FrancophonIA/ELRC3.0 huggingface dataset:
English: • Preparation for the revision of the Fee Regulation, which will be carried out in two steps: first,
Danish: • Forberedelse til revisionen af gebyrforordningen, som udføres i to trin: Først ændres gebyrforordningen for at tillade, at EMA opkræver gebyrer for aktiviteter i forbindelse med
English: Kingdom, finalised on 11 January 2011.
Danish: Kongerige, afsluttet 11. januar 2011.
English: European Medicines Agency attendees
Danish: Deltagere fra Det Europæiske Lægemiddelagentur
English: • No 33/2010 - the appointment of Dalibor VALÍK as CHMP member, proposed by the Czech
Danish: • Nr. 33/2010 - udnævnelse af Dalibor VALÍK som CHMP-medlem, foreslået af Den Tjekkiske
English: • No 32/2010 - the appointment of Dana Gabriela MARIN as CHMP alternate, proposed by Romania,
Danish: • Nr. 32/2010 - udnævnelse af Dana Gabriela MARIN som CHMP-suppleant, foreslået af Rumænien,
English: • No 01/2011 - the appointment of Helen JUKES as CVMP member, proposed by the United
Danish: • Nr. 01/2011 - udnævnelse af Helen JUKES som CVMP-medlem, foreslået af Det Forenede
English: Republic, finalised on 3 January 2011.
Danish: Republik, afsluttet 3. januar 2011.
English: Republic, finalised on 4 February 2011.
Danish: Republik, afsluttet 4. februar 2011.
English: • implementation of the new pharmacovigilance legislation, presented by Noël Wathion, of the EMA;
Danish: • gennemførelse af ny lovgivning vedrørende lægemiddelovervågning, præsentation ved Noël
English: • No 03/2011 - the appointment of Zanda AUCE as CVMP member, proposed by Latvia, finalised on
Danish: • Nr. 03/2011 - udnævnelse af Zanda AUCE som CVMP-medlem, foreslået af Letland, afsluttet 4.
English: [EMA/MB/218686/2011] The Management Board adopted a decision giving its approval for the currently declared activities of Thomas Lönngren, who stepped down as Executive Director of the Agency on 31 December 2010.
Danish: [EMA/MB/218686/2011] Bestyrelsen vedtog en beslutning om at godkende de af Thomas Lönngren aktuelt erklærede aktiviteter.
English: Highlights from the Acting Executive Director
Danish: Den fungerende administrerende direktørs redegørelse for de vigtigste begivenheder
English: • impact of health-technology assessment on the work of regulators, presented by Kent Woods, of the Medicines and Healthcare products Regulatory Agency (MHRA).
Danish: • medicinsk teknologivurderings indflydelse på myndighederne, præsentation ved Kent Woods,
English: • No 04/2011 - the appointment of Lyubina TODOROVA as CHMP alternate, proposed by Bulgaria,
Danish: • Nr. 04/2011 - udnævnelse af Lyubina TODOROVA som CHMP-suppleant, foreslået af Bulgarien,
English: • [EMA/634206/2010] Minutes from the latest Management Board Telematics Committee meeting
Danish: • [EMA/634206/2010] Referat af det seneste bestyrelsesmøde i telematikudvalget 2010-11-002.
English: • No 02/2011 - the appointment of Miloslav SALAVEC as CHMP alternate, proposed by the Czech
Danish: • Nr. 02/2011 - udnævnelse af Miloslav SALAVEC som CHMP-suppleant, foreslået af Den Tjekkiske
English: (Ernst & Young report), presented by Nerimantas Steikūnas, of the EMA;
Danish: • resultater og anbefalinger fra agenturets evaluerings- og interessentkonference (Ernst & Young rapport), præsentation ved Nerimantas Steikūnas,
English: • The enquiry by MEPs into off-label use of medicines in the EU (the MEPs' letters will be included on the April HMA agenda).
Danish: (MEP'ernes breve er med på HMA's aprildagsorden).
English: The members noted the update report from the Heads of Medicines Agencies on a range of topics, including the following:
Danish: Medlemmerne tog den opdaterede rapport fra cheferne for de nationale lægemiddelstyrelser til efterretning.
English: Jiří Deml
Danish: Den Tjekkiske Republik Jiří Deml Danmark
English: Minutes from the 69th meeting, held on 7 October 2010
Danish: Referat af det 69.
English: For the other three patients, this information was lacking.
Danish: For de andre tre patienter manglede disse oplysninger.
English: Methadone is a synthetic opioid.
Danish: Metadon er et syntetisk opioid.
English: Therefore, the PRAC recommends the suspension of this product.
Danish: PRAC anbefaler derfor suspendering af dette lægemiddel.
English: The cases concerned former or current injecting drug abusers, aged 24 to 53 years old.
Danish: De pågældende tilfælde vedrørte tidligere eller nuværende stiknarkomaner i alderen 24-53 år.
English: Fourteen (14) cases of renal failure were reported.
Danish: Der blev beskrevet fjorten (14) tilfælde af nyresvigt.
English: The review took into account 15 cases of serious adverse reactions reported in Norway.
Danish: Ved gennemgangen blev der taget hensyn til 15 tilfælde af alvorlige bivirkninger, der er indberettet i Norge.
English: The condition for lifting the suspension of these marketing authorisations is set out in Annex IV.
Danish: Betingelsen for ophævelse af suspenderingen af markedsføringstilladelserne fremgår af bilag IV.
English: However, available data do not demonstrate the effectiveness of povidone in mitigating this risk.
Danish: De foreliggende data viser imidlertid ikke, at povidon er effektivt til at afbøde denne risiko.
English: Additional warnings in the label were further considered, but a direct information to the patients is challenging and according to the experts, such measures are unlikely to further minimise the risk of injection.
Danish: Det blev overvejet at indsætte yderligere advarsler i produktinformationen, men direkte information til patienterne er vanskelig, og ifølge eksperterne vil sådanne foranstaltninger næppe yderligere kunne minimere risikoen for injektion.
English: For 12 of the 15 patients, evidence that they had been prescribed or used methadone (urine sample or patient's statement) was available.
Danish: For 12 af de 15 patienter var der evidens for, at de havde fået ordineret metadon eller anvendte dette (urinprøve eller patientens udsagn).
English: This leads to ‘povidone storage disease' that may cause serious harm.
Danish: Dette medfører povidon-aflejringssygdom, som kan føre til alvorlige skader.
English: For the suspension to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAH:
Danish: For at suspenderingen kan ophæves, sikrer medlemsstaternes kompetente nationale myndigheder, at indehaveren af markedsføringstilladelsen opfylder følgende vilkår:
English: The product information of this methadone oral solution already contains clear advice that it should not be injected.
Danish: Produktinformationen for denne orale opløsning af metadon indeholder i forvejen klare anvisninger om, at den ikke må ikke injiceres.
English: The distribution and elimination of povidone when administered intravenously has been well investigated and studies using radioactive labelled povidone of different molecular weight have demonstrated that clearance of polymers after intravenous administration is dependent on molecular weight.
Danish: Fordelingen og eliminationen af povidon efter intravenøs administration er velundersøgt, og undersøgelser med radioaktivt mærket povidon af forskellig molekylvægt har vist, at clearance af polymerer efter intravenøs administration afhænger af molekylvægten.
English: Should this oral solution be repeatedly injected, povidone would be permanently retained and accumulate within organs and tissues, leading to potential serious harm.
Danish: Hvis denne orale opløsning injiceres gentagne gange, vil povidon blive permanent tilbageholdt og ophobet i organer og væv med påfølgende potentielle alvorlige skadevirkninger.
English: Treatment with methadone should be given in the context of a wider rehabilitation program, opioid substitution therapy (OST).
Danish: Metadonbehandling bør anvendes i sammenhæng med et bredere rehabiliteringsprogram, opioidsubstitutionsterapi.
English: Overall summary of the scientific evaluation of methadone products for oral use containing povidone
Danish: Samlet resumé af den videnskabelige vurdering af orale metadonlægemidler indeholdende povidon
English: The review of oral methadone medicines containing povidone started on 10 April 2014 under Article 107i of Directive 2001/83/EC.
Danish: Gennemgangen af orale metadonlægemidler indeholdende povidon begyndte den 10. april 2014 i henhold til artikel 107i i direktiv 2001/83/EF.
English: Supervised administration of every dose was also discussed but this would be difficult to consistently incorporate into daily OST practice and would lead to serious non-compliance.
Danish: Overvåget administration af hver dosis blev ligeledes drøftet, man ville være vanskeligt at indføre konsekvent i daglig praksis med opioidsubstitutionsterapi og ville føre til alvorlig manglede compliance.
English: Most of the patients were currently or previously included in OST programs.
Danish: Størstedelen af patienterne deltog på daværende tidspunkt eller tidligere i programmer for opioidsubstitutionsterapi.
English: The inclusion of povidone K90 in oral methadone solutions was initially intended to enhance viscosity and reduce the risk of misuse by injection.
Danish: Den oprindelige hensigt med anvendelsen af povidon K90 i orale metadonopløsninger var at øge viskositeten og mindske risikoen for misbrug ved injektion.
English: To lift the suspension, this product should be appropriately reformulated taking into account its misuse potential.
Danish: For at ophæve suspenderingen skal lægemidlet omformuleres på passende måde under hensyn til sit misbrugspotentiale.
English: For the other eight cases, renal biopsies were lacking, but povidone deposits were detected in biopsies from other tissues.
Danish: For de øvrige otte tilfælde manglede der nyrebiopsier, men der blev fundet aflejringer af povidon i andre væv.
English: In all cases, staining of biological samples supports the conclusion that povidone accumulated in the affected organs.
Danish: I alle tilfældene underbygger farvning af biologiske prøver konklusionen om, at der var ophobning af povidon i de berørte organer.
English: The overall effectiveness of methadone maintenance treatment is established in the literature and has been reviewed in several articles.
Danish: Den overordnede effektivitet af vedligeholdelsesbehandling med metadon er anerkendt i litteraturen og har været genstand for flere oversigtsartikler.
English: The PRAC noted that all these 15 cases reported “intentional drug misuse”, “product deposit” and “drug administered via inappropriate route” and were assessed by the regional pharmacovigilance centre in Norway as possibly or probably related to the injection of povidone.
Danish: PRAC bemærkede, at der for alle disse 15 tilfælde var anført »forsætligt stofmisbrug«, »aflejringer af lægemiddel« og »lægemidlet administreret ad ukorrekt vej«, og at det regionale lægemiddelovervågningscenter i Norge anså dem for at have sandsynlig eller mulig sammenhæng med injektion af povidon.
English: Available data from the scientific literature suggests that an association between deposits of povidone and renal impairment has not been well established.
Danish: De foreliggende data fra den videnskabelige litteratur tyder på, at der ikke er fastslået en tydelig sammenhæng mellem aflejringer af povidon og nedsat nyrefunktion.
English: For one of the five patients the bone marrow biopsy showed about 90% histiocytic infiltration characteristic for povidone deposit and only about 5% of bone marrow available for erythropoiesis.
Danish: Hos en af de fem patienter viste knoglemarvsbiopsi, at knoglemarven var ca. 90 % infiltreret med histiocytter, hvilket er karakteristisk for aflejring af povidon, og kun ca. 5 % af knoglemarven var til rådighed for erythropoiese.
English: In most cases, prescription or use of methadone can be confirmed, while some of them also have admitted injecting oral methadone.
Danish: I de fleste tilfælde kan ordination eller anvendelse af metadon bekræftes, og for nogles vedkommende blev det vedgået, at der var injiceret oralt metadon,
English: Six kidney biopsies were presented and all demonstrated deposits of povidone in the tubular-interstitial area.
Danish: Der blev forelagt seks nyrebiopsier, der alle viste aflejringer af povidon i det tubulære interstitielle område.
English: It followed the decision of NOMA to suspend the only methadonecontaining oral solution that contains povidone present on the national market, on the basis of reports of serious adverse events in former or current drug abusers in Norway.
Danish: Gennemgangen fulgte NOMA's beslutning om at suspendere den eneste nationalt markedsførte metadonholdige orale opløsning, der indeholder povidon, efter indberetninger om alvorlige bivirkninger hos tidligere og nuværende stofmisbrugere i Norge.
English: Following parenteral administration, it is generally accepted that low molecular weight povidone (Mw <25 000) is readily excreted by the kidney: the glomerulus can excrete within a few days all povidone of Mw 40 000 or below; the normal glomerulus of healthy human subjects is relatively impermeable to povidone Mw >70 000 (while in humans with nephrotic disease, the permeability for larger molecules was increased); the reticuloendothelial system (RES) retains molecules with a Mw >110,000 (Ravin et al. 1952; Hulme and Hardwicke 1968).
Danish: Efter parenteral administration er det almindelig anerkendt, at lavmolekylært povidon (molekylvægt <25 000) let udskilles gennem nyrerne: Glomerulus kan inden for få dage udskille alt povidon med molekylvægt 40 000 eller derunder; hos raske voksne personer er den normale glomerulus relativt upermeabel for povidon ved molekylvægt >70 000 (hvorimod der ved nefrotisk sygdom er øget permeabilitet for større molekyler); det retikuloendoteliale system tilbageholder molekyler med molekylvægt >110,000 (Ravin et al., 1952 og Hulme og Hardwicke, 1968).
English: Pathological fractures were observed in two of the five patients, with deposits of povidone also in the bone tissue.
Danish: Der blev iagttaget patologiske frakturer hos to af de fem patienter, hos hvem der ligeledes var aflejring af povidon i knoglevævet.
English: The PRAC reviewed all available safety data, in particular with regards to the risks associated with the misuse by injection of methadone products for oral use containing povidone.
Danish: PRAC gennemgik alle foreliggende sikkerhedsdata, navnlig vedrørende risiciene forbundet med misbrug bestående i injektion af orale metadonlægemidler indeholdende povidon.
English: In nine cases a history of drug abuse with substances that have been injected was specified and in eight of these nine cases a history of injecting methadone intended for oral use was reported.
Danish: I ni tilfælde var der misbrug af stoffer ved injektion i anamnesen, og i otte af disse ni tilfælde blev det vedgået, at der var sket injektion af metadon til oral anvendelse.
English: Methadone is used in the treatment of moderate to severe pain and is also used as maintenance/substitution medication in the management of opioid dependence.
Danish: Metadon anvendes til behandling af moderate til svære smerter og desuden som vedligeholdelses- eller substitutionsbehandling ved opioidafhængighed.
English: • The PRAC was of the opinion that available pre-clinical and clinical data provide evidence that high molecular weight povidone (>110,000) when injected is likely to be permanently retained in the body, in particular in the bone marrow and bone tissue.
Danish: • PRAC mente, at de foreliggende prækliniske og kliniske data giver evidens for, at højmolekylært povidon (>110,000) ved injektion må forventes at blive permanent tilbageholdt i kroppen, navnlig i knoglemarv og knoglevæv.
English: There is evidence that lower molecular weight povidone (<25,000) is readily excreted but that higher Mw povidone (>110,000) is not, or (>70,000) only partially excreted;
Danish: Der er dokumentation for, at povidon med lavere molekylvægt (<25,000) udskilles let, men at povidon med højere molekylvægt (>110 000) slet ikke eller (>70 000) kun delvis udskilles,
English: It was also noted that misuse by injection of methadone product is an inherent risk in the target population with evidence showing an occurrence of injection of methadone for oral use among injecting drug users varying from 5.0% to 79.5% (Winstock et al. 2010, Guichard et al. 2003, Waldvogel et al 2005, Judson G et al. 2010, and Vlahov D et al. 2007) and an underreporting considered to be likely.
Danish: Det blev desuden bemærket, at misbrug med injektion af metadonlægemidler er en iboende risiko hos målpopulationen, da injektion af metadon til oral anvendelse forekommer hos mellem 5 % og 79,5 % af stiknarkomaner (Winstock et al., 2010; Guichard et al., 2003; Waldvogel et al., 2005; Judson G. et al., 2010, og Vlahov D et al., 2007), og underrapportering anses for sandsynlig.
English: • The PRAC reviewed all available data from published literature, pre-clinical and clinical studies and post-marketing experience on the safety of methadone medicinal products for oral use containing povidone, responses submitted by the marketing authorisation holders (MAHs) in writing and during the oral explanations, the outcome of the ad-hoc expert advisory group meeting as well as stakeholders' submissions in particular with regards to the risks associated with the misuse of the products by injection which is a well-known risk in the target population;
Danish: • PRAC gennemgik alle foreliggende data fra den videnskabelige litteratur, prækliniske og kliniske undersøgelser og erfaringer efter markedsføring vedrørende sikkerheden af orale metadonholdige lægemidler indeholdende povidon, dels fra indehaverne af markedsføringstilladelsernes skriftlige besvarelser og mundtlige fremlæggelser, dels resultatet af ad hoc-ekspertgruppens møde og dels materiale fra interessenter, navnlig vedrørende den velkendte misbrugsrisiko med injektion af lægemidlerne hos målpopulationen,
English: High Mw povidone (>110,000) will not be excreted by the kidney and therefore will be retained in the body if repeatedly injected and may lead to serious harm;
Danish: Højmolekylært povidon (>110 000) udskilles ikke gennem nyrerne og vil ved gentagne injektioner blive tilbageholdt i kroppen og kan medføre alvorlig skade,
English: For five patients, bone destruction and/or bone marrow affection (including anaemia) were reported and findings from biopsies showed accumulation of povidone in the bone marrow.
Danish: For fem patienter blev der beskrevet knogledestruktion og/eller knoglemarvspåvirkning (herunder anæmi), og biopsierne viste ophobning af povidon i knoglemarven.
English: • The PRAC considered case reports, including fatal cases, in former or current injecting drug users, and noted the serious adverse reactions, the nature of which (including bone marrow adverse effects and pathological fractures) was consistent with the accumulation of povidone and also noted that povidone deposition in organs and tissues had been seen on biopsies.
Danish: • PRAC gennemgik case-rapporter om tidligere eller nuværende stiknarkomaner, herunder fatale tilfælde, og noterede sig de alvorlige bivirkninger (herunder knoglemarvspåvirkning og patologiske frakturer), hvis art var overensstemmende med ophobning af povidon, og bemærkede desuden, at der i biopsier var set aflejring af povidon i organer og væv.
English: However, the causality of povidone deposits and bone marrow failure and skeletal fracture has been reasonably demonstrated, and the mechanism of pathophysiology appears to be related to the spatial competition of deposits and bone marrow (Kepes et al 1993; Kuo et al 1997; Dunn et al 1998; Huang et al 2012).
Danish: Årsagssammenhængen mellem aflejringer af povidon og knoglemarvssvigt og fraktur er imidlertid rimeligt veldokumenteret, og den patofysiologiske mekanisme synes at hænge sammen med spatial konkurrence mellem aflejringerne og knoglemarven (Kepes et al., 1993; Kuo et al., 1997; Dunn et al., 1998, og Huang et al., 2012).
English: The PRAC concluded that the benefit-risk of these products was favourable provided that amendments are introduced in the product information, to harmonise and reinforce the message that tablets are for oral administration only and must not be injected.
Danish: PRAC konkluderede, at benefit/risk-forholdet for disse lægemidler var positivt, forudsat at produktinformationen ændres med henblik på at harmonisere og styrke advarslen om, at tabletterne kun er til oral administration og ikke må injiceres.
English: • The PRAC noted that the risk of misuse by injection of methadone products for oral use is wellknown in the target population, evidence of which is available from the literature;
Danish: • PRAC bemærkede, at risikoen for misbrug ved injektion af metadonlægemidler til oral anvendelse er velkendt hos målpopulationen og desuden er beskrevet i litteraturen,
English: The efficacy of methadone in OST was acknowledged in this referral procedure.
Danish: Virkningen af metadon til opioidsubstitutionsterapi blev anset for anerkendt i denne indbringelsesprocedure.
English: Methadone tablets containing low Mw povidone (K25 or K30)
Danish: Metadontabletter indeholdende lavmolekylært povidon (K25 eller K30)
English: It is mainly used in oral solutions (K90) as a viscosity-increasing agent, or as a binding agent (e.g. K25, K30) in tablets.
Danish: Det anvendes hovedsagelig i orale opløsninger som viskositetsforøgende middel (K90) samt i tabletter som bindemiddel (f.eks. K25 og K30).
English: Other methadone products containing povidone concerned by the review are tablets and have lower Mw povidone (e.g. K25, K30, also in lower amount), which is known to be excreted from the kidney and therefore is expected not to be retained in the body.
Danish: Andre af gennemgangen omfattede metadonlægemidler, der indeholder povidon, er tabletter med povidon med lavere molekylvægt (f.eks. K25 og K30, også i lavere mængde), som vides at udskilles gennem nyrerne og derfor ikke forventes tilbageholdt i kroppen.
English: Methadone oral solution containing high molecular weight povidone (K90)
Danish: Oral metadonopløsning med højmolekylært povidon (K90)
English: Povidone is an excipient available in a variety of different molecular sizes from K12 (low molecular weight (Mw), average Mw ~ 2000) to K90 (high Mw, average Mw 1,100,000).
Danish: Povidon er et hjælpestof, der findes i forskellige molekylstørrelser fra K12 (lavmolekylært, gennemsnitlig molekylvægt ~ 2000) til K90 (højmolekylært, gennemsnitlig molekylvægt 1 100 000).
English: • The PRAC considered that the potential for harm was likely to be associated with the misuse of methadone oral solutions containing high molecular weight povidone K90;
Danish: • PRAC fandt, at potentialet for skade måtte forventes at være forbundet med misbrug af orale opløsninger af metadon indeholdende højmolekylært povidon K90,
English: • The PRAC noted that high molecular weight povidone was present only in one methadone oral solution dosed at 2 mg/ml, which contains povidone K90 with an average molecular weight of 1,100,000.
Danish: • PRAC bemærkede, at højmolekylært povidon kun fandtes i en enkelt oral metadonopløsning med styrken 2 mg/ml, som indeholder povidon K90 med en gennemsnitlig molekylvægt på 1 100 000.
English: Flexible-dose methadone maintenance therapy is more clinically effective than no drug therapy in dependent opioid users.
Danish: Vedligeholdelsesbehandling med metadon i fleksibel dosering ved opioidafhængighed er mere effektiv end ingen narkotikabehandling.
English: These products are therefore not associated with the potential for harm of oral solutions containing high Mw.
Danish: Disse lægemidler har derfor ikke samme skadespotentiale som orale opløsninger indeholdende højmolekylært povidon.
English: The CMDh also reached an agreement on the variation to the terms of the Marketing Authorisations for methadone tablets containing low molecular weight povidone (K25 or K30) for which the amendments to be introduced to the Summary of Product Characteristics and package leaflet are set out in Annex III.
Danish: CMD(h) vedtog ligeledes ændrede betingelser for markedsføringstilladelserne for metadontabletter indeholdende lavmolekylært povidon (K25 ellers K30), for hvilke ændringerne af produktresuméet og indlægssedlen fremgår af bilag III.