FrancophonIA/ELRC3.0 huggingface dataset:
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: 2D-stregkode med det unikke id.
English: Please read the “Possible side effects” section of the Package Leaflet for the other medicines used in combination with Ribavirin Mylan.
Danish: Læs afsnittet "Bivirkninger" i indlægssedlen for de andre lægemidler, der bruges i kombination med Ribavirin Mylan.
English: Hepatic decompensation in HCV/HIV co-infected patients with advanced cirrhosis Co-infected patients with advanced cirrhosis receiving combined anti-retroviral therapy (cART) may be at increased risk of hepatic decompensation and death.
Danish: Hepatisk dekompensering hos HCV/hiv co-inficerede patienter med fremskreden cirrose Co-inficerede patienter med fremskreden cirrose, der modtager kombineret antiretroviral terapi (cART), kan have øget risiko for leverdekompensation og død.
English: Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Danish: Tillæg af behandling med alfa interferoner alene eller i kombination med ribavirin kan øge risikoen hos denne patientundergruppe.
English: The recommended dose and duration of Ribavirin Mylan depends on how much the patient weighs and the medicines that are used in combination.
Danish: Den anbefalede dosis og varighed for Ribavirin Mylan afhænger af, hvor meget patienten vejer, samt de lægemidler, der anvendes i kombination.
English: The selection of formulation is based on individual characteristics of the patient (see section 4.1).
Danish: Valg af formulering er baseret på patientens individuelle karakteristika (se pkt.
English: No data are available regarding dose modification for paediatric patients with renal impairment.
Danish: Der foreligger ingen data om dosisændring for pædiatriske patienter med nedsat nyrefunktion.
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 Within the 5 years follow-up post-treatment period, the children had a mean height of 44
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: All but one of the paediatric subjects remained sustained virologic responders during long-term follow-up after completion of treatment with interferon alfa-2b plus ribavirin.
Danish: Alle på nær én af de pædiatriske patienter forblev vedvarende virologisk respondenter under den langvarige opfølgning efter afslutning af behandling med interferon alfa-2b plus ribavirin.
English: Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits > 15 percentiles, 10 to 12 years after the end of treatment.
Danish: Sluthøjden var tilgængelig for 14 af disse børn og viste, at 12 fortsat udviste manglende højdevækst > 15 percentiler 10-12 år efter afsluttet behandling.
English: Excipient with known effect: each hard capsule contains 15 mg of lactose monohydrate.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 15 mg lactosemonohydrat.
English: In females of childbearing potential, Ribavirin Mylan must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Danish: Hos kvinder i den fødedygtige alder må behandling med Ribavirin Mylan ikke påbegyndes, før der foreligger en negativ graviditetstest umiddelbart forud for indledningen af behandlingen.
English: Anaemia (haemoglobin < 9.4 g/dl) was reported in 12% (23/194) of patients treated with ribavirin in combination with peginterferon alfa-2b.
Danish: Anæmi (hæmoglobin < 9,4 g/dl) blev rapporteret i 12 % (23/194) af patienterne, der blev behandlet med ribavirin i kombination med peginterferon alfa-2b.
English: The haemolytic anaemia associated with ribavirin therapy may result in deterioration of cardiac function and/or worsening of pre-existing cardiac disease.
Danish: Den hæmolytiske anæmi, der forbindes med ribavirinbehandling, kan medføre forringelse af hjertefunktionen og/eller forværring af allerede eksisterende hjertesygdom.
English: Ribavirin does not inhibit cytochrome P450 enzymes.
Danish: Ribavirin hæmmer ikke CYP-enzymer.
English: Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Povidone
Danish: Mikrocrystallinsk cellulose Lactosemonohydrat Natriumcroscarmellose Povidon
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 + 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 you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: - Hvis du oplever bivirkninger, skal du tale med din læge, apoteker eller sygeplejerske.
English: Bottles - Do not store above 30°C.
Danish: Flaske: Må ikke opbevares ved temperaturer over 30 °C.
English: Case by case benefit/risk assessment in children: The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1).
Danish: Den forventede fordel ved behandling skal nøje vægtes mod de sikkerhedsresultater observeret hos børn og unge i de kliniske forsøg (se pkt.
English: In children and adolescent patients receiving body surface area-adjusted dosing of peginterferon alfa-2b at 60 µg/m2/week, the log transformed ratio estimate of exposure during the dosing interval is predicted to be 58 % (90 % CI: 141-177 %) higher than observed in adults receiving 1.5 µg/kg/week.
Danish: Hos børn og unge patienter, der fik legemsflade-justeret dosering af peginterferon alfa-2b på 60 μg/m2/uge, forventes det log-transformerede forholdsskøn over eksponering i doseringsinterval at være 58 % (90 % CI: 141177 %) højere end observeret hos voksne, der fik 1,5 μg/kg/uge.
English: In children and adolescent patients treated with Ribavirin Mylan plus interferon alfa-2b, reduce Ribavirin Mylan dose to 7.5 mg/kg/day.
Danish: Hos børn og unge patienter behandlet med Ribavirin Mylan plus interferon alfa-2b skal Ribavirin Mylan-dosis reduceres til 7,5 mg/kg/dag.
English: Table 13 Sustained virological response rates (na,b (%)) in previously untreated children and adolescents by genotype and treatment duration - All subjects n = 107 24 weeks
Danish: (%)) i tidligere ubehandlede børn og unge med genotype og behandlingsvarighed - Alle forsøgspersoner n = 107 24 uger
English: Haemolysis: Ribavirin Mylan can cause a break down in red blood cells causing anaemia which may impair your heart function or worsen symptoms of heart disease.
Danish: Hæmolyse: Ribavirin Mylan kan forårsage nedbrydelse af røde blodlegemer og give anæmi, som kan forringe hjertefunktionen eller forværre symptomer på hjertesygdomme.
English: In clinical trials of 118 children and adolescents 3 to 16 years of age treated with combination therapy of interferon alfa-2b and ribavirin, 6% discontinued therapy due to adverse reactions.
Danish: I kliniske undersøgelser med 118 børn og unge 3 til 16 år, behandlet i kombination med interferon alfa-2b og ribavirin, afbrød 6 % behandling på grund af bivirkninger.
English: If you forget to take Ribavirin Mylan
Danish: Hvis du har glemt at tage Ribavirin Mylan
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with peginterferon alfa-2b (1.5 µg/kg)/ ribavirin combination therapy resulted in a higher sustained virologic response rate compared to peginterferon alfa-2b 1 µg/kg dose.
Danish: Hos patienter med afroamerikansk oprindelse (som er kendt for at være en dårlig prognostisk faktor for HCV udryddelse), medførte en behandling med peginterferon alfa-2b (1,5 μg/kg)/ribavirin kombinationsbehandling højere vedvarende virologisk responsrate sammenlignet med peginterferon alfa-2b 1 μg/kg dosis.
English: Response to the treatment was measured by Sustained Virologic Response (SVR) which is defined as undetectable HCV-RNA at 24 weeks post-treatment (see Table 9).
Danish: Respons på behandlingen blev målt ved vedvarende virologisk respons (SVR), der er defineret som ikke målbart HCV-RNA 24 uger efter behandlingen (se Tabel 9).
English: The pharmacokinetics of ribavirin (dose-normalized) in this trial was similar to those reported in a prior study of ribavirin in combination with interferon alfa-2b in children and adolescent patients and in adult patients.
Danish: De farmakokinetiske data for ribavirin (dosis-normaliseret) i dette studie svarede til dem rapporteret i et forudgående studie af ribavirin i kombination med interferon alfa-2b hos børn og unge patienter og hos voksne patienter.
English: BGP Products SRLTel: +40 372 579 000
Danish: BGP Products SRL Tel: +40 372 579 000
English: Talk to your doctor or pharmacist before taking Ribavirin Mylan.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Ribavirin Mylan.
English: Thus, Ribavirin Mylan must be administered with caution to patients with pre-existing cardiac disease (see section 4.3).
Danish: Ribavirin Mylan skal således anvendes med forsigtighed til patienter med forudeksisterende hjertesygdom (se pkt.
English: peginterferon alfa-2b (1.5 µg /kg/ week)
Danish: Peginterferon alfa-2b (1,5 µg/kg/ uge)
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Ribavirin Mylan, skal du henvende digtil den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Do not use this medicine after the expiry date which is stated on the bottle or blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Adult patients with severe renal impairment (creatinine clearance of < 30 mL/minute) and patients with End Stage Renal Disease (ESRD) or on haemodialysis should be administered Ribavirin Mylan 200 mg/day.
Danish: Voksne patienter med alvorlig nedsat nyrefunktion (kreatinin-clearance < 30 ml/minut) og patienter med terminal nyresygdom (End Stage Renal Disease, ESRD) eller i hæmodialyse skal administreres Ribavirin Mylan 200 mg/dag.
English: The following side effects have been reported with the combination of this medicine and an interferon alfa-2b product in children and adolescents:
Danish: Følgende bivirkninger er registreret for kombinationen af dette lægemiddel med et interferon alfa-2bprodukt hos børn og unge:
English: Haemoglobin: Patients with History of Stable Cardiac Disease
Danish: Hæmoglobin: Patienter med tidligere stabil hjertesygdom
English: Ribavirin Mylan is indicated for the treatment of chronic hepatitis C (CHC) and must only be used as part of a combination regimen with interferon alfa-2b (adults, children (3 years of age and older) and adolescents).
Danish: Ribavirin Mylan er indiceret til behandling af kronisk hepatitis C (CHC) og må kun anvendes som del af en kombinationsbehandling med interferon alfa-2b (voksne, børn (på 3 år eller derover) og unge).
English: - Retreatment of relapse patients with ribavirin and interferon alfa-2b combination treatment 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: - Genbehandling af relaps patienter med ribavirin og interferon alfa-2b kombinations behandling To undersøgelser vurderede anvendelsen af ribavirin + interferon alfa-2b kombinationsbehandling hos relaps patienter (C95-144 og I95-145); 345 patienter med kronisk hepatitis, som havde fået relaps efter tidligere interferonbehandling, blev behandlet i seks måneder med en seks måneders opfølgning.
English: Caution should be taken in HIV-positive subjects co-infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa-2b/ribavirin treatment.
Danish: Der bør udvises forsigtighed hos hiv-positive personer, som samtidig er inficeret med HCV, og som får behandling med nukleosid revers transcriptasehæmmer (NRTI) (især ddI og d4T) og kombineret interferon alfa-2b/ribavirin behandling.
English: Ribavirin Mylan must be used in combination therapy as described in section 4.1.
Danish: Ribavirin Mylan skal anvendes i kombinationsterapi som beskrevet i pkt.
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and pegylated interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Danish: Populationen der var indrulleret bestod hovedsageligt af børn med mild til moderat hepatitis C. På grund af mangel på data hos børn med svær progression af sygdommen, og potentialet for uønskede virkninger, fordel/risiko for kombinationen af ribavirin og pegyleret interferon alfa-2b skal det overvejes nøje i denne population (se pkt.
English: Ribavirin Mylan must be used in combination with interferon alfa-2b (3 million international units [MIU] three times a week).
Danish: Ribavirin Mylan skal bruges i kombination med interferon alfa-2b (3 millioner internationale enheder [MIE] tre gange ugenligt).
English: Ribavirin Mylan has no or negligible influence on the ability to drive and use machines; however, peginterferon alfa-2b or interferon alfa-2b used in combination may have an effect.
Danish: Ribavirin Mylan påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner; dog kan peginterferon alfa-2b eller interferon alfa-2b anvendt i kombination, der anvendes i kombination, have en effekt.
English: Not Known:
Danish: Ikke kendt
English: Ribavirin Mylan therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
Danish: Behandling med Ribavirin Mylan må kun initieres, når der foreligger en negativ graviditetstest umiddelbart før behandlingsstart.
English: If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Ribavirin and peginterferon alfa-2b or interferon alfa-2b be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Danish: Hvis psykiatriske symptomer vedvarer eller forværres, eller selvmordstanker identificeres, anbefales det, at behandling med ribavirin og peginterferon alfa-2b eller interferon alfa-2b afbrydes, og at patienten følges, og psykiatrisk intervention institueres efter behov.
English: Thrombocytopenia, lymphadenopathy
Danish: Thrombocytopeni, lymfadenopati,
English: Twenty-four percent of children (11/46) treated for 24 weeks and 40 % of children (19/48) treated for 48 weeks had a > 15 percentile height-for-age decrease from pre-treatment to the end of 5 year long-term follow-up compared to pre-treatment baseline percentiles.
Danish: Hos 24 % (11/46) af de børn, der blev behandlet i 24 uger, og 40 % (19/48) af de børn, der blev behandlet i 48 uger, var der en reduktion på > 15 percentil for alderen i perioden fra før behandling til afslutningen af den 5-årige langtidsopfølgning i forhold til baseline-percentilerne før forbehandlingen.
English: Patients with existence of, or history of severe psychiatric conditions: If treatment with Ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Danish: Patienter med aktuelle eller tidligere alvorlige psykiatriske lidelser: Hvis behandling med ribavirin i kombination med peginterferon alfa-2b eller interferon alfa-2b vurderes nødvendig hos voksne patienter med eksisterende eller tidligere alvorlige psykiatriske lidelser, bør denne kun initieres efter en passende individualiseret diagnostisk og terapeutisk håndtering af den psykiatriske lidelse er blevet sikret.
English: Capsule contents:
Danish: Kapselindhold:
English: Propylene glycol Ammonia solution, concentrated Yellow iron oxide (E172) Indigotine (E132) Titanium dioxide (E171)
Danish: Koncentreret ammoniakopløsning Gul jernoxid (E172) Indigotin (E132)
English: Very rarely reported side effects (may affect up to 1 in 10,000 people): suicide, stroke (cerebrovascular events).
Danish: Meget sjældne bivirkninger (forekommer hos op til 1 ud af 1.0000 patienter): - selvmord.
English: - Genotoxicity: ribavirin induces genotoxicity (see section 5.3).
Danish: - Genotoksicitet: Ribavirin bevirker genotoksicitet (se pkt.
English: Ribavirin Dose (mg/kg)
Danish: HCV Genotype ribavirin dosis (mg/kg)
English: Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Ribavirin combination therapy with peginterferon alfa-2b or interferon alfa-2b, and even after treatment discontinuation mainly during the 6-month follow-up period.
Danish: Alvorlig CNS-påvirkning, særlig depression, selvmordstanker og selvmordsforsøg, er set hos nogle patienter under ribavirin kombinationsbehandling med peginterferon alfa-2b eller interferon alfa-2b, og selv efter behandlingsophør især under 6-måneders opfølgningsperioden.
English: Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated-ribavirin for co-HCV infection (see section 4.4).
Danish: Mitokondriel toksicitet og mælkesyreacidose har været rapporteret hos HIV-positive patienter, der modtog NRTI regimen og associeret ribavirin for samtidig HCV-infektion (se pkt.
English: Multiple-dose pharmacokinetic properties for ribavirin and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 15.
Danish: Flerdosis farmakokinetiske egenskaber for ribavirin kapsler og interferon alfa-2b hos børn og unge med kronisk hepatitis C i alderen 5 til 16 år er opsummeret i Tabel 15.
English: There are no data for paediatric patients with cardiac disease (see section 4.4).
Danish: Der er ingen data for pædiatriske patienter med hjertesygdom (se pkt.
English: If you get any side effects talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, skal du tale med din læge, apoteker eller sygeplejerske.
English: Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of Ribavirin Mylan.
Danish: Derfor anbefales det, at alle patienters nyrefunktion evalueres før påbegyndelse af behandling med Ribavirin Mylan.
English: Cardiac murmur * Since ribavirin has always been prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or non-pegylated).
Danish: * Da ribavirin altid er blevet ordineret med et alfa interferon-produkt, og da de anførte bivirkninger, der afspejler erfaring efter markedsføringen, ikke tillader nøjagtig kvantificering af hyppighed, stammer den ovenfor indberettede frekvens fra kliniske forsøg med ribavirin i kombination med interferon alfa-2b (pegyleret eller ikke-pegyleret).
English: Thyroid supplemental monitoring specific for children and adolescents: Approximately 12% to 21% of children treated with Ribavirin and interferon alfa-2b (pegylated and non-pegylated) developed increase in thyroid stimulating hormone (TSH).
Danish: Supplerende thyroideamonitorering specifikt for børn og unge Omtrent 12 til 21 % af børn behandlet med ribavirin og interferon alfa-2b (pegyleret og ikke pegyleret) fik øget thyroideastimulerende hormon (TSH).
English: Extreme care must be taken to avoid pregnancy in partners of male patients taking Ribavirin Mylan (see sections 4.3, 4.4 and 5.3).
Danish: Den yderste forsigtighed skal udvises for at undgå graviditet hos partnere til mandlige patienter, der tager Ribavirin Mylan (se pkt.
English: Alternating doses, 200 mg and 400 mg every other day Less than 30 mL/min 200 mg daily
Danish: Vekslende doser, 200 mg og 400 mg hver anden dag
English: Only the description of the use of ribavirin from the original development with (peg)interferon alfa-2b is detailed in the current SmPC.
Danish: Kun beskrivelsen af brugen af ribavirin fra den oprindelige udvikling med (peg)interferon alfa-2b er beskrevet i det nuværende produktresume.
English: The pharmacokinetics of ribavirin is altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients (see section 5.2).
Danish: Farmakokinetikken for ribavirin er ændret hos patienter med nedsat nyrefunktion på grund af tilsyneladende reduktion af kreatinin-clearance hos disse patienter (se pkt.
English: For complete information be sure to read the “How to use” section of the Package Leaflet for interferon alfa-2b.
Danish: For yderligere oplysninger bedes du læse afsnittet "Sådan bruges" i indlægssedlen for interferon alfa-2b.
English: Table 7 Sustained response rates with ribavirin + peginterferon alfa-2b (By ribavirin dose [mg/kg], genotype and viral load) HCV Genotype
Danish: Tabel 7 Vedvarende responsrater med ribavirin + peginterferon alfa2b (efter ribavirindosis [mg/kg], genotype og virusbelastning)
English: Abdominal pain, abdominal pain upper, vomiting, diarrhoea, nausea
Danish: Abdominal smerte, øvre abdominal smerte, opkastning, diarre, kvalme
English: Note 2: In adult patients and children and adolescent patients treated with Ribavirin Mylan plus interferon alfa-2b, reduce the interferon alfa-2b dose by one-half dose.
Danish: Note 2: Hos voksne patienter og børn samt unge patienter behandlet med Ribavirin Mylan plus interferon alfa-2b skal interferon alfa-2b-dosis reduceres med en halv dosis.
English: % (number) of patients peginterferon alfa-2b 1.5 µg/kg + Ribavirin peginterferon alfa-2b 1 µg/kg + Ribavirin peginterferon alfa-2a 180 µg + Ribavirin
Danish: % (antal) af patienter peginterferon alfa2b 1,5 μg/kg + ribavirin peginterferon alfa-2b 1 μg/kg + ribavirin peginterferon alfa-2a 180 µg + ribavirin
English: Paediatric population (patients under the age of 18 years): Ribavirin Mylan may be used in combination with interferon alfa-2b in children (3 years of age and older) and adolescents.
Danish: Pædiatrisk population (patienter under 18 år): Ribavirin Mylan kan bruges i kombination med interferon alfa-2b til børn på 3 år og derover og unge.
English: Predictability of sustained virological response in naïve patients Virological response by week 12 is defined as at least 2-log viral load decrease or undetectable levels of HCV-RNA.Virological response by week 4 is defined as at least 1-log viral load decrease or undetectable levels of HCV-RNA.
Danish: Forudsigelighed med hensyn til vedvarende virologisk respons hos naive patienter Det virologisk respons ved uge 12, defineret som et fald på mindst 2-log viral load eller ikkedetekterbart niveau af HCV RNA.