FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Direct acting antivirals, nucleosides and nucleotides (excl. reverse transcriptase inhibitors), ATC code: J05AB04.
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antivirale stoffer, nukleosider og nukleotider eksklusive reverse transcriptase-hæmmere, ATC-kode: J05AB04.
English: Long-term efficacy data - Adults
Danish: Langtidsdata - Børn og unge
English: If serum creatinine rises to > 2.0 mg/dl (Table 3), Ribavirin BioPartners and interferon alfa-2b must be discontinued.
Danish: Hvis serumkreatinin stiger til > 2,0 mg/dl (Tabel 3), skal Ribavirin BioPartners og interferon alfa-2b
English: Food effect: 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: Effekt af fødeindtagelse: 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: Taking Ribavirin BioPartners with food and drink Ribavirin BioPartners must be taken with food.
Danish: Brug af Ribavirin BioPartners sammen med mad og drikke Ribavirin BioPartners skal tages til et måltid.
English: If you receive ribavirin in combination with an alpha interferon, you should have a baseline eye examination.
Danish: Hvis du får ribavirin i kombination med et alfa interferon, skal du have foretaget en grundig øjenundersøgelse ved baseline.
English: Ribavirin BioPartners film-coated tablets for oral use - dose based on body weight
Danish: Ribavirin BioPartners filmovertrukne tabletter til oral brug - dosis baseret på kropsvægt
English: There are no data in children or adolescents with a history of cardiac disease.
Danish: Der er ingen resultater for børn eller unge med hjertesygdomme
English: - Patients with chronic renal failure, patients with creatinine clearance < 50 ml/minute and/or on haemodialysis.
Danish: Patienter med kronisk nyreinsufficiens, patienter med kreatininclearance < 50 ml/minut og/eller i hæmodialyse.
English: Rhabdomyolysis*, myositis*
Danish: Rhabdomyolyse٭, myositis٭
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 samtidig var inficeret med HIV.
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 gennemsnitlig reduktion fra baseline i vægt- og højdepercentiler stadig henholdsvis 3 percentiler og 7 percentiler, og 20 % af børnene fortsatte med at have hæmmet vækst (væksthastighed < 3. percentil).
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: Renal function: Single-dose ribavirin pharmacokinetics were altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance > 90 ml/minute).
Danish: Nyrefunktion: Enkeltdosis ribavirin farmakokinetik var ændret (øget AUCtf og Cmax) hos patienter med nedsat nyrefunktion sammenlignet med kontrolpersoner (kreatininclearance > 90 ml/minut).
English: Reminder: If the child is under the age of 3 years, do not administer.
Danish: Bemærk: Må ikke gives til børn under 3 år.
English: - Severe hepatic impairment (Child-Pugh Classification B or C) or decompensated cirrhosis of
Danish: Alvorligt nedsat leverfunktion (Child-Pugh klassifikation B eller C) eller ikke-kompenseret levercirrose.
English: In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when ribavirin is
Danish: Hos den HIV-positive population, som får et NRTI-regimen, bør lægen nøje følge markører for mitokondrietoksicitet og mælkesyreacidose, når ribavirin indgives.
English: Antacid: The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14 %.
Danish: Antacida: Biotilgængeligheden af ribavirin 600 mg blev reduceret ved samtidig indtagelse af et antacidum indeholdende magnesium, aluminium og simeticon; AUCtf faldt 14 %.
English: One film-coated tablet contains 200 mg ribavirin.
Danish: En filmovertrukket tablet indeholder 200 mg ribavirin.
English: - severe rashes which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes (erythema multiforme, Stevens Johnson syndrome), toxic epidermal necrolysis (blistering and peeling of the top layer of skin).
Danish: alvorligt udslæt, som kan være forbundet med blærer i munden, på næsen, i øjnene og andre mukosale membraner (erythema multiforme, Stevens Johnson syndrom), toksisk epidermal nekrolyse (blæredannelse og afskalling af det øverste hudlag).
English: Read all of this leaflet carefully before you start taking this medicine - Keep this leaflet.
Danish: Læs denne indlægsseddel grundigt inden du begynder at bruge medicinen.
English: Male patients and their female partners: Extreme care must be taken to avoid pregnancy in partners of male patients taking Ribavirin (see sections 4.3 and 5.3).
Danish: Mandlige patienter og deres kvindelige partnere: Den yderste forsigtighed skal udvises for at undgå graviditet hos partnere til mandlige patienter, der tager Ribavirin (se pkt.
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
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 general, the adverse reaction 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 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,såvel som nedsat højdepercentil (gennemsnitlig percentilreduktion på 9 percentil) og vægtpercentil (gennemsnitlig percentilreduktion på 13 percentil) blev observeret under behandling.
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: Important treatment-emergent adverse reactions that occurred in this patient population were nervousness (8 %), aggression (3 %), anger (2 %), depression/depressed mood (4 %) and hypothyroidism (3 %) and 5 subjects received levothyroxine treatment for hypothyroidism/elevated TSH.
Danish: Vigtig behandlingsrelaterede bivirkninger, som opstod i denne patientpopulation, var nervøsitet (8 %), aggression (3 %), vrede (2 %), depression / trykket stemning (4 %) og hypothyroidism (3 %) og 5 forsøgspersoner modtog levothyroxin behandling for hypothyroidism / forhøjede TSH.
English: • Genotype Non-1: The decision to extend therapy to one year in patients with negative HCVRNA after six months of treatment should be based on other prognostic factors (e.g., age > 40 years, male gender, bridging fibrosis).
Danish: • Genotype non-1: Beslutningen om at forlænge behandling til et år hos patienter med negativ HCV-RNA efter seks måneders behandling bør træffes på grundlag af andre prognostiske faktorer (såsom alder > 40 år, mandligt køn, brofibrose).
English: Two trials have been conducted in patients co-infected with HIV and HCV.
Danish: Der har været udført to undersøgelser af patienter med samtidig infektion af HCV og HIV.
English: - Pregnant women (see sections 4.4, 4.6 and 5.3).
Danish: 4.4, 4.6 og 5.3).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister foil
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterfolie
English: Ribavirin BioPartners must be used in combination with interferon alfa-2b (3 million international units [MIU] three times a week).
Danish: Ribavirin BioPartners skal anvendes i kombination med interferon alfa-2b (3 millioner internationale enheder [MIU] tre gange om ugen).
English: The dose of Ribavirin BioPartners is based on patient body weight.
Danish: Dosis af Ribavirin BioPartners er baseret på patientens kropsvægt.
English: Most of the changes in laboratory values in the ribavirin/peginterferon alfa-2b clinical trial were mild or moderate.
Danish: De fleste af ændringerne i laboratorieværdierne for de kliniske forsøg med ribavirin/peginterfron alfa-2b var milde eller moderate.
English: Ribavirin concentrations are essentially unchanged by haemodialysis.
Danish: Ribavirinkoncentrationerne er praktisk taget uforandrede ved hæmodialyse.
English: < 25 x 109/l (adults) < 50 x 109/l (children and adolescents) 2.5 x ULN* > 4 mg/dl (adults) > 5 mg/dl (for > 4 weeks) (children and adolescents treated with interferon alfa-2b),
Danish: < 25 x 109/l (voksne) < 50 x 109/l (børn og unge) 2,5 x ULN** > 4 mg/dl (voksne) > 5 mg/dl (i > 4 uger) (børn og unge behandlet med interferon alfa-2b)
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: ≥ 2 g/dl decrease in haemoglobin during any
Danish: ≥ 2 g/dl fald i hæmoglobin under en hvilken som helst 4 ugers periode under behandling
English: Ocular changes: Ribavirin is used in combination therapy with alpha interferons.
Danish: Okulære ændringer: Ribavirin anvendes i kombinationsbehandling med alfa-interferoner.
English: Acute hypersensitivity: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Ribavirin must be discontinued immediately and appropriate medical therapy instituted.
Danish: Akut overfølsomhed: I tilfælde af udvikling af akut overfølsomhedsreaktion (for eksempel urticaria, angioødem, bronkiekonstriktion, anafylaksi), skal Ribavirin øjeblikkeligt seponeres og passende medicinsk behandling initieres.
English: During treatment with Ribavirin BioPartners in combination therapy with an alpha interferon, patients may experience eye problems, or loss of vision in rare instances.
Danish: Under behandling med Ribavirin BioPartners i kombinationsbehandling med et alfa interferon kan patienter opleve øjenproblemer eller i sjældne tilfælde tab af synet.
English: Based on results of clinical trials, the use of ribavirin as monotherapy is not effective and Ribavirin must not be used alone.
Danish: Anvendelse af ribavirin som monoterapi er ifølge resultater fra kliniske undersøgelser ikke effektivt, og Ribavirin skal ikke anvendes alene.
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: Ribavirin BioPartners does not affect your ability to drive or use machines; however, interferon alfa-2b may affect your ability to drive or use machines.
Danish: Ribavirin BioPartners påvirker ikke din evne til at køre bil eller betjene maskiner, men interferon alfa-2b kan påvirke din evne til at køre bil eller betjene maskiner.
English: The adverse reactions listed in Table 4 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.
Danish: Tabel 4 viser de bivirkninger, som er set i kliniske undersøgelser på voksne naive patienter behandlet i 1 år, såvel som de bivirkninger, som er set efter markedsføring.
English: The use of ribavirin in combination with peginterferon alfa-2b had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Danish: Anvendelsen af ribavirin i kombination med peginterferon alfa-2b havde ingen observerbar negativ indvirkning på kontrollen af HIV-viræmi under behandling eller opfølgning.
English: - are receiving azathioprine in combination with ribavirin and pegylated alpha interferons and, therefore may be at an increased risk of developing severe blood disorders.
Danish: - får azathioprin i kombination med ribavirin og pegyleret alfa-interferon og dermed har en øget risiko for at udvikle alvorlige blodsygdomme.
English: In the pivotal clinical efficacy trial, patients were instructed to take ribavirin with food to achieve the maximal plasma concentration of
Danish: I den pivotale kliniske undersøgelse blev patienterne instrueret i at indtage ribavirin til et måltid for at opnå maksimal plasmakoncentration af ribavirin.
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 kombinatin med alfa interferoner have øget risiko for at udvikle anæmi (lavt antal røde blodlegemer).
English: Interferon alfa-2b (pegylated and non-pegylated) therapy may be initiated if TSH levels can be maintained in the normal range by medication.
Danish: Interferon alfa-2b-behandling (pegyleret og ikke pegyleret) kan initieres, hvis TSH-niveauet kan fastholdes inden for normalområdet ved medicinsk behandling.
English: The longer term data available in children treated with the combination therapy with standard interferon/ribavirin are also indicative of substantial growth retardation (> 15 percentile decrease in height percentile as compared to baseline) in 21 % of children despite being off treatment for more
Danish: Tilgængelige langtidsdata hos børn i kombinationsbehandling med standard interfron/ribavirin er også indikativ for betragtelig højdereduktion (> 15 percentilreduktion i højdepercentilen i sammenligning med baseline) hos 21 % af børnene, til trods for at børnene ikke har været behandlet i mere end 5 år.
English: The dose of Ribavirin BioPartners is based on patient body weight (Table 1).
Danish: Dosis af Ribavirin BioPartners er baseret på patientens kropsvægt (Tabel 1).
English: In those patients that received > 10.6 mg/kg ribavirin (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, response rates were significantly higher than in those patients that received ≤ 10.6 mg/kg ribavirin (Table 6), while response rates in patients that received > 13.2 mg/kg ribavirin were even
Danish: For de patienter, som fik > 10,6 mg/kg ribavirin (800 mg dosis til en typisk patient på 75 kg), uafhængigt af genotype eller virusmængde, var responsrater signifikant højere end for de patienter, der fik ≤ 10,6 mg/kg ribavirin (Tabel 6), mens responsrater for patienter, der fik > 13,2 mg/kg ribavirin, var endnu højere.
English: Arthralgia, myalgia, musculoskeletal pain
Danish: Arthralgi, myalgi, muskoloskeletal smerte
English: Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with non-pegylated interferon alfa-2b (with or without ribavirin) and pegylated interferon alfa-2b (with or without ribavirin), respectively.
Danish: To store undersøgelser med langtidsopfølgning inkluderede 1.071 patienter og 567 patienter efter behandling i tidligere undersøgelser med henholdsvis non-pegyleret interferon alfa-2b (med eller uden ribavirin) og pegyleret interferon alfa-2b (med eller uden ribavirin).
English: Ribavirin BioPartners in combination with an alpha interferon product may also cause: - aplastic anaemia, pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells); this causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy,
Danish: Ribavirin BioPartners i kombination med et alfa-interferonprodukt kan også forårsage: aplastisk anæmi, ren erytroaplasi (en tilstand hvor kroppen stoppede eller reducerede produktionen af røde blodlegemer); dette forårsager alvorlig anæmi, med symptomer som vil omfatte usædvanlig træthed og mangel på energi,
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
English: During treatment with Ribavirin in combination therapy with an alpha interferon, dental and gum disorders, which may lead to loss of teeth, have been reported.
Danish: Under behandlingen med Ribavirin i kombinationsbehandling med et alfa interferon er der blevet rapporteret tand- og tandkødslidelser, som kan føre til tab af tænder.
English: Survival of foetuses and offspring was
Danish: Overlevelsen af fostre og afkom var reduceret.
English: Please refer also to the interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.
Danish: Se også Produktresumeet (SPC) interferon alfa-2b for speciel ordinationsinformation for dette produkt.
English: Children and adolescents are particularly prone to develop depression when being treated with ribavirin and interferon alpha.
Danish: Børn og unge er særligt udsatte for at udvikle depression, når de behandles med Ribavirin BioPartners og interferon alfa.
English: You should consult your doctor immediately if any of the following side effects occur during treatment with Ribavirin BioPartners and interferon alfa-2b:
Danish: Du bør omgående kontakte lægen, hvis nogle af de følgende bivirkninger forekommer under behandling med Ribavirin BioPartners og interferon alfa-2b,
English: As in adult patients, children and adolescents experienced other psychiatric adverse reactions (e.g. depression, emotional lability, and somnolence).
Danish: Som hos voksne patienter oplevede børn og unge andre psykiatriske bivirkninger (såsom depression, emotionel labilitet og døsighed).
English: Females of childbearing potential must use an effective contraceptive during treatment and for four months after treatment has been concluded; routine monthly pregnancy tests must be performed during this time.
Danish: Fertile kvinder skal anvende effektiv antikonception under behandling og i fire måneder efter behandlingen er afsluttet; månedlige rutinegraviditetsundersøgelser skal udføres i denne periode.
English: Female patients: Ribavirin must not be used by females who are pregnant (see sections 4.3 and 5.3).
Danish: Kvindelige patienter: Ribavirin må ikke anvendes af kvinder, der er gravide (se pkt.
English: Taking other medicines Please tell your doctor or pharmacist if you or the child you are caring for: - are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du eller det barn du har ansvar for: - bruger anden medicin eller har brugt det for nylig.
English: Female: dysmenorrhoea
Danish: Kvinder: dysmenoré
English: Blood thyroid stimulating hormone increased, thyroglobulin increased
Danish: Øget blod thyroid stimulerende hormon, øget
English: Safety and effectiveness of ribavirin with other forms of interferon (i.e. not alfa-2b) in these patients have not been evaluated.
Danish: Sikkerhed og effekt af ribavirin med andre former for interferon (det vil sige foruden alfa-2b) hos disse patienter er ikke blevet evalueret.
English: Current treatment guidelines should be consulted as to whether a liver biopsy is needed
Danish: Gældende behandlingsvejledninger bør tages i betragtning med hensyn til, om en leverbiopsi er nødvendig før start af behandling.
English: Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Danish: Selvom hæmatologisk toksicitet af neutropeni, trombocytopeni og anæmi forekom mere hyppigt hos patienter med samtidig infektion af HCV/HIV, kunne hovedparten afhjælpes med modificering af dosis og krævede sjældent for tidlig afbrydelse af behandling (se pkt.
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 97 % (95 % CI: 95-99 %) for patients receiving non-pegylated interferon alfa-2b (with or without ribavirin), and is 99 % (95 % CI: 98-100 %) for patients receiving pegylated interferon alfa-2b (with or without ribavirin).
Danish: Kaplan-Meier-estimatet for fortsat vedvarende respons over 5 år er 97 % (95 % CI: 95-99 %) for patienter, der fik non-pegyleret interferon alfa-2b (med eller uden ribavirin), og det er 99 % (95 % CI: 98-100 %) for patienter, der fik pegyleret interferon alfa-2b (med eller uden ribavirin).
English: Prior to initiation of interferon alfa-2b therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Danish: Inden initiering af interferon alfa-2b-behandling, skal TSH-niveauet evalueres og mulige thyreoideaabnormaliteter detekteret på dette tidspunkt, skal behandles med konventionel behandling.
English: Female partners of male patients must have a routine pregnancy test performed monthly during treatment and for seven months thereafter (see
Danish: Kvindelige partnere til mandlige patienter skal have en rutinegraviditetstest udført hver måned under behandling og i syv måneder derefter (se pkt.
English: Among children and adolescents, treated with ribavirin in combination with interferon alfa-2b, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4 % versus 1 %) during treatment and during the 6-month follow-up after treatment.
Danish: Blandt børn og unge, behandlet med ribavirin i kombination med interferon alfa-2b, blev selvmordstanker eller -forsøg rapporteret oftere end hos voksne patienter (2,4 % mod 1 %) i behandling og i løbet af de 6 måneders opfølgning efter behandling.
English: Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (> 30 IU/ml), a liver biopsy consistent with a histological diagnosis of chronic hepatitis with no other cause for the chronic hepatitis, and abnormal serum ALT.
Danish: Mulige patienter til disse undersøgelser havde kronisk hepatitis C bekræftet ved en positiv HCVRNA-polymerasekædereaktionstest (PCR) (> 30 IU/ml), en leverbiopsi i overensstemmelse med en histologisk diagnose med kronisk hepatitis uden anden årsag til den kroniske hepatitis, samt en abnorm serum ALAT.
English: In this study, the most prevalent adverse reactions in all subjects were pyrexia (80 %), headache (62 %), neutropenia (33 %), fatigue (30 %), anorexia (29 %) and injection-site erythema (29 %).
Danish: I denne undersøgelse var den mest udbredte bivirkning i alle forsøgspersonerne feber (80 %), hovedpine (62 %), neutropeni (33 %), træthed (30 %), anoreksi (29 %) og injektionssted -site erytem (29 %).