FrancophonIA/ELRC3.0 huggingface dataset:
English: Failure to prior therapy was defined as relapse or non-response (HCV-RNA positive at the end of a minimum of 12 weeks of treatment).
Danish: At tidligere behandling var uden effekt, blev defineret som værende relaps eller non respons (HCV-RNA positiv ved afslutningen på en 12 ugers behandling).
English: particularly Genotype 1, in which the relapse rate was reduced by 30 % compared with interferon alfa-2b monotherapy.
Danish: Dette var tilfældet for alle HCV genotyper, især genotype 1, i hvilken relapsraten blev reduceret med 30 % sammenlignet med interferon alfa-2b monoterapi.
English: In children and adolescent patients receiving body surface area-adjusted dosing of peginterferon alfa-2b at 60 µg/m2/week, the log transformed ratio estimate of exposure during the dosing interval is predicted to be 58 % (90 % CI: 141-177 %) higher than observed in adults receiving 1.5 µg/kg/week.
Danish: Hos børn og unge patienter, der fik legemsoverflade-justeret dosering af peginterferon alfa-2b på 60 μg/m2/uge, forventes det log-transformerede forholdsskøn over eksponering i doseringsinterval at være 58 % (90 % CI: 141-177 %) højere end observeret hos voksne, der fik 1,5 μg/kg/uge.
English: - Retreatment of relapse patients with Rebetol and interferon alfa-2b combination treatment Two trials examined the use of Rebetol and interferon alfa-2b combination treatment in relapse patients (C95-144 and I95-145); 345 chronic hepatitis patients who had relapsed after previous interferon treatment were treated for six months with a six month follow-up.
Danish: - Genbehandling af relaps patienter med Rebetol og interferon alfa-2b kombinations behandling To undersøgelser vurderede anvendelsen af Rebetol + interferon alfa-2b kombinationsbehandling hos relaps patienter (C95-144 og I95-145); 345 patienter med kronisk hepatitis, som havde fået relaps efter tidligere interferonbehandling, blev behandlet i seks måneder med en seks måneders opfølgning.
English: Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Danish: Vigtige behandlingsrelaterede bivirkninger, som opstod i denne patientpopulation var nervøsitet (8 %), aggression (3 %), vrede (2%), depression/trykket stemning (4 %) og hypothyroidisme (3 %) og 5 forsøgspersoner modtog levothyroxin behandling for hypothyroidisme / forhøjede TSH.
English: Response at Treatment Week
Danish: Respons ved behandlingsuge
English: Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare
Danish: Abnorm opførelse, nedtrykt humør, følelsesmæssig forstyrrelse, frygt, mareridt
English: Mitochondrial toxicity and lactic acidosis:
Danish: Mitokondriel toksicitet og mælkesyreacidose:
English: How to use Rebetol
Danish: Sådan skal du bruge Rebetol
English: attempted suicide and aggressive behaviour, etc.) - Growth inhibition in children and adolescents that may be irreversible in some patients - Increased thyroid stimulating hormone (TSH) in children and adolescents - Severe ocular disorders - Dental and periodontal disorders.
Danish: selvmordstanker, selvmordsforsøg og aggressiv adfærd osv.) - Væksthæmning hos børn og unge, som kan være irreversibel hos nogle patienter - Forhøjet thyreoideastimulerende hormon (TSH) hos børn og unge - Svære øjensygdomme - Dentale og parodontale lidelser.
English: Thus, Rebetol must be administered with caution to patients with pre-existing cardiac disease (see section 4.3).
Danish: Rebetol skal således anvendes med forsigtighed til patienter med forudeksisterende hjertesygdom (se pkt.
English: Haematological abnormalities were more frequently reported in patients receiving Rebetol in combination with peginterferon alfa-2b when compared to patients receiving Rebetol in combination with interferon alfa-2b.
Danish: Hæmatologiske unormaliteter blev rapporteret mere hyppigt hos patienter, der modtog Rebetol i kombination med peginterferon alfa-2b sammenlignet med patienter, der modtog Rebetol i kombination med interferon alfa-2b.
English: The capsule shell imprint contains shellac, propylene glycol, ammonium hydroxide, colouring agent (E 132).
Danish: Kapselskalprægningen indeholder shellac, propylenglycol, ammoniumhydroxid og farvestof (E 132).
English: Response to the treatment was measured by Sustained Virologic Response (SVR) which is defined as undetectable HCV-RNA at 24 weeks post-treatment (see Table 9).
Danish: Respons på behandlingen blev målt ved vedvarende virologisk respons (SVR), der er defineret som ikke målbart HCV-RNA 24 uger efter behandlingen (se tabel 9).
English: Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Danish: Vogt-Koyanagi-Harada syndrom, systemisk lupus erythematosus, vaskulitis, akutte overfølsomhedsreaktioner herunder urticaria, angioødem, forsnævring af bronkierne, anafylaksi
English: Table 3 Management of Adverse Reactions Laboratory values
Danish: Tabel 3 Håndtering af bivirkninger Laboratorieværdier
English: Although Rebetol has no direct cardiovascular effects, anaemia associated with Rebetol may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease or both.
Danish: Selv om Rebetol ikke har nogen direkte kardiovaskulære virkninger, kan anæmi i forbindelse med Rebetol medføre forringelse af hjertefunktionen eller forværring af symptomerne på koronarsygdom eller begge.
English: In 3-and 6-month studies in mice to investigate ribavirin-induced testicular and sperm effects, abnormalities in sperm occurred at doses of 15 mg/kg and above.
Danish: I 3 og 6 måneders undersøgelser på mus for at undersøge ribavirin induceret testis- og sædcellepåvirkninger forekom abnormaliteter i sædceller ved doser på 15 mg/kg og derover.
English: Please refer to the SmPC of the corresponding DAA for a full description of the clinical data with such combination.
Danish: Der henvises til SmPC for det pågældende direkte virkende antivirale lægemiddel for en fuldstændig beskrivelse af de kliniske data ved en sådan kombination.
English: Sorbitol liquid (crystallising) Propylene glycol
Danish: Sorbitol, flydende (krystalliserende) Propylenglycol
English: Twenty-four percent of children (11/46) treated for 24 weeks and 40 % of children (19/48) treated for 48 weeks had a > 15 percentile height-for-age decrease from pre-treatment to the end of 5 year long-term follow-up compared to pre-treatment baseline percentiles.
Danish: Hos 24 % (11/46) af de børn, der blev behandlet i 24 uger, og 40 % (19/48) af de børn, der blev behandlet i 48 uger, var der en reduktion på > 15 percentil for alderen i perioden fra før behandling til afslutningen af den 5-årige langtidsopfølgning i forhold til baseline-percentilerne før behandlingen.
English: Both the Metavir score and Ishak grade decreased among subjects treated with Rebetol in combination with peginterferon alfa-2b.
Danish: Både Metavirscore og Ishakgraden faldt blandt de forsøgspersoner, der blev behandlet med Rebetol i kombination med peginterferon alfa-2b.
English: The combination of Rebetol and other medicines is used to treat patients who have chronic hepatitis C (HCV).
Danish: Kombinationen af Rebetol og andre lægemidler anvendes til at behandle patienter, som har kronisk hepatitis C (kronisk HCV).
English: Table 11 Sustained virological response based on genotype after Rebetol in combination with peginterferon alfa-2b in HCV/HIV co-infected patients Study 1
Danish: Tabel 11 Vedvarende virologisk respons baseret på genotype efter Rebetol i kombination med peginterferon alfa-2b hos patienter med samtidig infektion af HCV/hiv Undersøgelse 1
English: 4 % (8/194) of patients receiving Rebetol in combination with peginterferon alfa-2b.
Danish: 3 blev observeret i 4 % (8/194) af de patienter, der modtog Rebetol i kombination med peginterferon alfa-2b.
English: Warnings and precautions There are several serious adverse reactions associated with the combination therapy of ribavirin with (peg)interferon alfa.
Danish: Advarsler og forsigtighedsregler Der er mange alvorlige bivirkninger forbundet med kombinationsbehandling med ribavirin og (peg)interferon alfa.
English: Rebetol oral solution 40 mg/mL
Danish: Rebetol oral opløsning 40 mg/ml
English: In case of serious adverse reaction potentially related to medicinal products used in combination with Rebetol, refer to the corresponding SmPC of these medicinal products as some combination regimens do not adhere to the Rebetol dose modification and/or discontinuation guidelines as described in Table 2.
Danish: I tilfælde af en alvorlig bivirkning, som potentielt er relateret til lægemidler, der anvendes i kombination med Rebetol, henvises til SmPC'erne for disse lægemidler, da visse kombinationsregimer ikke følger retningslinjerne for dosisjustering og/eller seponering af Rebetol som beskrevet i Tabel 2.
English: HCV-RNA negative or ≥ 2 log decrease in viral load
Danish: HCV-RNA negative eller ≥ 2 log fald i viral load
English: Packs of 84, 112, 140 and 168 capsules.
Danish: Pakninger med 84, 112, 140 og 168 kapsler.
English: There are several serious adverse reactions associated with the combination therapy of Rebetol with (peg)interferon alfa.
Danish: Der er mange alvorlige bivirkninger forbundet med kombinationsbehandling med Rebetol og (peg)interferon alfa.
English: peginterferon alfa-2b (100 or c µg/week)
Danish: peginterferon alfa-2b (100 or c µg/uge)
English: Adverse reactions reported with a > 10 % incidence in adult patients treated with Rebetol capsules in combination with interferon alfa-2b or pegylated interferon alfa-2b for one year have also been reported in children and adolescents.
Danish: Bivirkninger rapporteret med en forekomst på > 10 % hos voksne patienter behandlet med Rebetolkapsler i kombination med interferon alfa-2b eller pegyleret interferon alfa-2b i et år, blev også rapporteret hos børn og unge.
English: Table 7 Sustained response rates with Rebetol + peginterferon alfa-2b
Danish: Tabel 7 Vedvarende responsrater med Rebetol + peginterferon alfa-2b
English: The combination of Rebetol and other medicines is used to treat adult patients who have chronic hepatitis C (HCV).
Danish: Kombinationen af Rebetol og andre lægemidler anvendes til at behandle voksne patienter, som har kronisk hepatitis C (kronisk HCV).
English: Laboratory values for HCV/HIV co-infected patients Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Danish: Laboratorieværdier for samtidig infektion med HCV/hiv Selvom hæmatologisk toksicitet af neutropeni, trombocytopeni og anæmi forekom mere hyppigt hos patienter med samtidig infektion af HCV/hiv, kunne hovedparten afhjælpes med modificering af dosis og krævede sjældent for tidlig afbrydelse af behandling (se pkt.
English: Contains Sorbitol liquid (crystallising), sucrose.
Danish: Indeholder: Sorbitol, flydende (krystalliserende), saccharose.
English: Bitherapy with peginterferon alfa-2b or interferon alfa-2b The safety of Rebetol capsules is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied Rebetol in combination with interferon alfa-2b, two trials studied Rebetol in combination with peginterferon alfa-2b.
Danish: 2-stofsbehandling med peginterferon alfa-2b eller interferon alfa-2b Sikkerheden ved Rebetol kapsler er vurderet på basis af data fra fire kliniske undersøgelser hos patienter uden tidligere eksponering for interferon (interferon-naive patienter): to undersøgelser vurderede Rebetol i kombination med interferon alfa-2b, to undersøgelser vurderede Rebetol i kombination med peginterferon alfa-2b.
English: Severe adverse reactions were reported in 7 % (8/107) of all subjects and included injection site pain (1 %), pain in extremity (1 %), headache (1 %), neutropenia (1 %), and pyrexia (4 %).
Danish: Alvorlige bivirkninger blev rapporteret hos 7 % (8/107) af alle forsøgspersonerne og inkluderede smerter ved injektionsstedet (1 %), smerter i ekstremitet (1 %), hovedpine (1 %), neutropeni (1 %), og feber (4 %).
English: - Men:
Danish: - Mænd:
English: - History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease,
Danish: - Anamnese med allerede eksisterende alvorlig hjertesygdom, inklusive ustabil eller ukontrolleret hjertesygdom, i de foregående seks måneder (se pkt.
English: Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity occurred within one or two spermatogenic cycles (see section 4.6).
Danish: Efter behandlingsophør forekom praktisk taget fuldstændig bedring fra ribavirin induceret testistoksicitet inden for en til to sædcelledannende cykli (se pkt.
English: For BMI, pre-treatment to end of long-term follow-up, BMI-for-age percentiles decreased 1.8 and 7.5 percentiles among children treated for 24 weeks or 48 weeks, respectively.
Danish: Med hensyn til BMI var der en reduktion i BMI for alderen fra før behandling til afslutning af langtidsopfølgningen på henholdsvis 1,8 og 7,5 percentiler blandt de børn, der var blevet behandlet i 24 eller 48 uger.
English: peginterferon alfa-2b (1.5 µg/kg/ week)
Danish: Peginterferon alfa-2b (1,5 µg/kg/ uge)
English: Each mL of oral solution contains 40 mg of ribavirin.
Danish: Hver ml oral opløsning indeholder 40 mg ribavirin.
English: Eleven percent of children (5/46) treated for 24 weeks and 13 % of children (6/48) treated for 48 weeks were observed to have a decrease from pre-treatment baseline > 30 height-for-age percentiles to the end of the 5 year long-term follow-up.
Danish: Hos 11 % (5/46) af de børn, der blev behandlet i 24 uger og 13 % (6/48) af de børn, der blev behandlet i 48 uger, var der en reduktion fra baseline før behandling til afslutningen af den 5-årige langtidsopfølgning på > 30 percentiler for alderen.
English: % (number) of patients peginterferon alfa-2b 1.5 µg/kg + Rebetol peginterferon alfa-2b 1 µg/kg + Rebetol peginterferon alfa-2a 180 µg + ribavirin
Danish: % (antal) af patienter peginterferon alfa-2b 1,5 μg/kg + Rebetol peginterferon alfa-2b 1 μg/kg + Rebetol peginterferon alfa-2a 180 µg + ribavirin
English: The pharmacokinetics of Rebetol is altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients (see section 5.2).
Danish: Rebetols farmakokinetik er ændret hos patienter med nedsat nyrefunktion som følge af en reduktion af den tilsyneladende kreatininclearance hos disse patienter (se pkt.
English: Caution should be taken in HIV-positive subjects co-infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa/ribavirin treatment.
Danish: Der bør udvises forsigtighed hos hiv-positive personer, som samtidig er inficeret med HCV, og som får behandling med nukleosid revers transcriptasehæmmer (NRTI) (især ddI og d4T) og kombineret interferon alfa/ribavirin behandling.
English: Rebetol in combination with peginterferon alfa-2b Multiple-dose pharmacokinetic properties for Rebetol and peginterferon alfa-2b in children and adolescent patients with chronic hepatitis C have been evaluated during a clinical study.
Danish: Rebetol i kombination med peginterferon alfa-2b Flerdosis farmakokinetiske egenskaber for Rebetol og peginterferon alfa-2b hos børn og unge patienter med kronisk hepatitis C er blevet evalueret i en klinisk undersøgelse.
English: Response week 12 was defined as undetectable HCV-RNA after 12 weeks of treatment.
Danish: 12 ugers respons på behandlingen blev defineret som ikke-målbart HCV-RNA efter 12 ugers behandling.
English: • are allergic to ribavirin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for ribavirin eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Number of 200 mg capsules
Danish: Antal 200 mg kapsler
English: In a clinical trial with 107 children and adolescent patients (3 to 17 years of age) treated with combination therapy of peginterferon alfa-2b and Rebetol, dose modifications were required in 25 % of patients, most commonly for anaemia, neutropenia and weight loss.
Danish: I et klinisk forsøg med 107 børn og unge patienter (3 til 17 år) behandlet med peginterferon alfa-2b og Rebetol som kombinationsbehandling, var dosis ændring nødvendig hos 25 % af patienterne, mest almindeligt for anæmi, neutropeni og vægttab.
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of Rebetol and pegylated interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Danish: Populationen der var indrulleret bestod hovedsageligt af børn med mild til moderat hepatitis C. På grund af mangel på data hos børn med svær progression af sygdommen, og potentialet for uønskede virkninger, fordel/risiko for kombinationen af Rebetol og pegyleret interferon alfa-2b skal det overvejes nøje i denne population (se pkt.
English: For weight, pre-treatment to end of long-term follow-up, weight-for-age percentiles decreased 1.3 and 5.5 percentiles among children treated for 24 weeks or 48 weeks, respectively.
Danish: Med hensyn til vægten var der en reduktion i vægten for alderen fra før behandling til afslutning af langtidsopfølgningen på henholdsvis 1,3 og 5,5 percentiler blandt de børn, der var blevet behandlet i 24 eller 48 uger.
English: Tell your doctor or pharmacist if you or the child you are caring for are taking, have recently taken or might take: - azathioprine is a medicine that suppresses your immune system, using this medicine in combination with Rebetol may increase your risk of developing severe blood disorders.
Danish: Brug af anden medicin sammen med Rebetol Fortæl det altid til lægen eller apotekspersonalet, hvis du eller det barn du har ansvar for bruger anden medicin eller har gjort det for nylig: - azathioprin er et lægemiddel, der undertrykker immunsystemet (immunsuppressivum), og anvendelse af denne medicin i kombination med Rebetol kan øge risikoen for at udvikle alvorlige blodsygdomme.
English: nd dose reduction of Rebetol is by an additional 200 mg/day.
Danish: 2. dosisreduktion af Rebetol er med yderligere 200 mg/dag, hvis det er nødvendigt.
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. 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 (see Table 7).
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 (se Tabel 7).
English: No data are available regarding dose modification for paediatric patients with renal impairment.
Danish: Der foreligger ingen data vedrørende dosisjustering for pædiatriske patienter med nedsat nyrefunktion.
English: Rebetol 40 mg/mL oral solution ribavirin
Danish: Rebetol 40 mg/ml oral opløsning ribavirin
English: Depression, anxiety, emotional lability, insomnia
Danish: Depression, angst, emotionel labilitet, søvnløshed
English: However, response rates in this trial were shown to be dependent also on the dose of Rebetol administered in combination with peginterferon alfa-2b or interferon alfa-2b.
Danish: Responsrater i denne undersøgelse blev imidlertid vist også at være afhængige af dosis af Rebetol givet i kombination med peginterferon alfa-2b eller interferon alfa-2b.
English: Sustained Virologic Response (SVR) is defined as undetectable HCV-RNA at 24 weeks post-treatment (Table 12).
Danish: Sustained virologisk respons (SVR) er defineret som ikke-målbart HCV-RNA 24 uger efter endt behandling (Tabel 12).
English: The following side effects have been reported with the combination of this medicine hard capsules and an alpha interferon product in adults:
Danish: Følgende bivirkninger er blevet rapporteret med kombinationen af dette lægemiddel hårde kapsler og et alfa interferon produkt hos voksne:
English: Rebetol, by having an inhibitory effect on inosine monophosphate dehydrogenase, may interfere with azathioprine metabolism possibly leading to an accumulation of 6-methylthioinosine monophosphate (6-MTIMP), which has been associated with myelotoxicity in patients treated with azathioprine.
Danish: Dette kan muligvis føre til en akkumulering af 6-methylthioinosinmonofosfat (6-MTIMP), som har været forbundet med myelotoksicitet hos patienter, som behandles med azathioprin.
English: Please refer to the corresponding SmPC of medicinal products used in combination with Rebetol.
Danish: Der henvises til SmPC'erne for de lægemidler, der anvendes i kombination med Rebetol.
English: Endocrine disorders Common:
Danish: Det endokrine system Almindelig:
English: Table 10 Predictive Value of In-Treatment Virologic Response while on peginterferon alfa-2b 1.5 µg/kg/Rebetol 800-1,400 mg Combination Therapy Negative
Danish: Tabel 10 Prædiktiv værdi af virologisk respons under behandling med peginterferon alfa-2b 1,5 µg/kg/Rebetol 800-1.400 mg kombinationsterapi Negativ
English: Excipient with known effect Each hard capsule contains 40 mg of lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 40 mg lactosemonohydrat.
English: Co-infected patients receiving both antiretroviral (ARV) and anti-hepatitis treatment should be closely monitored, assessing their Child-Pugh score during treatment.
Danish: Co-inficerede patienter, der får både antiretroviral (ARV) og antihepatitis-behandling, bør monitoreres tæt.
English: Co-infected patients with advanced liver disease receiving cART may be at increased risk of worsening liver function.
Danish: - Patienter med både hiv- og HCV-infektion med fremskreden leversygdom, der tager cART, kan have øget risiko for forværring af leverfunktionen.
English: Rebetol (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
Danish: Rebetol (1.000/1.200 mg) + interferon alfa-2b (3 MIE)
English: A large randomized trial compared the safety and efficacy of treatment for 48 weeks with two peginterferon alfa-2b/Rebetol regimens [peginterferon alfa-2b 1.5 µg/kg and 1 µg/kg subcutaneously once weekly both in combination with Rebetol 800 to 1,400 mg p.o. daily (in two divided doses)] and peginterferon alfa-2a 180 µg subcutaneously once weekly with ribavirin 1,000 to 1,200 mg p.o. daily (in two divided doses) in 3,070 treatment-naïve adults with chronic hepatitis C genotype 1.
Danish: Et stort randomiseret studie sammenlignede sikkerhed og effekt af behandling i 48 uger med to peginterferon alfa-2b/Rebetol regimer [peginterferon alfa-2b 1,5 μg/kg og 1 μg/kg subkutant en gang ugentligt begge i kombination med Rebetol 800 til 1.400 mg p.o. dagligt (fordelt på to doser)] og peginterferon alfa-2a 180 μg subkutant en gang ugentligt med ribavirin 1.000 til 1.200 mg p.o. dagligt (fordelt på to doser) hos 3.070 behandlingsnaive voksne med kronisk hepatitis C genotype 1.
English: Neuralgia, lethargy, psychomotor hyperactivity
Danish: Neuralgi, sløvhed, psykomotorisk hyperaktivitet
English: Tel: +40 21 529 2900 msdromania@merck.com
Danish: Tel: Tel: +40 21 529 2900 msdromania@merck.com