FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents must not take combination therapy with Ribavirin Mylan 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 Mylan og alfa interferon, når der er eller har været alvorlige nervøse eller psykiske problemer så som svær depression, selvmordstanker eller selvmordsforsøg.
English: Sarcoidosis*, rheumatoid arthritis (new or aggravated)
Danish: Sarcoidosis٭, reumatoid artrit (nyopstået eller forværret)
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 4 måneder efter behandlingen er stoppet.
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: In this subgroup, there was a 56 % (463/823) sustained virological response rate.
Danish: I denne undergruppe opretholdt 56 % (463/823) den virulogiske respons rate.
English: 4 capsules b Refer to adult dose recommendations a1 morning, 2 evening 2 morning, 2 evening
Danish: Se dosisanbefalinger for voksne a1 morgen, 2 aften 2 morgen, 2 aften
English: Pancytopenia: Ribavirin Mylan can cause a decrease in your platelet and red and white blood cell count when used in combination with peginterferon.
Danish: Pancytopeni: Ribavirin Mylan kan forårsage et fald i dine tal for blodplader samt røde og hvide blodlegemer, når det anvendes i kombination med peginterferon.
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: - The active substance is ribavirin 200 mg. - The other ingredients are croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, povidone.
Danish: - Det aktive stof er ribavirin 200 mg. - De øvrige indholdsstoffer er natriumcroscarmellose, laktosemonohydrat, mikrokrystallinsk cellulose, povidon.
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: Enkeltdosis farmakokinetik for ribavirin hos patienter med let, moderat eller svær leverfunktionsnedsættelse (Child-Pugh Classification A, B eller C) svarer til værdier for normale kontroller.
English: Blisters: Cardboard box containing 56 or 168 hard capsules in PVC/Aclar - Aluminium foil blisters
Danish: Blisterpakning: Karton med 56 eller 168 hårde kapsler i PVC/Aclar - aluminiumsfolieblistre
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det landsdækkende indberetningssystem nævnt i bilag V*:
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: Det valgte behandlingsregimen skal baseres på den forventede effekt og sikkerhed af kombinationsbehandling for den enkelte patienten (se pkt.
English: A total of 118 patients were enrolled: 57 % male, 80 % Caucasian, and 78 % genotype 1, 64 % ≤ 12 years of age.
Danish: I alt 118 patienter blev inkluderet: 57 % mænd, 80 % kaukasiske og 78 % genotype 1, 64 % i alderen  12 år.
English: Any potential for interactions may persist for up to two months (five half-lives for ribavirin) after cessation of Ribavirin Mylan 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 Mylan behandling på grund af den lange halveringstid (se pkt.
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: The sustained response at the end of follow-up was significantly increased by the addition of ribavirin capsules 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 kapsler til interferon alfa-2b (41 % mod 16 %, p < 0,001).
English: For laboratory monitoring of pregnancy, please refer to Laboratory tests.
Danish: Se Laboratorieprøver for laboratorieovervågning af graviditet.
English: Preclinical data - Fertility: In animal studies, ribavirin produced reversible effects on spermatogenesis (see section 5.3).
Danish: Prækliniske data: - Fertilitet: I dyrestudier gav ribavirin reversible virkninger på spermatogenese (se pkt.
English: Psychiatric and Central Nervous System (CNS):
Danish: Psykiatriske sygdomme og sygdomme i centralnervesystemet (CNS):
English: It is not known whether ribavirin is excreted in human milk.
Danish: Det vides ikke, om ribavirin udskilles i modermælk.
English: However, as in younger patients, renal function must be determined prior to administration of Ribavirin Mylan (see section 5.2).
Danish: Men som ved yngre patienter skal nyrefunktionen afgøres før administration af Ribavirin Mylan (se pkt.
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: Forud for påbegyndelse af behandling med ribavirin skal lægen udførligt informere både mandlige og kvindelige patienter om den teratogene risiko ved ribavirin, nødvendigheden af effektiv og vedvarende svangerskabsforebyggelse, muligheden for, at svangerskabsforebyggende metoder kan mislykkes, og de mulige konsekvenser ved graviditet, hvis den opstår under eller efter behandling med ribavirin (se pkt.
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: Doseringen til børn over 3 år samt unge afhænger af, hvor meget personen vejer, og de lægemidler, der anvendes i kombination.
English: If you take more Ribavirin Mylan than you should Tell your doctor or pharmacist as soon as possible.
Danish: Hvis du har taget for meget Ribavirin Mylan Fortæl din læge eller apoteket det så hurtigt som muligt.
English: Titanium dioxide (E171) Capsule imprint:
Danish: Titandioxid (E171) Kapselprægning:
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 de kliniske forsøg, hvor patienterne blev behandlet i et år, var det usandsynligt, at de patienter, der ikke udviste virologisk respons efter seks måneders behandling (HCV-RNA under laveste detektionsgrænse) opnåede vedvarende virologisk respons (HCV-RNA under den laveste detektionsgrænse seks måneder efter behandlingens ophør).
English: White opaque body imprinted "riba/200" in green and a white opaque cap imprinted "riba/200" in green.
Danish: Hvid, uigennemsigtig krop mærket "riba/200" med grønt, og en hvid uigennemsigtig hætte mærket "riba/200" med grønt.
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 og interferon alfa.
English: a: Response to treatment was defined as undetectable HCV-RNA at 24 weeks post-treatment, lower limit of detection = 125 IU/ml.
Danish: a: Respons på behandling blev defineret som ikke detekterbar HCV-RNA ved 24 uger efter behandlingen, lavere grænse for detektion = 125 IE/ml.
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 genotype and viral load).
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 coinfektion) såvel som prognostiske faktorer på respons (HCV-genotype og virusbelastning).
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 behandling.
English: Anti-thyroid antibody positive
Danish: Positiv anti-thyroid antistof
English: When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy can induce a growth inhibition that may be irreversible in some patients.
Danish: Ved beslutningen om ikke at udsætte behandlingen, til barnet er voksent, er det vigtigt at tage med i betragtning, at kombinationsterapi kan forårsage væksthæmning, som kan være irreversibel hos nogle patienter.
English: The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14%.
Danish: Bioavailabiliteten af ribavirin 600 mg blev reduceret ved samtidig indtagelse af et antacidum indeholdende magnesium, aluminium og simeticon; AUCtf faldt 14 %.
English: NR: Non-responder- defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
Danish: NR: Non-responders defineres som serum/plasma-HCV-RNA-positive ved afslutning af mindst 12 ugers behandling.
English: Haemoglobin concentrations should be monitored closely during treatment and corrective action taken as necessary (see section 4.2).
Danish: Hæmoglobinkoncentrationer skal overvåges nøje under behandling, og der skal foretages korrigerende handlinger efter behov (se pkt.
English: A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age.
Danish: Ialt 107 patienter fik behandling hvoraf 52 % var kvinder, 89 % kaukasiske, 67 % med HCV Genotype 1 og 63 % < 12 år.
English: Table 4 provides guidelines for dose modification for patients with renal dysfunction.
Danish: Tabel 4 giver retningslinjer for dosisændring for patienter med nedsat nyrefunktion.
English: This medicine does not affect your ability to drive or use machines; however, interferon alfa-2b may affect your ability to drive or use machines.
Danish: Dette lægemiddel påvirker ikke din evne til at føre motorkøretøj eller betjene maskiner; dog kan interferon alfa-2b, påvirke din evne til at føre motorkøretøj eller betjene maskiner.
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 behovet for passende terapeutisk håndtering bør overvejes.
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 blevet set med alfa interferoner.
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det landsdækkende indberetningssystem angivet i Bilag V*.
English: Ribavirin concentrations are essentially unchanged by haemodialysis.
Danish: Ribavirinkoncentrationer er stort set uændrede af hæmodialyse.
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 abnormiteten aftager igen, kan ribavirin-dosen påbegyndes igen ved 600 mg dagligt og yderligere øges til 800 mg dagligt efter den behandlende læges skøn.
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: Ribavirin Mylan contains the active substance ribavirin.
Danish: Ribavirin Mylan indeholder det aktive stof ribavirin.
English: Plasma HCV -RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory *Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
Danish: HCV-RNA-serum måles ved et videnskabeligt baseret kvantitativt polymerase-kædereaktions-assay på et centralt laboratorium *Hensigt til at behandle-populationen inkluderer 7 patienter, hvor mindst 12 ugers tidligere behandling ikke er bekræftet.
English: Overall, approximately 36% (821/2,286) of patients had undetectable plasma HCV-RNA levels at week 12 of therapy measured using a research-based test (limit of detection 125 IU/ml).
Danish: Overordnet havde ca. 36 % (821/2.286) af patienterne ikke målbart HCV-RNA plasma niveau i den 12. behandlingsuge, målt ved hjælp af en videnskabelig baseret test (detektionsgrænse 125 IE/ml).
English: Co-infected patients with advanced liver disease receiving cART may be at increased risk of worsening liver function.
Danish: - Co-inficerede patienter med fremskreden leversygdom, der modtager cART, kan have øget risiko for forværring af leverfunktionen.
English: Table 9 Virologic response at treatment week 12, end of treatment response, relapse rate* and Sustained Virologic Response (SVR)
Danish: Tabel 9 Virologisk respons ved behandlingsuge 12, respons ved afslutning af behandlingen, tilbagefaldsrate *og vedvarende virologisk respons (SVR) Behandlingsgruppe
English: Ribavirin 15 mg/kg/day as 2 divided doses (n = 17)
Danish: Parameter ribavirin 15 mg/kg/dag fordelt på 2 doser (n = 17)
English: Table 3 Management of Adverse Reactions Laboratory Values
Danish: Tabel 3 Håndtering af bivirkninger Laboratorieværdier
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 CYP-enzymmedieret metabolisme af ribavirin.
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: Bioavailabiliteten af en enkelt oral dosis ribavirin forøgedes ved samtidig indtagelse af et måltid med højt fedtindhold (AUCtf og Cmax steg begge med 70 %).
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 daglig blev steady-state nået efter cirka fire uger med gennemsnitlige steady-state plasmakoncentrationer omkring 2.200 ng/ml.
English: If serum creatinine rises to > 2 mg/dl (Table 2) Ribavirin Mylan and interferon alfa-2b must be discontinued.
Danish: Hvis serumkreatinin stiger til > 2 mg/dl (Tabel 3) skal Ribavirin Mylan og interferon alfa-2b seponeres.
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 % (n=20) of children despite being off treatment for more than 5 years.
Danish: Tilgængelige langtidsdata hos børn i kombinationsbehandling med standard interferon/ribavirin er også indikativ for betragtelig højdereduktion (> 15 percentilreduktion i højdepercentilen i sammenligning med baseline) hos 21 % (n=20) af børnene, til trods for at børnene ikke har været behandlet i mere end 5 år.
English: Adult: ≥ 12g/dL (females); ≥ 13g/dL (males) Children and adolescents: ≥ 11g/dL (females); ≥ 12g/dL (males)
Danish: Voksne:  12 g/dl (kvinder);  13 g/dl (mænd) Børn og unge:  11 g/dl (kvinder);  12 g/dl (mænd)
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: Almindelige hæmatologiske test, blodkemi (komplet blodtælling [CBC] og differentialtælling, trombocyttal, elektrolytter, serumkreatinin, leverfunktionstest, urinsyre) og graviditetstest skal udføres hos alle patienter forud for behandling.
English: There were some cases of more severe neutropenia in patients treated with ribavirin capsules 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-kapsler 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: 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 listet i Tabel 5.
English: d: Ribavirin dosing was 800mg for patients < 60 kg, 1,000 mg for patients 60-75 kg, and 1,200 mg for patients > 75 kg.
Danish: d: ribavirin dosis var 800 mg for patienter < 60 kg, 1.000 mg for patienter 60-75 kg, og 1.200 mg for patienter
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 bioavailabilitet i denne undersøgelse skyldtes forsinket overførsel af ribavirin eller ændret pH.
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: Elderly patients (≥ 65 years of age)
Danish: Ældre patienter (i alderen  65 år)
English: • Psychiatric and central nervous system effects (such as depression, suicidal thoughts, attempted suicide and aggressive behaviour, etc.).
Danish: Psykiatriske effekter og centralnervesystemeffekter (f.eks. depression, selvmordstanker, selvmordsforsøg, aggressiv adfærd osv.).
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 bioavailabilitet i denne undersøgelse skyldtes forsinket overførsel af ribavirin eller ændret pH.
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: Indenfor 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: Your doctor has determined the correct dose of Ribavirin Mylan based on how much you or the child you are caring for weighs.
Danish: Din læge har bestemt den korrekte dosis af Ribavirin Mylan på basis af din eller barnets vægt.
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: The Ribavirin Mylan hard capsule is a white, opaque, hard capsule imprinted with green ink.
Danish: Ribavirin Mylan hårde kapsler er hvide, uigennemsigtige hårde kapsler med grønt påtryk.
English: If you are caring for a child and your doctor decides not to defer combination treatment with peginterferon alfa-2b or interferon alfa-2b until adulthood, it is important to understand that this combination therapy induces a growth inhibition that may be irreversible in some patients.
Danish: Hvis du er værge for et barn, og lægen beslutter ikke at udsætte kombinationsbehandling med peginterferon alfa-2b eller interferon alfa-2b indtil voksenalderen, er det vigtigt at forstå, at denne kombinationsbehandling inducerer en væksthæmning, der kan være irreversibel hos visse patienter.
English: The safety and efficacy of ribavirin used together with direct-acting-anti-virals in these patients has not been established.
Danish: Sikkerheden og effekten ved Ribavirins sikkerhed og virkning i anvendelse sammen med direkte virkende antivirale lægemidler hos disse patienter er endnu ikke klarlagt.
English: These time points (treatment week 4 and treatment week 12) have been shown to be predictive for sustained response (Table 10).
Danish: Disse tidspunkter (4- og 12 behandlingsuge) har vist sig at være prædiktiv med hensun til vedvarende respons (Tabel 10).
English: If an acute hypersensitivity reaction (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Ribavirin Mylan must be discontinued immediately and appropriate medical therapy instituted.
Danish: I tilfælde af udvikling af akut overfølsomhedsreaktion (for eksempel urticaria, angioødem, bronkiekonstriktion, anafylaksi), skal Ribavirin Mylan øjeblikkeligt seponeres og passende medicinsk behandling initieres.
English: c: Patients with genotype 3 low viral load (< 600,000 IU/ml) were to receive 24 weeks of treatment while those with genotype 3 and high viral load (≥ 600,000 IU/ml) were to receive 48 weeks of treatment.
Danish: c: Patienter med genotype 3 lav viral load (< 600.000 IE/ml) skulle modtage 24 ugers behandling mens de med genotype 3 og høj viral load (≥ 600.000 IE/ml) skulle modtage 48 uger behandling.
English: Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation, or suicide attempt.
Danish: Eksisterende eller tidligere alvorlig psykiatrisk lidelse, især alvorlig depression, selvmordstanker eller selvmordsforsøg.