FrancophonIA/ELRC3.0 huggingface dataset:
English: Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
Danish: Mænd, hvis partnere er gravide, skal underrettes om at anvende kondom for at mindske overførsel af ribavirin til partneren.
English: Patients with low CD4 counts:
Danish: Patienter med lave CD4-tællinger:
English: Laboratory evaluations are to be conducted at weeks 2 and 4 of therapy, and periodically thereafter as clinically appropriate.
Danish: Laboratorieundersøgelser skal udføres efter 2 og 4 ugers behandling og herefter regelmæssigt efter klinisk behov.
English: Seek medical help immediately if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while taking this treatment.
Danish: Søg omgående læge, hvis du udvikler symptomer på en svær allergisk reaktion (såsom vanskeligheder med at trække vejret, hvæsen eller nældefeber) under denne behandling.
English: Neuropathy, peripheral neuropathy
Danish: Neuropati, perifer neuropati
English: Dose modifications were required in 30 % of patients, most commonly for anaemia and neutropenia.
Danish: Dosisjusteringer var nødvendige hos 30 % af patienterne, mest almindeligt for anæmi og neutropeni.
English: Dose reduction in paediatric patients without cardiac disease follows the same guidelines as adult patients without cardiac disease regarding haemoglobin levels (Table 2).
Danish: Dosisreduktion hos pædiatriske patienter uden hjertesygdom følger de samme retningslinjer som for voksne patienter uden hjertesygdom med hensyn til hæmoglobinniveauer (Tabel 2).
English: Less than 30 mL/min
Danish: Under 30 ml/min
English: Seventy percent (68/97) of all enrolled subjects completed this study of which 75 % (42/56) were sustained responders.
Danish: Halvfjerds procent (68/97) af alle indrullerede forsøgspersoner fuldførte undersøgelsen, hvoraf 75 % (42/56) var vedholdende respondenter.
English: Ribavirin is embryotoxic or teratogenic, or both, at doses well below the recommended human dose in all animal species in which studies have been conducted.
Danish: Ribavirin er embryotoksisk, teratogent eller begge dele ved doser et godt stykke under den anbefalede humane dosis i alle dyrearter, i hvilke undersøgelser er blevet udført.
English: Adding treatment with alfa interferons 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 patientundergruppe.
English: If you are a woman who is breast-feeding, you must not take this medicine.
Danish: Hvis du er kvinde og ammer, må du ikke tage dette lægemiddel.
English: Your doctor has determined the correct dose of this medicine based on how much you or the child you are caring for weighs.
Danish: Din læge har bestemt den korrekte dosis af lægemidlet på basis af din eller barnets vægt.
English: 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 84 film-coated tablets 112 film-coated tablets 140 film-coated tablets 168 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 42 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 112 filmovertrukne tabletter 140 filmovertrukne tabletter 168 filmovertrukne tabletter
English: > 4 mg/dL (adults)
Danish: > 4 mg/dl (voksne)
English: Acceptable baseline values that may be considered as a guideline prior to initiation of ribavirin therapy:
Danish: Acceptable baselineværdier, der kan betragtes som en vejledning før initiering af ribavirin-behandling:
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 administration af ribavirin påbegyndes (se pkt.
English: Effects of these covariates on ribavirin clearance appear to be of limited clinical significance due to the substantial residual variability not accounted for by the model.
Danish: Effekten af disse kovarianser på ribavirinclearance synes at være af begrænset klinisk betydning på grund af den kraftige restvariabilitet, der ikke tages højde for med denne model.
English: Haemoglobin Adult: ≥ 12 g/dL (females); ≥ 13 g/dL (males) Children and adolescents: ≥ 11 g/dL (females); ≥ 12 g/dL (males)
Danish: Voksne: ≥12 g/dl (kvinder); ≥13 g/dl (mænd) Børn og unge: ≥11 g/dl (kvinder); ≥12 g/dl (mænd)
English: Tmax (hr) Cmax (ng/mL) AUC* Apparent clearance L/hr/kg
Danish: Tmax (timer) Cmax (ng/ml) AUC* Tilsyneladende clearance l/time/kg
English: Pharmacologically, ribavirin increases phosphorylated metabolites of purine nucleosides in vitro.
Danish: Farmakologisk øger ribavirin phosphorylerede metabolitter af purinnukleosider in vitro.
English: - Breast-feeding - History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease, in the previous six months (see section 4.4).
Danish: - Anamnese med allerede eksisterende alvorlig hjertesygdom, inklusive ustabil eller ukontrolleret hjertesygdom, i de foregående seks måneder (se pkt.
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 dosis.
English: No paediatric subjects with SVR relapsed during the 5 years of follow-up.
Danish: Ingen af de pædiatriske forsøgspersoner med SVR fik tilbagefald i den 5-årige opfølgningsperiode.
English: Both ribavirin and its triazole carboxamide and triazole carboxylic acid metabolites are also excreted renally.
Danish: Både ribavirin og dets triazolcarboxamid- og triazolcarboxylsyremetabolitter udskilles renalt.
English: Adults:
Danish: Voksne:
English: Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits > 15 percentiles, 10 to 12 years after the end of treatment.
Danish: Endelig sluthøjde var tilgængelig for 14 af disse børn og viste, at 12 fortsatte med at udvise manglende højde på > 15 percentiler 10-12 år efter afsluttet behandling.
English: Genotoxicity studies have demonstrated that ribavirin does exert some genotoxic activity.
Danish: Genotoksicitetsundersøgelser har vist, at ribavirin udøver nogen genotoksisk aktivitet.
English: There does not appear to be a significant age-related effect on the pharmacokinetics of ribavirin.
Danish: Der synes ikke at være en signifikant aldersrelateret effekt på ribavirins farmakokinetik.
English: Ribavirin plus interferon
Danish: Ribavirin og interferon
English: 3 MIU/m2 3 times a week (n = 54)
Danish: 3 MIE/m2 3 gange om ugen (n = 54)
English: Patients with impaired renal function should be more carefully monitored with respect to the development of anaemia.
Danish: Patienter med nedsat nyrefunktion bør monitoreres mere omhyggeligt med hensyn til udvikling af anæmi.
English: Study 22
Danish: Undersøgelse 22
English: suicide, stroke (cerebrovascular events).
Danish: - selvmord, - slagtilfælde (cerebrovaskulær hændelse).
English: 15 mg/kg/day as 2 divided doses (n = 17)
Danish: 15 mg/kg/dag fordelt på 2 doser (n = 17)
English: Ribavirin does not inhibit cytochrome P450 enzymes.
Danish: Ribavirin hæmmer ikke cytokrom P450enzymer.
English: The safety and efficacy of ribavirin used together with direct-acting-anti-virals in these patients has not been established.
Danish: Ribavirins sikkerhed og virkning ved anvendelse sammen med direkte virkende antivirale midler hos disse patienter er ikke klarlagt.
English: It is recommended that those patients who have pre-existing cardiac abnormalities have electrocardiograms taken prior to and during the course of treatment.
Danish: Det anbefales, at de patienter, som har haft hjerteproblemer, skal have taget elektrokardiogram før og under behandlingsforløbet.
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 gigt, men ingen af dem krævede behandlingsjustering eller afbrydelse fra de kliniske undersøgelser.
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 i øjeblikket, men er i den fødedygtige alder, skal hun testes for graviditet hver måned under behandlingen, og i syv måneder efter behandlingen er stoppet.
English: Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with ribavirin and for seven months after treatment.
Danish: Selvom resultater fra omkring 300 prospektivt fulgte graviditeter med paternal eksposition for ribavirin ikke har vist en øget risiko for misdannelse sammenlignet med den almindelige population, og heller intet specifikt mønster af misdannelser, skal mandlige patienter eller deres kvindelige partnere i fertil alder rådes til at anvende effektiv kontraception under behandling med ribavirin og i syv måneder efter behandling.
English: Within the 5 years follow-up post-treatment period, the children had a mean height of 44th percentile, which was below the median of the normative population and less than their mean baseline height (48th percentile).
Danish: Inden for de 5 års opfølgning efter behandlingsperioden, havde børnene en gennemsnitlig højde af 44. percentil, der lå under medianen af den normative population og mindre end deres gennemsnitlige baseline-højde (48. percentil).
English: 1 tablet in the morning and 2 tablets in the evening
Danish: 1 tablet om morgenen og 2 tabletter om aftenen
English: Ribavirin is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Danish: Ribavirin er en syntetisk nukleosidanalog, der har vist in vitro-aktivitet mod nogle RNA- og DNA-virus.
English: This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Danish: Denne virkning kunne øge den risiko for lactacidose, der er forårsaget af purinnukleosid-analoger (såsom didanosin eller abacavir).
English: The salient safety issue of ribavirin is haemolytic anaemia occurring within the first weeks of therapy.
Danish: Ribavirins vigtigste sikkerhedsaspekt er hæmolytisk anæmi, der opstår inden for de første uger af behandlingen.
English: attempted suicide and aggressive behaviour, etc.) - Growth inhibition in children and adolescents that may be irreversible in some patients
Danish: selvmordstanker, selvmordsforsøg og aggressiv adfærd osv.) - Væksthæmning hos børn og unge, som kan være irreversibel hos nogle patienter
English: Anaemia, neutropenia
Danish: Anæmi, neutropeni
English: Conflicting findings are reported in literature on co-administration between abacavir and ribavirin.
Danish: Der er rapporteret modstridende resultater i litteraturen om samtidig administration af abacavir og ribavirin.
English: In general, the adverse reactions profile in children and adolescents was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition.
Danish: Generelt svarede bivirkningsprofilen hos børn og unge til den profil, der er observeret hos voksne, selvom der er en specifik pædiatrisk bekymring vedrørende væksthæmning.
English: Decrease in mean height percentile at year 1 of long term follow-up was most prominent in prepubertal age children.
Danish: Reduktion i den gennemsnitlige højdepercentil efter 1 års langtidsopfølgning var mest fremtrædende hos børn i præpuberteten.
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 risikoen for mælkesyreacidose (ophobning af mælkesyre i kroppen) og pancreatitis kan brugen af ribavirin og didanosin ikke anbefales, og brugen af ribavirin og stavudin skal undgås.
English: This decline was significant among responders (0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among non-responders.
Danish: Dette fald var signifikant blandt de responderende (-0,3 for Metavir og -1,2 for Ishak) og stabile (-0,1 for Metavir og -0,2 for Ishak) blandt de ikke-responderende.
English: For laboratory monitoring of pregnancy, please refer to Laboratory tests.
Danish: Se under Laboratorieanalyser for oplysninger om laboratoriekontrol af graviditet.
English: Erythrocytes are a primary target of toxicity for ribavirin in animal studies.
Danish: Erytrocytterne er et primært mål for toksicitet af ribavirin i dyreundersøgelser.
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-studier med både humane og rotte-levermikrosompræparater viste ingen cytokrom P450-enzymmedieret metabolisme af ribavirin.
English: The other ingredients are
Danish: Øvrige indholdsstoffer:
English: Anaemia occurs shortly after initiation of dosing, but is rapidly reversible upon cessation of treatment.
Danish: Anæmi forekommer kort efter påbegyndt dosering, men er hurtigt reversibelt efter behandlingsophør.
English: Debrecen H-4042
Danish: Debrecen H-4042 Ungarn
English: Ribavirin has two pathways of metabolism: 1) a reversible phosphorylation pathway; 2) a degradative pathway involving deribosylation and amide hydrolysis to yield a triazole carboxyacid metabolite.
Danish: Ribavirin har to metaboliseringsveje: 1) en reversibel phosphorylering; 2) en nedbrydning, der involverer deribosylation og amidhydrolyse til at danne en triazolcarboxylsyremetabolit.
English: Suicide attempts, panic attack, hallucination
Danish: Selvmordsforsøg, panikanfald, hallucinationer
English: The purpose of the studies was to evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes.
Danish: Formålet med undersøgelserne var at evaluere varigheden af vedvarende virologisk respons (SVR) og bestemme virkningen af fortsat viral negativitet på kliniske resultater.
English: Haemodialysis (ESRD)
Danish: Hæmodialyse (ESRD)
English: The ratio of whole blood:plasma ribavirin concentrations is approximately 60:1; the excess of ribavirin in whole blood exists as ribavirin nucleotides sequestered in erythrocytes.
Danish: Forholdet mellem fuldblod og plasmaribavirinkoncentrationer er cirka 60:1; det overskydende ribavirin i blodet er til stede som ribavirinnukleotider afsondret i erytrocytter.
English: Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Danish: Pure red cell-aplasi, idiopatisk thrombocytopenisk purpura, thrombotisk thrombocytopenisk purpura
English: The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Danish: Faldet i CD4+ celletællinger var reversibelt efter dosisreduktion eller behandlingsophør.
English: Most cases of anaemia, neutropenia, and thrombocytopenia were mild (WHO grades 1 or 2).
Danish: De fleste tilfælde af anæmi, neutropeni og trombocytopeni var milde (WHO grad 1 eller 2).
English: However, ribavirin systemic exposure of a female partner after sexual intercourse with a treated patient has been estimated and remains extremely limited compared to therapeutic plasma concentration of ribavirin.
Danish: Den systemiske eksponering for ribavirin er imidlertid blevet vurderet hos en kvindelig partner efter samleje med en behandlet patient, og den forbliver yderst begrænset sammenlignet med den terapeutiske plasma-koncentration af ribavirin.
English: Absorption is extensive with approximately 10 % of a radiolabelled dose excreted in the faeces.
Danish: Absorptionen er omfattende med omkring 10 % af en radioaktivt mærket dosis udskilt i fæces.
English: Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders must be closely monitored.
Danish: Voksne patienter med tidligere hjertesvigt, myokardieinfarkt og/eller tidligere eller eksisterende arytmisygdomme skal følges tæt.
English: If pregnancy does occur during treatment or within four months from stopping treatment, the patient must be advised of the significant teratogenic risk of ribavirin to the foetus (see section 4.4).
Danish: Hvis graviditet forekommer under behandling eller inden for fire måneder efter ophørt behandling, skal patienten informeres om den betydelige teratogene risiko ved ribavirin for fostret (se pkt.
English: Transient rashes do not necessitate interruption of treatment.
Danish: Forbigående udslæt kræver ikke behandlingsophør.
English: The decline of height, weight and BMI Z scores observed during the treatment phase in comparison to a normative population did not fully recover at the end of long-term follow-up period for children treated with 48 weeks of therapy (see section 4.4).
Danish: Reduktionen i højde, vægt og BMI, som blev set i behandlingsfasen i sammenligning med en normativ population, var ikke fuldstændigt indhentet ved afslutningen af perioden med langtidsopfølgning for børn, der havde været i behandling i 48 uger (se pkt.
English: Sarcoidosis*, rheumatoid arthritis (new or aggravated)
Danish: Sarkoidose٭, reumatoid artrit (nyopstået eller forværret)
English: For children or adolescents who cannot swallow a film-coated tablet, an oral solution of ribavirin is available.
Danish: Til børn og unge, som ikke kan sluge en filmovertrukken tablet, findes en oral opløsning af ribavirin.
English: Not Known:
Danish: Ikke kendt:
English: Table 2 Management of Adverse Reactions Laboratory values
Danish: Tabel 2 Håndtering af bivirkninger Laboratorieværdier
English: Treatment with ribavirin in combination with peginterferon alfa-2b was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Danish: Behandling med ribavirin i kombination med peginterferon alfa-2b blev associeret med fald i absolut CD4+ celletælling inden for de 4 første uger uden en reduktion i CD4+ celleprocenten.
English: Preclinical data: - Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis (see section
Danish: Prækliniske data: - Fertilitet: I dyrestudier gav ribavirin reversible virkninger på spermatogenese (se pkt.
English: • are a male and your female partner is of childbearing age (see section “Pregnancy and breast feeding”).
Danish: • er en mand, og din kvindelige partner er i den fødedygtige alder (se afsnittet "Graviditet og amning
English: At the end of 5 years, 85 % (80/94) of all enrolled subjects and 86 % (54/63) of sustained responders completed the study.
Danish: Efter 5 år afsluttede 85 % (80/94) af alle deltagende patienter og 86 % (54/63) af de vedvarende respondenter studiet.
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials sustained virological response rates in children and adolescents were similar to those in adults.
Danish: Den inkluderede population bestod hovedsageligt af børn med mild til moderat hepatitis C. I de to multicenterforsøg, svarede vedvarende virologiske responsrater hos børn og unge svarede til dem, der sås hos voksne.
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 IE/ml (Amplicor), som blev behandlet i 24 uger med en 6 måneders opfølgningsperiode.
English: 4 x 200 mg tabletsb Refer to adult dose recommendation a: 1 morning, 2 evening b: 2 morning, 2 evening
Danish: 4 x 200 mg tabletterb Se venligst anbefalinger for dosering til voksne a: 1 morgen, 2 aften b: 2 morgen, 2 aften
English: The sustained response at the end of follow-up was significantly increased by the addition of ribavirin to interferon alfa-2b (41 % vs 16 %, p < 0.001).
Danish: Det vedvarende respons ved slutningen af opfølgningen var signifikant forhøjet ved tilføjelsen af ribavirin til interferon alfa-2b (41 % mod 16 %, p < 0,001).
English: Ischaemic colitis
Danish: Iskæmisk colitis
English: Patients who are treated with interferon alfa-2b and ribavirin after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below.
Danish: Patienter, som behandles med interferon alfa-2b og ribavirin efter tidligere tilbagefald efter interferonbehandling, eller som behandles i en kortere periode, har sandsynligvis en bedre sikkerhedsprofil end den nedenfor beskrevne.
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, feber, anoreksi, opkastning og emotionel labilitet hyppigere hos børn og unge sammenlignet med voksne patienter.
English: Any potential for interactions may persist for up to two months (five half-lives for ribavirin) after cessation of ribavirin therapy due to the long half-life (see section 5.2).
Danish: En mulighed for interaktioner kan være til stede i op til to måneder (fem halveringstider for ribavirin) efter ophør af ribavirin-behandling på grund af den lange halveringstid (se pkt.
English: Study 11
Danish: Undersøgelse 11
English: Single-dose pharmacokinetics of ribavirin in patients with mild, moderate or severe hepatic dysfunction (Child-Pugh Classification A, B or C) is similar to those of normal controls.
Danish: Enkeltdosisfarmakokinetikken for ribavirin hos patienter med let, moderat eller svær leverfunktionsnedsættelse (Child-Pugh Classification A, B eller C) svarer til værdier for normale kontroller.
English: Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of therapy.
Danish: Hjertearytmier (primært supraventrikulære) responderer normalt på sædvanlig behandling, men behandlingsophør kan være påkrævet.
English: This would be particularly important in patients with a known history of zidovudine induced anaemia.
Danish: Dette vil være særligt vigtigt for patienter, der har zidovudininduceret anæmi i anamnesen.
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.