FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-responders to prior therapy with pegylated interferon alpha/ribavirin were less likely to achieve a week 12 response to retreatment than non-responders to non-pegylated interferon alpha/ribavirin (12.4 % vs. 28.6 %).
Danish: Non-responders som tidligere havde fået behandling med pegyleret interferon alfa/ribavirin, var mindre tilbøjelige til at respondere i 12. uge på genbehandling end non-responders på ikke pegyleret interferon alfa/ribavirin (12,4 % versus 28,6 %).
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 30 IU/mL), a liver biopsy consistent with a histological diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Danish: Mulige patienter til disse undersøgelser havde kronisk hepatitis C bekræftet ved en positiv HCV-RNA polymerase kædereaktionstest (PCR) (> 30 IE/ml), en leverbiopsi i overensstemmelse med en histologisk diagnose med kronisk hepatitis uden anden årsag til den kroniske hepatitis, samt en abnorm serum ALAT.
English: Because of the potential for adverse reactions in breast-fed infants, breast-feeding must be discontinued prior to initiation of treatment.
Danish: På grund af risikoen for bivirkninger hos de ammede børn skal amning ophøre, før behandling påbegyndes.
English: In the pivotal clinical efficacy trial, patients were instructed to take ribavirin with food to achieve the maximal plasma concentration of ribavirin.
Danish: I den pivotale kliniske undersøgelse af effekt blev patienterne instrueret i at indtage ribavirin til et måltid for at opnå maksimal plasmakoncentration af ribavirin.
English: In those patients that received > 10.6 mg/kg Rebetol (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, response rates were significantly higher than in those patients that received  10.6 mg/kg Rebetol (Table 7), while response rates in patients that received > 13.2 mg/kg Rebetol were even higher.
Danish: For de patienter, som fik > 10,6 mg/kg Rebetol (800 mg dosis i en typisk patient på 75 kg), uafhængigt af genotype eller virusmængde, var responsrater signifikant højere end for de patienter, der fik  10,6 mg/kg Rebetol (Tabel 7), mens responsrater for patienter, der fik > 13,2 mg/kg Rebetol, var endnu højere.
English: Virological response by week 4 is defined as at least 1-log viral load decrease or undetectable levels of HCV-RNA.
Danish: Virologisk respons i uge 4, defineres som et fald på mindst 1-log viral load eller et ikke-detekterbart niveau af HCV-RNA.
English: Rebetol Dose (daily)
Danish: Rebetol-dosis (daglig)
English: Most of the changes in laboratory values in the Rebetol/peginterferon alfa-2b clinical trial were mild or moderate.
Danish: De fleste af ændringerne i laboratorieværdierne for de kliniske forsøg med Rebetol/peginterferon alfa-2b var milde eller moderate.
English: In this subgroup, there was a 92 % (89/97) sustained virological response rate.
Danish: I denne undergruppe af patienter var der 92 % (89/97) med vedvarende virologisk responsrate.
English: The use of Rebetol in combination with peginterferon alfa-2b had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Danish: Anvendelsen af Rebetol i kombination med peginterferon alfa-2b havde ingen observerbar negativ indvirkning på kontrollen af hiv-viræmi under behandling eller opfølgning.
English: The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6 month follow-up period.
Danish: Behandlingsvarigheden var 48-uger med en opfølgningsperiode på 6 måneder med undtagelse af patienter, der var inficeret med genotype 2 eller 3 og viral load < 800.000 IE/ml (Amplicor), som blev behandlet i 24 uger med en 6 måneders opfølgningsperiode.
English: Table 6 Sustained virological response rates (n a,b
Danish: Tabel 6 Vedvarende virologisk respons rate (n a,b
English: Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/kg in a mouse micronucleus assay.
Danish: Genotoksisk aktivitet sås i mus lymfomtest og ved doser på 20200 mg/kg i en mus mikronucleusprøve.
English: Table 13 Sustained virological response rates (n a,b
Danish: Tabel 13 Vedvarende virologisk respons rate (n a,b
English: Do not use this medicine without advice of your doctor or pharmacist if you notice any change in the appearance of the solution.
Danish: Brug ikke lægemidlet uden at tale med din læge eller apotekspersonalet, hvis du bemærker en ændring i udseendet af opløsningen.
English: Three trials examined the use of interferon in naïve patients, two with Rebetol + interferon alfa-2b (C95-132 and I95-143) and one with Rebetol + peginterferon alfa-2b (C/I98-580).
Danish: Tre undersøgelser vurderede anvendelsen af interferon hos naive patienter, to med Rebetol + interferon alfa-2b (C95-132 og I95-143) og en med Rebetol + peginterferon alfa-2b (C/I98580).
English: The pharmacokinetics of Rebetol and interferon alfa-2b (dose-normalized) is similar in adults and children or adolescents.
Danish: Farmakokinetikken for Rebetol og interferon alfa-2b (dosis-normaliseret) er ens hos voksne og børn eller unge.
English: Dosing of Rebetol for children and adolescent patients is determined by the patient body weight.
Danish: Dosering af Rebetol for børn og unge patienter er baseret på patientens legemsvægt.
English: Rebetol oral solution is administered orally in two divided doses (morning and evening) with food.
Danish: Rebetol oral opløsning indtages oralt fordelt på to doser (morgen og aften) i forbindelse med et måltid.
English: Excipients with known effect Rebetol contains 142 mg of sorbitol and 300 mg of sucrose per mL.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Rebetol indeholder 142 mg sorbitol og 300 mg saccharose per ml.
English: For patients with prior failure on therapy with non-pegylated interferon or pegylated interferon and negative at week 12, the sustained response rates were 59 % and 50 %, respectively.
Danish: For patienter som tidligere har været behandlet med ikke pegyleret interferon eller pegyleret interferon og som har været negative i 12. behandlingsuge, var den fortsatte responsrate henholdsvis 59 % og 50 %.
English: Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with non-pegylated interferon alfa-2b (with or without Rebetol) and pegylated interferon alfa-2b (with or without Rebetol), respectively.
Danish: To store undersøgelser med langtidsopfølgning inkluderede 1.071 patienter og 567 patienter efter behandling i tidligere undersøgelser med henholdsvis non-pegyleret interferon alfa-2b (med eller uden Rebetol) og pegyleret interferon alfa-2b (med eller uden Rebetol).
English: It is possible that the decreased bioavailability in this study was due to delayed transit of Rebetol or modified pH.
Danish: Det er muligt, at den mindskede biotilgængelighed i denne undersøgelse skyldtes forsinket overførsel af Rebetol eller ændret pH.
English: What you need to know before you use Rebetol
Danish: Det skal du vide, før du begynder at bruge Rebetol
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 97 % (95 % CI: 95-99 %) for patients receiving non-pegylated interferon alfa-2b (with or without Rebetol), and is 99 % (95 % CI: 98-100 %) for patients receiving pegylated interferon alfa-2b (with or without Rebetol).
Danish: Kaplan-Meier estimatet for fortsat vedvarende respons over 5 år er 97 % (95 % CI: 95-99 %) for patienter, der fik non-pegyleret interferon alfa 2b (med eller uden Rebetol), og det er 99 % (95 % CI: 98-100 %) for patienter, der fik pegyleret interferon alfa-2b (med eller uden Rebetol).
English: The study results are summarized in Table 13.
Danish: Undersøgelsens resultater er sammenfattet i Tabel 13.
English: Very rarely reported side effects (may affect up to 1 in 10,000 people): suicide, stroke (cerebrovascular events).
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer): - selvmord, - slagtilfælde (cerebrovaskulær hændelse).
English: The bioavailability of Rebetol 600 mg was decreased by co-administration with an antacid containing magnesium, aluminium and simethicone; AUCtf decreased 14 %.
Danish: Biotilgængeligheden af Rebetol 600 mg blev reduceret ved samtidig indtagelse af et antacidum indeholdende magnesium, aluminium og simeticon; AUCtf faldt 14 %.
English: Standard haematologic tests, blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) and pregnancy tests must be conducted in all patients prior to initiating therapy.
Danish: Standard hæmatologiske test, blodkemi (komplet blodtælling og differentialtælling, blodpladetal, elektrolytter, serum kreatinin, leverfunktionsundersøgelser, urinsyre) og graviditetstest skal udføres hos alle patienter før påbegyndelse af behandling.
English: If you are not sure, talk to your doctor or pharmacist before taking Rebetol.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet, før du tager Rebetol.
English: No pharmacokinetic interaction appears between Rebetol and hepatic function (see section 5.2).
Danish: Der synes ikke at være farmakokinetisk interaktion mellem Rebetol og leverfunktionen (se pkt.
English: Name and address of the manufacturer responsible for batch release for the oral solution
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse af den orale opløsning
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 98 % [95 % CI: 95 %, 100 %] for paediatric patients treated with interferon alfa-2b and ribavirin.
Danish: KaplanMeier estimatet for fortsat vedvarende respons i 5 år er 98 % [95 % CI: 95 %, 100 %] for pædiatriske patienter behandlet med interferon alfa-2b og ribavirin.
English: * For patients receiving a 1,000 mg (< 75 kg) or 1,200 mg (> 75 kg) dose, Rebetol dose should be reduced to 600 mg/day (administered as one 200 mg capsule in the morning and two 200 mg capsules in the evening).
Danish: * For patienter, som får en dosis på 1.000 mg (< 75 kg) eller 1.200 mg (> 75 kg), skal Rebetol-dosis reduceres til 600 mg/dag (administreret som en 200 mg kapsel om morgenen og to 200 mg kapsler om aftenen).
English: In this trial, the combination of Rebetol and peginterferon alfa-2b (1.5 micrograms/kg/week) was significantly more effective than the combination of Rebetol and interferon alfa-2b, particularly in patients infected with Genotype 1.
Danish: I denne undersøgelse var kombinationen af Rebetol og peginterferon alfa-2b (1,5 mikrogram/kg/uge) signifikant mere effektiv end kombinationen af Rebetol og interferon alfa-2b, især hos patienter inficeret med genotype 1.
English: The pharmacokinetics of Rebetol is altered in patients with renal dysfunction due to reduction of apparent clearance in these patients.
Danish: Rebetols farmakokinetik er ændret hos patienter med nedsat nyrefunktion som følge af en reduktion af den tilsyneladende clearance hos disse patienter.
English: Sustained Response
Danish: Vedvarende respons
English: At the peginterferon alfa-2b 1.5 µg/kg plus Rebetol dose, sustained virologic response rates were lower in patients with cirrhosis, in patients with normal ALT levels, in patients with a baseline viral load > 600,000 IU/mL and in patients > 40 years old.
Danish: Ved peginterferon alfa-2b 1,5 μg/kg plus Rebetol dosen, var den vedvarende virologiske responsrate lavere hos patienter med cirrose, end patienter med normal ALT-værdi, hos patienter med en baseline viral load > 600.000 IE/ml, og hos patienter > 40 år.
English: In addition, in a 26 week carcinogenicity study using the heterozygous p53(+/-) mouse model, ribavirin did not produce tumours at the maximally tolerated dose of 300 mg/kg (plasma exposure factor approximately 2.5 compared to human exposure).
Danish: Derudover fremkaldte ribavirin ikke tumorer i en 26 ugers karcinogenicitetsundersøgelse med den heterozygote p53(+/-) musemodel og den maksimale tolererede dosis på 300 mg/kg (plasma ekspositionsfaktor cirka 2,5 sammenlignet med human eksponering).
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: Rebetol contains sucrose and sorbitol
Danish: Rebetol indeholder saccharose og sorbitol
English: There is no evidence that Rebetol interacts with non-nucleoside reverse transcriptase inhibitors or protease inhibitors.
Danish: Der er ingen tegn på, at Rebetol har interaktion med ikke-nukleosid reverse transcriptasehæmmere eller proteasehæmmere.
English: Based on published data, single-dose ribavirin pharmacokinetics was altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance > 90 mL/minute).
Danish: Baseret på offentliggjorte data var enkeltdosisfarmakokinetikken for ribavirin ændret (øget AUCtf og Cmax) hos patienter med nedsat nyrefunktion sammenlignet med kontrolpersoner (kreatininclearance > 90 ml/minut).
English: Predictability of sustained virological response in naïve patients Virological response by week 12 is defined as at least 2-log viral load decrease or undetectable levels of HCV-RNA.
Danish: Forudsigelighed med hensyn til vedvarende virologisk respons hos naive patienter Virologisk respons ved uge 12, defineret som et fald på mindst 2-log viral load eller ikke-detekterbart niveau af HCV RNA.
English: - The active substance is ribavirin 200 mg. - The other ingredients are microcrystalline cellulose, lactose monohydrate (40 mg), croscarmellose sodium, magnesium stearate.
Danish: Rebetol indeholder: - Aktivt stof: Ribavirin 200 mg. - Øvrige indholdsstoffer: Mikrokrystallinsk cellulose, lactosemonohydrat (40 mg), croscarmellosenatrium og magnesiumstearat.
English: Genotype 1 (n = 92) Genotype 2/3/4 (n = 26)
Danish: Genotype 2/3/4 (n=26)
English: There is no evidence from toxicity studies that Rebetol induces liver enzymes.
Danish: Der er ingen tegn fra toksicitetsundersøgelser på, at Rebetol inducerer leverenzymer.
English: The concomitant use of Rebetol with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
Danish: Samtidig anvendelse af Rebetol med zidovudin kan ikke anbefales som følge af en øget risiko for anæmi (se pkt.
English: In individual cases where the benefit of administering Rebetol concomitantly with azathioprine warrants the potential risk, it is recommended that close hematologic monitoring be done during concomitant azathioprine use to identify signs of myelotoxicity, at which time treatment with these medicines should be stopped (see section 4.4).
Danish: I individuelle tilfælde, hvor fordelen ved administrationen af Rebetol sammen med azathioprin opvejer den potentielle risiko, anbefales tæt hæmatologisk monitorering ved samtidig brug af azathioprin for at identificere tegn på myelotoksicitet.
English: In clinical trials C95-132 and I95-143, Rebetol + interferon alfa-2b combination therapy proved to be significantly more effective than interferon alfa-2b monotherapy (a doubling in sustained response).
Danish: I kliniske undersøgelser C95-132 og I95-143 viste Rebetol + interferon alfa-2b kombinationsbehandling sig at være signifikant mere effektiv end interferon alfa-2b monoterapi (en fordobling i vedvarende respons).
English: You or your female partner must use an effective contraceptive during the time you are taking Rebetol and for 7 months after stopping treatment.
Danish: Du eller din kvindelige partner skal bruge sikker prævention i den periode, du tager Rebetol og i 7 måneder efter, behandlingen er stoppet.
English: Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
Danish: Patienter, som udvikler leverdekompensation, skal seponere antihepatitis-behandlingen øjeblikkeligt, og ARV-behandlingen skal revurderes.
English: A certain number of adverse reactions, generally attributed to interferon therapy but that have been reported in the context of hepatitis C therapy (in combination with Rebetol) are also listed for reference in Table 5.
Danish: Et givet antal bivirkninger tilskrevet interferonbehandling, men som har været rapporteret i sammenhæng med hepatitis C-behandling (i kombination med Rebetol) er også listet i Tabel 5.
English: Interferon alfa-2b 3 MIU/m 2 3 times a week (n = 54)
Danish: Interferon alfa-2b 3 MIE/m 2 3 gange om ugen (n = 54)
English: Usual daily Rebetol dose
Danish: Normal daglig Rebetol-dosis
English: Immune system disorders Uncommon:
Danish: Immunsystemet Ikke almindelig:
English: Rebetol must be used in combination therapy as described in section 4.1.
Danish: Rebetol skal altid anvendes i kombinationsbehandling som beskrevet i pkt.
English: MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
Danish: Danmark MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
English: 1 bottle of 100 mL 10 mL oral dosing syringe
Danish: oral opløsning 1 flaske på 100 ml 10 ml oral doseringssprøjte
English: Weight loss and growth inhibition were very common during the treatment (at the end of treatment, mean decrease from baseline in weight and in height percentiles were of 15 percentiles and 8 percentiles, respectively) and growth velocity was inhibited (< 3
Danish: Vægttab og væksthæmning var meget almindeligt under behandlingen (ved slutningen af behandlingen var gennemsnitlig reduktion fra baseline i vægt- og højdepercentil henholdsvis 15 percentiler og 8 percentiler) og væksthastighed var inhiberet (< 3. percentil i 70 % af patienterne).
English: It is possible that the increased bioavailability in this study was due to delayed transit of ribavirin or modified pH.
Danish: Det er muligt, at den øgede biotilgængeligheden i denne undersøgelse skyldtes forsinket overførsel af ribavirin eller ændret pH.
English: Propylene glycol Ammonium hydroxide Colouring agent (E 132)
Danish: Propylenglycol Ammoniumhydroxid Farvestof (E 132)
English: If week 12 HCV-RNA is positive and decreased ≥ 2 log10 from baseline, then retest HCV-RNA at week 24 and if positive, patients to stop therapy.
Danish: Hvis HCV-RNA findes positivt i uge 12 og der er et fald på ≥ 2log10 fra baseline, skal der re-testes for HCV-RNA i uge 24, og hvis denne findes positivt, skal patienten stoppe behandlingen.
English: REBETOL - 84, 112, 140, 168 hard capsules
Danish: REBETOL - 84, 112, 140, 168 hårde kapsler
English: oral solution 100 mL
Danish: oral opløsning 100 ml
English: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite
Danish: Hyperglykæmi, hyperurikæmi, hypokalcæmi, dehydrering, øget appetit
English: Anti-thyroid antibody positive
Danish: Positiv anti-tyroid antistof
English: Combination therapy with Rebetol and interferon alfa-2b resulted in a sustained virological response that was ten-fold higher than that with interferon alfa-2b alone (49 % vs 5 %, p < 0.0001).
Danish: Kombinationsbehandling med Rebetol + interferon alfa-2b resulterede i et vedvarende virologisk respons, der var ti gange større end ved interferon alfa-2b alene (49 % mod 5 %, p < 0,0001).
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with peginterferon alfa-2b (1.5 µg/kg)/Rebetol combination therapy resulted in a higher sustained virologic response rate compared to peginterferon alfa-2b 1 µg/kg dose.
Danish: Hos patienter med afroamerikansk oprindelse (som er kendt for at være en dårlig prognostisk faktor for HCV udryddelse), medførte en behandling med peginterferon alfa-2b (1,5 μg/kg)/Rebetol kombinationsbehandling højere vedvarende virologisk responsrate sammenlignet med peginterferon alfa-2b 1 μg/kg dosis.
English: The study results are summarized in Table 7.
Danish: Undersøgelsens resultater er summerede i Tabel 7.
English: Rebetol does not inhibit cytochrome P450 enzymes.
Danish: Rebetol hæmmer ikke CYP-enzymer.
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials, sustained virological response rates in children and adolescents were similar to those in adults.
Danish: Den inkluderede population bestod hovedsageligt af børn med mild til moderat hepatitis C. I de to multicenterforsøg, vedvarende virologiske responsrater hos børn og unge svarede til dem, der sås hos voksne.
English: Depression, insomnia, emotional lability
Danish: Depression, søvnløshed, emotionel labilitet
English: Natural and artificial bubble gum flavouring
Danish: Naturlig og kunstig tyggegummismag.
English: Daily Rebetol dose
Danish: Daglig Rebetol-dosis
English: In clinical trials of 118 children and adolescents 3 to 16 years of age treated with combination therapy of interferon alfa-2b and Rebetol, 6 % discontinued therapy due to adverse reactions.
Danish: I kliniske undersøgelser med 118 børn og unge 3 til 16 år, behandlet i kombination med interferon alfa-2b og Rebetol, afbrød 6 % behandling på grund af bivirkninger.
English: This medicinein combination with peginterferon alfa-2b or interferon alfa-2b may also cause: dark, cloudy or abnormally coloured urine, difficulty breathing, changes in the way your heart beats, chest pain, pain down left arm, jaw pain,
Danish: Dette lægemiddel i kombination med peginterferon alfa-2b eller interferon alfa-2b kan også bevirke: - mørk, grumset eller unormalt farvet urin, - vejrtrækningsproblemer, ændringer i den måde dit hjerte slår, brystsmerte, smerte i venstre arm,
English: The pharmacokinetics of Rebetol (dose-normalized) in this trial was similar to those reported in a prior study of Rebetol in combination with interferon alfa-2b in children and adolescent patients and in adult patients.
Danish: De farmakokinetiske data for Rebetol (dosis-normaliseret) i dette studie svarede til dem rapporteret i et forudgående studie af Rebetol i kombination med interferon alfa-2b hos børn og unge patienter og hos voksne patienter.
English: c: Patients with genotype 3 low viral load (< 600,000 IU/mL) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/mL) were to receive 48 weeks of treatment.
Danish: c: Patienter med genotype 3 lav viral load (< 600,000 IE/ml) skulle modtage 24 ugers behandling mens de med genotype 3 og høj viral load (≥ 600,000 IE/ml) skulle modtage 48 uger behandling.
English: Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated-Rebetol for co-HCV infection (see section 4.4).
Danish: Mitokondriel toksicitet og mælkesyreacidose har været rapporteret hos hiv-positive patienter, der modtog NRTI regimen og associeret Rebetol for samtidig HCV-infektion (se pkt.
English: The haemolytic anaemia associated with Rebetol therapy may result in deterioration of cardiac function and/or worsening of pre-existing cardiac disease.
Danish: Hæmolytisk anæmi forbundet med Rebetol-behandling kan resultere i forringelse af hjertefunktion og/eller forværring af allerede eksisterende hjertesygdom.
English: Paediatric patients (children 3 years of age and older and adolescents) Rebetol may be used in combination with peginterferon alfa-2b or interferon alfa-2b (see section 4.4).
Danish: Pædiatriske patienter (børn i alderen 3 år og ældre samt unge) Rebetol kan bruges i kombination med peginterferon alfa-2b eller interferon alfa-2b (se pkt.
English: There may be some further treatment limitations if you have or have not been previously treated for chronic hepatitis C infection.
Danish: Der kan være yderligere begrænsninger til behandlingen afhængigt af, om du tidligere er blevet behandlet for kronisk hepatitis C-infektion eller ej. Din læge vil anbefale en passende behandling.