FrancophonIA/ELRC3.0 huggingface dataset:
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: 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 hos rotter og 1 hos mus).
English: p value b
Danish: p-værdib
English: Uncommonly reported side effects: - hearing or seeing images that are not present, - heart attack, panic attack, - hypersensitivity reaction to the medication, - inflammation of pancreas, pain in bone, diabetes mellitus,
Danish: Ikke almindelige rapporterede bivirkninger: at høre eller se billeder, der ikke er til stede, hjerteanfald, panikanfald, overfølsomhedsreaktion over for medicinen, betændelse i bugspytkirtlen, knoglesmerte, diabetes mellitus (sukkersyge),
English: Because of co-administration with peginterferon alfa-2b or interferon alfa-2b: - Autoimmune hepatitis; or history of autoimmune disease.
Danish: På grund af samtidig indgift af peginterferon alfa-2b eller interferon alfa-2b: Autoimmun hepatitis eller tidligere autoimmun sygdom.
English: Adverse Reactions
Danish: Histologisk respons
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: Some data suggest that HIV/HCV co-infected patients receiving abacavir-containing ART may be at risk of a lower response rate to pegylated interferon/ribavirin therapy.
Danish: Nogle data tyder på, at hiv/HCV-co-inficerede patienter, der får abacavir-holdig ARbehandling, kan være i risiko for respondere dårligere på pegyleret interferon/ribavirin-behandling.
English: - Initiation of peginterferon alfa-2b is contraindicated in HCV/HIV patients with cirrhosis and a
Danish: Initiering af peginterferon alfa-2b er kontraindiceret i HCV/HIV patienter med cirrhose og en Child-Pugh score ≥ 6.
English: Ribavirin BioPartners must be used in combination with interferon alfa-2b.
Danish: Ribavirin BioPartners skal bruges i kombination med interferon alfa-2b.
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 modtager både antiretroviral (ARV) og antihepatisk behandling, bør monitoreres tæt.
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-2bkombinationsbehandling.
English: NAME OF THE MEDICINAL PRODUCT Ribavirin BioPartners 200 mg
Danish: LÆGEMIDLETS NAVN Ribavirin BioPartners 200 mg
English: Both female and male patients must take special precautions in their sexual activity if there is any
Danish: Både kvindelige og mandlige patienter skal tage særlige forholdsregler under deres seksuelle aktivitet, hvis der er nogen risiko for at en graviditet kan forekomme: - Piger eller kvinder i den fødedygtige alder:
English: P1.5/R Ribavirin (800 mg) + peginterferon alfa-2b (1.5 micrograms/kg) P0.5/R Ribavirin (1,000/1,200 mg) + peginterferon alfa-2b (1.5 to 0.5 microgram/kg) I/R Ribavirin (1,000/1,200 mg) + interferon alfa-2b (3 MIU)
Danish: P1,5/R Ribavirin (800 mg) + peginterferon alfa-2b (1,5 mikrogram/kg) P0,5/R Ribavirin (1.000/1.200 mg) + peginterferon alfa-2b (1,5 til 0,5 mikrogram/kg) I/R Ribavirin (1.000/1.200 mg) + interferon alfa-2b (3 MIE)
English: Hepatic decompensation in HCV/HIV co-infected patients with advanced cirrhosis: Co-infected patients with advanced cirrhosis receiving highly active anti-retroviral therapy (HAART) may be at increased risk of hepatic decompensation and death.
Danish: Hepatisk dekompensering hos patienter med samtidig HCV/HIV-infektion med fremskreden cirrose: Patienter med samtidig HCV/HIV-infektion og fremskreden cirrose, som modtager højaktiv antiretroviral behandling (HAART), kan have en øget risiko for leverdekompensation og død.
English: 2 tablets in the morning and 2 tablets in the evening see adult dose and corresponding number of film-coated tablets
Danish: Antal af 200 mg tabletter 1 tablet om morgenen og 2 tabletter om aftenen 2 tabletter om morgenen og 2 tabletter om aftenen se voksen dosis og tilsvarende antal af filmovertrukne tabletter
English: Ribavirin BioPartners 200 mg film-coated tablets ribavirin
Danish: Ribavirin BioPartners 200 mg filmovertrukne tabletter ribavirin
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 (see sections 4.8 and 5.1).
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 (se pkt.
English: If you are a woman who is breast-feeding, you must not take Ribavirin BioPartners.
Danish: Hvis de er kvinde og ammer, må du ikke tage Ribavirin BioPartners.
English: Neoplasm unspecified Blood and lymphatic system disorders Very common:
Danish: Blod og lymfesystem Meget almindelig:
English: Thyroid dysfunction during treatment with ribavirin and interferon alfa-2b and during treatment with ribavirin and peginterferon alfa-2b has been observed.
Danish: Thyreoideadysfunktion under behandling med ribavirin og interferon alfa-2b og under behandling med ribavirin og peginterferon alfa-2b har været observeret.
English: ** Refer to the SPC for interferon alfa-2b for dose modification and discontinuation.
Danish: * Øvre grænse for normalområdet ** Se SPC for interferon alfa-2b for dosismodifikation og seponering.
English: Table 7 Sustained virological response based on genotype after ribavirin in combination with peginterferon alfa-2b in HCV/HIV co-infected patients
Danish: Tabel 7 Vedvarende virologisk respons baseret på genotype efter ribavirin i kombination med peginterferon alfa-2b hos patienter med samtidig infektion af HCV/HIV Undersøgelse 22
English: Therefore the use of zidovudine and ribavirin in combination with alpha
Danish: Derfor kan brugen af zidovudin og ribavirin i kombination med alfa interferoner ikke
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 MIU TIW) i 48 uger med en opfølgningsperiode på 6 måneder.
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: 4.3 Contraindications
Danish: 6.2 Uforligeligheder
English: During combination therapy for up to 48 weeks with interferon alfa-2b and ribavirin, growth inhibition is observed, the reversibility of which is uncertain.
Danish: Under kombinationsbehandlingen i op til 48 uger med interferon alfa-2b og ribavirin, blev væksthæmning observeret; reversibiliteten er uvis.
English: Patients with preexisting ophthalmologic disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic ophthalmologic exams during combination therapy with alpha interferons.
Danish: Patienter med allerede eksisterende øjensygdomme (f.eks. diabetisk eller hypertensiv retinopati) bør få foretaget regelmæssige øjenundersøgelser, hvis de er i kombinationsbehandling med alfa-interferoner.
English: Children 3 years of age and older and adolescents: Ribavirin BioPartners is intended for use, in a combination regimen with interferon alfa-2b, for the treatment of children 3 years of age and older and adolescents, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA.
Danish: Børn i alderen 3 år eller ældre samt unge: Ribavirin BioPartners er beregnet til brug i kombination med interferon alfa-2b, til behandling af børn i alderen 3 år eller ældre og unge, som lider af alle typer tidligere ubehandlet kronisk hepatitis C, undtagen genotype 1, uden leverdekompensation, og som er positive med hensyn til HCV-RNA.
English: A reduction in haemoglobin concentrations by > 4 g/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: Et fald i hæmoglobinkoncentration på > 4 g/dl blev set hos 30 % af patienter behandlet med ribavirin og peginterferon alfa-2b og 37 % af patienter behandlet med ribavirin og interferon alfa-2b.
English: Adding treatment with an alpha interferon alone or in combination with ribavirin may increase the risk in this patient subset.
Danish: Tilføjelse af behandling med en alfa interferon alene eller i kombination med ribavirin kan øge risikoen i denne
English: Cerebrovascular haemorrhage*, cerebrovascular ischaemia*, encephalopathy*, polyneuropathy*
Danish: Cerebrovaskulær blødning٭, cerebrovaskulær iskæmi ٭ encefalopati٭, polyneuropati٭ Ansigtslammelse, mononeuropati
English: Seek medical advice immediately if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while taking this treatment.
Danish: Vær ekstra forsigtig med at tage Ribavirin BioPartners Søg omgående medicinsk rådgivning, hvis du udvikler symptomer på en svær allergisk reaktion (såsom vanskeligheder med at trække vejret, hvæsen eller nældefeber) under denne behandling.
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 bilirubinværdier 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 baselineniveau fire uger efter afsluttet behandling.
English: The use of Ribavirin and interferon alfa-2b or peginterferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated
Danish: Brug af Ribavirin og interferon alfa-2b eller peginterferon alfa-2b hos børn og unge med aktuelle eller tidligere alvorlige psykiatriske lidelser er kontraindiceret (se pkt.
English: For complete information be sure to read the “How to use” section of the Package Leaflet for interferon alfa-2b.
Danish: For fuldstændig information læs afsnittet ”Sådan skal du tage” i indlægssedlen for interferon alfa-2b.
English: Female: amenorrhea, menorrhagia, menstrual disorder, dysmenorrhea, breast pain, ovarian disorder, vaginal disorder.
Danish: Kvinder: Amenorrhea, menorrhagi, menstruationsforstyrrelser, dysmenorrhea, brystsmerte, ovarielidelse, vaginallidelse.
English: What Ribavirin BioPartners looks like and contents of the pack Ribavirin BioPartners is a round, white film coated-tablet, rounded on the upper and lower side.
Danish: Ribavirin BioPartners er en rund, hvid, filmovertrukket tablet, afrundet på over- og undersiden.
English: Reported adverse reactions listed in Table 5 are based on experience from the two multicentre children and adolescents clinical trials using ribavirin with interferon alfa-2b or peginterferon alfa-2b.
Danish: Rapporterede bivirkninger i Tabel 5 er baseret på erfaring fra to multicenter kliniske undersøgelser med børn og unge i behandling med ribavirin med interferon alfa-2b eller peginterferon alfa-2b.
English: a: p value based on Cochran-Mantel Haenszel Chi square test. b: p value based on chi-square test. c: subjects < 75 kg received 100 μg/week peginterferon alfa-2b and subjects ≥ 75 kg received 150 μg/week peginterferon d: Ribavirin dosing was 800 mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Danish: a: p-værdi baseret på Cochran-Mantel Haenszel Chi square test. b: p-værdi baseret på chi-square test. c: forsøgspersoner < 75 kg fik 100 µg/uge peginterferon alfa-2b og forsøgspersoner ≥ 75 kg fik 150 µg/uge peginterferon alfa-2b.
English: Adult patients: Ribavirin BioPartners 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 hepatitis C viral ribonucleic acid HCV-RNA (see section 4.4).
Danish: Voksne patienter: Ribavirin BioPartners er indiceret i kombination med interferon alfa-2b til behandling af voksne patienter med alle typer tidligere ubehandlet kronisk hepatitis C, undtagen genotype 1, uden leverdekompensation, med forhøjet alaninaminotransferase (ALAT) og som er positive med hensyn til hepatitis C viral ribonukleinsyre HCV-RNA (se pkt.
English: Palpitation, tachycardia
Danish: Hjertebanken, takykardi
English: Cardiomyopathy, arrhythmia* Pericardial effusion*, pericarditis* Hypotension, hypertension, flushing
Danish: Perikardial effusion*, perikarditis* Hypotension, hypertension, synkope, rødme
English: Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Ribavirin
Danish: For de antiretrovirale lægemidler, der skal tages samtidig med HCV-behandling, henvises der til disses respektive produktresuméer for kendskab og håndtering af toksiciteter, der er specifikke for det enkelte produkt samt potentialet for overlappende toksiciteter med ribavirin i kombination med
English: SVR after treatment of chronic HCV with interferon alfa-2b (pegylated and non-pegylated, with or without ribavirin) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical 'cure' from chronic HCV.
Danish: SVR efter behandling af kronisk HCV med interferon alfa-2b (pegyleret eller non-pegyleret, med eller uden ribavirin) resulterer i langtidsclearance af virus, hvilket medfører resolution af den hepatiske infektion og klinisk 'helbredelse' af kronisk HCV.
English: If you are a HCV/HIV co-infected adult patient receiving anti-HIV treatment, the addition of Ribavirin BioPartners and peginterferon alfa-2b may increase your risk of worsening liver function highly active anti-retroviral therapy (HAART) 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 får anti-HIV behandling, kan tilføjelsen af Ribavirin BioPartners og peginterferon alfa-2b forøge din risiko for forværring af leverfunktionen, højaktiv antiretroviral behandling (HAART) og øge risikoen for mælkesyreacidose, leversvigt og udvikling af uregelmæssigheder i blodet (reduktion i antallet af røde blodlegemer, som transporterer oxygen, hvide blodlegemer, der bekæmper infektion, og blodstørkningsceller kaldet blodplader)
English: Please read the “Possible side effects” section of the Package Leaflet for interferon alfa-2b.
Danish: Læs afsnittet “Bivirkninger” i Indlægssedlen for interferon alfa-2b.
English: While changes in laboratory values were observed in some patients treated with ribavirin used in combination with peginterferon alfa-2b in the clinical trial, values returned to baseline levels within a
Danish: Selv om der blev observeret ændringer i laboratorieværdier hos nogle patienter behandlet med ribavirin anvendt i kombination med peginterferon alfa-2b i kliniske forsøg, vendte værdierne tilbage til baseline niveau inden for et par uger efter afslutningen af behandlingen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each Ribavirin BioPartners film-coated tablet contains 200 mg of ribavirin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver Ribavirin BioPartners filmovertrukne tablet indeholder 200 mg ribavirin Alle hjælpestoffer er anført under pkt.
English: During combination therapy for up to 48 weeks with pegylated interferon alfa-2b and ribavirin, growth inhibition is observed, the reversibility of which is uncertain (see section 4.4).
Danish: I kombination behandling i op til 48 uger med pegyleret interferon alfa-2b og ribavirin, væksthæmning er observeret, reversibiliteten er uvis (se pkt.
English: Chest discomfort, facial pain, injection site induration
Danish: Bryst ubehag, ansigtssmerte, injektionssteds induration
English: Patients were randomized to receive either ribavirin (800-1,200 mg/day based on weight) plus peginterferon alfa-2b (100 or 150 μg/week based on weight) or ribavirin (800-1,200 mg/day based on weight) plus interferon alfa-2b (3 MIU TIW).
Danish: Patienterne blev randomiseret til enten at modtage ribavirin (800-1.200 mg/dag baseret på vægt) plus peginterferon alfa-2b (100 eller 150 µg/uge baseret på vægt) eller ribavirin (800-1.200 mg/dag baseret på vægt) plus interferon alfa-2b (3 MIU TIW).
English: Ribavirin, 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 6methylthioinosinmonofosfat (6-MTIMP), som har været forbundet med myelotoksicitet hos patienter, som behandles med azathioprin.
English: Dose to be administered for the combination therapy with interferon alfa-2b:
Danish: Dosis der skal administreres ved kombinationsterapi med interferon alfa-2b:
English: Also, refer to peginterferon alfa-2b and interferon alfa-2b SPCs for adverse reactions that may be attributable to interferons monotherapy.
Danish: Desuden refererer SPC'et for peginterferon alfa-2b og interferon alfa-2b til bivirkninger, der kan tilskrives interferonmonoterapi.
English: Creatinine
Danish: Hypothyreoidisme
English: 4.7 Effects on ability to drive and use machines Ribavirin has no or negligible influence on the ability to drive and use machines; however, peginterferon alfa-2b or interferon alfa-2b used in combination may have an effect.
Danish: Ribavirin har ingen eller ubetydelig indflydelse på evnen til at føre bil og betjene maskiner; peginterferon alfa-2b eller interferon alfa-2b anvendt i kombination kan imidlertid have en virkning.
English: Pulmonary infiltrates*, pneumonitis*, interstitial
Danish: Lungeinfiltration٭, pneumoni٭, interstitial pneumonitis٭
English: Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal
Danish: Børn og unge: Eksisterende eller tidligere alvorlig psykiatrisk lidelse, især alvorlig depression,
English: Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm3 was observed in 4 % (8/194) of patients and decrease in platelets below 50,000/mm3 was observed in 4 %
Danish: 5.1) blev fald i niveau af absolut neutrofiltælling under 500 celler/mm3 observeret hos 4 % (8/194) af patienterne, og fald i blodplader under 50.000/mm3 blev observeret hos 4 % (8/194) af de patienter, der modtog ribavirin i kombination med peginterferon alfa-2b.
English: There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e.,
Danish: Der er ingen oplysninger om sikkerhed eller effekt ved anvendelse af ribavirin med andre former for
English: - dark or bloody stools, intense abdominal pain - sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin
Danish: mørk eller blodig afføring, intense mavesmerter, sarcoidose (en sygdom karakteriseret ved længerevarende feber, vægttab, ledsmerte ogopsvulmen, hudskader og hævede kirtler),
English: Please refer to the respective Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with ribavirin in combination with peginterferon alfa-2b.
Danish: For de antiretrovirale lægemidler, der skal tages samtidig med HCV-behandling, henvises der til disses respektive produktresuméer for kendskab til og håndtering af toksiciteter, der er specifikke for det enkelte produkt samt potentialet for overlappende toksiciteter med Ribavirin BioPartners og peginterferon alfa-2b.
English: The safety and efficacy of this combination have been established only using ribavirin together with peginterferon alfa-2b or interferon alfa-2b solution for injection.
Danish: Sikkerhed og virkning af denne kombination er udelukkende vist for ribavirin sammen med peginterferon alfa-2b eller interferon alfa-2b-injektionsvæske,
English: The combination of Ribavirin BioPartners with interferon alfa-2b is used to treat adult patients with chronic hepatitis C, who have previously responded to a treatment with an alpha interferon alone, but
Danish: Kombinationen af Ribavirin BioPartners med interferon alfa-2b anvendes til at behandle voksne patienter med kronisk hepatitis C, som tidligere har responderet på behandling med et alfa interferon alene, men hvor sygdommen er vendt tilbage.
English: Combination therapy with alpha interferons should be discontinued in patients who develop new or
Danish: Kombinationsbehandling med alfa-interferoner skal ophøre hos patienter, der udvikler ny eller forværring af øjensygdom.
English: or have had thoughts of suicide or have attempted suicide, or have a history of substance
Danish: bevidstløshed, eller har haft selvmordstanker eller har forsøgt selvmord , eller tidligere har haft et misbrug (eksempelvis af alkohol eller stoffer).
English: Patients co-infected with HCV/HIV: Patients taking nucleoside reverse transcriptase inhibitor (NRTI) treatment in association with ribavirin and interferon alfa-2b may be at increased risk of mitochondrial toxicity, lactic acidosis and hepatic decompensation (see section 4.4).
Danish: Patienter med samtidig HCV/HIV-infektion: Patienter som får behandling med nukleosid revers transcriptase-hæmmer (NRTI) i kombination med ribavirin og interferon alfa-2b kan have øget risiko for mitokondrietoksicitet, lactacidose og nedsat leverfunktion (se pkt.