FrancophonIA/ELRC3.0 huggingface dataset:
English: There are several serious adverse reactions associated with the combination therapy of ribavirin with (peg)interferon alfa.
Danish: Der er flere alvorlige bivirkninger i forbindelse med kombinationsbehandling med ribavirin og (peg)interferon alfa.
English: Bitherapy with peginterferon alfa-2b or interferon alfa-2b The safety of ribavirin is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied ribavirin capsules in combination with interferon alfa-2b, two trials studied ribavirin capsules in combination with peginterferon alfa-2b.
Danish: Bioterapi med peginterferon alfa-2b eller interferon alfa-2b Sikkerheden ved ribavirin kapsler er vurderet på basis af data fra fire kliniske undersøgelser hos patienter uden tidligere eksponering for interferon (interferon-naive patienter): to undersøgelser vurderede ribavirin-kapsler i kombination med interferon alfa-2b, to undersøgelser vurderede ribavirin-kapsler i kombination med peginterferon alfa-2b.
English: Table 10 Predictive Value of In-Treatment Virologic Response while on peginterferon alfa-2b 1.5 µg/kg/ Ribavirin 800-1,400 mg Combination Therapy Negative
Danish: Table 10 Prædiktiv værdi af virologisk respons under behandling med peginterferon alfa-2b 1,5 µg/kg/ribavirin 800-1.400 mg kombinationsterapi Negativ
English: interferon alpha/ribavirin peginterferon alpha/ribavirin
Danish: Peginterferon alpha/ribavirin
English: • Genotypes Non-1: The decision to extend therapy to one year in patients with negative HCVRNA after six months of treatment should be based on other prognostic factors (e.g., age >40 years, male gender, bridging fibrosis).
Danish: • Andre genotyper end type 1: Beslutningen om at forlænge behandlingen til et år ved HCVRNA-negative patienter efter seks måneders behandling bør være baseret på andre prognostiske faktorer (f.eks. alder >40 år, mandligt køn, brodannende fibrose).
English: Ribavirin Mylan 200 mg hard capsules
Danish: Ribavirin Mylan 200 mg hårde kapsler
English: Ribavirin Mylan 200 mg hard capsules ribavirin
Danish: Ribavirin Mylan 200 mg hårde kapsler ribavirin
English: P 1.5/R P 0.5/R
Danish: P 0,5/R
English: Haematological abnormalities were more frequently reported in patients receiving ribavirin in combination with peginterferon alfa2b when compared to patients receiving ribavirin in combination with interferon alfa-2b.
Danish: Hæmatologiske unormaliteter blev rapporteret mere hyppigt hos patienter, der modtog ribavirin i kombination med peginterferon alfa-2b sammenlignet med patienter, der modtog ribavirin i kombination med interferon alfa-2b.
English: Ribavirin Mylan must not be used by females who are pregnant (see sections 4.3 and 5.3).
Danish: Ribavirin Mylan må ikke anvendes af gravide kvinder (se pkt.
English: Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV-RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received ribavirin 15 mg/kg per day plus interferon alfa-2b 3 MIU/m times a week for 1 year followed by 6 months follow-up after treatment.
Danish: Børn og unge i alderen 3 til 16 år med kompenseret kronisk hepatitis C og påviselig HCV RNA (målt hos et centralt laboratorium ved brug af en forskningsbaseret RT-PCR analyse) blev inkluderet i to multicenter undersøgelser og fik ribavirin 15 mg/kg per dag plus interferon alfa-2b 3 MIE/m tre gange om ugen i 1 år efterfulgt af 6 måneders opfølgning efter behandling.
English: Conventional carcinogenicity rodent studies with low exposures compared to human exposure under therapeutic conditions (factor 0.1 in rats and 1 in mice) did not reveal tumorigenicity of ribavirin.
Danish: Ribavirin blev ikke fundet tumorfremkaldende i konventionelle carcinogenicitetsundersøgelser på gnavere med lav eksposition sammenlignet med human eksponering under terapeutiske omstændigheder (faktor 0,1 i rotter og 1 i mus).
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
English: During combination therapy for up to 48 weeks with interferon alfa-2b and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients.
Danish: Under kombinationsbehandlingen i op til 48 uger med interferon alfa-2b og ribavirin, blev væksthæmning observeret, som medførte reduceret sluthøjde hos nogle patienter.
English: Endocrine disorders Common:
Danish: Det endokrine system Almindelig
English: The combination of Ribavirin Mylan with interferon alfa-2b is used in paedriatic patientes (children 3 years of age and older) who have chronic hepatitis C (HCV) infection.
Danish: Kombinationen af Ribavirin Mylan med interferon alfa-2b anvendes hos pædiatriske patienter (børn fra 3 år samt unge), der har kronisk hepatitis C-infektion (HCV).
English: Skin and subcutaneous tissue disorders Very common:
Danish: Hud og subkutane væv Meget almindelig
English: Ribavirin in combination with peginterferon alfa-2b Multiple-dose pharmacokinetic properties for ribavirin and peginterferon alfa-2b in children and adolescent patients with chronic hepatitis C have been evaluated during a clinical study.
Danish: Ribavirin i kombination med peginterferon alfa-2b Flerdosis farmakokinetiske egenskaber for ribavirin og peginterferon alfa-2b hos børn og unge patienter med kronisk hepatitis C er blevet evalueret i en klinisk undersøgelse.
English: - have any blood disorders, such as anaemia (low blood count), thalassemia, sickle-cell anaemia.
Danish: • har en eller anden form for blodsygdom, såsom blodmangel (lavt blodtal), thalassemia,
English: Reproductive system and breast disorders Common:
Danish: Det reproduktive system og mammae Almindelig
English: What Ribavirin Mylan contains
Danish: Ribavirin Mylan indeholder
English: Hypotension, hypertension, flushing
Danish: Hypotension, hypertension, rødme
English: Hypothyroidism, hyperthyroidism
Danish: Hypothyroidisme, hypertyroidisme
English: Please refer to the corresponding SmPC of medicinal products used in combination with ribavirin as some combination regimens do not adhere to the ribavirin dosing guidance provided in Table 1.
Danish: Se det tilsvarende produktresume for lægemidler, der anvendes i kombination med ribavirin, da visse kombinationsbehandlinger ikke overholder doseringsvejledningen for ribavirin i Tabel 1..
English: Do not store the bottles above 30°C.
Danish: Flasken må ikke opbevares ved temperaturer på over 30 °C.
English: Ribavirin in combination with peginterferon alfa-2b Children and adolescents 3 to 17 years of age with compensated chronic hepatitis C and detectable HCVRNA were enrolled in a multicentre trial and treated with ribavirin 15 mg/kg per day plus pegylated interferon alfa-2b 60 µg/m once weekly for 24 or 48 weeks, based on HCV genotype and baseline viral load.
Danish: Ribavirin i kombination med peginterferon alfa-2b Børn og unge i alderen 3 til 17 år med kompenseret kronisk hepatitis C og påviselig HCV-RNA blev indrulleret i et multicenter forsøg og behandlet med ribavirin 15 mg/kg per dag plus pegyleret interferon alfa-2b 60 μg/m én gang ugentligt i 24 eller 48 uger, baseret på HCV genotype og baseline viral load.
English: 4% (8/194) of patients and decrease in platelets below 50,000/mm was observed in 4% (8/194) of patients receiving ribavirin capsules in combination with peginterferon alfa-2b.
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 blev observeret i 4 % (8/194) af de patienter, der modtog ribavirin-kapsler i kombination med peginterferon alfa-2b.
English: Table 11 Sustained virological response based on genotype after ribavirin in combination with peginterferon alfa-2b in HCV/HIV co-infected patients Study 11
Danish: Tabel 11 Vedvarende virologisk respons baseret på genotype efter ribavirin i kombination med peginterferon alfa-2b hos patienter med samtidig infektion af HCV/hiv Undersøgelse 1
English: A large randomized trial compared the safety and efficacy of treatment for 48 weeks with two peginterferon alfa-2b/ ribavirin regimens [peginterferon alfa-2b 1.5 µg/kg and 1 µg/kg subcutaneously once weekly both in combination with ribavirin 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/ribavirin regimer [peginterferon alfa-2b 1,5 μg/kg og 1 μg/kg subkutant en gang ugentligt begge i kombination med ribavirin 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: Ribavirin has been shown in preclinical studies to be teratogenic and genotoxic see section 4.4 and 5.3).
Danish: Ribavirin har i prækliniske forsøg vist sig at være teratogent og genotoksisk (se pkt.
English: For use in patients with decompensated cirrhosis, see the corresponding SmPC of the medicinal products used in combination with Ribavirin Mylan.
Danish: Ved brug hos patienter med dekompenseret cirrose henvises der til det tilsvarende produktresume for de lægemidler, der anvendes i kombination med Ribavirin Mylan.
English: If you are a HCV/HIV co-infected adult patient receiving anti-HIV treatment, the addition of this medicine and peginterferon alfa may increase your risk of worsening liver function (combined antiretroviral therapy (cART)) and increase your risk of lactic acidosis, liver failure and blood abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets) (NRTI).
Danish: Hvis du er en HCV/HIV-co-inficeret voksen patient, der modtager anti-HIV-behandling, kan tilføjelsen af dette lægemiddel og peginterferon alfa øge din risiko for forværring af leverfunktionen (kombineret antiretroviral terapi (cART)) og øge risikoen for mælkesyreacidose, leversvigt og blodabnormiteter (nedgang i antallet af røde blodlegemer, som transporterer ilt, visse hvide blodlegemer, der bekæmper infektioner, og blodkoaguleringsceller kaldet blodplader) (NRTI).
English: Interferon alfa-2b: No pharmacokinetic interactions were noted between ribavirin and peginterferon alfa-2b or interferon alfa-2b in a multiple-dose pharmacokinetic study.
Danish: Interferon alfa-2b: Der sås ingen farmakokinetiske interaktioner mellem ribavirin og peginterferon alfa-2b eller interferon alfa-2b i en flerdosis farmakokinetisk undersøgelse.
English: The use of ribavirin in combination treatment with peginterferon alfa-2b or interferon alfa-2b was evaluated in a number of clinical trials.
Danish: Anvendelsen af ribavirin i kombinationsbehandling med peginterferon alfa-2b eller interferon alfa-2b blev vurderet i en række kliniske undersøgelser.
English: In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Ribavirin and peginterferon alfa-2b or interferon alfa-2b.
Danish: Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling med kombinationen af ribavirin og peginterferon alfa-2b eller interferon alfa-2b.
English: High-density polyethylene (HDPE) bottle, closed with a child-resistant (CR) polypropylene (PP) screw cap.
Danish: Flaske af højdensitetspolyethylen (HDPE), lukket med børnesikret polypropylenskruelåg.
English: Infections and infestations Very common:
Danish: Infektioner og parasitære sygdomme Meget almindelig
English: The mechanism by which ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b exerts its effects against HCV is unknown.
Danish: Mekanismen ved hvilken ribavirin i kombination med peginterferon alfa-2b eller interferon alfa-2b udøver sine virkninger mod HCV er ukendt.
English: Due to the lack of data in these two multicentre trials for children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Danish: Grundet manglende resultater, fra disse to multicenterforsøg med børn med alvorlig sygdomsprogression, samt muligheden for bivirkninger, bør forholdet mellem fordele og ulemper af kombinationen ribavirin og interferon alfa-2b overvejes nøje i denne population (se pkt.
English: An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with ribavirin used in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials, but values returned to baseline levels by four weeks after the end of therapy.
Danish: En stigning i urinsyre og indirekte bilirubin værdier forbundet med hæmolyse blev set hos nogle patienter behandlet med ribavirin anvendt i kombination med peginterferon alfa-2b eller interferon alfa-2b i kliniske undersøgelser, men værdierne vendte tilbage til baseline niveau fire uger efter afsluttet behandling.
English: Thyroid dysfunction during treatment with Ribavirin and interferon alfa-2b and during treatment with Ribavirin and peginterferon alfa-2b has been observed.
Danish: Thyroideadysfunktion har været observeret under behandling med ribavirin og interferon alfa-2b og under behandling med ribavirin og peginterferon alfa-2b.
English: Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and ribavirin when administered to paediatric patients with chronic hepatitis C Parameter
Danish: Tabel 15 Gennemsnitlige (% CV) flerdosis-farmakokinetiske parametre for interferon alfa-2b og ribavirin ved administration til pædiatriske patienter med kronisk hepatitis C
English: In clinical studies performed in this population ribavirin and interferon alfa-2b were used in doses of 15 mg/kg/day and 3 million international units (MIU)/m2 three times a week respectively (Table 1).
Danish: I kliniske studier af denne population blev der anvendt ribavirin og interferon alfa-2b i doser på henholdsvis 15 mg/kg/dag og 3 millioner internationale enheder (MIE)/m tre gange ugenligt
English: The combination of Ribavirin Mylan with interferon alfa-2b is used to treat adult patients with chronic hepatitis C, who have previously responded to treatment with an alpha interferon alone, but whose condition has recurred.
Danish: Ribavirin Mylan bruges i kombination med interferon alfa-2b til behandling af voksne patienter med kronisk hepatitis C, som tidligere har responderet på behandling med et alfa-interferon alene, men som har oplevet tilbagefald.
English: Endocrine disorders Very common:
Danish: Det endokrine system Meget almindelig
English: Psychiatric disorders Very common:
Danish: Psykiske forstyrrelser Meget almindelig
English: During combination therapy for up to 48 weeks with pegylated interferon alfa-2b and ribavirin, growth inhibition was observed that resulted in reduced height in some patients (see section 4.4).
Danish: Ved kombinationsbehandling i op til 48 uger med pegyleret interferon alfa-2b og ribavirin blev der observeret væksthæmning, som medførte reduceret højde hos nogle patienter (se pkt.
English: Patients were randomized to receive either ribavirin (800 mg/day) plus peginterferon alfa-2b (1.5 µg/kg/week) or ribavirin (800 mg/day) plus interferon alfa-2b (3 MIU TIW) for 48 weeks with a follow-up period of 6 months.
Danish: Patienterne blev randomiseret til enten at modtage ribavirin (800 mg/dag) plus peginterferon alfa-2b (1,5 μg/kg/uge) eller ribavirin (800 mg/dag) plus interferon alfa-2b (3-MIE TIW) i 48 uger med en opfølgningsperiode på 6 måneder.
English: A reduction in haemoglobin concentrations by > 4g/dL was observed in 30% of patients treated with ribavirin and peginterferon alfa-2b and 37% of patients treated with ribavirin and interferon alfa-2b.
Danish: En reduktion af hæmoglobinkoncentrationer på > 4 g/dl blev observeret hos 30 % af patienterne, der blev behandlet med ribavirin og peginterferon alfa-2b, og 37 % af patienterne, der blev behandlet med ribavirin og interferon alfa-2b.
English: Periodontal disorder, dental disorder, tongue pigmentation
Danish: Rodbetændelse, tandlidelse, pigmentering af tungen
English: Response week 12 was defined as undetectable HCVRNA after 12 weeks of treatment.
Danish: 12 ugers respons på behandlingen blev defineret som ikke-målbart HCV-RNA efter 12 ugers behandling.
English: 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: The safety and efficacy of this combination have been established only using ribavirin capsules together with peginterferon alfa-2b or interferon alfa-2b solution for injection.
Danish: Sikkerhed og effekt af denne kombination er udelukkende vist for ribavirin kapsler sammen med peginterferon alfa-2b eller interferon alfa-2b injektionsvæske, opløsning.
English: • Ribavirin (1,000/1,200 mg/day) + interferon alfa-2b (3 MIU three times a week) (n=505).
Danish: • ribavirin (1.000/1.200 mg/dag) + interferon alfa-2b (3 MIE tre gange om ugen) (n = 505).
English: Ribavirin Mylan hard capsules
Danish: Ribavirin Mylan hårde kapsler
English: There is no safety or efficacy information on the use of ribavirin with other forms of interferon (i.e., not alfa-2b).
Danish: Der foreligger ingen oplysninger om sikkerhed og effekt ved brug af ribavirin sammen med andre former for interferon (dvs. ikke-alfa-2b).
English: Patients with undetectable HCV-RNA at treatment week 12 and SVR upon retreatment
Danish: Patienter med ikke-målbart HCV-RNA efter 12 ugers behandling og SVR lige efter genbehandling
English: SVR* SVR in patients with undetectable HCV-RNA at treatment week 12
Danish: SVR SVR i patienter med ikke detekterbar HCV-RNA ved behandlingsuge
English: Other medicines and Ribavirin Mylan
Danish: Brug af anden medicin sammen med Ribavirin Mylan
English: Tabulated list of adverse reactions for adults
Danish: Tabel over bivirkninger for voksne
English: Discontinue Ribavirin Mylan if:
Danish: seponer Ribavirin Mylan, hvis:
English: Sustained virological response in previously untreated children and adolescents Ribavirin 15 mg/kg/day interferon alfa-2b 3 MIU/m2 3 times a week
Danish: Tabel 14 Vedvarende virologisk respons: Tidligere ubehandlede børn og unge ribavirin 15 mg/kg/dag interferon alfa-2b 3 MIE/m
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Danish: Lungebetændelse, ascaris, enterobiasis, herpes zoster, cellulitis Benigne, maligne og uspecificerede tumorer (inkl.
English: Reminder: Please read the “Warnings and precautions” section of the Package Leaflet for interferon alfa-2b before you begin combination treatment.
Danish: Husk: Læs afsnittet "Advarsler og forholdsregler" i indlægssedlen for interferon alfa-2b, før du påbegynder en kombinationsbehandling.
English: Dental and periodontal disorders: Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Ribavirin and peginterferon alfa-2b or interferon alfa-2b combination therapy.
Danish: Dentale og parodontale lidelser: Dentale og parodontale lidelser, som kan føre til tab af tænder, er blevet rapporteret hos patienter, der fik ribavirin og peginterferon alfa-2b eller interferon alfa-2b kombinationsbehandling.
English: Paediatric patients (children 3 years of age and older and adolescents): Ribavirin Mylan is indicated, in a combination regimen with interferon alfa-2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Danish: Pædiatriske patienter (børn i alderen 3 år eller ældre samt unge): Ribavirin Mylan er i et kombinationsregimen med interferon alfa-2b indiceret til behandling af børn på 3 år eller derover og unge, der har en hvilken som helst type kronisk hepatitis C, bortset fra genotype 1, uden leverdekompensation, og som er serum-HCV-RNA-positive.
English: Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence, disturbance in attention, poor quality of sleep
Danish: Hyperkinesi, tremor, dysfoni, paræstesi, hypoæstesi, hyperæstesi, nedsat koncentration, somnolens, opmærksomheds forstyrrelser, dårlig søvn kvalitet
English: Bitherapy with peginterferon alfa-2b or interferon alfa-2b:
Danish: Biterapi med peginterferon alfa-2b eller interferon alfa-2b:
English: What you need to know before you take Ribavirin Mylan
Danish: Det skal du vide, før du begynder at tage Ribavirin Mylan
English: The adverse reactions listed in this section are primarily derived from clinical trials and/or as adverse drug reactions from spontaneous reports when ribavirin was used in combination with interferon alfa2b or peginterferon alfa-2b.
Danish: De bivirkninger, der er nævnt i dette afsnit, er primært afledt af kliniske forsøg og/eller bivirkninger fra spontane indberetninger, når ribavirin anvendt i kombination med interferon alfa-2b eller peginterferon alfa-2b.
English: In a non-comparative trial, 235 patients with genotype 1 and low viral load (< 600,000 IU/ml) received peginterferon alfa-2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted ribavirin.
Danish: I et ikke-sammenlignende studie fik 235 patienter med genotype 1 og lav virusmængde (< 600.000 IE/ml) peginterferon alfa-2b 1,5 mikrogram/kg subkutant en gang ugentlig i kombination med vægtjusteret ribavirin.
English: The Ribavirin Mylan hard capsule is available in different pack sizes:
Danish: Ribavirin Mylan hårde kapsler fås i forskellige pakningsstørrelser.
English: Haematological abnormalities in HCV/HIV co-infected patients HCV/HIV co-infected patients receiving peginterferon alfa-2b/ribavirin treatment and cART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
Danish: Hæmatologiske unormaliteter hos patienter med samtidig HCV/hiv-infektion Patienter, der samtidig er inficeret med HCV/hiv og som modtager peginterferon alfa-2b/ribavirin behandling og cART kan have øget risiko for at udvikle hæmatologiske unormaliteter (som neutropeni, trombocytopeniog anæmi) sammenlignet med HCV mono-inficerede patienter.
English: Adult Patients (18 years of age or older): Ribavirin Mylan is indicated in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA (see section 4.4).
Danish: Voksne patienter (18 år eller ældre): Ribavirin Mylan er i kombination med interferon alfa-2b indiceret til behandling af voksne patienter med alle typer tidligere ubehandlet kronisk hepatitis C, bortset fra genotype 1, som ikke har leverdekompensation, men har forhøjet alaninaminotransferase (ALAT) og er serum-HCV-RNA-positive) (se pkt.