FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Incivo (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), nausea (feeling sick), diarrhoea, vomiting, haemorrhoids (piles), proctalgia (anal pain), pruritus (itching) and rash.
Danish: De hyppigste bivirkninger ved Incivo (som kan forekomme hos flere end 1 ud af 10 patienter) er anæmi (lavt antal røde blodlegemer), kvalme, diarré, opkastning, hæmorider, proktalgi (smerter i endetarmen), pruritus (kløe) og udslæt.
English: Incivo was investigated in three main studies in patients infected with hepatitis C. The first study involved 1,095 previously untreated patients, and the second study involved 663 patients who had already been treated with peginterferon alfa and ribavirin but were still infected.
Danish: Incivo blev undersøgt i tre hovedundersøgelser hos patienter med hepatitis C. Den første undersøgelse omfattede 1 095 tidligere ubehandlede patienter, og den anden undersøgelse omfattede 663 patienter, som allerede var blevet behandlet med peginterferon alfa og ribavirin, men som stadig led af sygdommen.
English: It is used in adults who have compensated liver disease (when the liver is damaged but is still functioning normally) including cirrhosis (scarring of the liver) either in previously untreated patients or in those who have already been treated with interferon alfa.
Danish: Det anvendes hos voksne med kompenseret leversygdom (når leveren er beskadiget, men stadig er i stand til at fungere normalt), herunder cirrose (skrumpelever), enten hos patienter, som ikke er blevet behandlet tidligere, eller hos patienter, som tidligere er blevet behandlet med interferon alfa.
English: Treatment with ribavirin and peginterferon alfa will continue for a longer period, based on whether the patient has been treated before and test results during their Incivo treatment.
Danish: Behandling med ribavirin og peginterferon alfa skal fortsætte i en længere periode, alt efter om patienten er blevet behandlet tidligere og alt efter testresultaterne under behandlingen med Incivo.
English: A third study in previously untreated patients compared the effects of giving peginterferon alfa and ribavirin for different lengths of time (either six months or one year) together with three months of Incivo treatment.
Danish: I en tredje undersøgelse hos tidligere ubehandlede patienter sammenlignedes virkningerne af at give peginterferon alfa og ribavirin med forskellig behandlingsvarighed (enten seks måneder eller et år) sammen med tre måneders behandling med Incivo.
English: The Committee noted that the main risks identified were severe rash and the possibility of the virus developing drug resistance, but considered that these risks were manageable.
Danish: Udvalget bemærkede, at de største risici, der blev identificeret, var alvorligt udslæt og muligheden for, at virussen udvikler resistens mod lægemidlet.
English: Incivo is used to treat chronic (long term) hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in combination with two other medicines, peginterferon alfa and ribavirin.
Danish: Incivo anvendes til behandling af kronisk (langvarig) hepatitis C (en leversygdom, der skyldes infektion med hepatitis C-virus) i kombination med to andre lægemidler, peginterferon alfa og ribavirin.
English: The third study showed that in patients treated with Incivo, giving peginterferon alfa and ribavirin for six months was as effective as giving these medicines for one year, since 92% of patients receiving them for six months tested negative for hepatitis C compared with 88% of patients
Danish: Den tredje undersøgelse viste, at hos patienter, der fik Incivo, var det lige så effektivt at give peginterferon alfa og ribavirin i seks måneder som at give disse lægemidler i et år, eftersom 92 % af de patienter, der fik dem i seks måneder, blev testet negative for hepatitis C sammenlignet med 88 % af de patienter, der fik dem i et år.
English: Both studies compared Incivo with placebo (a dummy treatment) added to a course of peginterferon alfa and ribavirin.
Danish: I begge undersøgelser sammenlignedes Incivo med placebo (en uvirksom behandling), som blev tilføjet et behandlingsforløb med peginterferon alfa og ribavirin.
English: What benefit has Incivo shown during the studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Incivo?
English: For more information about treatment with Incivo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Incivo, kan du læse indlægssedlen (også en del af denne EPAR) eller
English: For the full list of all side effects reported with Incivo, see the
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved
English: In the first study, when Incivo was given for three months, 75% of patients tested negative for hepatitis C compared with 44% of patients receiving placebo.
Danish: I den første undersøgelse, hvor Incivo blev givet i tre måneder, blev 75 % af patienterne testet negative for hepatitis C sammenlignet med 44 % af de patienter, der fik placebo.
English: In the second study, 88% of patients receiving Incivo for three months tested negative for hepatitis C compared with 24% of patients receiving placebo.
Danish: I den anden undersøgelse blev 88 % af de patienter, der fik Incivo i tre måneder, testet negative for hepatitis C sammenlignet med 24 % af de patienter, der fik placebo.
English: The first European approval was in Sweden on 12 April 1996.
Danish: Den første europæiske godkendelse var i Sverige den 12. april 1996.
English: The pregnancy section has been revised in line with the relevant guideline[7].
Danish: Afsnittet om graviditet er revideret i henhold til den relevante vejledning[7].
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC
Danish: • udvalget behandlede henvisningen i henhold til artikel 30 i direktiv 2001/83/EF,
English: Etoposide is used for the treatment of various neoplastic diseases.
Danish: Etoposid anvendes til behandling af forskellige neoplastiske sygdomme.
English: Cancer Patients 2014, Chapter 15, pp.251-269.
Danish: Renal Disease in Cancer Patients 2014, Chapter 15, pp.251-269.
English: However, the treatment regimen and posology in these paediatric indications should be chosen according to the local standard of care.
Danish: Behandlingsregime og dosering ved disse pædiatriske indikationer bør dog vælges i overensstemmelse med lokal behandlingsstandard.
English: - Small-cell lung cancer
Danish: - småcellet lungekræft
English: The CHMP also noted that etoposide may decrease male fertility.
Danish: CHMP noterede sig også, at etoposid kan nedsætte fertiliteten hos mænd.
English: • The product information proposed by the Marketing Authorisation Holder has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: • den af markedsføringstilladelsesindehaverne foreslåede produktinformation er blevet vurderet på grundlag af den forelagte dokumentation og den videnskabelige drøftelse i udvalget,
English: A text to consider preservation of the sperm has been included in this section.
Danish: En tekst om at overveje sæddeponering er indsat i dette punkt.
English: In relation to lactation, information on the fact that etoposide is excreted in the milk (Medications and Mothers' Milk: Thomas W. Hale) has been added.
Danish: I forbindelse med amning er der tilføjet oplysninger om, at etoposid udskilles i mælken (Medications and Mothers' Milk, Thomas W. Hale).
English: As breastfeeding women could replace breastfeeding by dairy products to feed their child the text has been amended accordingly.
Danish: Ammende kvinder kan erstatte amning med mejeriprodukter til deres barn; teksten er ændret i overensstemmelse hermed.
English: In section 4.5 of the SmPC the interactions that were documented in the majority of current national SmPCs have been retained in the harmonised text.
Danish: 4.5 i produktresuméet er de interaktioner, der er dokumenteret i størstedelen af de gældende nationale produktresuméer, bibeholdt i den harmoniserede tekst.
English: As immunosuppression is a very common side effect of etoposide, concomitant use of live vaccines has been added as a contraindication, which is in line as well with the guideline on SmPC.
Danish: Da immunosuppression er en meget almindelig bivirkning af etoposid, er sideløbende brug af levende vacciner tilføjet som kontraindikation, hvilket ligeledes er i overensstemmelse med retningslinjerne for produktresuméer.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product, the European Commission therefore notified the CHMP/European Medicines Agency on 14 October 2015 of a referral under Article 30 of Directive 2001/83/EC for Etopophos and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise the product information across the EU.
Danish: På grund af de divergerende nationale afgørelser, der var truffet af medlemsstaterne ved godkendelsen af ovenstående produkt, anmeldte Europa-Kommissionen den 14. oktober 2015 en officiel indbringelse til CHMP/Det Europæiske Lægemiddelagentur i medfør af artikel 30 i direktiv 2001/83/EF for Etopophos og relaterede navne med henblik på at få ophævet divergenserne mellem de nationalt godkendte produktinformationer og dermed få produktinformationerne harmoniseret i EU.
English: Etoposide is a semi-synthetic derivative of podophyllotoxin which ruptures double strand DNA by means of an interaction with DNA-topoisomerase II, or by the formation of free radicals.
Danish: Etoposid er et semisyntetisk derivat af podophyllotoxin, som bryder dobbeltstrenget DNA gennem interaktion med DNA-topoisomerase II eller ved dannelse af frie radikaler.
English: - Gestational trophoblastic neoplasia
Danish: - gestationel trofoblastneoplasi
English: The recommended dose in adult patients is 50 to 100 mg/m2/day on days 1 to 5 in line with the current clinical practice guidelines, however when administered on three days (e.g. days 1, 3, and 5) the daily dose that is most commonly used can be either 100 to 120 mg/m2 every 3 to 4 weeks in combination with other drugs indicated in the disease to be treated.
Danish: Den anbefalede dosis hos voksne patienter er 50 til 100 mg/m2/dag på dag 1 til 5 i overensstemmelse med gældende retningslinjer for klinisk praksis, men ved administration på tre dage (f.eks. dag 1, 3 og 5), er den almindeligst anvendte daglige dosis 100-120 mg/m hver 3. til 4. uge i kombination med andre lægemidler, der er indiceret til den behandlede sygdom.
English: In renal impairment (creatinine clearance (CrCl) 15-50 mL/min) a dose reduction of 25% is recommended.
Danish: Ved nedsat nyrefunktion (kreatininclearance 15-50 ml/min) anbefales en dosisreduktion på 25 %.
English: • The Committee considered the divergences identified in the notification for Etopophos and associated names, as well as the remaining sections of the product information.
Danish: • udvalget behandlede de divergenser, der var konstateret i anmeldelsen vedrørende Etopophos og relaterede navne samt de øvrige punkter i produktinformationen,
English: As regards the posology, section 4.2 of the SmPC, the doses were harmonised for all indications and patient populations - adult and paediatric.
Danish: 4.2 i produktresuméet), blev doserne harmoniseret for alle indikationer og patientpopulationer - voksne og pædiatriske.
English: In paediatric patients diagnosed with Hodgkin's lymphoma, non-Hodgkin's lymphoma or acute myeloid leukaemia, the CHMP recommended the range of 75 to 150 mg/ m2/day for 2 to 5 days in combination with other antineoplastic agents as supported in studies conducted by major international groups such as The German Society of Paediatric Oncology and Haematology Hodgkin's Disease, The Children's Cancer Group and The European Organization of Research and Treatment of Cancer Children Leukaemia Group among others.
Danish: Hos pædiatriske patienter, der er diagnosticeret med Hodgkins lymfom, non-Hodgkins lymfom eller akut myeloid leukæmi, anbefalede CHMP området fra 75 til 150 mg/m2/dag i 2 til 5 dage i kombination med andre antineoplastiske midler, hvilket støttes af undersøgelser foretaget af store internationale grupper som blandt andre det tyske Gesellschaft für Pädiatrische Onkologie und Hämatologie, Hodgkin's Disease, Children's Cancer Group og European Organization of Research and Treatment of Cancer Children Leukaemia Group.
English: In patients with renal impairment, the CHMP agreed not to recommend a dose reduction when creatinine clearance is > 50 mL/min as supported by available literature[1][2][3][4][5].
Danish: Hos patienter med nedsat nyrefunktion vedtog CHMP at undlade at anbefale dosisreduktion ved kreatininclearance > 50 ml/min, som understøttet af den tilgængelige litteratur[1][2][3][4][5].
English: • The scope of the referral was the harmonisation of the product information,
Danish: • indbringelsen vedrørte harmonisering af produktinformationen,
English: Finally, lactation has also been included as a contraindication with a reference to section 4.6 of the SmPC where lactation is further described.
Danish: Endelig er amning også inkluderet som kontraindikation med en henvisning til punkt 4.6 i produktresuméet, hvor amning er omhandlet yderligere.
English: Etopophos contains etoposide phosphate, a pro-drug of etoposide which is rapidly converted to etoposide in vivo.
Danish: Etopophos indeholder etoposidfosfat, der er et prodrug til etoposid og hurtigt omdannes til etoposid in vivo.
English: - Testicular cancer: first line, recurrent or refractory testicular cancer
Danish: - testikelcancer: førstevalgsbehandling af recidiverende eller refraktær testikelcancer
English: The data in literature for patients with CrCl less than 15 mL/min and on dialysis strongly suggest that further dose reduction is required in these patients as reviewed by Inoue et al. (2004)[6].
Danish: Litteraturdata om dialysepatienter med kreatininclearance under 15 ml/min tyder stærkt på, at der kræves yderligere dosisreduktion hos disse patienter, som det fremgår af oversigtsartiklen af Inoue et al. (2004))[6].
English: Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally.
Danish: De foretagne ændringer af produktresuméet afspejler sig konsekvent i etiketteringen i relevant omfang, dog er de fleste afsnit
English: The revised indications in section 4.1 of the Summary of Product characteristics (SmPC) are:
Danish: 4.1 i produktresuméet er:
English: Overall summary of the scientific evaluation by the CHMP
Danish: Samlet resumé af CHMP's videnskabelige vurdering De reviderede indikationer i pkt.
English: The following special warnings and precautions for use have been harmonised in section 4.4 where they were already included in some or most of the national SmPCs: myelosuppression, secondary leukaemia, hypersensitivity, injection site reaction, low serum albumin, impaired renal and hepatic function, tumour lysis syndrome and mutagenic potential.
Danish: 4.4, hvor de i forvejen var anført i de fleste nationale produktresuméer: myelosuppression, sekundær leukæmi, hypersensitivitet, reaktion på injektionsstedet, lavt serumalbumin, nedsat nyre- og leverfunktion, tumorlysesyndrom og mutagent potentiale.
English: With regards to fertility, pregnancy and lactation section 4.6 of the SmPC, information addressed to women of childbearing potential with regards to contraception in males and females was included.
Danish: Angående fertilitet, graviditet og amning (punkt 4.6 i produktresuméet), er der vedrørende kvinder i den fødedygtige alder tilføjet oplysninger om antikonception til mænd og kvinder.
English: • The Committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information.
Danish: • udvalget gennemgik alle data, som markedsføringstilladelsesindehaveren har forelagt til underbygning af den foreslåede harmonisering af produktinformationen,
English: Etopophos and associated names was included in the list of products for summary of product characteristics (SmPC) harmonisation, drawn up by the CMDh, in accordance with Article 30(2) of Directive 2001/83/EC.
Danish: Etopophos er på nuværende tidspunkt godkendt i DE, FR, SE og UK. Etopophos og relaterede navne er optaget på listen over produkter, der kræver harmonisering af produktresuméet som angivet af CMDh, i overensstemmelse med artikel 30, stk. 2, i direktiv 2001/83/EF.
English: The changes to the SmPC, when relevant for the user, have also been reflected in the PL and endorsed by the CHMP.
Danish: Ændringerne i produktresuméet afspejler sig desuden i indlægssedlen i det omfang, de er relevante for brugeren, hvilket blev godtaget af CHMP.
English: The MAH also discussed a dose reduction for patients with end stage renal disease (CrCl < 15mL/min).
Danish: Indehaveren af markedsføringstilladelsen diskuterede desuden en dosisreduktion for patienter med terminal nyresygdom (kreatininclearance <15 ml/min).
English: Minor changes were included in the remaining sections of the SmPC.
Danish: I de øvrige punkter af produktresuméet er foretaget mindre ændringer.
English: Grounds for the CHMP opinion Whereas
Danish: Begrundelse for CHMP's udtalelse Begrundelsen fremsættes ud fra følgende betragtninger:
English: Etoposide phosphate injection is supplied as a nonpyrogenic lyophilized powder intended for reconstitution and/or dilution with a suitable parenteral vehicle prior to intravenous (IV) administration and is available as 114 mg etoposide phosphate (100 mg etoposide equivalent) single dose sterile vial and 1140 mg etoposide phosphate (1000 mg etoposide equivalent) pharmacy bulk vial (Germany only).
Danish: administration og dispenseres som 114 mg etoposidfosfat (ækvivalent med 100 mg etoposid) i sterile enkeltdosishætteglas, og 1 140 mg etoposidfosfat (ækvivalent med 1 000 mg etoposid) i apoteks-bulk-hætteglas (kun Tyskland).
English: This has been addressed by a warning in section 4.2 of the SmPC.
Danish: Dette er taget i betragtning med en advarsel i pkt.
English: The CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Etopophos and associated names (see Annex I).
Danish: • udvalget vedtog en harmoniseret produktinformation for Etopophos og relaterede navne, anbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktinformationen fremgår af bilag III for Etopophos og relaterede navne (se bilag I), konkluderede CHMP, at benefit/risk-forholdet for Etopophos og relaterede navne fortsat er positivt under forudsætning af,at de vedtagne ændringer af produktinformationen gennemføres.
English: - Ovarian cancer: non-epithelial ovarian cancer and platinum-resistant/refractory epithelial ovarian cancer
Danish: - ovariecancer: ikke-epiteliel ovariecancer og platinresistent/-refraktær epiteliel ovariecancer Pædiatriske indikationer blev godtaget ved følgende indikationer:
English: Hypersensitivity has been added as contraindication in section 4.3 of the SmPC in line with the guideline on SmPC.
Danish: Hypersensitivitet er tilføjet som kontraindikation i pkt.
English: Benefit-risk evaluation
Danish: Benefit/risk-vurdering
English: These observations are further supported by data from epidemiological and laboratory studies;
Danish: Disse observationer underbygges yderligere af data fra epidemiologiske undersøgelser og laboratorieundersøgelser;
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Pregsure BVD AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: Samlet resumé af den faglige vurdering af Pregsure BVD og tilknyttede navne (se bilag I)
English: therefore, in accordance with Article 83 (1)(a) of Directive 2001/82/EC, the CVMP recommends the suspension of the marketing authorisations for the veterinary medicinal products referred to in Annex I of the CVMP Opinion.
Danish: Derfor anbefaler CVMP i henhold til artikel 83, stk. 1, litra a), i direktiv 2001/82/EF en suspendering af markedsføringstilladelserne for de veterinærlægemidler, der er omhandlet i bilag I til CVMP's udtalelse.
English: The marketing authorisation holder voluntarily stopped the sales of the product from the market in Germany in April 2010 and from all other concerned EU Member States in June 2010.
Danish: Indehaveren af markedsføringstilladelsen standsede frivilligt markedsføringen af lægemidlet i Tyskland i april 2010 og i alle de andre berørte EU-medlemsstater i juni 2010.
English: 2900 AA Capelle a/d Ijssel
Danish: 2900 AA Capelle a/d
English: The marketing authorisation holder has taken precautionary measures to stop sales of the product in EU.
Danish: Indehaveren af markedsføringstilladelsen har truffet forholdsregler for at standse salget af lægemidlet i EU.
English: 81109 Bratislava
Danish: 81109 Bratislava SLOVAK REPUBLIC
English: Conditions for lifting the suspension
Danish: Betingelser for ophævelse af suspenderingen
English: List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker for de veterinærmedicinske produkter, dyrearter, indgivelsesvej, tilbageholdelsestid, indehavere af markedsføringstilladelse i medlemsstaterne
English: In this particular case, for a prophylactic measure such as vaccination this figure was considered unacceptable for a potentially fatal disorder.
Danish: I dette særlige tilfælde, hvor der er tale om en profylaktisk foranstaltning som vaccination, blev dette tal anset for at være uacceptabelt for en potientielt dødelig sygdom.
English: Box 37
Danish: P.O. Box 37
English: L-1855 - Luxembourg
Danish: Kennedy L-1855 - Luxembourg
English: Bovine neonatal pancytopenia has been reported in eleven EU Member States.
Danish: Bovin neonatal pancytopeni er blevet indberettet i 11 EU-medlemsstater.
English: These reports raised concern over a potential association with the use of Pregsure BVD.
Danish: Disse indberetninger gav anledning til bekymring over en potentiel sammenhæng med brugen af Pregsure BVD.
English: The overall incidence for bovine neonatal pancytopenia at EU level between 2004 and 2009 was estimated to be 0.016% based on a single dose.
Danish: Den samlede incidens for bovin neonatal pancytopeni på EU-plan mellem 2004 og 2009 blev anslået til at være 0,016 % baseret på en enkelt dosis.
English: Whilst the economic and animal health and welfare benefits of vaccination against BVDV type 1 are acknowledged, there are valid alternative BVD vaccines available on the EU market with similar claims to that of Pregsure BVD.
Danish: Selv om de økonomiske, dyresundheds- og dyrevelfærdsmæssige fordele ved vaccination mod BVDV type 1 er anerkendt, er der effektive alternative BVD-vacciner til rådighed på EU's marked, som har de samme virkningsangivelser som Pregsure BVD.
English: • no specific measures could be recommended to ensure that the product is not associated with an unacceptable risk of bovine neonatal pancytopenia under the authorised conditions of use;
Danish: • der kan ikke anbefales nogen specifikke foranstaltninger for at sikre, at lægemidlet ikke er forbundet med en uacceptabel risiko for bovin neonatal pancytopeni med de godkendte anvendelsesbetingelser;
English: In addition, the CVMP considered that temporary measures are needed and therefore recommends that all batches of the product be recalled at wholesale level.
Danish: Desuden var CVMP af den opfattelse, at det er nødvendigt med midlertidige foranstaltninger, og derfor anbefaler CVMP, at alle batcher af lægemidlet trækkes tilbage fra grossisterne.