FrancophonIA/ELRC3.0 huggingface dataset:
English: Adult:  12 g/dL (females);  13 g/dL (males) Children and adolescents:  11 g/dL (females);  12 g/dL (males)
Danish: Voksne:  12 g/dl (kvinder);  13 g/dl (mænd) Børn og unge:  11 g/dl (kvinder);  12 g/dl (mænd)
English: *AUC12 (ng.hr/mL) for Rebetol; AUC0-24 (IU.hr/mL) for interferon alfa-2b
Danish: *AUC12 (ng.time/ml) for Rebetol; AUC0-24 (IE.time/ml) for interferon alfa-2b
English: 15 mg/kg/day as 2 divided doses (n = 17)
Danish: Rebetol 15 mg/kg/dag fordelt på 2 doser (n = 17)
English: 84 hard capsules 112 hard capsules 140 hard capsules 168 hard capsules
Danish: 84 hårde kapsler 112 hårde kapsler 140 hårde kapsler 168 hårde kapsler
English: *Number (%) of patients a. Defined as HCV RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period
Danish: *Antal (%) patienter a. Defineret som HCV-RNA under detektionsgrænsen ved brug af en forskningsbaseret RT-PCR-analyse ved afslutningen af behandlingen og i opfølgningsperioden
English: This medicine contains sucrose and sorbitol, these are types of sugars.
Danish: Dette lægemiddel indeholder saccharose og sorbitol, disse er former for sukker.
English: Rebetol has no or negligible influence on the ability to drive and use machines; however, other medicinal products used in combination may have an effect.
Danish: Rebetol påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner; andre lægemidler anvendt i kombination kan imidlertid have en negativ virkning.
English: You must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Danish: Du skal have en negativ graviditetstest før behandlingen, hver måned under behandlingen og i 4 måneder efter, behandlingen er stoppet.
English: Do not use this medicine without advice of your doctor or pharmacist if you notice any change in the appearance of the hard capsules.
Danish: Brug ikke lægemidlet uden at tale med din læge eller apotekspersonalet, hvis du bemærker en ændring i udseendet af de hårde kapsler.
English: The child-resistant cap has inner and outer polypropylene shells.
Danish: Det børnesikrede låg har indre og ydre polypropylenskaller.
English:  11 g/dL (females);  12 g/dL (males)
Danish:  11 g/dl (kvinder);  12 g/dl (mænd)
English: Injury, poisoning and procedural complications Common:
Danish: Traumer, forgiftninger og behandlingskomplikationer Almindelig:
English: A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age.
Danish: I alt 107 patienter fik behandling hvoraf 52 % var kvinder, 89 % kaukasiske, 67 % med HCV Genotype 1 og 63 % < 12 år.
English: In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm was observed in 4 % (8/194) of patients and decrease in platelets below 50,000/mm
Danish: 5.1) blev fald i niveau af absolut neutrofiltælling under 500 celler/mm observeret hos 4 % (8/194) af patienterne, og fald i blodplader under 50.000/mm
English: a: Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment, lower limit of detection = 125 IU/mL.
Danish: a: Respons på behandling blev defineret som ikke detekterbar HCV-RNA ved 24 uger efter behandlingen, lavere grænse for detektion = 125 IE/ml.
English: Your doctor has determined the correct dose of this medicine based on how much you or the child you are caring for weighs.
Danish: Din læge har bestemt den korrekte dosis af dette lægemiddel på basis af din eller barnets vægt.
English: Note: For patients who weigh < 47 kg, or are unable to swallow capsules, please refer to the SmPC for Rebetol 40 mg/mL oral solution.
Danish: Bemærk: For patienter som vejer < 47 kg, eller som ikke er i stand til at synke kapsler, se SmPC for Rebetol 40 mg/ml oral opløsning.
English: Although data on approximately 300 prospectively followed pregnancies with paternal exposure to Rebetol have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with Rebetol and for seven months after treatment.
Danish: Selvom resultater fra omkring 300 prospektivt fulgte graviditeter med paternal eksponering for Rebetol ikke har vist en øget risiko for misdannelse sammenlignet med den almindelige population, og heller intet specifikt mønster for misdannelser, skal mandlige patienter eller deres kvindelige fertile partnere rådes til at anvende effektiv kontraception under behandling med Rebetol og i syv måneder efter behandlingen.
English: Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C.
Danish: Behandlingen skal indledes og følges op af en læge med erfaring i behandling af kronisk hepatitis C.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known.
Danish: Indenfor systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt.
English: These criteria were used in the protocol: If week 12 HCV-RNA is positive and < 2 log10 decrease from baseline, patients to stop therapy.
Danish: Disse kriterier blev anvendt i protokollen: Hvis HCV-RNA findes positiv i uge 12 og der er et fald på < 2log10 fra baseline, skal patienterne stoppe behandlingen.
English: Additionally, patients receiving zidovudine with ribavirin in combination with alpha interferons could be at increased risk of developing anaemia (low number of red blood cells).
Danish: Endvidere kan patienter, der får zidovudin med ribavirin i kombination med alfa interferoner have øget risiko for at udvikle anæmi (lavt antal røde blodceller).
English: NR: Non-responder defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
Danish: NR: Non-responders defineres som serum/plasma-HCV-RNA-positive ved afslutning af mindst 12 ugers behandling.
English: As in adult patients, children and adolescents also experienced other psychiatric adverse reactions (e.g., depression, emotional lability, and somnolence) (see section 4.4).
Danish: Som hos voksne patienter oplevede børn og unge også andre psykiatriske bivirkninger (såsom depression, emotionel labilitet og søvnighed) (se pkt.
English: If the abnormality is reversed, Rebetol may be restarted at 600 mg daily, and further increased to 800 mg daily at the discretion of the treating physician.
Danish: Hvis unormaliteten forsvinder, kan behandlingen med Rebetol genoptages med en daglig dosis på 600 mg og kan yderligere øges til 800 mg dagligt efter nøje vurdering af den behandlende læge.
English: Sexual dysfunction (not specified)*
Danish: Begge køn: Seksuel dysfunktion (ikke specificeret)٭
English: Dose modification for adults
Danish: Dosisjustering for voksne
English: Rebetol oral solution is supplied in a concentration of 40 mg/mL.
Danish: Rebetol oral opløsning leveres i en koncentration på 40 mg/ml.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs http://www.ema.europa.eu hjemmeside.
English: In a single dose, crossover study of ribavirin in healthy adult subjects, the capsule and oral solution formulations were found to be bioequivalent.
Danish: I et crossover-studie med enkeltdosis-ribavirin hos raske voksne forsøgspersoner var formuleringerne kapsel og oral opløsning bioækvivalente.
English: Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory *Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
Danish: HCV-RNA-serum måles ved et videnskabeligt baseret kvantitativt polymerase-kædereaktions-assay på et centralt laboratorium *Hensigt til at behandle-populationen inkluderer 7 patienter, hvor mindst 12 ugers tidligere behandling ikke er bekræftet.
English: This benefit was maintained irrespective of standard predictors of response to interferon alfa-2b such as virus level, HCV genotype and histological staging.
Danish: Den gavnlige effekt blev opretholdt uafhængigt af standardforudsigelser om respons på interferon alfa-2b såsom virusmængde, HCV genotype og histologisk stadie.
English: Overall, approximately 36 % (821/2,286) of patients had undetectable plasma HCV-RNA levels at week 12 of therapy measured using a research-based test (limit of detection 125 IU/mL).
Danish: Overordnet havde ca. 36 % (821/2.286) af patienterne ikke målbart HCV-RNA plasma niveau i den 12. behandlingsuge, målt ved hjælp af en videnskabelig baseret test (detektionsgrænse 125 IE/ml).
English: • are pregnant or planning to become pregnant (see section “Pregnancy and breast-feeding”).
Danish: • hvis du er gravid eller planlægger at blive gravid (se afsnittet ”Graviditet og amning”).
English: d: Rebetol dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Danish: d: Rebetol dosis var 800 mg for patienter < 60 kg, 1.000 mg for patienter 60-75 kg, og 1.200 mg for patienter > 75 kg.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Danish: 6.3 for oplysninger om opbevaringsforhold efter første åbning af lægemidlet.
English: • are a male and your female partner is of childbearing age (see section “Pregnancy and breast-feeding”).
Danish: • er en mand, og din kvindelige partner er i den fødedygtige alder (se afsnittet "Graviditet og amning").
English: There were some cases of more severe neutropenia in patients treated with Rebetol in combination with peginterferon alfa-2b (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]); WHO grade 3 leukopenia was also reported in 7 % of this treatment group.
Danish: Der var nogle tilfælde af mere alvorlig neutropeni hos patienter behandlet med Rebetol i kombination med peginterferon alfa-2b (WHO grad 3: 39 af 186 [21 %)] og WHO grad 4: 13 af 186 [7 %]); WHO grad 3 leukopeni blev også rapporteret hos 7 % af denne behandlingsgruppe.
English: In general, the adverse reaction profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition, as decrease in height percentile (mean percentile decrease of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment.
Danish: Generelt svarede bivirkningsprofilen i den begrænsede undersøgte børn og unge population til den profil, der er observeret hos voksne, selvom der er en specifik pædiatrisk bekymring vedrørende væksthæmning, såvel som nedsat højdepercentil (gennemsnitlig percentilreduktion på 9 percentil) og vægtpercentil (gennemsnitlig percentilreduktion på 13 percentil) blev observeret under behandling.
English: At the end of 24 weeks post-treatment follow-up, mean decrease from baseline in weight and height percentiles were still 3 percentiles and 7 percentiles, respectively, and 20% of the children continued to have inhibited growth (growth velocity < 3
Danish: Ved udgangen af 24 ugers opfølgning efter behandlingen var den gennemsnitlige reduktion i forhold til baseline i vægt- og højdepercentiler stadig henholdsvis 3 percentiler og 7 percentiler, og 20 % af børnene forsatte med at have hæmmet vækst (væksthastighed < 3. percentil).
English: Following oral dosing with 600 mg BID, steady-state was reached by approximately four weeks, with mean steady state plasma concentrations approximately 2,200 ng/mL.
Danish: Efter peroral dosering med 600 mg to gange daglig blev steady-state nået efter cirka fire uger med gennemsnitlige steady-state plasmakoncentrationer omkring 2.200 ng/ml.
English: Results of in vitro studies using both human and rat liver microsome preparations indicated no cytochrome P450 enzyme mediated metabolism of Rebetol.
Danish: Resultater af in vitro studier med både humane og rotte levermikrosompræparater viste ingen CYPenzymmedieret metabolisme af Rebetol.
English: If you take more Rebetol than you should Tell your doctor or pharmacist as soon as possible.
Danish: Hvis du har taget for meget Rebetol Fortæl det til din læge eller apotekspersonalet så hurtigt som muligt.
English: In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when Rebetol is administered.
Danish: Hos den hiv-positive population, som får et NRTI regimen, bør lægen nøje følge markører for mitokondrietoksicitet og mælkesyreacidose, når Rebetol administreres.
English: Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate
Danish: Mikrokrystallinsk cellulose Lactosemonohydrat Croscarmellosenatrium Magnesiumstearat
English: Ribavirin concentrations are essentially unchanged by haemodialysis.
Danish: Ribavirin koncentrationerne er praktisk taget uforandrede ved hæmodialyse.
English: This solution is packaged in 118 mL size amber glass bottles containing 100 mL of oral solution.
Danish: Denne opløsning er emballeret i 118 ml ravgule glasflasker indeholdende 100 ml oral opløsning.
English: Pancytopenia and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the administration of a peginterferon and Rebetol concomitantly with azathioprine.
Danish: Litteraturen angiver, at pancytopeni og knoglemarvssuppression indtræder inden for 3 til 7 uger efter administrationen af peginterferon og Rebetol samtidig med azathioprin.
English: Other baseline factors in co-infected patients that may be associated with a higher risk of hepatic decompensation include treatment with didanosine and elevated bilirubin serum concentrations.
Danish: Andre baseline-faktorer hos co-inficerede patienter, som kan associeres med en højere risiko for leverdekompensation, omfatter behandling med didanosin og forhøjet bilirubin.
English: Co-administration of Rebetol and didanosine is not recommended.
Danish: Samtidig indgivelse af Rebetol og didanosin anbefales ikke.
English: This medicine is available in different pack sizes containing 84, 112, 140 or 168 capsules of 200 mg to be swallowed.
Danish: Lægemidlet fås i forskellige pakningsstørrelser indeholdende 84, 112, 140 eller 168 kapsler a 200 mg til at sluge.
English: Patients who weigh > 47 kg and are able to swallow capsules may take the equivalent dose of ribavirin 200 mg capsules in two divided doses (Please see SmPC for Rebetol capsules).
Danish: Patienter, der vejer > 47 kg og desuden er i stand til at synke kapsler, kan tage den ækvivalente dosis ribavirin 200 mg kapsler fordelt på to doser (se SmPC for Rebetol-kapsler).
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10), and uncommon (≥ 1/1,000 to < 1/100).
Danish: Indenfor systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10) og ikke almindelig (≥1/1.000 til <1/100).
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Danish: Undersøgelse 2 (P02080) var en randomiseret, enkelt centerundersøgelse, der omfattede 95 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med hiv.
English: Contains lactose See leaflet for further information
Danish: Indeholder lactose Se indlægssedlen for yderligere information.
English: This medicine does not affect your ability to drive or use machines; however, other medicines used in combination with Rebetol may affect your ability to drive or use machines.
Danish: Dette lægemiddel påvirker ikke din evne til at køre bil eller betjene maskiner, men andre lægemidler anvendt i kombination med Rebetol kan påvirke din evne til at køre bil eller betjene maskiner.
English: This myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of either treatment alone (see section 4.5).
Danish: Denne myelotoksicitet var reversibel inden for 4 til 6 uger efter ophør af HCV-antiviral-behandling sammen med azathioprin og opstod ikke igen ved genoptagelse af behandlingerne hver for sig (se pkt.
English: Rebetol must be used in combination with other medicinal products (see section 5.1).
Danish: Rebetol skal anvendes i kombination med andre lægemidler (se pkt.
English: Patients whose dose of Rebetol is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Danish: Patienter, hvis dosis af Rebetol er reduceret til 600 mg dagligt får en 200 mg kapsel om morgenen og to 200 mg kapsler om aftenen.
English: * Any subject with an undetectable HCV-RNA level at the follow-up week 12 visit and missing data at the follow-up week 24 visit was considered a sustained responder.
Danish: * Enhver patient med et ikke målbart HCV-RNA niveau ved besøget i opfølgningsuge 12 og manglende resultater ved besøget i opfølgningsuge 24 blev betragtet som vedvarende responder.
English: EU/1/99/107/001 84 hard capsules EU/1/99/107/005 112 hard capsules EU/1/99/107/002 140 hard capsules EU/1/99/107/003 168 hard capsules
Danish: EU/1/99/107/001 84 hårde kapsler EU/1/99/107/005 112 hårde kapsler EU/1/99/107/002 140 hårde kapsler EU/1/99/107/003 168 hårde kapsler
English: Patients who were HCV-RNA negative at Treatment week 12 continued treatment for 48 weeks and were followed for 24 weeks post-treatment.
Danish: Patienter som var HCV-RNA negative ved afslutningen af en 12 ugers behandling fortsatte behandlingen i alt 48 uger og blev overvåget i de næste 24 uger efter behandlingen var afsluttet.
English: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Danish: Pure red cell-aplasi, idiopatisk trombocytopenisk purpura, trombotisk trombocytopenisk purpura
English: Pancytopenia: Rebetol can cause a decrease in your platelet and red and white blood cell count when used in combination with peginterferon.
Danish: Pancytopeni: Rebetol kan medføre nedsat antal blodplader samt røde og hvide blodlegemer, når det anvendes sammen med peginterferon.
English: Measure: You can measure the dose with the oral dosing syringe provided.
Danish: Afmåling: Du kan afmåle dosen med den vedlagte orale doseringssprøjte.
English: Discontinue breast-feeding before starting to take this medicine.
Danish: Afbryd amning, før du begynder at tage lægemidlet.
English: Rebetol capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Danish: Rebetol kapsler skal indtages oralt hver dag fordelt på to doser (morgen og aften) i forbindelse med et måltid.
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 µg/week peginterferon alfa-2b and subjects ≥ 75 kg received 150 µg/week peginterferon alfa-2b .
Danish: a: p-værdi baseret på Cochran-Mantel Haenszel Chi square-test. b: p værdi baseret på chi-square test. c: forsøgspersoner < 75 kg fik 100 µg/uge peginterferon alfa-2b og forsøgspersoner ≥ 75 kg fik 150 µg/uge peginterferon alfa-2b.
English: Preclinical data - Fertility: In animal studies, Rebetol produced reversible effects on spermatogenesis (see section 5.3).
Danish: Prækliniske data - Fertilitet: I dyrestudier gav Rebetol reversible virkninger på spermatogenese (se pkt.
English: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Rebetol must be discontinued immediately and appropriate medical therapy instituted.
Danish: I tilfælde af udvikling af akut overfølsomhedsreaktion (for eksempel urticaria, angioødem, bronkiekonstriktion, anafylaksi), skal Rebetol øjeblikkeligt seponeres og passende medicinsk behandling initieres.
English: Deliver:
Danish: Levering:
English: Rebetol (8001,200 mg/day)
Danish: Rebetol (8001.200 mg/dag)
English: Use in children and adolescents If the child is weighing less than 47 kg or unable to swallow an oral solution of Rebetol is available.
Danish: Brug til børn og unge Hvis barnet vejer under 47 kg eller ikke kan sluge kapslen, findes en oral opløsning af Rebetol.
English: By Week 12 (n=215) HCV-RNA negative or ≥ 2 log decrease in viral load
Danish: Ved uge 12 (n= 215) HCV-RNA negativ eller ≥ 2 log fald i viral load
English: Hepatotoxicity (including fatalities)*
Danish: Hepatoksicitet (herunder dødelig)٭
English: Dose reduction of Rebetol depends on the initial Rebetol posology which depends on the medicinal product that is used in combination with Rebetol.
Danish: Dosisreduktion af Rebetol afhænger af initialdosis af Rebetol, hvilket afhænger af det lægemiddel, som anvendes i kombination med Rebetol.
English: A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in two previously mentioned multicentre trials.
Danish: Et fem-årigt langtidsopfølgende observationsstudie indrullerede 97 pædiatriske patienter med kronisk hepatitis-C efter behandling i to af de tidligere nævnte multicenterstudier.
English: Any subject with missing data in and after the follow-up week 12 window was considered to be a non-responder at week 24 of follow-up.
Danish: Enhver patient med manglende resultater i og efter perioden omkring opfølgningsuge 12 blev betragtet som en non-responder ved 24 ugers opfølgning.
English: - Teratogenicity: Significant teratogenic and/or embryocidal potential have been demonstrated for Rebetol in all animal species in which adequate studies have been conducted, occurring at doses as low as one twentieth of the recommended human dose (see section 5.3).
Danish: - Teratogenicitet: Betydeligt teratogent og/eller embryocidt potentiale er vist for Rebetol i alle dyrearter, i hvilke tilstrækkelige undersøgelser er blevet udført, og forekommer ved så lave doser som en tyvendedel af den anbefalede humane dosis (se pkt.
English: In children and adolescent patients treated with Rebetol plus interferon alfa-2b, reduce Rebetol dose to 7.5 mg/kg/day.
Danish: Hos børn og unge patienter behandlet med Rebetol plus interferon alfa-2b reduceres Rebetol-dosis til 7,5 mg/kg/dag.
English: Forty-one percent of subjects (97/235) had nondetectable plasma HCV-RNA levels at week 4 and week 24 of therapy.
Danish: Enogfyrre procent af forsøgspersonerne (97/235) havde plasma HCV-RNA niveauer under detektionsgrænsen ved behandlingens uge 4 og uge 24.
English: Oral formulations of Rebetol monotherapy have been investigated as therapy for chronic hepatitis C in several clinical trials.
Danish: Orale former for Rebetol monoterapi er blevet undersøgt til behandling af kronisk hepatitis C i flere kliniske undersøgelser.
English: Due to substantial increases in ribavirin plasma concentrations in patients with moderate and severe renal impairment, Rebetol dose adjustments are recommended in adult patients with creatinine clearance < 50 mL/minute.
Danish: På grund af væsentlige stigninger i plasmakoncentrationen af ribavirin hos patienter med moderat og svært nedsat nyrefunktion anbefales dosisjustering af Rebetol hos voksne patienter med kreatininclearance < 50 ml/min.