FrancophonIA/ELRC3.0 huggingface dataset:
English: Transfer into seminal fluid: Seminal transfer of ribavirin has been studied.
Danish: Overførsel til sædvæske: Der er foretaget undersøgelser af overførsel af ribavirin via sæd.
English: Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Danish: Tillæg af behandling med alfa-interferoner alene eller i kombination med ribavirin kan øge risikoen hos denne patientundergruppe.
English: For females of childbearing potential: Female patients must have a routine pregnancy test performed monthly during treatment and for four months thereafter.
Danish: For fertile kvinder: Kvindelige patienter skal have en rutine-graviditetstest udført hver måned under behandling og i fire måneder derefter.
English: Because of the potential for adverse reactions in breast-fed infants, breast-feeding must be discontinued prior to initiation of
Danish: Af hensyn til muligheden for bivirkninger hos de ammede børn, skal amning afbrydes før påbegyndelse af behandling.
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 maksimalt tolererede dosis på 300 mg/kg (plasma ekspositionsfaktor cirka 2,5 sammenlignet med human eksponering).
English: 462 patients and 327 patients, respectively.
Danish: Mindst 5 års langtidsopfølgning er fuldført efter behandling af henholdsvis 462 patienter og 327 patienter.
English: Multiple-dose pharmacokinetic properties for ribavirin and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 9.
Danish: Flerdosis farmakokinetiske egenskaber for ribavirin og interferon alfa-2b hos børn og unge med kronisk hepatitis C i alderen 5 til 16 år er opsummeret i Tabel 9.
English: Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
Danish: Patienter som udvikler leverdekompensation, bør have deres antihepatiske behandling seponeret øjeblikkeligt, og
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 98 % [95 % CI: 95 %, 100 %] for paediatric patients treated with interferon alfa-2b and ribavirin.
Danish: Kaplan-Meier estimatet for fortsat vedvarende respons i 5 år er 98 % [95 % CI: 95 %, 100 %] for pædiatriske patienter behandlet med interferon alfa-2b og ribavirin.
English: 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 ribavirininduceret testistoksicitet inden for en til to sædcelledannende cycli (se pkt.
English: If you are pregnant, you must not take Ribavirin BioPartners.
Danish: Hvis du er gravid, må du ikke tage Ribavirin BioPartners.
English: Reminder: Please read the “Do not use” section of the Package Leaflet for interferon alfa-2b before you begin combination treatment with Ribavirin BioPartners.
Danish: Læs afsnittet "Brug ikke" i Indlægssedlen for interferon alfa-2b, før du begynder kombinationsbehandling med Ribavirin BioPartners.
English: In clinical trials of 118 children and adolescents 3 to 16 years of age treated with combination therapy of interferon alfa-2b and ribavirin, 6 % discontinued therapy due to adverse reactions.
Danish: I kliniske undersøgelser med 118 børn og unge 3 til 16 år, behandlet i kombination med interferon alfa-2b og ribavirin afbrød 6 % behandling på grund af bivirkninger.
English: In clinical trials C95-132 and I95-143, ribavirin + interferon alfa-2b combination therapy proved to be significantly more effective than interferon alfa-2b monotherapy (a doubling in sustained response).
Danish: I kliniske undersøgelser C95-132 og I95-143 viste ribavirin + interferon alfa-2b kombinationsbehandling sig at være signifikant mere effektiv end interferon alfa-2b monoterapi (en fordobling i vedvarende respons).
English: The use of ribavirin is contraindicated in patients with severe hepatic impairment or decompensated cirrhosis (see section 4.3).
Danish: Anvendelse af ribavirin er kontraindiceret hos patienter med alvorlig nedsat leverfunktion eller ikke-kompenseret cirrhose (se pkt.
English: Decreases in haemoglobin, white blood cells, platelets, neutrophils and increase in bilirubin may require dose reduction or permanent discontinuation from therapy (see section 4.2).
Danish: Fald i hæmoglobin, hvide blodlegemer, blodplader, neutrophils og stigning i bilirubin kan påkræve en dosisreduktion eller permanent seponering af behandlingen (se pkt.
English: Discontinue breast-feeding before starting to take Ribavirin BioPartners.
Danish: Afbryd amning før du begynder at tage Ribavirin BioPartners.
English: Hypothyroidism, hyperthyroidism
Danish: Hypothyreoidisme, hyperthyreoidisme
English: This benefit was maintained irrespective of standard predictors of response to interferon alfa-2b such as virus level, HCV genotype
Danish: Den gavnlige effekt blev opretholdt uafhængigt af standardforudsigelser om respons på interferon alfa-2b såsom virusmængde, HCV-genotype og histologisk stadie.
English: Long-term efficacy data - Children and adolescents A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in two previously mentioned multicentre trials.
Danish: Et fem-års langvarigt observatorisk opfølgningsstudie indrullerede 97 pædiatriske kronisk hepatitis C patienter, efter behandling i to af de tidligere nævnte multicenterforsøg.
English: If you are self-administering treatment, or if you are the caregiver of a child taking Ribavirin BioPartners in combination with interferon alfa-2b, take/administer the missed dose as soon as possible during the same day.
Danish: Hvis du har glemt at tage Ribavirin BioPartners Hvis du selv administrerer din behandling, eller hvis du er omsorgsperson for et barn, der får ribavirin BioPartners i kombination med interferon alfa-2b, så tag/giv den glemte dosis så hurtigt som muligt samme dag.
English: In children and adolescent patients treated with Ribavirin BioPartners plus interferon alfa-2b, reduce ribavirin dose to 7.5 mg/kg/day.
Danish: Hos børn og unge patienter behandlet med Ribavirin BioPartners plus interferon alfa-2b, reducere ribavirin dosis til 7,5 mg/kg/dag.
English: Ribavirin plus interferon: When used in combination with peginterferon alfa-2b or interferon alfa-2b, ribavirin did not cause any effects not previously seen with either active substance alone.
Danish: Ribavirin og interferon: Ved anvendelse i kombination med peginterferon alfa-2b eller interferon alfa-2b forårsagede ribavirin ikke nogen virkninger, som ikke tidligere var set med hvert aktivt stof alene.
English: • tablet core: microcrystalline cellulose, crospovidone, povidone K25, silica colloidal, magnesium stearate
Danish: • tabletkerne; mikrokrystallinsk cellulose, crospovidon, povidon K25, silica kolloid,
English: Thrombocytopenia, lymphadenopathy
Danish: Thrombocytopeni, lymfadenopati
English: Cardiac status must be assessed before start of therapy and monitored clinically during therapy; if any deterioration occurs, therapy must be
Danish: Hjertestatus skal undersøges før behandlingsstart og overvåges klinisk under behandling; ved eventuel forringelse skal
English: Anaemia (haemoglobin < 9.4 g/dl) was reported in 12 % (23/194) of patients treated with ribavirin in combination with peginterferon alfa-2b.
Danish: Anæmi (hæmoglobin < 9,4 g/dl) blev rapporteret i 12 % (23/194) af patienterne, der blev behandlet med ribavirin i kombination med peginterferon alfa-2b.
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 2).
Danish: I kliniske undersøgelser udført i denne population, blev ribavirin og interferon alfa-2b benyttet i doser på henholdsvis 15 mg/kg/dag og 3 millioner internationale enheder (MIE)/m2 tre gange ugentligt (Tabel 2).
English: 5.2 Pharmacokinetic properties
Danish: 5.1 Farmakodynamiske egenskaber
English: In particular, decrease in mean height percentile at year 1 of long term follow-up was most prominent in prepubertal age children (see section 4.4).
Danish: Især fald i middeltophøjde percentil på 1. år langsigtet opfølgning var mest fremtrædende i før pubertal børn (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/m2 3 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 assay) blev inkluderet i to multicenter undersøgelser og fik ribavirin 15 mg/kg per dag plus interferon alfa-2b 3 MIE/m2 tre gange om ugen i 1 år efterfulgt af 6 måneders opfølgning efter behandling.
English: Laboratory values for HCV/HIV co-infected patients:
Danish: Laboratorieværdier for samtidig infektion med HCV/HIV:
English: 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 in combination with interferon alfa-2b, two trials studied ribavirin in combination with peginterferon alfa-2b.
Danish: Sikkerheden ved ribavirin er vurderet på basis af data fra fire kliniske undersøgelser hos patienter uden tidligere eksponering for interferon (interferon-naive patienter): to undersøgelser vurderede ribavirin i kombination med interferon alfa-2b, to undersøgelser vurderede ribavirin i kombination med
English: In HCV/HIV co-infected patients receiving HAART, the following other side effects have occurred with the combination of ribavirin and peginterferon alfa-2b (not listed above in adults side effects):
Danish: Hos HCV/HIV co-inficerede patienter, der fik HAART, er følgende andre bivirkninger opstået med kombinationen af ribavirin og peginterferon alfa-2b (ikke listet oven for for bivirkninger hos voksne):
English: - 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.
Danish: mani (unormalt stor eller unødvendig entusiasme), perikarditis (betændelse i hjertesækken), perikardial effusion [en væskeansamling, der udvikles mellem perikardium (hjertesækken) og selve hjertet].
English: In
Danish: Alle
English: Use in hepatic impairment: No pharmacokinetic interaction appears between ribavirin and hepatic function (see section 5.2).
Danish: Anvendelse ved nedsat leverfunktion: Der synes ikke at være farmakokinetisk interaktion mellem ribavirin og leverfunktionen (se pkt.
English: Patients with existence of or history of severe psychiatric conditions: If treatment with Ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Danish: Patienter med aktuelle eller tidligere alvorlige psykiatriske lidelser: Hvis behandling med Ribavirin i kombination med peginterferon alfa-2b eller interferon alfa-2b vurderes nødvendig hos voksne patienter med eksisterende eller tidligere alvorlige psykiatriske lidelser, bør denne kun initieres efter en passende individualiseret diagnostisk og terapeutisk håndtering af den psykiatriske lidelse er blevet sikret.
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 ribavirin, 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 ribavirin som kombinationsbehandling var dosis ændring nødvendig hos 25 % af patienterne, mest almindeligt for anæmi, neutropeni og vægttab.
English: Ribavirin therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Danish: Ribavirin-behandling må ikke initieres før et negativt resultat fra en graviditetstest er opnået umiddelbart før behandlingsstart.
English: Retreatment of relapse patients with ribavirin and interferon alfa-2b combination treatment Two trials examined the use of ribavirin 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 tilbagefaldspatienter med ribavirin og interferon alfa-2b-kombinationsbehandling To undersøgelser vurderede anvendelsen af ribavirin og interferon alfa-2b kombinationsbehandling hos tilbagefaldspatienter (C95-144 og I95-145); 345 patienter med kronisk hepatitis, som havde fået tilbagefald efter tidligere interferonbehandling, blev behandlet i seks måneder med en seks måneders opfølgning.
English: Ribavirin BioPartners is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b.
Danish: Ribavirin BioPartners er indiceret til behandling af infektion med kronisk hepatitis C-virus (HCV) hos voksne, børn i alderen 3 år og ældre og unge og skal udelukkende anvendes som en del af en kombinationsbehandling med interferon alfa-2b.
English: If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Ribavirin and peginterferon alfa-2b or interferon alfa-2b be discontinued, and the patient followed, with psychiatric intervention as
Danish: Hvis psykiatriske symptomer vedvarer eller forværres, eller selvmordstanker identificeres, anbefales det, at behandling med Ribavirin og peginterferon alfa-2b eller interferon alfa-2b afbrydes, og at patienten følges, og psykiatrisk intervention institueres
English: If severe adverse reactions or laboratory abnormalities develop during therapy with ribavirin and interferon alfa-2b, modify the dosages of each product if appropriate, until the adverse reactions abate.
Danish: Hvis der udvikles alvorlige bivirkninger eller unormale laboratorieværdier under behandling med ribavirin og interferon alfa-2b, justeres doserne af hvert lægemiddel efter behov, indtil bivirkningerne aftager.
English: Combination therapy with ribavirin and an alpha interferon should be discontinued in patients who develop new or worsening eye disorders.
Danish: Kombinationsbehandling med ribavirin og et alfa interferon skal stoppes hos patienter, som udvikler nye eller oplever forværring af øjensygdomme.
English: Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated-ribavirin for co-HCV infection (see section 4.4).
Danish: Mitokondriel toksicitet og mælkesyreacidose har været rapporteret hos HIV-positive patienter, der modtog NRTI-regimen og associeret ribavirin for samtidig HCV-infektion (se pkt.
English: - Genotoxicity: Ribavirin induces genotoxicity (see section 5.3).
Danish: Genotoksicitet: Ribavirin bevirker genotoksicitet (se pkt.
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).The study
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: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite Diabetes mellitus, hypertriglyceridemia*
Danish: Hyperglykæmi, hyperuricæmi, hypokalcæmi, dehydrering, øget appetit Diabetes mellitus, hypertriglyceridæmi٭
English: • have had severe liver problems, which are not related to hepatitis C. have suffered from any blood disorder, for example anaemia (low blood count), thalassemia or sickle-cell anaemia.
Danish: • har lidt af nogle former for blodsygdomme, for eksempel blodmangel (lavt blodtal), talassæmi eller seglcelleanæmi.
English: - Haemoglobinopathies (e.g., thalassemia, sickle-cell anaemia).
Danish: Hæmoglobinopatier (for eksempel thalassemia, seglcelleanæmi).
English: What Ribavirin BioPartners contains The active substance is ribavirin.
Danish: Ribavirin BioPartners indeholder det aktive stof ribavirin.
English: Do not take more than the recommended dosage and take the medicine for as long as prescribed.
Danish: Er du i tvivl, så spørg lægen eller på Lad være med at bruge mere end den anbefalede dosis, og tag medicinen i hele den ordinerede periode.
English: In clinical trials with ribavirin used in combination with peginterferon alfa-2b or interferon alfa-2b, the maximum overdose reported was a total dose of 10 g of ribavirin (50 x 200 mg) and 39 MIU of interferon alfa-2b (13 subcutaneous injections of 3 MIU each) taken in one day by a patient in an attempt at suicide.
Danish: I kliniske undersøgelser med ribavirin anvendt i kombination med peginterferon alfa-2b eller interferon alfa-2b var den højeste rapporterede overdosering en total dosis på 10 g ribavirin (50 x 200 mg) og 39 MIU interferon alfa-2b (13 subkutane injektioner med 3 MIU hver) anvendt på en dag af en patient i forsøg på selvmord.
English: Dosing for children and adolescent patients is determined by body weight for Ribavirin BioPartners and by body surface area for interferon alfa-2b.
Danish: Dosering til børn og unge patienter er baseret på patientens legemsvægt for Ribavirin BioPartners og for legemsoverflade areal for interferon alfa-2b.
English: Always take Ribavirin BioPartners exactly as your doctor has told you.
Danish: Brug altid Ribavirin BioPartners nøjagtigt efter lægens anvisning.
English: Female: amenorrhea, menorrhagia, menstrual disorder, vaginal disorder, Male: testicular pain
Danish: Kvinder: Amenorrhea, menorrhagi, menstruationsforstyrrelser, vaginallidelse, Mænd: testikulær smerte
English: Reminder: Ribavirin BioPartners is only to be used in combination with interferon alfa-2b for hepatitis C virus infection.
Danish: Bemærk: Ribavirin BioPartners er kun til anvendelse i kombination med interferon alfa-2b mod hepatitis C virus infektion.
English: Note 2: In adult patients and children and adolescent patients treated with Ribavirin BioPartners plus interferon alfa-2b, reduce the interferon alfa-2b dose by one-half dose.
Danish: Note 2: Hos voksne patienter og børn og unge patienter behandlet med Ribavirin BioPartners plus interferon alfa-2b, reducere interferon alfa-2b dosis med en halv dosis.
English: Ribavirin BioPartners film-coated tablets in combination with interferon alfa-2b:
Danish: Ribavirin BioPartners filmovertrukne tabletter i kombination med interferon alfa-2b:
English: If needed, 2nd dose reduction of Ribavirin BioPartners is by an additional 200 mg/day.
Danish: 2. dosisreduktion af Ribavirin BioPartners er med yderligere 200 mg/dag, hvis det er nødvendigt.
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-2b/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-2b/ribavirin-behandling.
English: Abdominal pain, abdominal pain upper, vomiting , diarrhoea,
Danish: Abdominal smerte, øvre abdominal smerte, opkastning,
English: Table 2 Ribavirin BioPartners dose based on body weight when used in combination with interferon alfa-2b in children and adolescents Patient weight (kg)
Danish: Tabel 2 Ribavirin BioPartners dosis baseret på legemsvægt i kombination med interferon alfa-2b hos børn og unge Patientvægt (kg)
English: Like all medicines, Ribavirin BioPartners used in combination with an alpha interferon product can cause side effects, although not everybody gets them.
Danish: Ribavirin BioPartners, der er anvendt i kombination med et alfa-interferonprodukt, kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Ribavirin BioPartners in combination with peginterferon alfa-2b or interferon alfa-2b may also cause: - dark, cloudy or abnormally coloured urine, - difficulty breathing, changes in the way your heart beats, chest pain, pain down left arm, jaw
Danish: Ribavirin BioPartners i kombination med peginterferon alfa-2b eller interferon alfa-2b kan også mørk, grumset eller unormalt farvet urin, vejrtrækningsproblemer, ændringer i den måde dit hjerte slår, brystsmerte, smerte i venstre tab af brugsevne, hængende eller tab af kraft i ansigtsmuskler, tab af følesans,
English: Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during ribavirin combination therapy with peginterferon alfa-2b or interferon alfa-2b, and even after treatment discontinuation mainly during the 6-month follow-up period.
Danish: Alvorlig CNS-påvirkning, særligt depression, selvmordstanker og selvmordsforsøg, er set hos nogle patienter under ribavirinkombinationsbehandling med peginterferon alfa-2b eller interferon alfa-2b, og selv efter behandlingsophør især under 6-måneders opfølgningsperioden.
English: Psychiatric and Central Nervous System:
Danish: Psykiske sygdomme og sygdomme i centralnervesystemet:
English: - It is important to consider that the combination therapy induced a growth inhibition, the
Danish: Det er vigtigt at betænke at kombinationsterapien inducerede væksthæmning, hvor reversibiliteten er uvis.
English: Use in renal impairment: The pharmacokinetics of ribavirin are altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients (see section 5.2).
Danish: Anvendelse ved nedsat nyrefunktion: Ribavirins farmakokinetik er ændret hos patienter med nedsat nyrefunktion på grund af nedsat kreatininclearance hos disse patienter (se pkt.
English: The pharmacokinetics of ribavirin and interferon alfa-2b (dose-normalized) are similar in adults and
Danish: Farmakokinetikken for ribavirin og interferon alfa-2b (dosis-normaliseret) er ens hos voksne og børn eller unge.
English: In addition, dry mouth that could have a damaging effect on teeth and membranes of the mouth has been reported during long-term treatment with ribavirin in combination therapy with an alpha interferon.
Danish: Ydermere er der blevet rapporteret om mundtørhed, der kan have en skadelig virkning på tænder og slimhinder i munden under langtidsbehandling med ribavirin i kombination med et alfa interferon.
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 BioPartners i kombination med enten peginterferon alfa-2b eller interferon alfa-2b, voksede nogle børn og unge ikke eller tog ikke den vægt på som var forventet.