FrancophonIA/ELRC3.0 huggingface dataset:
English: During those clinical trials in which patients were treated for one year, patients who failed to show a virological response after six months of treatment (HCV-RNA below lower limit of detection) were unlikely to become sustained virological responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
Danish: I disse kliniske undersøgelser, i hvilke patienter blev behandlet i et år, var det usandsynligt, at patienter, der ikke viste et virologisk respons efter seks måneders behandling (HCV-RNA under laveste detektionsgrænse), fik vedvarende virologisk respons (HCV-RNA under laveste detektionsgrænse seks måneder efter afbrudt behandling).
English: In addition, injection site disorders, pyrexia, anorexia, vomiting and emotional lability occurred more frequently in children and adolescents compared to adult patients.
Danish: Derudover forekom lidelser på injektionsstedet, pyreksi, anoreksi, opkastning og emotionel labilitet hyppigere hos børn og unge sammenlignet med voksne patienter.
English: 4 tablets b Refer to adult dosing table (Table 1)
Danish: 4 tabletter b Se venligst doseringstabel for voksne (Tabel 1)
English: Children and adolescents weighing less than 47 kg: The use of Ribavirin BioPartners tablets is not recommended.
Danish: Børn og unge, der vejer mindre end 47 kg Brugen af Ribavirin BioPartners tabletter anbefales ikke.
English: Ribavirin does not inhibit cytochrome P450 enzymes.
Danish: Ribavirin hæmmer ikke cytokrom P450-enzymer.
English: Thus, patients who develop fatigue, somnolence, or confusion during treatment must be cautioned to avoid driving or
Danish: Patienter, der udvikler træthed, søvnighed eller forvirring under behandling, skal således advares mod
English: Discontinue treatment in patients who develop prolongation of coagulation markers which might indicate liver decompensation.
Danish: Afbryd behandling hos patienter, der udvikler forlængede koagulationsmarkører, hvilket kan være tegn på leverdekomposition.
English: Number of 200 mg tablets
Danish: Antal af 200 mg tabletter
English: Breast-feeding: It is not known whether ribavirin is excreted in human milk.
Danish: Amning: Det er uvist, om ribavirin udskilles i humanmælk.
English: • tablet coating: hypromellose, macrogol, titanium dioxide.
Danish: • filmovertræk: hypromellose, macrogol, titandioxid.
English: Round, white, biconvex film-coated tablet.
Danish: Rund, hvid, bikonveks filmovertrukket tablet.
English: • have ever had depression or develop symptoms associated with depression (e.g. feeling of sadness, dejection, etc.) while on treatment with Ribavirin.
Danish: • har haft en depression eller udvikler symptomer forbundet med depression (dvs. følelse af tristhed, modløshed eller andet) under behandling med Ribavirin.
English: Twenty (21 %) of 97 children had a > 15 percentile decrease in height percentile, of whom 10 of the 20 children had a > 30 percentile decrease in their height percentile from the start of treatment to the end of long-term follow-up (up to 5 years).
Danish: Tyve (21 %) af 97 børn havde en > 15 percentilreduktion i deres højdepercentil, hvoraf 10 af de 20 børn havde en > 30 percentilreduktion i deres højdepercentil fra starten af behandlingen til slutningen af langtidsopfølgningen (op til 5 år).
English: Plasma concentrations achieved in rat pups were below human plasma concentrations at the therapeutic dose.
Danish: Opnåede plasmakoncentrationer hos rotteunger var under humane plasmakoncentrationer ved den terapeutiske
English: Among those patients with elevated uric acid levels, very few patients treated with the combination developed clinical gout, none of which required treatment modification or discontinuation from the clinical trials.
Danish: Blandt disse patienter med forhøjede urinsyreværdier udviklede meget få patienter behandlet med kombinationen klinisk urinsyregigt, men ingen af dem krævede behandlingsjustering eller afbrydelse fra de kliniske undersøgelser.
English: You must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Danish: Du skal have en negativ graviditetstest før behandlingen, hver måned i løbet af behandlingen, og i 4 måneder, efter behandlingen er stoppet.
English: Results of in vitro studies using both human and rat liver microsome preparations indicated no cytochrome P450 enzyme mediated metabolism of ribavirin.
Danish: Resultater af in vitro-undersøgelser med både humane og rotte-levermikrosompræparater viste ingen cytokrom P450-enzymmedieret metabolisme af ribavirin.
English: • are a male and your female partner is of childbearing age (see section “Pregnancy and
Danish: • er en mand, og din kvindelige partner er i den fødedygtige alder (se afsnittet ”Graviditet og
English: Some people get depressed when taking ribavirin in combination treatment with an interferon, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others).
Danish: Nogle mennesker bliver deprimerede, når de anvender Ribavirin BioPartners i kombinationsbehandling med et interferon, og i nogle tilfælde har personer haft tanker om at true andre på livet, selvmordstanker eller aggressiv opførsel (sommetider rettet mod andre).
English: Cardiovascular: Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders must be closely monitored.
Danish: Kardiovaskulært: Voksne patienter med tidligere hjertesvigt, myokardieinfarkt og/eller tidligere eller eksisterende arytmisygdomme skal følges tæt.
English: Table 3 Dosage modification guidelines based on laboratory parameters Reduce only interferon alfa-2b dose (see note 2) if:
Danish: Tabel 3 Vejledning til justering af dosis baseret på laboratorieparameter Reducer kun interferon alfa-2b-dosis (se note 2) hvis:
English: Patients with creatinine clearance < 50 ml/minute must not be treated with ribavirin (see section 4.3).
Danish: Patienter med kreatininclearance < 50 ml/minut må ikke behandles med ribavirin (se pkt.
English: Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin
Danish: Mænd, hvis partnere er gravide, skal underrettes om at anvende kondom for at mindske overførsel af ribavirin til partneren.
English: • are pregnant or planning to become pregnant (see section “Pregnancy and breast-feeding”).
Danish: • er gravid eller planlægger at blive gravid (se afsnittet ”Graviditet og amning”).
English: Male: impotence, prostatitis, erectile dysfunction, Sexual dysfunction (not specified)*
Danish: Mænd: Impotens, prostatitis, erektil dysfunktion, Seksuel dysfunktion (ikke specificeret)٭
English: • Genotype 1: Treatment should be continued for another six month period (i.e., a total of one year) in patients who exhibit negative HCV-RNA after six months of treatment.
Danish: • Genotype 1: Behandling bør fortsættes i en periode på yderligere seks måneder (svarende til i alt et år) hos patienter, som udviser negativ HCV-RNA efter seks måneders
English: - Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis (see section 5.3).
Danish: Fertilitet: I dyrestudier gav ribavirin reversible virkninger på spermatogenese (se pkt.
English: < 50 x 109/l (adults) < 70 x 109/l (children and adolescents)
Danish: < 50 x 109/l (voksne) < 70 x 109/l (børn og unge)
English: Note 1: In adult patients, 1st dose reduction of Ribavirin BioPartners is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day).
Danish: Note 1: Hos voksne patienter, 1. dosisreduktion af Ribavirin BioPartners er med 200 mg/dag (undtagen hos patienter, der fik 1.400 mg, her bør dosis nedsættes med 400 mg/dag).
English: • are allergic (hypersensitive) to ribavirin or any of the other ingredients of Ribavirin BioPartners
Danish: • er overfølsom (allergisk) over for ribavirin eller et af de øvrige indholdsstoffer i Ribavirin
English: Based on interim data from the long-term follow-up portion of this study, 22 % (16/74) of children had a > 15 percentile decrease in height percentile, of whom 3 (4 %) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
Danish: Baseret på foreløbige data fra en langsigtet opfølgning del af dette studie, 22 % (16/74) af børnene havde en > 15 procentreduktion i højdepercentil, hvoraf 3 (4 %) børn havde en > 30 procentreduktion selvom de ikke havde været i behandling i mere end 1 år.
English: Both ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are also excreted
Danish: Både ribavirin og dets triazolcarboxamid- og triazolcarboxylsyremetabolitter udskilles renalt.
English: The regimen administered should be selected based on the anticipated efficacy and safety of the combination treatment for an individual patient (see section 5.1).
Danish: Den givne behandling bør vælges på baggrund af den forventede effekt og sikkerhed af kombinationsbehandlingen hos den individuelle patient (se pkt.
English: Laboratory tests: Standard haematologic tests and blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) must be conducted in all patients prior to initiating therapy.
Danish: Laboratorieanalyser: Standard hæmatologiske tests og blodkemi (komplet blodtælling og differentialtælling, blodpladetal, elektrolytter, serumkreatinin, leverfunktionsundersøgelser, urinsyre) skal udføres hos alle patienter før påbegyndelse af behandling.
English: Ribavirin BioPartners tablets are to be administered orally each day in two divided doses (morning and evening) with food.
Danish: Ribavirin BioPartners tabletter skal indtages oralt hver dag fordelt på to doser (morgen og aften) samtidig med et måltid.
English: - This risk should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV-co-infection), as well as prognostic factors of response (HCV
Danish: Denne risiko skal vægtes mod sygdomskarakteristika hos barnet, såsom tegn på sygdomsudvikling (især fibrose), co-morbiditet der kan have en negativ effekt på sygdomsudviklingen (såsom HIV co-infektion) såvel som prognostiske faktorer på respons
English: - Due to the risk of lactic acidosis (a build-up of lactic acid in the body) and pancreatitis, the use of ribavirin and didanosine is not recommended and the use of ribavirin and stavudine should be avoided.
Danish: På grund af risiko for mælkesyreacidose (en ophobning af mælkesyre i kroppen) og betændelse i bugspytkirtlen kan brugen af ribavirin og didanosin ikke anbefales, og brugen af ribavirin og stavudin skal undgås.
English: Serum Creatinine
Danish: Serum-kreatinin
English: Results of these investigations showed that ribavirin monotherapy had no effect on eliminating hepatitis virus (HCV-RNA) or improving hepatic histology after 6 to 12 months of therapy and 6 months of follow-up.
Danish: Resultater fra disse undersøgelser viste, at ribavirin-monoterapi ikke havde nogen effekt på at fjerne hepatitis virus (HCV-RNA) eller forbedre leverhistologien efter 6 til 12 måneders behandling og 6 måneders opfølgning.
English: These studies suggest that a carcinogenic potential
Danish: Disse undersøgelser antyder, at potentiel carcinogenicitet af ribavirin hos mennesker, er
English: There is no evidence that ribavirin interacts with non-nucleoside reverse transcriptase inhibitors or
Danish: Der er ingen tegn på, at ribavirin har interaktion med ikke-nukleosid reverse transcriptase-hæmmere
English: Duration of treatment in children and adolescents • Genotype 2 or 3: The recommended duration of treatment is 24 weeks.
Danish: • Genotype 2 eller 3: Den anbefalede behandlingsvarighed er 24 uger.
English: Homicidal ideation*, mania*, mental status change
Danish: Drabstanker*, mani, ændring i mental status
English: If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Danish: Hvis sådanne symptomer forekommer, skal den behandlende læge være opmærksom på den potentielle alvor af disse bivirkninger, og behov for passende terapeutisk håndtering bør overvejes.
English: *AUC12 (ng.hr/ml) for Ribavirin; AUC0-24 (IU.hr/ml) for interferon alfa-2b
Danish: *AUC12 (ng.time/ml) for Ribavirin; AUC0-24 (IU.time/ml) for interferon alfa-2b
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 virusmængde < 800.000 IU/ml (Amplicor), som blev behandlet i 24 uger med en 6 måneders
English: If you take more Ribavirin BioPartners than you should Tell your doctor or pharmacist as soon as possible.
Danish: Hvis du har taget for meget Ribavirin BioPartners Fortæl det til din læge eller dit apotek så hurtigt som muligt.
English: If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Danish: Hvis din kvindelige partner ikke er gravid på nuværende tidspunkt, men er i den fødedygtige alder, skal hun testes for graviditet hver måned under behandlingen og i 7 måneder, efter
English: Patients whose dose of Ribavirin BioPartners is reduced to 600 mg daily receive one 200 mg tablet in the morning and two 200 mg tablets in the evening.
Danish: Patienter, hvis dosis af Ribavirin BioPartners er reduceret til 600 mg dagligt får en 200 mg tabletter om morgenen og to 200 mg tabletter om aftenen.
English: Ribavirin has been shown to produce high inter- and intra-subject pharmacokinetic variability following single oral doses (intrasubject variability of approximately 30 % for both AUC and Cmax), which may be due to extensive first pass metabolism and transfer within and beyond the blood
Danish: Det er vist for ribavirin, at det kan give høj farmakokinetisk inter- og intrapersonvariabilitet efter enkelte orale doser (intrapersonvariabilitet på cirka 30 % for både AUC og Cmax), hvilket kan skyldes stor first pass-metabolisme og overførsel inden for og uden for blodfordelingsrummet.
English: You or your female partner must use an effective contraceptive during the time you are taking Ribavirin BioPartners and for 7 months after stopping treatment.
Danish: Du elledin kvindelige partner skal anvende en effektiv præventionsmetode i løbet af den tid du tager Ribavirin BioPartners, og i 7 måneder efter behandlingen er stoppet.
English: Other CNS effects including aggressive behaviour (sometimes directed against others such as homicidal ideation), bipolar disorder, mania, confusion and alterations of mental status have been observed with alpha interferons.
Danish: Andre CNS-virkninger inklusive aggressiv opførsel (sommetider rettet mod andre såsom drabstanker), bipolare lidelser, mani, forvirring og ændret mental tilstand er set med alfa-interferoner.
English: Use in patients under the age of 18 years: Ribavirin may be used in combination with interferon alfa-2b in children 3 years of age and older and adolescents.
Danish: Anvendelse hos patienter i alderen under 18 år: Ribavirin kan bruges i kombination med interferon alfa-2b til børn 3 år eller ældre og unge.
English: or 2 x baseline and > 10 x ULN*
Danish: 2 x baseline og > 10 x ULN* eller 2 x baseline og > 10 x ULN*
English: This myelotoxicity was reversible within 4 to 6 weeks upon withdrawal of HCV antiviral therapy and concomitant azathioprine and did not recur upon reintroduction of either treatment alone (see section 4.5).
Danish: Denne myelotoksicitet var reversibel inden for 4 til 6 uger efter ophør af HCV-antiviral-behandling sammen med azathioprin og opstod ikke igen ved genoptagelse af behandlingerne hver for sig (se afsnit 4.5).
English: - various laboratory blood values abnormalities.
Danish: forskellige unormale laboratoriemæssige blodparametre.
English: The purpose of the study was to annually evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes for patients who were sustained responders 24 weeks post-treatment of the 48-week interferon alfa-2b and ribavirin treatment.
Danish: Formålet med undersøgelsen var årligt at vurdere varigheden af vedvarende virologisk respons (SVR) og vurdere virkningen af fortsat viral negativitet på de kliniske resultater hos patienter, der var vedholdende respondenter 24 uger efter behandlingen med interferon alfa-2b og ribavirin i 48-uger.
English: A certain number of adverse reactions, generally attributed to interferon therapy but that have been reported in the context of hepatitis C therapy (in combination with ribavirin) are also listed for reference in Table 4.
Danish: Et givet antal bivirkninger, som normalt er tilskrevet interferonbehandling, men som har været rapporteret i sammenhæng med hepatitis C-behandling (i kombination med ribavirin) er også anført i Tabel 4.
English: Co-administration of Ribavirin BioPartners and didanosine is not recommended.
Danish: Samtidig indgivelse af Ribavirin BioPartners og didanosin anbefales ikke.
English: Children and adolescents must not take combination therapy with Ribavirin BioPartners and alpha interferon when there is existence or history of serious nervous or mental problems, such as severe depression, thoughts of suicide or attempted suicide.
Danish: Børn og unge må ikke få kombinationsbehandling med Ribavirin BioPartners og alfa interferon, når der er eller har været nervøse eller psykiske problemer, såsom alvorlig depression, tanker om selvmord eller har forsøgt at begå selvmord.
English: The selection of the formulation is based on individual characteristics of the patient (see section 4.1).
Danish: Valg af formulering er baseret på patientens individuelle karakteristika (se pkt.
English: • had a previous serious heart condition or have cardiac disease.
Danish: • tidligere har haft alvorlig hjertelidelse eller har en hjertesygdom.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known.
Danish: Inden for systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt.
English: - Teratogenicity: Significant teratogenic and/or embryocidal potential have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted, occurring at doses as low as one twentieth of the recommended human dose (see section 5.3).
Danish: Teratogenecitet: Betydeligt teratogent og/eller embryocidt potentiale er vist for ribavirin i alle dyrearter, i hvilke tilstrækkelige undersøgelser er blevet udført, og forekommer ved så lave doser som en tyvendedel af den anbefalede humane dosis (se pkt.
English: The mechanism by which ribavirin in combination with interferon alfa-2b exerts its effects against HCV is unknown.
Danish: Mekanismen ved hvilken ribavirin i kombination med interferon alfa-2b udøver sine virkninger mod HCV er ukendt.
English: However, as in younger patients, renal function must be determined prior to administration of Ribavirin (see section 5.2).
Danish: Som hos yngre patienter skal nyrefunktionen imidlertid bestemmes før anvendelse af ribavirin påbegyndes (se pkt.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Du må ikke tage en dobbeltdosis
English: Following oral dosing with 600 mg BID, steady-state was reached by approximately four weeks, with mean steady state plasma concentrations approximately 2,200 ng/ml.
Danish: Efter peroral dosering med 600 mg to gange dagligt blev steady-state nået efter cirka fire uger med gennemsnitlige steady-state plasmakoncentrationer omkring 2.200 ng/ml.
English: BioPartners if CrCl < 50 ml/minute
Danish: Ribavirin BioPartners seponeres hvis CrCl < 50 ml/minut
English: - Co-infected patients with advanced liver disease receiving HAART may be at increased risk of worsening liver function.
Danish: Co-inficerede patienter med fremskreden leversygdom, der tager HAART, kan have øget risiko for forværring af leverfunktionen.
English: Potential to exacerbate immunosuppression: Pancytopenia and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the administration of a peginterferon and ribavirin concomitantly with azathioprine.
Danish: Mulighed for forværret immunsuppression: Litteraturen angiver, at pancytopeni og knoglemarvssuppression indtræder inden for 3 til 7 uger efter administrationen af peginterferon og ribavirin samtidig med azathioprin.
English: The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1).
Danish: Den forventede fordel ved behandling skal nøje vægtes mod de sikkerhedsresultater observeret hos børn og unge i de kliniske forsøg (se pkt.
English: Ribavirin BioPartners must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Danish: Ribavirin BioPartners må ikke initieres, før et negativt resultat fra en graviditetstest er opnået umiddelbart før behandlingsstart.
English: Hepatic function: Single-dose pharmacokinetics of ribavirin in patients with mild, moderate or severe hepatic dysfunction (Child-Pugh Classification A, B or C) are similar to those of normal controls.
Danish: Leverfunktion: Enkeltdosis farmakokinetik for ribavirin hos patienter med let, moderat eller svær leverfunktionsnedsættelse (Child-Pugh Classification A, B eller C) svarer til værdier for normale
English: The PSUR submission schedule should follow the PSUR schedule for the reference medicinal product.
Danish: Den fastsatte plan for indsendelse af PSUR skal følge den fastsatte plan for indsendelse af PSUR for
English: - Hypersensitivity to the active substance or to any of the excipients.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne.
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: Therefore, no dose adjustment of ribavirin is required in patients with hepatic impairment.
Danish: Ingen dosisjustering af ribavirin er derfor nødvendig hos patienter med nedsat leverfunktion.
English: There were some cases of more severe neutropenia in patients treated with ribavirin in combination with peginterferon alfa-2b (WHO grade 3: 39 of 186 [21 %]; and WHO grade 4: 13 of 186 [7 %]); WHO grade 3 leukopenia was also reported in 7 % of this treatment group.
Danish: Der var nogle tilfælde af mere alvorlig neutropeni hos patienter behandlet med ribavirin i kombination med peginterferon alfa-2b (WHO grad 3: 39 af 186 [21 %] og WHO grad 4: 13 af 186 [7 %]); WHO grad 3 leukopeni blev også rapporteret hos 7 % af denne behandlingsgruppe.
English: Alanine aminotransferase (ALT)
Danish: Alanin aminotransferase (ALAT) eller aspartat aminotransferase (ASAT)
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10), and uncommon (≥ 1/1,000 to < 1/100).
Danish: Inden for systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10) og ikke almindelig (≥ 1/1,000 til < 1/100).