FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who are treated with interferon alfa-2b and ribavirin after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below.
Danish: Patienter, som behandles med interferon alfa-2b og ribavirin efter tidligere relaps efter interferon behandling, eller som behandles i en kortere periode, har sandsynligvis en bedre sikkerhedsprofil end den nedenfor beskrevne.
English: Do not take Ribavirin Mylan Do not take Ribavirin Mylan if any of the following apply to you or the child you are caring for.
Danish: Undgå at tage Ribavirin Mylan, hvis følgende gælder for dig eller det barn, du er værge for.
English: Limited safety data (N = 25) are available in co-infected patients with CD4+ cell counts < 200/µl (see section 4.4).
Danish: Begrænsede sikkerhedsdata er tilgængelige (N = 25) hos co-inficerede patienter med CD4+ celletællinger < 200/μl (se pkt.
English: Although ribavirin has no direct cardiovascular effects, anaemia associated with ribavirin may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both.
Danish: Selv om ribavirin ikke har nogen direkte kardiovaskulære virkninger, kan anæmi i forbindelse med ribavirin medføre forringelse af hjertefunktionen eller forværring af symptomerne på koronarsygdom eller begge.
English: Cardboard box containing 56x1, 84x1, 112x1, 140x1, 168x1 hard capsules in PVC/Aclar - Aluminium foil perforated unit dose blisters
Danish: Karton med 56x1, 84x1, 112x1, 140x1, 168x1 hårde kapsler i PVC/Aclar - aluminiumsfolie perforerede enkeltdosisblistre
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 publicerede data, farmakokinetik for enkeltdosis af ribavirin ændredes (øget AUCtf og Cmax) hos patienter med nedsat nyrefunktion sammenlignet med kontrolpersoner (kreatinin-clearance > 90 ml/minut).
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: 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 hepatisk dekompensering omfatter behandling med didanosin og forhøjet bilirubin.
English: An increase in uric acid and indirect bilirubin values associated with haemolysis were also observed in some patients.
Danish: Der blev også fundet øgede af urinsyreværdier og indirekte bilirubinværdier forbundet med hæmolyse hos nogle patienter.
English: In case of serious adverse reaction potentially related to medicinal products used in combination with Ribavirin Mylan, refer to the corresponding SmPC of these medicinal products as some combination regimens do not adhere to the ribavirin dose modification and/or discontinuation guidelines as described in Table 2.
Danish: I tilfælde af alvorlige bivirkninger, der kan være relateret til lægemidler anvendt i kombination med Ribavirin Mylan, henvises der til de tilsvarende produktresumeer for disse lægemidler, da visse kombinationsbehandlinger ikke overholder retningslinjerne for ribavirin-dosisændring og/eller seponering som beskrevet i Tabel 2.
English: Dose reduction of ribavirin depends on the initial ribavirin posology which depends on the medicinal product that is used in combination with ribavirin.
Danish: Dosisreduktion af ribavirin afhænger af den oprindelige ribavirinposologi, som afhænger af det lægemiddel, der anvendes i kombination med ribavirin.
English: Table 12 Rates of Response to retreatment in prior treatment failures
Danish: Tabel 12 Responsrater på genbehandling af patienter som ikke har responderet på tidligere behandling
English: Hepatotoxicity (including fatalities)*
Danish: Hepatoxicitet (herunder dødelig)٭
English: The capsule shell contains gelatine and titanium dioxide (E171).
Danish: Kapselskallen indeholder gelatine og titandioxid (E171).
English: During the one year of treatment with Ribavirin in combination with interferon alfa-2b, some children and adolescents did not grow or gain weight as much as expected.
Danish: I løbet af det ene år i behandling med ribavirin i kombination med enten interferon alfa-2b, voksede nogle børn og unge ikke eller tog ikke den vægt på som var forventet.
English: For children or adolescents who cannot swallow a hard capsule, an oral solution of ribavirin is available.
Danish: Til børn og unge, som ikke kan sluge en hård kapsel, findes en oral opløsning af Ribavirin Mylan.
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: Vigtig behandlingsrelaterede bivirkninger, som opstod i denne patientpopulation var nervøsitet (8 %), aggression (3 %), vrede (2%), depression / trykket stemning (4 %) og hypothyroidism (3 %) og 5 forsøgspersoner modtog levothyroxin behandling for hypothyroidism / forhøjede TSH.
English: Please refer also to the relevant product information for antiretroviral medicinal products.
Danish: Der henvises også til produktresuméerne for antiretrovirale lægemidler
English: Oral formulations of ribavirin monotherapy have been investigated as therapy for chronic hepatitis C in several clinical trials.
Danish: Orale former for ribavirin monoterapi er blevet undersøgt til behandling af kronisk hepatitis C i flere kliniske undersøgelser.
English: Initiation of peginterferon alfa-2b is contraindicated in HCV/HIV patients with cirrhosis and a ChildPugh score ≥ 6.
Danish: Initiering af peginterferon alfa-2b er kontraindiceret i HCV/hiv-patienter med cirrhose og en ChildPugh score ≥ 6.
English: You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Danish: Du vil måske overveje at bede et familiemedlem eller en tæt ven hjælpe dig med at være opmærksom på tegn på depression eller ændringer i din opførsel.
English: In subjects with creatinine clearance between 30 and 50 mL/min, AUCtf was twofold greater compared with control subjects.
Danish: Hos patienter med kreatinin-clearance mellem 30 og 50 ml/min var AUCtf to gange større sammenlignet med kontrolpersonerne.
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were coinfected 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: The capsule shell imprint contains shellac, propylene glycol, strong ammonia solution, colouring agents (E172, E132, E171).
Danish: Prægningen på kapselskallen indeholder shellac, propylenglycol, stærk ammoniakopløsning og farvestoffer (E172, E132, E171).
English: Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Danish: Sørg for at søge akut lægebehandling, hvis du opdager, at du bliver deprimeret eller har selvmordstanker eller ændringer i din adfærd.
English: Prior to initiation of interferon alfa-2b therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Danish: Inden initiering af interferon alfa-2b-behandling, skal TSHniveauet evalueres, og mulige thyroideaabnormaliteter detekteret på dette tidspunkt skal behandles med konventionel behandling.
English: If thyroid abnormalities are detected, the patient's thyroid status should be evaluated and treated as clinically appropriate.
Danish: Hvis thyroideaabnormaliteter detekteres, bør patientens thyroideastatus evalueres, og passende behandling initieres efter klnisk overvejelse.
English: In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µl.
Danish: Hos patienter, der er co-inficeret med HCV/hiv, er begrænsede effekt- og sikkerhedsdata (N = 25) tilgængelige i patienter med CD4-tællinger mindre end 200 celler/μl.
English: - azathioprine is a medicine that suppresses your immune system, using this medicine in combination with ribavirin and pegylated alpha interferons and, therefore may increase your risk of developing severe blood disorders.
Danish: Azathioprin er et lægemiddel, der dæmper immunforsvaret, og brug af dette lægemiddel i kombination med ribavirin og pegylerede alpha-interferoner kan derfor øge din risiko for at udvikle alvorlige blodsygdomme.
English: Ribavirin (800 mg/day)
Danish: ribavirin (800 mg)
English: Table 2 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration, cardiac status and indirect bilirubin concentration.
Danish: Tabel 2 giver retningslinjer for dosisændringer og seponering baseret på patientens hæmoglobinkoncentration, hjertestatus og indirekte bilirubinkoncentration.
English: Patients whose dose of Ribavirin Mylan 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 Ribavirin Mylan reduceres til 600 mg per dag, skal tage en kapsel à 200 mg om morgenen og to kapsler à 200 mg om aftenen.
English: Use in children and adolescents If the child is weighing less than 47 kg or unable to swallow an oral solution of Ribavirin is available.
Danish: Anvendelse hos børn og unge Hvis barnet vejer mindre end 47 kg eller er ude af stand til at sluge, findes en oral ribavirinopløsning.
English: You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour
Danish: Du kan overveje at bede et familiemedlem eller en nær ven om at hjælpe dig med at være opmærksom på tegn på depression eller ændringer i din adfærd
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: Based on results of clinical trials, the use of ribavirin as monotherapy is not effective and Ribavirin must not be used alone.
Danish: Anvendelse af ribavirin som monoterapi er ifølge resultater fra kliniske undersøgelser ikke effektivt, og ribavirin skal ikke anvendes alene.
English: If pregnancy does occur during treatment or within four months from stopping treatment, the patient must be advised of the significant teratogenic risk of ribavirin to the foetus (see section 4.4).
Danish: Hvis graviditet indtræder under behandlingen eller inden for 4 måneder efter endt behandling, skal patienten orienteres om den betydelige teratogene risiko, som ribavirin udgør for fostret (se pkt.
English: Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of ribavirin.
Danish: Derfor anbefales det, at nyrefunktionen vurderes hos alle patienter før påbegyndelse af behandling med ribavirin.
English: Ribavirin Mylan capsules are packaged in:
Danish: Ribavirin Mylan kapsler er pakket i:
English: • Increased hormone related to your thyroid (TSH) in children and adolescents
Danish: Øget hormonniveau i forbindelse med skjoldbruskkirtlen (TSH) hos børn og unge
English: In those patients that received >10.6 mg/kg ribavirin (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 Ribavirin (Table 7), while response rates in patients that received > 13.2 mg/kg ribavirin were even higher.
Danish: For de patienter, som fik > 10,6 mg/kg ribavirin (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 Ribavirin (Tabel 7), mens responsrater for patienter, der fik > 13,2 mg/kg ribavirin, var endnu højere.
English: The mean AUCtf was threefold greater in subjects with creatinine clearance between 10 and 30 mL/min compared with control subjects.
Danish: Den gennemsnitlige AUCtf var tre gange større hos patienter med kreatinin-clearance mellem 10 og 30 ml/min sammenlignet med kontrolpersonerne.
English: The combination of Ribavirin Mylan and other medicines is used to treat adult patients who have chronic hepatitis C (HCV).
Danish: Kombinationen af Ribavirin Mylan og andre lægemidler anvendes til behandling af voksne patienter, der har kronisk hepatitis C (HCV).
English: Interferon alfa-2b (pegylated and non-pegylated) therapy may be initiated if TSH levels can be maintained in the normal range by medication.
Danish: Interferon alfa-2b (pegyleret og ikke pegyleret) behandling kan initieres, hvis TSH-niveauet kan fastholdes indenfor normalområdet ved medicinsk behandling.
English: If you are not sure, talk to your doctor or pharmacist before taking Ribavirin Mylan.
Danish: Hvis du er i tvivl, skal du tale med din læge eller apoteker, før du tager Ribavirin Mylan.
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 ammede spædbørn, skal amningen ophøre, før behandlingsstart.
English: Reduce Ribavirin Mylan dose* if:
Danish: Reducer Ribavirin Mylan-dosis* hvis:
English: Reminder: This medicine is used in combination with interferon alfa-2b for hepatitis C virus infection.
Danish: Husk: Dette lægemiddel anvendes i kombination med interferon alfa-2b mod infektion med hepatitis
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: No pharmacokinetic interaction appears between ribavirin and hepatic function (see section 5.2).
Danish: Der sker ingen farmakokinetisk interaktion mellem ribavirin og leverfunktion (se pkt.
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: Adult patients with moderate renal impairment (creatinine clearance of 30-50 mL/minute) should be administered alternating daily doses of 200 mg and 400 mg.
Danish: Voksne patienter med moderat nedsat nyrefunktion (kreatinin-clearance på 30-50 ml/minut) skal administreres vekslende daglige doser på 200 mg og 400 mg.
English: Bottles:
Danish: Flaske:
English: Each Ribavirin Mylan hard capsule contains a small amount of lactose.
Danish: Hver Ribavirin Mylan kapsel indeholder en lille mængde lactose.
English: * For patients receiving a 1,000 mg (< 75 kg) or 1,200 mg (> 75 kg) dose, ribavirin 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, der modtager en dosis på 1.000 mg (< 75 kg) eller 1.200 mg (> 75 kg), skal ribavirindosen reduceres til 600 mg/dag (administreret som én 200 mg-kapsel om morgenen og to 200 mgkapsler om aftenen).
English: 56x1 hard capsules 84x1 hard capsules 112x1 hard capsules 140x1 hard capsules 168x1 hard capsules56 hard capsules 84 hard capsules
Danish: 56x1 hårde kapsler 84x1 hårde kapsler 112x1 hårde kapsler 140x1 hårde kapsler 168x1 hårde kapsler 56 hårde kapsler 84 hårde kapsler 112 hårde kapsler 140 hårde kapsler 168 hårde kapsler
English: Most of the changes in laboratory values in the ribavirin /peginterferon alfa-2b clinical trial were mild or moderate.
Danish: De fleste af ændringerne i laboratorieværdierne for de kliniske forsøg med ribavirin /peginterferon alfa-2b var milde eller moderate.
English: The following side effects have been reported with the combination of this medicine and an alpha interferon product in adults:
Danish: Følgende bivirkninger er registreret for kombinationen af dette lægemiddel med et alfa-interferonprodukt hos voksne:
English: Due to substantial increases in ribavirin plasma concentrations in patients with moderate and severe renal impairment, Ribavirin Mylan dose adjustments are recommended in adult patients with creatinine clearance < 50 mL/minute.
Danish: På grund af betydelige stigninger i ribavirinplasmakoncentrationer hos patienter med moderat til svært nedsat nyrefunktion anbefales Ribavirin Mylan-dosisjusteringer for voksne patienter med kreatinin-clearance < 50 ml/minut.
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 ALT.
English: Because of co-administration with interferon alfa-2b: - Autoimmune hepatitis; or history of autoimmune disease.
Danish: På grund af samtidig indgift af interferon alfa-2b: Autoimmun hepatitis eller tidligere autoimmun sygdom.
English: Among children and adolescents, treated with Ribavirin in combination with interferon alfa2b, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% versus 1%) during treatment and during the 6-month follow-up after treatment.
Danish: Blandt børn og unge, behandlet med ribavirin i kombination med interferon alfa-2b, blev selvmordstanker eller -forsøg rapporteret oftere end hos voksne patienter (2,4 % mod 1 %) i behandling og i løbet af de 6-måneders opfølgning efter behandling.
English: In the treatment phase of this study, the most prevalent adverse reactions in all subjects were pyrexia (80 %), headache (62 %), neutropenia (33 %), fatigue (30 %), anorexia (29 %) and injection-site erythema (29 %).
Danish: I behandlingsfasen af dette studie var den mest udbredte bivirkning hos alle forsøgspersonerne feber (80 %), hovedpine (62 %), neutropeni (33 %), træthed (30 %), anoreksi (29 %) og injektionskoncentration-site erytem (29 % ).
English: As in adult patients, children and adolescents experienced other psychiatric adverse reactions (e.g., depression, emotional lability, and somnolence).
Danish: Som hos voksne patienter oplevede børn og unge andre psykiatriske reaktioner (såsom depression, emotionel labilitet og døsighed).
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 ribavirin), and is 99 % (95 % CI: 98-100 %) for patients receiving pegylated interferon alfa-2b (with or without ribavirin).
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 ribavirin), og det er 99 % (95 % CI: 98-100 %) for patienter, der fik pegyleret interferon alfa-2b (med eller uden ribavirin).
English: Ribavirin Mylan contains lactose
Danish: Ribavirin Mylan indeholder lactose
English: The pharmacokinetics of ribavirin is altered in patients with renal dysfunction due to reduction of apparent clearance in these patients.
Danish: Farmakokinetikken for ribavirin er ændret hos patienter med nedsat nyrefunktion på grund af tilsyneladende reduktion af clearance hos disse patienter.
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 carcinogenicitetsundersøgelse med den heterozygote p53(+/-) musemodel og den maksimale tolererede dosis på 300 mg/kg (plasma ekspositionsfaktor cirka 2,5 sammenlignet med human eksponering).
English: Not known side effects (frequency cannot be estimated from the available data): thoughts about threatening the life of others, mania (excessive or unreasonable enthusiasm), pericarditis (inflammation of the lining of the heart), pericardial effusion [a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself, change in colour of the tongue.
Danish: Ukendte bivirkninger (frekvensen kan ikke estimeres ud fra de tilgængelige data): - tanker om at true andre på livet, - mani (unormalt stor eller unødvendig entusiasme), - perikarditis (betændelse i hjertesækken), perikardial effusion [en væskeansamling, der udvikles mellem perikardium (hjertesækken) og selve hjertet].
English: Genotype 2/3/4 (n = 26)
Danish: Genotype 1 (n=92) Genotype 2/3/4 (n=26)
English: Tabulated list of adverse reactions in paediatric population
Danish: Tabel over bivirkninger i pædiatrisk population
English: Table 15
Danish: Tabel 13.
English: Usual daily Ribavirin Mylan dose
Danish: Normal daglig Ribavirin Mylan dosis
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 ribavirin) and pegylated interferon alfa2b (with or without ribavirin), 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 ribavirin) og pegyleret interferon alfa-2b (med eller uden ribavirin).
English: GSP Proizvodi d.o.o Tel: +386 1 236 31 85
Danish: GSP Proizvodi d.o.o Tél: +386 1 236 31 85
English: At the peginterferon alfa-2b 1.5 µg/kg plus ribavirin 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 ribavirin 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: 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: During the course of interferon (standard and pegylated)/ribavirin therapy lasting up to 48 weeks in patients ages 3 through 17 years, weight loss and growth inhibition were common.
Danish: Under behandlingsforløbet med interferon (standard og pegyleret)/ribavirin i kombinationsterapi, der varede op til 48 uger hos patienter i alderen 3 til 17 år, var vægttab og væksthæmning almindeligt.