FrancophonIA/ELRC3.0 huggingface dataset:
English: Male: impotence, prostatitis, erectile dysfunction, Sexual dysfunction (not specified)*
Danish: Mænd: Impotens, prostatitis, erektil dysfunktion, Begge køn: Seksuel dysfunktion (ikke specificeret)٭
English: Oral formulations of ribavirin monotherapy have been investigated as therapy for chronic hepatitis C in several clinical trials.
Danish: Orale former for ribavirin-monoterapi er blevet undersøgt til behandling af kronisk hepatitis C i flere kliniske undersøgelser.
English: - If you get any side effects talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: - Increased thyroid stimulating hormone (TSH) in children and adolescents - Severe ocular disorders - Dental and periodontal disorders.
Danish: - Forhøjet thyreoideastimulerende hormon (TSH) hos børn og unge - Svære øjensygdomme - Dentale og parodontale lidelser.
English: Only 1 subject discontinued therapy as the result of an adverse reaction (thrombocytopenia).
Danish: Kun 1 forsøgsperson ophørte behandlingen som følge af en bivirkning (trombocytopeni).
English: Due to substantial increases in ribavirin plasma concentrations in patients with moderate and severe renal impairment, ribavirin dose adjustments are recommended in adult patients with creatinine clearance < 50 mL/minute.
Danish: På grund af væsentlige stigninger i plasmakoncentrationen af ribavirin hos patienter med moderat og svært nedsat nyrefunktion anbefales dosisjustering af ribavirin hos voksne patienter med kreatininclearance < 50 ml/min.
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 hypothyroidisme (3 %) og 5 forsøgspersoner modtog levothyroxinbehandling for hypothyroidisme / forhøjede TSH.
English: Dose modification for paediatric patients
Danish: Dosisjustering for pædiatriske patienter
English: Ribavirin must be used in combination with other medicinal products (see section 5.1).
Danish: Ribavirin skal anvendes i kombination med andre lægemidler (se pkt.
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: If the child is weighing less than 47 kg or unable to swallow tablets an oral solution of ribavirin should be used.
Danish: Hvis barnet vejer under 47 kg eller ikke kan sluge tabletten, skal der anvendes en oral opløsning af ribavirin.
English: Pancytopenia: Ribavirin Teva Pharma B.V. can cause a decrease in your platelet and red and white blood cell count when used in combination with peginterferon.
Danish: Pancytopeni: Ribavirin Teva Pharma B.V kan medføre nedsat antal blodplader samt røde og hvide blodlegemer, når det anvendes sammen med peginterferon.
English: Weight loss and growth inhibition were very common during the treatment (at the end of treatment, mean decrease from baseline in weight and in height percentiles were of 15 percentiles and 8 percentiles, respectively) and growth velocity was inhibited (< 3rd percentile in 70 % of the patients).
Danish: Vægttab og væksthæmning var meget almindeligt under behandlingen (ved slutningen af behandlingen var gennemsnitlig reduktion fra baseline i vægt- og højdepercentil henholdsvis 15 percentiler og 8 percentiler) og væksthastighed var inhiberet (< 3. percentil i 70 % af patienterne).
English: The following side effects have been reported with the combination of ribavirin and an alpha interferon product in adults:
Danish: Følgende bivirkninger er blevet rapporteret med kombinationen af ribavirin og et alfa interferon produkt hos voksne :
English: Note: For patients who weigh < 47 kg, or are unable to swallow tablets, ribavirin oral solution is available and should be used if appropriate.
Danish: Bemærk: For patienter som vejer < 47 kg eller som ikke er i stand til at synke tabletter, er ribavirin oral opløsning tilgængelig og skal anvendes, hvis det skønnes nødvendigt.
English: In particular, decrease in mean height percentile from baseline to the end of the long-term follow-up was most prominent in prepubertal age children (see section 4.4).
Danish: Reduktion i middelhøjdepercentil fra baseline til udgangen af langtidsopfølgningen var mest fremtrædende hos præpubertale børn (se pkt.
English: Haemoglobin in patients with No Cardiac Disease
Danish: Hæmoglobin hos patienter uden hjertesygdom
English: Elderly ( 65 years of age)
Danish: Ældre (i alderen ≥ 65 år)
English: Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme*
Danish: Stevens Johnson syndrom٭, toksisk epidermal nekrolyse٭, erythema multiforme٭
English: Discontinue ribavirin if:
Danish: Afbryd ribavirin-behandlingen, hvis:
English: Ribavirin Teva Pharma B.V. tablets are to be administered orally each day in two divided doses (morning and evening) with food.
Danish: Ribavirin Teva Pharma B.V.-tabletter skal indtages oralt hver dag fordelt på to doser (morgen og aften) samtidig med et måltid.
English: thoughts about threatening the life of others, mania (excessive or unreasonable enthusiasm), pericarditis (inflammation of the lining of the heart), pericardial effusion [a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself], change in colour of the tongue.
Danish: - tanker om at true andre på livet, - mani (unormalt stor eller unødvendig entusiasme), - perikarditis (betændelse i hjertesækken), perikardial effusion [en væskeansamling, der udvikles mellem perikardium (hjertesækken) og selve hjertet], - ændring i tungens farve.
English: Two trials examined the use of ribavirin and interferon alfa-2b combination treatment in relapse patients (C95-144 and I95-145); 345 chronic hepatitis patients who had relapsed after previous interferon treatment were treated for six months with a six month follow-up.
Danish: To undersøgelser vurderede anvendelsen af Ribavirin og interferon alfa-2b-kombinationsbehandling hos tilbagefaldspatienter (C95-144 og I95-145); 345 patienter med kronisk hepatitis, som havde fået tilbagefald efter tidligere interferonbehandling, blev behandlet i seks måneder med en seks måneders opfølgning.
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/peginterferon alfa-2b var milde eller moderate.
English: Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite
Danish: Hyperglykæmi, hyperuricæmi, hypokalcæmi, dehydrering, øget appetit
English: Micturition frequency, polyuria, urine abnormality
Danish: Øget vandladningsfrekvens, polyuri, abnorm urin
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: Patients whose dose of Ribavirin Teva Pharma B.V. is reduced to 600 mg daily receive one 200 mg tablet in the morning and two 200 mg tablets in the evening.
Danish: Patienter, hvis dosis af Ribavirin Teva Pharma B.V er reduceret til 600 mg dagligt får en 200 mg tablet om morgenen og to 200 mg tabletter om aftenen.
English: Please refer to the SmPC of (peg)interferon alfa for details on the recommendations of monitoring and management regarding the adverse reactions listed below before initiating therapy and other precautions associated with (peg)interferon alfa.
Danish: Der henvises til SmPC for (peg)interferon alfa for nærmere oplysninger om monitorering og håndtering af de bivirkninger, som er anført nedenfor, før initiering af behandling og for oplysninger vedrørende andre forsigtighedsregler forbundet med (peg)interferon alfa.
English: Genotype 1 ≤ 600,000 IU/mL
Danish: Genotype 1 ≤ 600.000 IE/ml
English: 3 x 200 mg tabletsa
Danish: 3 x 200 mg tablettera
English: Table 2 provides guidelines for dose modifications and discontinuation based on the patient's haemoglobin concentration, cardiac status and indirect bilirubin concentration.
Danish: Tabel 2 viser retningslinjer for dosisjustering og behandlingsafbrydelse på basis af patientens hæmoglobinkoncentration, kardialstatus og indirekte bilirubinkoncentration.
English: The decision to treat should be made on a case by case.
Danish: Beslutningen om at behandle skal træffes individuelt fra patient til patient.
English: Creatinine Clearance
Danish: Kreatininclearance
English: Facial palsy, mononeuropathies
Danish: Ansigtslammelse, mononeuropati
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: Homicidal ideation*, mania*, mental status change
Danish: Drabstanker٭, mani٭, ændring i mental status
English: Ribavirin therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Danish: Ribavirin behandling må ikke initieres før et negativt resultat fra en graviditetstest er opnået umiddelbart før behandlingsstart.
English: The use of ribavirin in combination treatment with interferon alfa-2b was evaluated in a number of clinical trials.
Danish: Anvendelsen af ribavirin i kombinationsbehandling med interferon alfa-2b blev vurderet i en række kliniske undersøgelser.
English: Three trials examined the use of interferon in naïve patients, two with ribavirin + interferon alfa-2b (C95-132 and I95-143) and one with ribavirin + peginterferon alfa-2b (C/I98-580).
Danish: Tre undersøgelser vurderede anvendelsen af interferon hos naive patienter, to med ribavirin + interferon alfa-2b (C95-132 og I95-143) og en med ribavirin + peginterferon alfa-2b (C/I98-580).
English: Haemoglobin concentrations should be monitored closely during treatment and corrective action taken as necessary (see section 4.2).
Danish: Hæmoglobinkoncentrationen skal monitoreres nøje under behandlingen, og korrigerende tiltag skal kunne iværksættes, såfremt det er nødvendigt (se pkt.
English: Ribavirin dose (mg/kg)
Danish: Ribavirin-dosis (mg/kg)
English: Due to the lack of data in these two multicentre trials for children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Danish: Grundet manglende resultater fra disse to multicenterforsøg med børn med alvorlig sygdomsprogression, samt muligheden for bivirkninger, bør forholdet mellem fordele og ulemper af kombinationen ribavirin og interferon alfa-2b overvejes nøje i denne population (se pkt.
English: Table 4 provides guidelines for dose modification for patients with renal dysfunction.
Danish: Tabel 4 viser retningslinjer for dosisjustering for patienter med nedsat nyrefunktion.
English: The adverse reactions listed in Table 5 are based on experience from clinical trials in adult naïve patients treated for 1 year and post-marketing use.
Danish: Tabel 5 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: A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in two previously mentioned multicentre trials.
Danish: Et fem-årigt langtidsopfølgende studie indrullerede 97 pædiatriske patienter med kronisk hepatitis C, efter behandling i to af de tidligere nævnte multicenterstudier.
English: Upon multiple dosing, ribavirin accumulates extensively in plasma with a six-fold ratio of multiple-dose to single-dose AUC12hr.
Danish: Efter flergangsdosering ophobes ribavirin i udstrakt grad i plasma med en seks gange større AUC12hr end ved engangsdosis.
English: Polyvinyl alcohol - partly hydrolysed Macrogol / Polyethylene glycol 3350 Titanium dioxide (E171) Talc
Danish: Polyvinylalkohol - delvist hydrolyseret Macrogol// Polyethylenglycol 3350 Titandioxid (E171)
English: Method of administration Ribavirin Teva Pharma B.V. tablets should be administered orally with food.
Danish: Administration Ribavirin Teva Pharma B.V.-tabletter skal gives oralt sammen med mad.
English: Laboratory values
Danish: Laboratorieværdier
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 7), while response rates in patients that received > 13.2 mg/kg ribavirin were even higher.
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 7), mens responsrater for patienter, der fik > 13,2 mg/kg ribavirin, var endnu højere.
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 98 % [95 % CI: 95 %, 100 %] for paediatric patients treated with interferon alfa-2b and ribavirin.
Danish: Kaplan-Meier-estimatet for fortsat vedvarende respons i 5 år er 98 % [95 % CI: 95 %, 100 %] for pædiatriske patienter behandlet med interferon alfa-2b og ribavirin.
English: A five-year long-term, observational, follow-up study enrolled 94 paediatric chronic hepatitis C patients after treatment in a multicentre trial.
Danish: Et fem-årigt langtidsopfølgende observationsstudie indrullerede 94 pædiatriske patienter med kronisk hepatitis-C efter behandling i et multicenterstudie.
English: All
Danish: Alle
English: 2 tablets in the morning and 2 tablets in the evening See adult dose
Danish: 2 tabletter om morgenen og 2 tabletter om aftenen Se voksendosis
English: Pneumonia, ascariasis, enterobiasis, herpes zoster, cellulitis
Danish: Lungebetændelse, askariose, enterobiasis, herpes zoster, cellulitis
English: In the treatment phase of 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 behandlingsfasen af dette studie var den mest udbredte bivirkning i alle forsøgspersonerne feber (80 %), hovedpine (62 %), neutropeni (33 %), træthed (30 %), anoreksi (29 %) og injektionskoncentration-site erytem (29 %).
English: The haemolytic anaemia associated with ribavirin therapy may result in deterioration of cardiac function and/or worsening of pre-existing cardiac disease.
Danish: Hæmolytisk anæmi forbundet med ribavirin-behandling kan resultere i forringelse af hjertefunktion og/eller forværring af allerede eksisterende hjertesygdom.
English: Light pink to pink, (debossed with “93” on one side and “7232” on the other).
Danish: Lys pink til pink, (præget med "93" på den ene side og "7232" på den anden side).
English: In this trial, the combination of ribavirin and peginterferon alfa-2b (1.5 micrograms/kg/week) was significantly more effective than the combination of ribavirin and interferon alfa-2b, particularly in patients infected with Genotype 1.
Danish: I denne undersøgelse var kombinationen af ribavirin og peginterferon alfa-2b (1,5 mikrogram/kg/uge) signifikant mere effektiv end kombinationen af ribavirin og interferon alfa-2b, især hos patienter inficeret med genotype 1.
English: In case of serious adverse reaction potentially related to medicinal products used in combination with ribavirin, refer to the corresponding SmPC of these medicinal products as some combination regimens do not adhere to the ribavirin dose modification and/or discontinuation guidelines as described in
Danish: I tilfælde af en alvorlig bivirkning, som potentielt er relateret til lægemidler, der anvendes i kombination med ribavirin, henvises til SmPC'erne for disse lægemidler, da visse kombinationsregimer ikke følger retningslinjerne for dosisjustering og/eller seponering af ribavirin som beskrevet i Tabel 2.
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 97 % (95 % CI: 95-99 %) for patients receiving nonpegylated 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: In addition, in a 26 week carcinogenicity study using the heterozygous p53(+/-) mouse model, ribavirin did not produce tumours at the maximally tolerated dose of 300 mg/kg (plasma exposure factor approximately 2.5 compared to human exposure).
Danish: Derudover fremkaldte ribavirin ikke tumorer i en 26 ugers karcinogenicitetsundersøgelse med den heterozygote p53(+/-) musemodel og den maksimalt tolererede dosis på 300 mg/kg (plasma eksponeringsfaktor cirka 2,5 sammenlignet med human eksponering).
English: Ribavirin monotherapy must not be used.
Danish: Ribavirin må ikke anvendes som monoterapi.
English: When used in combination with peginterferon alfa-2b or interferon alfa-2b, ribavirin did not cause any effects not previously seen with either active substance alone.
Danish: Ved anvendelse i kombination med peginterferon alfa-2b eller interferon alfa-2b forårsagede ribavirin ikke nogen virkninger, som ikke tidligere var set med hvert aktivt stof alene.
English: Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare
Danish: Abnorm opførsel, nedtrykt humør, følelsesmæssig forstyrrelse, frygt, mareridt
English: No pharmacokinetic interaction appears between ribavirin and hepatic function (see section 5.2).
Danish: Der synes ikke at være farmakokinetisk interaktion mellem ribavirin og leverfunktionen (se pkt.
English: In clinical trials C95-132 and I95-143, ribavirin + interferon alfa-2b combination therapy proved to be significantly more effective than interferon alfa-2b monotherapy (a doubling in sustained response).
Danish: I kliniske undersøgelser C95-132 og I95-143 viste ribavirin + interferon alfa-2bkombinationsbehandling sig at være signifikant mere effektiv end interferon alfa-2b monoterapi (en fordobling i vedvarende respons).
English: All Genotype
Danish: Alle Genotype
English: In individual cases where the benefit of administering ribavirin concomitantly with azathioprine warrants the potential risk, it is recommended that close hematologic monitoring be done during concomitant azathioprine use to identify signs of myelotoxicity, at which time treatment with these medicines should be stopped (see section 4.4).
Danish: I individuelle tilfælde, hvor fordelen ved administrationen af ribavirin sammen med azathioprin opvejer den potentielle risiko, anbefales tæt hæmatologisk monitorering ved samtidig brug af azathioprin for at identificere tegn på myelotoksicitet.
English: Severe adverse reactions were reported in 7 % (8/107) of all subjects and included injection site pain (1 %), pain in extremity (1 %), headache (1 %), neutropenia (1 %), and pyrexia (4 %).
Danish: Alvorlige bivirkninger blev rapporteret hos 7 % (8 / 107) af alle forsøgspersonerne og inkluderede smerter ved injektionsstedet (1 %), smerter i ekstremitet (1 %), hovedpine (1 %), neutropeni (1 %) og feber (4 %).
English: Film coating, composed of : polyvinyl alcohol - partly hydrolysed, macrogol / polyethylene glycol 3350, titanium dioxide (E171), talc, iron oxide red, iron oxide yellow, iron oxide black.
Danish: Filmovertræk: polyvinylalkohol - delvist hydrolyseret, macrogol/polyethylenglycol 3350, titandioxid (E171), talcum, rød jernoxid, gul jernoxid, sort jernoxid.
English: * For patients receiving a 1,000 mg (< 75 kg) or 1,200 mg (> 75 kg) dose, ribavirin dose should be reduced to 600 mg/day (administered as one 200 mg tablet in the morning and two 200 mg tablets in the evening).
Danish: * For patienter, som får en dosis på 1.000 mg (< 75 kg) eller 1.200 mg (> 75 kg), skal ribavirin-dosis reduceres til 600 mg/dag (administreret som en 200 mg tablet om morgenen og to 200 mg tabletter om aftenen).
English: Upon cessation of treatment, essentially total recovery from ribavirin-induced testicular toxicity occurred within one or two spermatogenic cycles (see section 4.6).
Danish: Efter behandlingsophør forekom praktisk taget fuldstændig bedring fra ribavirininduceret testistoksicitet inden for en til to sædcelledannende cykli (se pkt.
English: For use in patients with decompensated cirrhosis, see the corresponding SmPC of the medicinal products used in combination with ribavirin.
Danish: Ved brug hos patienter med dekompenseret cirrose henvises til SmPC'erne for de lægemidler, der anvendes i kombination med ribavirin.
English: This should be discussed with your doctor (see “Do not take Ribavirin Teva Pharma B.V.”).
Danish: Dette skal du tale med din læge om (se afsnittet ”Tag ikke Ribavirin Teva Pharma B.V.”).
English: Combination therapy with ribavirin and interferon alfa-2b resulted in a sustained virological response that was ten-fold higher than that with interferon alfa-2b alone (49 % vs 5 %, p < 0.0001).
Danish: Kombinationsbehandling med ribavirin og interferon alfa-2b resulterede i et vedvarende virologisk respons, der var ti gange større end ved interferon alfa-2b alene (49 % mod 5 %, p < 0,0001).
English: If needed, 2nd dose reduction of Ribavirin Teva Pharma B.V. is by an additional 200 mg/day.
Danish: 2. dosisreduktion af Ribavirin Teva Pharma B.V er med yderligere 200 mg/dag, hvis det er nødvendigt.
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 (see section 4.4).
Danish: Fertile kvinder skal anvende effektiv antikonception under behandling og i fire måneder efter, behandlingen er afsluttet; månedlige rutine graviditetsundersøgelser skal udføres i denne periode.
English: These include: - Severe psychiatric and central nervous system effects (such as depression, suicidal ideation,
Danish: Disse inkluderer: - Svære psykiatriske påvirkninger og påvirkninger af centralnervesystemet (såsom depression,
English: All Genotypes
Danish: Alle genotyper
English: Thus, ribavirin must be administered with caution to patients with pre-existing cardiac disease (see section 4.3).
Danish: Ribavirin skal således anvendes med forsigtighed hos patienter med forudeksisterende hjertesygdom (se pkt.
English: Decreases in haemoglobin, white blood cells, platelets, neutrophils and increase in bilirubin may require dose reduction or permanent discontinuation from therapy (see section 4.2).
Danish: Fald i hæmoglobin, hvide blodlegemer, blodplader, neutrofiler og stigning i bilirubin kan påkræve en dosisreduktion eller permanent seponering af behandlingen (se pkt.
English: 200 mg daily
Danish: 200 mg dagligt
English: Teva Pharmaceutical Works Private Limited Company Pallagi út 13
Danish: Teva Pharmaceutical Works Private Limited Company
English: Alopecia, pruritus, skin dry, rash
Danish: Alopeci, pruritus, tør hud, udslæt
English: peginterferon alfa-2b (1.5 µg /kg/ week)
Danish: peginterferon alfa-2b (1,5 µg /kg/ uge)
English: CD4 lymphocytes decrease
Danish: Fald i CD4-lymfocytter