FrancophonIA/ELRC3.0 huggingface dataset:
English: You must use an effective birth control during the time you are taking ribavirin and for 4 months after stopping treatment.
Danish: Du skal bruge effektiv prævention i den periode, hvor du tager ribavirin og i 4 måneder efter ophørt behandling.
English: Among the variants, 91% of V36M, 98% of T54A, 71% of T54S, 78% of V55A, 76% of R155K, 92% of A156S, 96% of I/V170A, 77% of R155K+T54S and 95% of R155K+V36M were undetectable by population sequencing.
Danish: Blandt varianterne var 91 % af V36M, 98 % af T54A, 71 % af T54S, 78 % af V55A, 76 % af R155K, 92 % af A156S, 96 % af I/V170A, 77 % af R155K+T54S og 95 % af R155K+V36M ikke-detekterbare ved populationssekventering.
English: In subjects treated with boceprevir who did not achieve SVR and with post-baseline samples analysed for RAVs, interferon responsiveness was associated with detection of fewer RAVs, with 31% of these subjects having post-baseline RAVs compared to 69% of subjects with < 1-log10 decline in viral load at Treatment Week 4.
Danish: Hos forsøgspersoner behandlet med boceprevir, der ikke opnåede SVR og med analyserede postbaseline-prøver for RAVer, blev interferonfølsomhed associeret med påvisning af færre RAVer, hvor 31 % af disse forsøgspersoner havde post-baseline RAV sammenlignet med 69 % af forsøgspersonerne med < 1 log10 fald i viral-load i behandlingsuge 4.
English: Victrelis 200 mg hard capsules boceprevir
Danish: Victrelis 200 mg hårde kapsler boceprevir
English: The degree of added value of Victrelis on top of the bitherapy in C/C patients will depend on the likelihood of achieving SVR with the bitherapy only.
Danish: Den gavnlige effekt af tilføjelsen af Victrelis til to-stofbehandlingen hos C/C patienter vil afhænge af sandsynligheden for, at der opnås SVR med to-stofbehandlingen alene.
English: Use in patients with an organ transplant
Danish: Anvendelse hos organtransplantatmodtagere
English: A greater than 10-fold reduction in boceprevir susceptibility was conferred by the amino acid substitutions R155T and A156S.
Danish: Mere end 10 gange reduceret følsomhed over for boceprevir opstod ved aminosyresubstitutionerne R155T og A156S.
English: • The Summary of Product Characteristics (in full)
Danish: • Produktresumé (fuld tekst)
English: Cases of HBV reactivation, some of them fatal, have been reported during or after treatment with direct-acting antivirals not given in combination with peginterferon alfa and ribavirin.
Danish: Der er rapporteret om tilfælde af reaktivering af hbv, herunder dødelige tilfælde, under eller efter behandling med direkte virkende antivirale lægemidler, som ikke blev givet i kombination med peginterferon alfa og ribavirin.
English: If other HCVRNA values were available after FW 24, the last available value in the period after FW 24 was used.
Danish: Hvis andre hcvRNA-værdier var tilgængelige efter FW 24, blev den sidst tilgængelige værdi i perioden efter FW 24 anvendt.
English: As a conservative measure in view of limitations of the data, in treatment experienced patients early responders, the total treatment duration is recommended to be prolonged to 48 weeks as compared to the tested 36 weeks total treatment duration (tested RGT), with a 12 weeks of peginterferon ribavirin consolidation phase after the end of the tritherapy at week 36.
Danish: Som en konservativ forholdsregel set i lyset af de begrænsede data hos behandlingserfarne patientertidlige respondenter - anbefales det at forlænge den samlede behandlingsvarighed til 48 uger sammenlignet med den undersøgte varighed på 36 ugers samlet behandlingsvarighed (undersøgt RGT) med en konsolideringsfase med peginterferon ribavirin på 12 uger efter afslutningen af trestofbehandlingen i uge 36.
English: If other HCV-RNA values were available after FW 24, the last available value in the period after FW 24 was used.
Danish: Hvis andre hcv-RNA-værdier var tilgængelige efter FW 24, blev den sidst tilgængelige værdi i perioden efter FW 24 anvendt.
English: Table 1 Duration of therapy using Response-Guided Therapy (RGT) guidelines in patients without cirrhosis who are previously untreated or who have failed previous therapy to interferon and ribavirin therapy
Danish: Behandlingsvarighed ved anvendelse af Response Guided Therapy (RGT)-retningslinjer hos patienter uden cirrose, der ikke tidligere er blevet behandlet eller med tidligere svigt af behandling med interferon og ribavirin
English: Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema) have been observed during combination therapy with Victrelis, peginterferon alfa, and ribavirin.
Danish: Der er set alvorlige, akutte overfølsomhedsreaktioner (f.eks. urticaria, angioødem) ved kombinationsbehandling med Victrelis, peginterferon alfa og ribavarin.
English: Combined use with peginterferon alfa-2a see specific section in section 4.4.
Danish: Kombineret brug med peginterferon alfa-2a, se specifikt afsnit under pkt.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ubrugt lægemiddel eller affald fra dette skal bortskaffes i overenstemmelse med lokale krav.
English: Therefore, female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Danish: Derfor skal kvindelige fertile patienter anvende effektiv antikonception under behandlingen og i fire måneder efter ophørt behandling.
English: • If you forget a dose and it is more than 2 hours before your next dose is due, take the missed dose with food.
Danish: • hvis du glemmer en dosis, og der er mere end 2 timer til du skal tage din næste dosis, tages den glemte dosis sammen med mad.
English: Boceprevir/metabolites are excreted in rat milk (see section 5.3).
Danish: Boceprevir/metabolitter udskilles i rottemælk (se pkt.
English: * The Full Analysis Set (FAS) consisted of all subjects who became anaemic (serum haemoglobin of approximately ≤10 g/dL within the treatment period) and were randomized to using either ribavirin dose reduction or erythropoietin (N=500).
Danish: * Fuldt analysesæt (Full Analysis Set) bestod af alle forsøgspersoner, der blev anæmiske (serumhæmoglobin ≤ ca. 6,2 mmol/l (≤ 10 g/dl) i behandlingsperioden), og som blev randomiseret til enten reduktion af ribavirindosis eller erythropoietin (N=500).
English: Plasma trough concentrations of Victrelis were decreased when administered with efavirenz.
Danish: Plasmakoncentration af Victrelis blev reduceret ved samtidig administration af efavirenz.
English: Subjects who enrolled in PROVIDE within 2 weeks after the last dose of PR in the parent study received Victrelis 800 mg three times daily + PR for 44 weeks.
Danish: Forsøgspersoner, der deltog i PROVIDE inden for 2 uger efter den sidste dosis PR i primærstudiet fik Victrelis 800 mg tre gange dagligt + PR i 44 uger.
English: Interferon-responsiveness (as defined by ≥ 1-log10 decline in viral load at TW 4) was predictive of SVR.
Danish: Interferon-følsomhed (defineret som ≥ 1 log10 fald i viral-load i behandlingsuge 4) var prædiktiv for SVR.
English: In both studies, the addition of Victrelis to the current standard of care (peginterferon alfa and ribavirin) significantly increased sustained virologic response (SVR) rates compared to the current standard of care alone.
Danish: Tilføjelsen af Victrelis til den aktuelle standardbehandling (peginterferon alfa og ribavirin) øgede i begge studier det vedvarende virologiske respons (SVR) i betydelig grad sammenlignet med den aktuelle standardbehandling.
English: Boceprevir has not been studied in patients with decompensated cirrhosis (see section 5.2).
Danish: Der er ikke foretaget studier af boceprevir hos patienter med dekompenseret cirrose (se pkt.
English: Fifty-seven percent (208/368) of subjects in the Victrelis-RGT arm and 56% (204/366) of subjects in the Victrelis-PR48 arm had undetectable HCV-RNA at TW 8 compared with 17% (60/363) of
Danish: 57 % (208/368) af forsøgspersonerne i Victrelis-RGT-armen og 56 % (204/366) af forsøgspersonerne i Victrelis-PR48-armen havde ikke-detekterbart hcv-RNA i behandlingsuge 8 sammenlignet med 17 % (60/363) af forsøgspersonerne i PR-armen.
English: If the patient has confirmed, detectable HCV-RNA at TW 24; then discontinue three-medicine
Danish: Hvis patienten har bekræftet, detekterbart hcv-RNA i behandlingsuge 24, afsluttes trestofbehandlingen.
English: In a pooled analysis of subjects who were previously untreated and subjects who have failed previous therapy who received four weeks of peginterferon alfa-2b and ribavirin followed by boceprevir 800 mg three times daily in combination with peginterferon alfa-2b and ribavirin in two Phase III studies, post-baseline RAVs were detected in 15% of all subjects.
Danish: I en poolet analyse af forsøgspersoner, der ikke var tidligere behandlet, og forsøgspersoner hvor tidligere behandling havde svigtet, og som fik fire ugers peginterferon alfa-2b og ribavirin efterfulgt af boceprevir 800 mg tre gange dagligt, i kombination med peginterferon alfa-2b og ribavirin, i to fase III-studier, blev post-baseline RAVer påvist hos 15 % af samtlige forsøgspersoner.
English: The most frequently reported adverse reactions were fatigue, anaemia (see section 4.4), nausea,
Danish: De hyppigst rapporterede bivirkninger var træthed, anæmi (se pkt.
English: The race distribution of subjects was as follows: 77% White, 19% Black, and 4% others.
Danish: Racefordelingen blandt forsøgspersonerne var: 77 % hvide, 19 % sorte og 4 % andre.
English: The study included 5 subjects with cirrhosis and 4 were in the
Danish: Studiet omfattede 5 forsøgspersoner med cirrose
English: In boceprevir-treated subjects who did not attain sustained virologic response (SVR) for whom samples were analysed, 53% had post
Danish: Hos boceprevirbehandlede forsøgspersoner, der ikke opnåede vedvarende virologisk respons (SVR), og hvis prøver blev analyseret, blev post-baseline RAVer påvist hos 53 %.
English: However, among poorly interferon-responsive patients to peginterferon alfa-2b/ribavirin during the 4-week lead-in period, the efficacy of boceprevir appeared to be reduced for those who had variants V36M, T54S, V55A or R155K detected at baseline.
Danish: Blandt patienter med ringe interferonrespons over for peginterferon alfa-2b/ribavirin i lead-in perioden på 4 uger forekom boceprevirs virkning dog at være reduceret for de, der ved baseline fik påvist varianterne V36M, T54S, V55A eller R155K.
English: Pharmacokinetic results were similar between healthy subjects and HCV-infected subjects.
Danish: Farmakokinetiske resultater var de samme hos raske forsøgspersoner som hos hcv
English: SVR rates with “missing=failure” approach were 17/80 [21.3%] for PR48, 94/162 [58.0%] for Victrelis-RGT,
Danish: SVR-rater (med “manglende=svigt”-metoden) var 17/80 [21,3 %] for PR48, 94/162 [58,0 %] for Victrelis-RGT, 106/161 [65,8 %] for Victrelis-PR48.
English: SVR rates with “missing=failure” approach were similar to those in the table: 69.9% (174/249) for subjects randomized to receive ribavirin dose reduction; 68.5% (172/251) for subjects randomized to receive
Danish: SVR-raterne (med "manglende=svigt"-metoden) var identiske med raterne i tabellen: 69,9 % (174/249) for forsøgspersoner randomiseret til reduktion af ribavirindosis; 68,5 % (172/251) for forsøgspersoner randomiseret til erythropoietin.
English: HCV-RNA levels should be monitored at Treatment Weeks 8, 12, and 24, and for other time points as
Danish: Niveauerne for hcv-RNA skal monitoreres i behandlingsuge 8, 12 og 24 og på andre klinisk relevante
English: Sustained Virologic Response (SVR) in patients receiving similar therapy up to treatment week 36
Danish: Vedvarende virologisk respons (SVR) hos patienter, der har fået samme behandling indtil uge 36
English: • antifungal medicines - ketaconazole, itraconazole, posaconazole, voriconazole
Danish: • svampemidler - ketoconazol, itraconazol, posaconazol, voriconazol
English: The most common HIV PI taken was atazanavir followed by lopinavir and darunavir.
Danish: Den hyppigste hivproteasehæmmer var atazanavir efterfulgt af lopinavir og darunavir.
English: Co-administration of oral midazolam and oral triazolam with Victrelis is contraindicated (see section 4.3).
Danish: Samtidig administration af oral midazolam, oral triazolam og Victrelis er kontraindiceret (se pkt.
English: The transfusion rate was 4% (10/249) in subjects randomized to receive ribavirin dose reduction and 2% (5/251) in subjects randomized to receive erythropoietin.
Danish: Transfusionsraten var 4 % (10/249) hos forsøgspersoner randomiseret til reduktion af ribavirindosis og 2 % (5/251) hos forsøgspersoner randomiseret til erythropoietin.
English: Mean age of subjects randomized was 43.6 years.
Danish: Gennemsnitsalderen for de randomiserede forsøgspersoner var 43,6 år.
English: In the limited number of co-infected subjects who did not achieve SVR and for whom population sequencing was performed, the prevalence of post-baseline RAVs was higher than that in mono
Danish: Hos det begrænsede antal co-inficerede forsøgspersoner, der ikke opnåede SVR, og hvor der var foretaget sekventering af populationen, var prævalensen af post-baseline RAVer højere end hos mono-inficerede forsøgspersoner i SPRINT-2 studiet.
English: Mean age of subjects randomized was 49.1 years.
Danish: Gennemsnitsalderen for de randomiserede forsøgspersoner var 49,1 år.
English: Heart or circulation: abnormal or rapid heart rate; heart disease caused by poor blood flow in
Danish: Hjerte eller kredsløb: unormal eller hurtig hjertefrekvens; hjertesygdom på grund af dårligt
English: Use in patients who have previously failed treatment with an HCV protease inhibitor
Danish: Anvendelse hos patienter med svigt af tidligere behandling med en hcv-proteasehæmmer
English: If a patient misses a dose and it is less than 2 hours before the next dose is due, the missed dose
Danish: Hvis en patient glemmer at tage en dosis, og der er mindre end 2 timer til næste dosis skal tages, skal
English: • intravenous sedatives - benzodiazepines (e.g., alprazolam, midazolam, triazolam)
Danish: • intravenøs beroligende medicin - benzodiazepiner (f.eks. alprazolam, midazolam, triazolam)
English: Patients receiving dabigatran should be monitored appropriately.
Danish: Patienter, der får dabigatran, skal monitoreres efter behov.
English: † Rates for using ribavirin dose reduction versus erythropoietin in the management of anaemia in previously untreated subjects
Danish: † ved reduktion af ribavirindosis versus erythropoietin i behandlingen af anæmi hos tidligere ubehandlede personer
English: Glomerular filtration rate decreased * Includes adverse reactions which may be serious as assessed by the investigator in clinical trial
Danish: Hjertemislyd, forhøjet hjertefrekvens Nedsat glomerulær filtrationshastighed * Omfatter bivirkninger, der kan være alvorlige ifølge investigatoren af kliniske forsøgspersoner.
English: The combination of boceprevir with these medicines is not recommended (see section 4.4).
Danish: Kombinationen af boceprevir med disse lægemidler frarådes (se pkt.
English: If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced.
Danish: I tilfælde af alvorlig bivirkning med mulig relation til peginterferon alfa og/eller ribavirin, kan dosis af peginterferon alfa og/eller ribavirin reduceres.
English: Erectile dysfunction Amenorrhoea, menorrhagia, metrorrhagia
Danish: Amenorré, menorragi, metroragi
English: Haemorrhagic diathesis, lymphadenopathy, lymphopenia
Danish: Hæmoragisk diatese, lymfeknudesvulst, lymfopeni
English: • Store outside of the refrigerator at or below 30°C for a period of not more than 3 months until expiry.
Danish: • Opbevares uden for køleskab ved eller under 30 °C i en periode på højst 3 måneder indtil udløbsdato.
English: Boceprevir, in combination with peginterferon alfa and ribavirin, was evaluated in a total of 98 patients (64 in the boceprevir arm) co-infected with Human Immunodeficiency Virus (HIV) and HCV genotype 1 who were previously untreated for chronic HCV infection (see section 4.8 and 5.1).
Danish: Boceprevir, i kombination med peginterferon alfa og ribavirin, er blevet evalueret hos i alt 98 patienter (64 i boceprevir-armen), der var co-inficerede med humant immundefektvirus (hiv) og hcv genotype-1, og som ikke tidligere havde været behandlet for kronisk hcv-infektion (se pkt.
English: General: difficult breathing and swallowing; tumour of the thyroid; infection of the blood; swelling or lumps in organs of the body; disease which leads to increasing muscle paralysis; disease of the brain - signs may include headache and fever, paralysis of a part of the body, a stiff neck or being sensitive to light
Danish: Generelt: besvær med at trække vejret og synke; svulst i skjoldbruskkirtlen; infektion i blodet; hævelse eller knuder i kroppens organer; sygdom, der fører til tiltagende muskellammelse; sygdom i hjernen - tegnene kan være hovedpine og feber, lammelse af dele af kroppen, stiv
English: No dose adjustment required for Victrelis or tenofovir.
Danish: Der kræves ingen dosisjustering for Victrelis eller tenofovir.
English: The most frequently (> 25% of subjects) detected post-baseline RAVs in these subjects were amino acid substitutions V36M (61%) and R155K (68%) in subjects infected with genotype 1a viruses and T54A (42%), T54S (37%), A156S (26%) and V170A (32%) in subjects infected with genotype 1b
Danish: De hyppigst (> 25 % af forsøgspersonerne) påviste post-baseline RAVer hos disse forsøgspersoner var aminosyre-substitutionerne V36M (61 %) og R155K (68 %) hos forsøgspersoner inficeret med genotype 1a-vira og T54A (42 %), T54S (37 %), A156S (26 %) og V170A (32 %) hos forsøgspersoner inficeret med genotype 1b-vira.
English: As compared to the combination of boceprevir with peginterferon alfa-2b and ribavirin, the combination of boceprevir with peginterferon alfa-2a and ribavirin was associated with a higher rate of neutropenia (including grade 4 neutropenia) and a higher rate of infections.
Danish: Sammenlignet med kombinationen af boceprevir og peginterferon alfa-2b og ribavirin blev kombinationen af boceprevir med peginterferon alfa-2a og ribavirin forbundet med en højere forekomst af neutropeni (inklusiv grad 4 neutropeni) samt en højere infektionsrate.
English: This is not observed in mice
Danish: Dette er ikke set hos mus eller aber.
English: (CYP3A inhibition and/or P-gp
Danish: (CYP3A-hæmning og/eller P
English: The efficacy of Victrelis as a treatment for chronic hepatitis C genotype 1 infection was assessed in approximately 1,500 adult subjects who were previously untreated (SPRINT-2) or who had failed previous therapy (RESPOND-2) in Phase III clinical studies.
Danish: Victrelis' effekt ved behandling af kronisk hepatitis C genotype 1-infektion blev undersøgt i fase IIIkliniske studier hos cirka 1.500 voksne forsøgspersoner, der ikke tidligere var behandlet (SPRINT-2), eller hvor tidligere behandling havde svigtet (RESPOND-2).
English: Cases of pancytopenia have been reported in patients receiving Victrelis in combination with peginterferon alfa and ribavirin.
Danish: Der er rapporteret om tilfælde af pancytopeni hos patienter, der får Victrelis i kombination med peginterferon alfa og ribavirin.
English: Concomitant administration of Victrelis with tacrolimus requires significant dose reduction and prolongation of the dosing interval of tacrolimus, with close monitoring of tacrolimus blood concentrations and frequent assessments of renal function and tacrolimus-related side effects.
Danish: Samtidig administration af Victrelis og tacrolimus kræver væsentlig dosisreduktion og forlængelse af dosisintervallet for tacrolimus med tæt monitorering af tacrolimusblodkoncentrationen og hyppig vurdering af nyrefunktion og tacrolimus-relaterede bivirkninger.
English: The SVR rates in subjects randomized to receive ribavirin dose reduction and randomized to receive
Danish: SVR-raterne hos forsøgspersoner, der var randomiseret til reduktion af ribavirindosis og til at få
English: • were a patient who has previously failed treatment with an HCV protease inhibitor
Danish: • tidligere har oplevet, at behandling med en hcv-proteasehæmmer har svigtet
English: HCV protease monotherapy
Danish: Monoterapi med hcv-proteasehæmmer
English: Victrelis, in combination with peginterferon alfa and ribavirin, is used for chronic hepatitis C virus infection in adults (also called HCV infection).
Danish: Victrelis bruges sammen med peginterferon alfa og ribavirin til behandling af kronisk hepatitis C virusinfektion hos voksne (også kaldet hcv-infektion).
English: Do not throw away any medicine via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: If there is no such value, the FW 12 value was carried forward.
Danish: Hvis der ikke er en sådan værdi, overføres FW
English: In clinical trials, the proportion of subjects who received erythropoietin for the management of anaemia was 43% (667/1,548) of subjects in the Victrelis-containing arms compared to 24% (131/547) of subjects receiving peginterferon alfa-2b and ribavirin alone.
Danish: I kliniske forsøg var andelen af forsøgspersoner, der fik erythropoietin til behandling af anæmi 43 % (667/1.548) af forsøgspersonerne i de Victrelis-indeholdende arme sammenlignet med 24 % (131/547) af forsøgspersonerne, der kun fik peginterferon alfa-2b og ribavirin.
English: Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
Danish: Tél/Tel: 0800 38 693 (+32 (0)27766211)
English: Caution should be exercised in patients with conditions that predispose them to hyperkalaemia or patients taking potassiumsparing diuretics (see section 4.4).
Danish: Der bør udvises forsigtighed hos patienter med lidelser, der prædisponerer til hyperkaliæmi eller hos patienter, der tager kalium-besparende diuretika (se pkt.
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for baseline, ontreatment and post-treatment laboratory testing recommendations including haematology, biochemistry (including hepatic function tests), and pregnancy testing.
Danish: Se produktresumeet for peginterferon alfa og ribavirin for hvilke laboratorieprøver, der anbefales ved baseline, under behandling og efter behandling, herunder hæmatologiske, klinisk-kemiske (inklusive leverfunktionsprøver) og graviditetstests.
English: Each capsule contains 56 mg of lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver kapsel indeholder 56 mg lactosemonohydrat.
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE12
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, proteasehæmmere, ATC
English: Dizziness*, headache*
Danish: Svimmelhed*, hovedpine*
English: Skin and hair: reddening of the skin; bacterial skin infection Stomach and gut: problems digesting food; vomiting blood; vomiting, diarrhoea, and severe right upper corner stomach (abdominal) pain
Danish: Hud og hår: rødmen i huden; bakteriel hudinfektion Mave og tarme: problemer med at fordøje maden; opkastning af blod; opkastning, diarré og svære smerter i øvre højre del af maven (bughulesmerter)
English: Co-administration of Victrelis with alfuzosin and silodosin is contraindicated (see section 4.3).
Danish: Samtidig administration af Victrelis og alfuzosin og silodosin er kontraindiceret (se pkt.
English: • tyrosine kinase inhibitors - used as anti-cancer medicines
Danish: • tyrosinkinasehæmmere - medicin til behandling af kræft
English: Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/or discontinuation of ribavirin.
Danish: Se produktresumeet for ribavirin for information vedrørende dosisreduktion og/eller seponering af ribavirin.
English: All subjects with detectable HCV-RNA in plasma at TW 12 were discontinued from treatment.
Danish: Hos alle forsøgspersoner med detekterbart hcv-RNA i plasma i behandlingsuge 12 blev behandling seponeret.