FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to initiation of treatment with ribavirin the physician must comprehensively inform both male and female patients of the teratogenic risk of ribavirin, the necessity of effective and continuous contraception, the possibility that contraceptive methods may fail and the possible consequences of pregnancy should it occur during or following treatment with ribavirin (see section 4.6).
Danish: Før initiering af behandling med ribavirin skal lægen grundigt informere både mandlige og kvindelige patienter om den teratogene risiko ved ribavirin, om nødvendigheden af effektiv og vedvarende kontraception, herunder at præventionsmetoden kan svigte, og om de mulige konsekvenser af graviditet, hvis en sådan skulle indtræffe under eller efter behandling med ribavirin (se pkt.
English: Women of childbearing potential/contraception in males and females
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder
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 hepatitisvirus (HCV-RNA) eller forbedre leverhistologien efter 6 til 12 måneders behandling og 6 måneders opfølgning.
English: Extreme care must be taken to avoid pregnancy in female patients (see section 5.3).
Danish: Den yderste forsigtighed skal udvises for at undgå graviditet hos kvindelige patienter (se pkt.
English: • are a woman of childbearing age (see section “Pregnancy and breast-feeding”).
Danish: • er en kvinde i den fødedygtige alder (se afsnittet ”Graviditet og amning”).
English: Ribavirin concentration in seminal fluid is approximately two-fold higher compared to serum.
Danish: Ribavirinkoncentrationen i sædvæske er cirka to gange højere end i serum.
English: 2 tablets in the morning and 2 tablets in the evening or 1 (400 mg) tablet in the morning and 1 (400 mg) tablet in the evening See adult dose
Danish: 2 tabletter om morgenen og 2 tabletter om aftenen eller 1 (400 mg) tablet om morgenen og 1 (400 mg) tablet om aftenen Se voksendosis
English: - Pregnancy (see sections 4.4, 4.6 and 5.3).
Danish: 4.4, 4.6 og 5.3).
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 under behandlingen og i fire måneder efter behandlingen er stoppet.
English: Any patient developing significant liver function abnormalities during treatment must be monitored closely.
Danish: Enhver patient, der udvikler betydelig påvirkning af leverfunktionen under behandling, skal følges nøje.
English: Laboratory tests
Danish: Laboratorieanalyser
English: Anorexia, increased appetite, decreased appetite
Danish: Anoreksi, øget appetit, appetitløshed
English: Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C.
Danish: Behandlingen skal indledes og følges op af en læge med erfaring i behandling af kronisk hepatitis C. Dosering
English: HCV-RNA should be measured periodically during treatment (see section 4.2).
Danish: HCV-RNA bør måles løbende under behandlingen (se pkt.
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: 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
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 pkt.
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 (IE.time/ml) for interferon alfa-2b
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 højdepercentilen, 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: Other baseline factors in co-infected patients that may be associated with a higher risk of hepatic decompensation include treatment with didanosine and elevated bilirubin serum concentrations.
Danish: Andre baseline-faktorer hos co-inficerede patienter, som kan associeres med en højere risiko for leverdekompensation, omfatter behandling med didanosin og forhøjede bilirubinserumkoncentrationer.
English: Tell your doctor or pharmacist if you or the child you are caring for, are taking, have recently taken or might take: - azathioprine is a medicine that suppresses your immune system, using this medicine in combination with ribavirin may increase your risk of developing severe blood disorders.
Danish: Fortæl det altid til lægen eller på apotekspersonalet, hvis du eller det barn du har ansvar for, bruger anden medicin eller har gjort det for nylig: - azathioprin er et lægemiddel, der undertrykker immunsystemet (immunsuppressivum), og anvendelse af denne medicin i kombination med ribavirin kan øge risikoen for at udvikle alvorlige blodsygdomme.
English: Although ribavirin has no direct cardiovascular effects, anaemia associated with ribavirin may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both.
Danish: Selvom ribavirin ikke har nogen direkte kardiovaskulære virkninger, kan anæmi i forbindelse med ribavirin medføre forringelse af hjertefunktionen eller forværring af symptomerne på koronarsygdom eller begge.
English: Based on published data, single-dose ribavirin pharmacokinetics was altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance > 90 mL/minute).
Danish: Baseret på offentliggjorte data var enkeltdosis-farmakokinetikken for ribavirin var ændret (øget AUCtf og Cmax) hos patienter med nedsat nyrefunktion sammenlignet med kontrolpersoner (kreatininclearance > 90 ml/minut).
English: Please refer to the Package Leaflet of (peg)interferon alfa for more detailed information on these safety issues.
Danish: Se indlægssedlen for (peg)interferon alfa for yderligere information om disse sikkerhedsforhold.
English: There is no evidence that ribavirin interacts with non-nucleoside reverse transcriptase inhibitors or protease inhibitors.
Danish: Der er ingen tegn på, at ribavirin har interaktion med ikke-nukleosid reverse transcriptase-hæmmere eller proteasehæmmere.
English: Pharmacotherapeutic group: Antivirals for systemic use, nucleosides and nucleotides excl.reverse transcriptase inhibitors, ATC code: J05AB04.
Danish: Farmakoterapeutisk klassifikation: antivirale midler til systemisk brug, nukleosider og nukleotider, eksklusive reverse transcriptase-hæmmere, ATC-kode: J05AB04.
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 compartment.
Danish: Ribavirin giver høj inter- og intraindividuel variabilitet efter en enkelt oral dosis (intraindividuel variabilitet på cirka 30 % for både AUC og Cmax), hvilket kan skyldes stor first pass metabolisme og overførsel inden for og uden for blodfordelingsrummet.
English: Additionally, patients receiving zidovudine with ribavirin in combination with alpha interferons could be at increased risk of developing anaemia (low number of red blood cells).
Danish: Endvidere kan patienter, der får zidovudin med ribavirin i kombination med alfa interferoner, have øget risiko for at udvikle anæmi (lavt antal røde blodceller).
English: The use of pegylated alpha interferons and ribavirin concomitantly with azathioprine should be avoided.
Danish: Brug af pegylerede alfa-interferoner og ribavirin sammen med azathioprin bør undgås.
English: Lower respiratory tract infection
Danish: Nedre luftvejsinfektion
English: Because of the potential for adverse reactions in breast-fed infants, breast-feeding must be discontinued prior to initiation of treatment.
Danish: Af hensyn til muligheden for bivirkninger hos de ammede børn, skal amning afbrydes før påbegyndelse af behandling.
English: Dosing of ribavirin for children and adolescent patients is determined by the patient body weight.
Danish: Dosering af ribavirin til børn og unge patienter er baseret på patientens legemsvægt.
English: As in adult patients, children and adolescents also experienced other psychiatric adverse events (e.g., depression, emotional lability, and somnolence) (see section 4.4).
Danish: Som hos voksne patienter oplevede børn og unge også andre psykiatriske bivirkninger (såsom depression, emotionel labilitet og søvnighed) (se pkt.
English: Patients progressing to hepatic decompensation should have their anti-hepatitis treatment immediately discontinued and the ARV treatment reassessed.
Danish: Patienter som udvikler leverdekompensation skal seponere antihepatitis-behandling øjeblikkeligt, og ARV-behandlingen skal revurderes.
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: In the pivotal clinical efficacy trial, patients were instructed to take ribavirin with food to achieve the maximal plasma concentration of ribavirin.
Danish: I den pivotale kliniske undersøgelse blev patienterne instrueret i at indtage ribavirin til et måltid for at opnå maksimal plasmakoncentration af ribavirin.
English: For additional details see section 4.5.
Danish: 4.5 for yderligere oplysninger.
English: Dosing for children above 3 years of age and adolescents depends on how much the person weighs and the medicines that are used in combination.
Danish: Dosering til børn over 3 år og unge afhænger af, hvor meget patienten vejer, og hvilken medicin der anvendes i kombinationsbehandlingen.
English: Table 3 provides guidelines for discontinuation based on the patient's indirect bilirubin concentration.
Danish: Tabel 3 viser retningslinjer for seponering på basis af patientens indirekte bilirubinkoncentration.
English: Standard haematologic tests, blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) and pregnancy tests must be conducted in all patients prior to initiating therapy.
Danish: Standard hæmatologiske tests, blodkemi (komplet blodtælling og differentialtælling, blodpladetal, elektrolytter, serumkreatinin, leverfunktionsundersøgelser, urinsyre) og graviditetstest skal udføres hos alle patienter før påbegyndelse af behandling.
English: Packs of 14, 28, 42, 56, 84, 112, 140 and 168 tablets Not all pack sizes may be marketed.
Danish: Pakninger a 14, 28, 42, 56, 84, 112, 140 og 168 tabletter Ikke alle pakningsstørrelser er nødvendigvis markedsført.
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 alfa-2b .
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: The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14 %.
Danish: Biotilgængeligheden af ribavirin 600 mg blev reduceret ved samtidig indtagelse af et antacidum indeholdende magnesium, aluminium og simeticon; AUCtf faldt 14 %.
English: If a patient has a serious adverse reaction potentially related to ribavirin, the ribavirin dose should be modified or discontinued, if appropriate, until the adverse reaction abates or decreases in severity.
Danish: Hvis en patient har en alvorlig bivirkning, som potentielt er relateret til ribavirin, skal ribavirin-dosis justeres eller behandlingen afbrydes efter behov, indtil bivirkningen aftager eller reduceres i sværhedsgrad.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Immediate packaging (blister foil)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS Indre emballage (blisterfolie)
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: In general, the adverse event profile in the limited children and adolescent population studied was similar to that observed in adults, although there is a paediatric-specific concern regarding growth inhibition, as decrease in height percentile (mean percentile decrease of growth velocity of 9 percentile) and weight percentile (mean percentile decrease of 13 percentile) were observed during treatment.
Danish: Generelt svarede bivirkningsprofilen i den begrænsede undersøgte børn og unge-population til den profil, der er observeret hos voksne, selvom der er en specifik pædiatrisk bekymring vedrørende væksthæmning, da nedsat højdepercentil (gennemsnitlig procentvis nedgang i væksthastighed på 9 percentil) og vægtpercentil (gennemsnitlig procentvis nedgang på 13 percentil) blev observeret under behandling.
English: Study 2 (P02080) was a randomized, single centre study that enrolled 95 previously untreated adult patients with chronic hepatitis C who were coinfected with HIV.
Danish: Undersøgelse 2 (P02080) var en randomiseret, enkelt centerundersøgelse, der omfattede 95 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der var co-inficeret med hiv.
English: Blood thyroid stimulating hormone increased, thyroglobulin increased
Danish: Forhøjet thyreoideastimulerende hormon i blodet, forhøjet thyroglobulin
English: In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when ribavirin is administered.
Danish: Hos den hiv-positive population, som får et NRTI-regimen, bør lægen nøje følge markører for mitokondrietoksicitet og mælkesyreacidose, når ribavirin administreres.
English: It is not known whether ribavirin is excreted in human milk.
Danish: Det er uvist, om ribavirin udskilles i modermælk.
English: > 5 mg/dL (for > 4 weeks) (children and adolescents treated with interferon alfa-2b), or > 4 mg/dL (for > 4 weeks) (children and adolescents treated with peginterferon alfa-2b)
Danish: > 5 mg/dl (i > 4 uger) (børn og unge behandlet med interferon alfa-2b), eller > 4 mg/dl (i > 4 uger) (børn og unge behandlet med peginterferon alfa-2b)
English: Mitochondrial toxicity
Danish: Mitokondriel toksicitet
English: You or your female partner must use an effective contraceptive during the time you are taking this medicine and for 7 months after stopping treatment.
Danish: Du eller din kvindelige partner skal bruge sikker prævention i den periode, du tager dette lægemiddel, og i syv måneder efter behandlingen er stoppet.
English: 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: Litteraturen angiver, at pancytopeni og knoglemarvssuppression indtræder inden for 3 til 7 uger efter administrationen af peginterferon og ribavirin samtidig med azathioprin.
English: If the abnormality is reversed, ribavirin may be restarted at 600 mg daily, and further increased to 800 mg daily at the discretion of the treating physician.
Danish: Hvis unormaliteten forsvinder, kan behandlingen med ribavirin genoptages med en daglig dosis på 600 mg og kan yderligere øges til 800 mg dagligt efter nøje vurdering af den behandlende læge.
English: Co-administration of ribavirin and didanosine is not recommended.
Danish: Samtidig indgivelse af ribavirin og didanosin anbefales ikke.
English: Ribavirin Teva Pharma B.V. tablets are packaged in aluminium blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinyl Acetate (PVAc)
Danish: Ribavirin Teva Pharma B.V.-tabletter er pakket i aluminiumblisterpakninger, som består af polyvinylklorid (PVC)/polyethylen (PE)/polyvinylactat (PVAc)
English: • Psychiatric and central nervous system effects (such as depression, suicidal thoughts, attempted suicide and aggressive behaviour, etc.).
Danish: • Psykiatriske påvirkninger og påvirkninger af centralnervesystemet (såsom depression, selvmordstanker, selvmordsforsøg, aggressiv adfærd osv.).
English: Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported (see section 4.4).
Danish: Rapporter om mitokondrietoksicitet, særligt mælkesyreacidose og pancreatitis, nogle fatale, har været rapporteret (se pkt.
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).
English: Hepatotoxicity (including fatalities)*
Danish: Hepatotoksicitet (herunder dødelig)٭
English: At the end of 24 weeks post-treatment follow-up, mean decrease from baseline in weight and height percentiles were still 3 percentiles and 7 percentiles, respectively, and 20% of the children continued to have inhibited growth (growth velocity < 3rd percentile).
Danish: Ved udgangen af 24 ugers opfølgning efter behandlingen var den gennemsnitlige reduktion i forhold til baseline i vægt- og højdepercentiler stadig henholdsvis 3 percentiler og 7 percentiler, og 20 % af børnene forsatte med at have hæmmet vækst (væksthastighed < 3. percentil).
English: Anti-thyroid antibody positive
Danish: Positiv anti-tyroid-antistof
English: Discontinue breastfeeding before starting to take this medicine.
Danish: Afbryd amning før du begynder at tage lægemidlet.
English: In patients co-infected with HCV/HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/µL.
Danish: Hos patienter, der er co-inficeret med HCV/hiv, er begrænsede effekt- og sikkerhedsdata (N = 25) tilgængelige i patienter med CD4-tællinger mindre end 200 celler/μl.
English: The bioavailability of a single oral dose of ribavirin was increased by co-administration of a high fat meal (AUCtf and Cmax both increased by 70 %).
Danish: Biotilgængeligheden af en enkelt oral dosis ribavirin forøgedes ved samtidig indtagelse af et måltid med højt fedtindhold (AUCtf og Cmax steg begge med 70 %).
English: It is possible that the decreased bioavailability in this study was due to delayed transit of ribavirin or modified pH.
Danish: Det er muligt, at den mindskede biotilgængelighed i denne undersøgelse skyldtes forsinket overførsel af ribavirin eller ændret pH.
English: Acute hypersensitivity
Danish: Akut overfølsomhed
English: Dose reduction of ribavirin depends on the initial ribavirin posology which depends on the medicinal product that is used in combination with ribavirin.
Danish: Dosisreduktion af ribavirin afhænger af initialdosis af ribavirin, hvilket afhænger af det lægemiddel, som anvendes i kombination med ribavirin.
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 5.
Danish: Et givet antal bivirkninger tilskrevet interferonbehandling, men som har været rapporteret i sammenhæng med hepatitis C-behandling (i kombination med ribavirin) er også anført i Tabel 5.
English: Study 1 (RIBAVIC; P01017) was a randomized, multicentre study which enrolled 412 previously untreated adult patients with chronic hepatitis C who were co-infected with HIV.
Danish: Undersøgelse 1 (RIBAVIC; P01017) var en randomiseret, multicenterundersøgelse, der omfattede 412 tidligere ubehandlede voksne patienter med kronisk hepatitis C, der samtidig var inficeret med hiv.
English: It is possible that the increased bioavailability in this study was due to delayed transit of ribavirin or modified pH.
Danish: Det er muligt, at den øgede biotilgængelighed i denne undersøgelse skyldtes forsinket overførsel af ribavirin eller ændret pH.
English: Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/kg in a mouse micronucleus assay.
Danish: Genotoksisk aktivitet sås hos muse-lymfomtesten og ved doser på 20-200 mg/kg i en muse-mikronucleusprøve.
English: Paediatric patients (children 3 years of age and older and adolescents: Ribavirin Teva Pharma B.V.
Danish: Pædiatriske patienter (børn i alderen 3 år eller ældre og unge): Ribavirin Teva Pharma B.V.
English: The mean AUCtf was threefold greater in subjects with creatinine clearance between 10 and 30 mL/min compared with control subjects.
Danish: Det gennemsnitlige AUCtf var tre gange højere hos forsøgspersoner med kreatininclearance mellem 10 og 30 ml/min sammenlignet med kontrolpersoner.
English: This benefit was maintained irrespective of standard predictors of response to interferon alfa-2b such as virus level, HCV genotype and histological staging.
Danish: Den gavnlige effekt blev opretholdt uafhængigt af standardforudsigelser om respons på interferon alfa-2b såsom virusmængde, HCV-genotype og histologisk stadie.
English: Therefore the use of zidovudine and ribavirin in combination with alpha interferons is not recommended.
Danish: Derfor kan brugen af zidovudin og ribavirin i kombination med alfa interferoner ikke anbefales.
English: • Increased hormone related to your thyroid (TSH) in children and adolescents
Danish: • Forhøjet hypofysehormon relateret til skjoldbruskkirtlen (TSH) hos børn og unge
English: Ribavirin concentrations are essentially unchanged by haemodialysis.
Danish: Ribavirin-koncentrationerne er praktisk taget uforandrede ved hæmodialyse.
English: In 3- and 6-month studies in mice to investigate ribavirin-induced testicular and sperm effects, abnormalities in sperm, occurred at doses of 15 mg/kg and above.
Danish: I 3 og 6 måneders undersøgelser på mus for at undersøge ribavirin-induceret testis- og sædcellepåvirkninger, forekom abnormaliteter i sædceller ved doser på 15 mg/kg og derover.
English: In subjects with creatinine clearance between 30 and 50 mL/min, AUCtf was twofold greater compared with control subjects.
Danish: Hos forsøgspersoner med kreatininclearance mellem 30 og 50 ml/min var AUCtf to gange højere sammenlignet med kontrolpersoner.
English: Genotype 1 > 600,000 IU/mL
Danish: Genotype 1 > 600.000 IE/ml
English: In addition some patients may experience vomiting.
Danish: Nogle patienter kan kaste op.