiently studied in
Danish: INCIVO må ikke anvendes til børn og unge, da det ikke er undersøgt tilstrækkeligt hos patienter under
English: Based on in vitro studies, telaprevir may potentially increase plasma concentrations of medicinal products in which excretion is dependent upon multidrug and toxin extrusion (MATE)-1 and MATE2-K (see table 2).
Danish: Ud fra in vitro-studier kan telaprevir potentielt øge plasmakoncentrationen af lægemidler, hvis elimination afhænger af MATE1 og MATE2-K (MATE = multidrug and toxin extrusion) (se tabel 2).
English: Other medicinal products associated with severe cutaneous reactions should be used with caution during administration of INCIVO combination treatment to avoid potential confusion as to which medicinal product could be contributing to a severe cutaneous reaction.
Danish: Forsigtighed tilrådes ved brug af andre lægemidler associeret med alvorlige kutane reaktioner under administration af INCIVO-kombinationsbehandling for at undgå potentiel usikkerhed med hensyn til, hvilket lægemiddel kunne have medvirket til en alvorlig kutan reaktion.
English: Therefore this combination should be used with caution or alternatives should be considered.
Danish: Kombinationen bør derfor anvendes med forsigtighed, og anden behandling bør overvejes.
English: T12/PR All Patients N=540
Danish: T12/PR Alle patienter N=540
English: Each bottle contains one pouch or two pouches of desiccant to keep the tablets dry.
Danish: Hver beholder indeholder en eller to poser med tørremiddel til at holde tabletterne tørre.
English: ECG should be monitored at baseline and regularly during telaprevir treatment.
Danish: Ekg-vurderinger bør udføres ved baseline og regelmæssigt under behandling med telaprevir.
English: INCIVO must always be taken together with food.
Danish: INCIVO skal altid tages i forbindelse med et måltid.
English: Your doctor may request additional monitoring during your INCIVO treatment.
Danish: Lægen kan foreskrive yderligere kontrol under din behandling med INCIVO.
English: On-treatment virologic failure during telaprevir treatment was predominantly associated with higher-level resistant variants, and relapse was predominantly associated with lower-level resistant variants or wild-type virus.
Danish: Virologisk svigt under behandlingen med telaprevir var overvejende associeret med mere resistente varianter, og relapse var overvejende associeret med mindre resistente varianter eller vildtype-virus.
English: Telaprevir is orally available, most likely absorbed in the small intestine, with no evidence for absorption in the colon.
Danish: Telaprevir er oralt tilgængelig og absorberes formentlig i tyndtarmen, mens absorption i colon ikke er påvist.
English: The clinical relevance of this is uncertain as administration of telaprevir with a single dose of buprenorphine, a partial UGT1A3 substrate, to healthy adult subjects did not result in increases in buprenorphine exposures.
Danish: Den kliniske relevans heraf er usikker, da administration af telaprevir sammen med en enkelt dosis buprenorphin, et partielt substrat for UGT1A3, til raske voksne forsøgspersoner ikke førte til øget eksponering for buprenorphin.
English: - who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders (see
Danish: - som tidligere er blevet behandlet med interferon-alfa (pegyleret eller ikke-pegyleret) alene eller i kombination med ribavirin, inklusive relapsers, partial responders og null responders (se
English: Contact your doctor or pharmacist immediately to ask for advice.
Danish: Kontakt straks lægen eller apoteket for at spørge dem til råds.
English: Hypoalbuminaemia and low platelet counts have been identified as predictors of severe complications of liver disease as well as of interferon-based therapies (e.g., hepatic decompensation, serious bacterial infections).
Danish: Hypoalbuminæmi og lavt trombocyttal er blevet identificeret som prædiktorer for svære komplikationer af leversygdom såvel som af interferonbaserede terapier (f.eks.dekompenseret leverlidelse, alvorlige bakterieinfektioner).
English: INCIVO can be used for patients with chronic hepatitis C infection who have never been treated before or can be used in patients with chronic hepatitis C infection who have been treated previously with an interferon-based regimen.
Danish: INCIVO kan anvendes til patienter med kronisk hepatitis C, som aldrig tidligere har været i behandling, eller det kan anvendes til patienter med kronisk hepatitis C, som tidligere har fået en behandling, der omfattede et interferon.
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency.
Danish: Patienter, der anvender østrogener til hormonerstatningsterapi, bør monitoreres klinisk for symptomer på østrogenmangel.
English: INCIVO may affect other medicines or other medicines may affect INCIVO.
Danish: INCIVO kan påvirke behandling med anden medicin, eller anden medicin kan påvirke behandling med INCIVO.
English: The total dose is 6 tablets or - 2 tablets of INCIVO every 8 hours with food.
Danish: Den samlede dosis er 6 tabletter dagligt eller - 2 tabletter INCIVO hver 8. time i forbindelse med et måltid.
English: If trazodone is used with telaprevir, the combination should be used with caution and a lower dose of trazodone should be considered.
Danish: Hvis trazodon eller anvendes sammen med telaprevir, skal der udvises forsigtighed ved denne kombination, og det bør overvejes at give en lavere dosis af trazodon.
English: oral midazolam*
Danish: oralt midazolam*
English: Table 14: Pooled response rates: Study C208
Danish: Tabel 14: Poolede responsrater: Studie C208
English: Animal studies are insufficient with respect to human reproductive toxicity (see section 5.3).
Danish: Data fra dyrestudier er utilstrækkelige, hvad angår human reproduktionstoksicitet (se pkt.
English: In two double-blind, randomised, placebo- and active-controlled studies conducted to evaluate the effect on the QT interval, telaprevir monotherapy at a dose of 750 mg every 8 hours was not associated with a clinically relevant effect on QTcF interval.
Danish: I to dobbeltblinde, randomiserede, placebo- og aktivt-kontrollerede studier, der blev udført for at evaluere virkningen på QT-intervallet, var telaprevir monoterapi i en dosis på 750 mg hver 8. time ikke forbundet med en klinisk relevant påvirkning af QTcF-intervallet.
English: Electrolyte disturbances (e.g., hypokalaemia, hypomagnesaemia and hypocalcaemia) should be monitored and corrected, if necessary, prior to initiation and during INCIVO therapy.
Danish: Forstyrrelser i elektrolytbalancen (f.eks., hypokaliæmi, hypomagnesiæmi og hypocalcæmi) bør kontrolleres og korrigeres efter behov før indledning af og under behandlingen med INCIVO.
English: Very common side effects (affects more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 behandlede)
English: • Incidence of rash and severe cutaneous reactions
Danish: • Incidensen af udslæt og alvorlige kutane reaktioner
English: When INCIVO is used in patients with advanced liver disease very close monitoring and early management of adverse events is recommended.
Danish: Hvis INCIVO anvendes til patienter med fremskreden leversygdom, anbefales meget tæt monitorering og tidlig behandling af uønskede
English: The lowest dose of digoxin should be initially prescribed.
Danish: Initialdosis af digoxin bør være den lavest mulige dosis.
English: Such patients should be closely monitored, including ECG assessments.
Danish: Disse patienter bør kontrolleres nøje inklusive ekg.
English: 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 and afterwards as recommended in the Summary of Product Characteristics for ribavirin, and as described below.
Danish: Kvindelige patienter i den fertile alder og deres mandlige partnere samt mandlige patienter og deres kvindelige partnere skal anvende 2 forskellige sikre kontraceptionsmetoder under INCIVO-behandling og efterfølgende som anbefalet i produktresumeet for ribavirin og som beskrevet nedenfor.
English: INCIVO contains a substance called telaprevir and belongs to a group of medicines called ‘NS3-4A protease inhibitors'.
Danish: INCIVO indeholder stoffet telaprevir og hører til en gruppe medicin, der kaldes ”NS3-4A-proteasehæmmere”.
English: It is important to stay hydrated with fluids during INCIVO combination treatment.
Danish: Det er vigtigt at indtage rigelig væske under INCIVO kombinationsbehandling.
English: Since it is highly unlikely that patients with inadequate viral responses will achieve a sustained virologic response (SVR), it is recommended that patients with HCV RNA > 1,000 IU/ml at week 4 or week 12 discontinue therapy (refer to table 1).
Danish: Eftersom det er højst usandsynligt, at patienter med utilstrækkeligt viralt respons opnår et vedvarende virologisk respons (sustained virologic response, SVR), anbefales det, at patienter med HCV-RNA > 1.000 IE/ml i uge 4 eller uge 12 stopper med behandlingen (se tabel 1).
English: No studies on the effects of INCIVO on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af INCIVO for virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: Hyperbilirubinaemia is frequent with this combination.
Danish: Hyperbilirubinæmi ses ofte med denne kombination.
English: Clinical monitoring is recommended.
Danish: Klinisk monitorering anbefales.
English: All rashes should be monitored for progression and until the rash is resolved.
Danish: Ethvert udslæt bør overvåges for progression, indtil udslættet forsvinder.
English: Clinical comment
Danish: Klinisk anmærkning
English: Half the rashes started during the first 4 weeks, but rash can occur at any time during INCIVO combination treatment.
Danish: Halvdelen af udslættene opstod i de første 4 uger, men der kan forekomme udslæt når som helst under INCIVO-kombinationsbehandling.
English: Suppression by telaprevir and VRT-127394 of CYP enzymes regulated via CAR, PXR and Ah nuclear receptors was observed in vitro in human hepatocytes.
Danish: In vitro fandtes det, at telaprevir og VRT-127394 supprimerer CYP-enzymer reguleret via de nukleære receptorer CAR, PXR og Ah i humane hepatocytter.
English: Haematology evaluations (including white cell differential count) are recommended at weeks 2, 4, 8
Danish: Hæmatologisk evaluering (inklusive differentialtælling af leukocytter) anbefales i uge 2, 4, 8 og 12 og
English: No or minimal fibrosis or portal fibrosis
Danish: Ingen eller minimal fibrose eller portal fibrose
English: Interactions between telaprevir and HIV antiretroviral agents are frequent, and the recommendations in table 2, section 4.5, should be carefully followed.
Danish: Interaktioner mellem telaprevir og antiretrovirale midler mod hiv er hyppige, og anbefalingerne i tabel 2, pkt.
English: However, patients treated with peginterferon alfa-2b experienced more frequent viral breakthrough, and were less likely to meet the criteria for shortened total treatment duration (see section 5.1).
Danish: Patienterne, der fik pegyleret interferon-alfa-2b, fik dog hyppigere viralt gennembrud og var mindre tilbøjelige til at opfylde kriterierne for en afkortet samlet behandlingsvarighed (se pkt.
English: If your doctor stops INCIVO because of side effects or because your treatment is not working,
Danish: Hvis lægen stopper INCIVO på grund af bivirkninger, eller fordi behandlingen ikke virker, må du ikke
English: oral triazolam
Danish: oralt triazolam
English: In an HCV subtype 1b replicon assay, the telaprevir IC50 value against wild-type HCV was 0.354 µM similar to a subtype 1a infectious virus assay IC50 of 0.28 µM.
Danish: I en HCV-subtype 1b replicon assay var telaprevirs IC50-værdi mod en vildtype-HCV 0,354 µM, hvilket svarede til en IC50 på 0,28 µM i et subtype 1a virusinfektionsassay.
English: The response rate in the Pbo/PR arm was higher than that seen in other clinical studies of peginterferon bitherapy (historical SVR rates < 36%).
Danish: Responsraten i Pbo/PR-gruppen var højere end i andre kliniske studier af pegyleret interferon baseret 2-stof behandling (historiske SVR-rater < 36%).
English: During this time, female patients of childbearing potential should use two effective non-hormonal methods of contraception.
Danish: I løbet af denne periode bør kvindelige patienter i den fertile alder anvende to sikre ikke-hormonale kontraceptionsmetoder.
English: INCIVO is not recommended for use in children and adolescents younger than 18 years of age because the safety and efficacy has not been established in this population.
Danish: INCIVO anbefales ikke til børn og unge under 18 år, da sikkerhed og virkning ikke er klarlagt hos
English: Female patients of childbearing age and their male partners A hormonal contraceptive (‘the pill') may not be reliable during the treatment with INCIVO.
Danish: Kvindelige patienter i den fødedygtige alder og deres mandlige partnere P-piller (hormonale kontraceptiva) er muligvis ikke effektive under behandling med INCIVO.
English: astemizole, terfenadine to treat allergy symptoms (antihistamines)
Danish: astemizol, terfenadin til at behandle symptomerne på allergi (antihistaminer)
English: In the case of missing data within the week 72 window, the last HCV RNA data point from week 12 of follow-up onwards was used.
Danish: I tilfælde af manglende data i vinduet for uge 72 anvendtes de sidste HCV-RNA-datapoint fra og med uge 12 i studiets opfølgning.
English: Telaprevir is a strong inhibitor of the important drug metabolising enzyme CYP3A4.
Danish: Telaprevir er en stærk hæmmer af det vigtige lægemiddelmetaboliserende enzym CYP3A4.
English: Studies using recombinant human CYP supersomes showed that telaprevir was a CYP3A4 inhibitor, and a time- and concentration-dependent inhibition of CYP3A4 by telaprevir was observed in human liver microsomes.
Danish: Det fremgik af studier, der anvendte humane rekombinante CYP-supersomer, at telaprevir er en CYP3A4-hæmmer, og telaprevirs tids- og koncentrationsafhængige hæmning af CYP3A4 blev observeret i humane levermikrosomer.
English: HCV variants associated with on-treatment virologic failure or relapse were evaluated by site-directed mutagenesis in the replicon assay.
Danish: HCV-varianter associeret med virologisk svigt eller relapse under behandlingen blev evalueret ved hjælp af site-directed mutagenese i replicon-analysen.
English: If you or your female partner become pregnant during INCIVO treatment or the months that follow, you must contact your doctor immediately (see section 'Pregnancy precautions for men and women' below).
Danish: Kontakt straks lægen, hvis du eller din kvindelige partner bliver gravid under behandling med INCIVO eller i månederne efter behandlingen (se afsnittet "Prævention til mænd og kvinder”