FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, cases of drug induced liver injury (DILI), including serious cases, continued to be received in EudraVigilance (EV) with flupirtine-containing medicinal products reported as suspected or interacting products.
Danish: Derudover blev der i EudraVigilance-databasen fortsat indberettet tilfælde af lægemiddelinduceret leverskade, herunder alvorlige tilfælde, hvor flupirtin-holdige lægemidler blev angivet som formodede eller interagerende produkter.
English: However, considering the failure of the previous measures, the absence of risk factors sensitive enough to predict the risk of hepatotoxicity, the clinical setting where these medicinal products are used, the PRAC could not identify further measures that would ensure effective minimisation of the risk of hepatotoxicity associated to the use of flupirtine-containing medicinal products.
Danish: I betragtning af den utilstrækkelige effekt af de tidligere foranstaltninger, manglen på risikofaktorer, der er tilstrækkeligt følsomme til at forudsige risikoen for levertoksicitet, og det kliniske miljø, hvori disse lægemidler anvendes, var PRAC ikke i stand til at identificere yderligere foranstaltninger, der kunne sikre en effektiv minimering af risikoen for levertoksicitet ved brug af flupirtin-holdige lægemidler.
English: Consequently, the PRAC recommend the revocation of the marketing authorisations for flupirtinecontaining medicinal products.
Danish: CHMP anbefaler derfor tilbagekaldelse af markedsføringstilladelserne for flupirtin-holdige lægemidler.
English: • Furthermore, the PRAC could not identify any condition, the fulfilment of which would demonstrate a positive benefit-risk balance for flupirtine-containing medicinal products in their current indication.
Danish: • Derudover har PRAC ikke kunnet identificere nogen betingelser, der, selv hvis de blev opfyldt, kan påvise et positivt benefit/risk-forhold for flupirtin-holdige lægemidler i deres aktuelle indikationer.
English: Therefore, in view of the impossibility to minimise sufficiently the risk of hepatotoxicity, the PRAC concluded that this risk outweighs the benefits of flupirtine in the treatment of acute pain, when treatment with other analgesics is contraindicated.
Danish: I betragtning af den manglende mulighed for at minimere risikoen for leverskade tilstrækkeligt konkluderede PRAC derfor, at denne risiko opvejer fordelene ved flupirtin til behandling af akutte smerter, når behandling med andre analgetika er kontraindiceret.
English: In 2013, as a result of an urgent Union procedure under Article 107i of Directive 2001/83/EC (EMEA/H/A-107i/1363), the marketing authorisations (MAs) for flupirtine-containing medicinal products were varied to impose restrictions and risk minimisations measures implemented in view of the risk of liver injury.
Danish: Som følge af en hasteprocedure i henhold til artikel 107i i direktiv 2001/83/EF i 2003 (EMEA/H/A107i/1363) blev markedsføringstilladelserne for flupirtin-holdige lægemidler ændret, således at der blev indført restriktioner og risikominimerende foranstaltninger på grund af risikoen for leverskade.
English: The PRAC concluded that while the use of flupirtine-containing products has decreased, the measures implemented have been ineffective to minimise the hepatotoxicity risk to an acceptable level.
Danish: Selvom brugen af flupirtin-holdige lægemidler er faldet, konkluderede PRAC, at de gennemførte foranstaltninger ikke har været tilstrækkeligt effektive til at minimere risikoen for levertoksicitet til et acceptabelt niveau.
English: Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisations for flupirtine-containing medicinal products.
Danish: I henhold til artikel 116 i direktiv 2001/83/EF anbefaler udvalget derfor tilbagekaldelse af markedsføringstilladelserne for flupirtin-holdige lægemidler.
English: Therefore, pursuant to Article 116 of Directive 2001/83/EC, the CMDh recommends the revocation of the marketing authorisations for flupirtine-containing medicinal products.
Danish: I henhold til artikel 116 i direktiv 2001/83/EF anbefaler CMDh derfor tilbagekaldelse af markedsføringstilladelserne for flupirtin-holdige lægemidler.
English: The CMDh, as a consequence, considers that flupirtine-containing medicinal products are harmful.
Danish: CMDh vurderer som følge heraf, at flupirtin-holdige lægemidler er skadelige, og at deres benefit/riskforhold ikke er positivt.
English: Cases of drug induced liver injury (DILI), including cases of acute liver failure, cases necessitating a liver transplant and cases with a fatal outcome have been received since the previous review.
Danish: Siden forrige gennemgang er der indberettet tilfælde af lægemiddelinduceret leverskade, herunder tilfælde af akut leversvigt, levertransplantation og dødsfald.
English: • Risk of gallstones
Danish: • Risiko for galdesten
English: The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to provide educational material on correct diagnosis and therapeutic managements of the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3Oxosteroid-5β-reductase deficiency and to inform on expected and potential risks associated with the treatment.
Danish: Indehaveren af markedsføringstilladelsen skal, i samråd med de kompetente myndigheder i medlemsstaterne, inden lanceringen gennemføre et uddannelsesprogram for læger, der tager sigte på at udlevere informationsmateriale om korrekt diagnose og terapeutisk håndtering af behandlingen af medfødte fejl i den primære galdesyresyntese på grund af 3β-hydroxy-Δ5-C27steroid-oxidoreduktasemangel eller Δ4-3-oxosteroid-5β-reduktasemangel og på at informere om forventede og potentielle risici i forbindelse med behandlingen.
English: • Prescription of a supratherapeutic dose (MedDRA term: drug toxicity)
Danish: • Ordinering af en supraterapeutisk dosis (MedDRA-term:lægemiddeltoksicitet)
English: Conditions or restrictions with regard to the safe and effective use of medicinal product to be implemented by the member states
Danish: Betingelser eller begrænsninger med hensyn til sikker og effektiv anvendelse af lægemidlet, som skal pålægges af medlemsstaterne
English: 100 tablets (2 x 50)
Danish: 100 tabletter (2 X 50)
English: bottle (HDPE) without outer carton 180 tablets
Danish: Flaske (HDPE) uden ydre pakning
English: The European Commission granted a marketing authorisation valid throughout the EU for Aivlosin on 9 September 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aivlosin den 9. september 2004.
English: The full EPAR for Aivlosin can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Aivlosin findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Aivlosin.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aivlosin.
English: In turkeys only laboratory studies were performed.
Danish: Hos kalkuner blev der udelukkende foretaget laboratorieundersøgelser.
English: Aivlosin is an antibiotic.
Danish: Aivlosin er et antibiotikum.
English: The main clinical studies on the effectiveness of Aivlosin were carried out on farms in a number of countries in Europe as well as outside the EU.
Danish: De vigtigste kliniske undersøgelser af Aivlosins virkning er blevet foretaget på landbrug i en række lande i og uden for EU.
English: Aivlosin should not be used in people.
Danish: Aivlosin må ikke anvendes til mennesker.
English: The granules are added to the drinking water system, either directly or after dilution into a stock solution.
Danish: Granulatet tilsættes drikkevandssystemet, enten direkte eller efter opløsning i en stamopløsning.
English: The active substance of Aivlosin is tylvalosin (previous name: acetylisovaleryltylosin), an antibiotic of the macrolide group.
Danish: Det aktive stof i Aivlosin er tylvalosin (tidligere navn: acetylisovaleryltylosin), der er et makrolidantibiotikum.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Aivlosin's benefits are greater that its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Aivlosin opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The antimicrobial effectiveness of tylvalosin against bacteria causing diseases was investigated in the laboratory.
Danish: Den antimikrobielle virkning af tylvalosin over for sygdomsfremkaldende bakterier er blevet undersøgt i laboratoriet.
English: It should not, therefore, be used in laying turkeys nor for three weeks before turkeys are likely to start laying eggs for human consumption.
Danish: Det bør derfor ikke anvendes til æglæggende kalkuner, og det må ikke gives senere end tre uger inden, at kalkuner sandsynligvis begynder at lægge æg til menneskeligt konsum.
English: The oral powder cannot properly be mixed into pellets and should therefore not be used in pelleted pig feed.
Danish: Det orale pulver kan ikke effektivt blandes i pellets og bør derfor ikke anvendes i pelleteret svinefoder.
English: What is Aivlosin and what is it used for?
Danish: Hvad er Aivlosin, og hvad anvendes det til?
English: It works by blocking the bacteria's ribosomes, the parts of the cell where proteins are produced, and inhibits the growth of bacteria.
Danish: Det virker ved at blokere bakteriernes ribosomer, dvs. de dele af cellen, der producerer nye proteiner, hvorved bakteriernes vækst hæmmes.
English: The premix is mixed into pig feed by an authorised feed mill and the resulting “medicated feeding stuff” is then distributed to the farmer to treat a large number of pigs.
Danish: Premixet blandes i svinefoderet ved hjælp af en godkendt foderblander, og det resulterende "foderlægemiddel" udleveres derefter til landmanden til behandling af et større antal svin.
English: The medicine is not authorised for use in turkeys producing eggs for human consumption.
Danish: Lægemidlet må ikke anvendes til kalkuner, der producerer æg til menneskeligt konsum.
English: The studies in pigs were carried out either in pigs already affected by the disease or in pigs who had been in contact with diseased animals on the same farm and were, therefore, likely to develop the disease as well.
Danish: Undersøgelserne hos svin blev gennemført hos allerede sygdomsramte svin eller hos svin, der havde været i kontakt med sygdomsramte dyr på samme brug og derfor måtte forventes også at udvikle sygdommen.
English: The treatment did not completely eliminate all bacteria in the respiratory system and some birds still showed the disease; however, the number of affected animals was significantly smaller than in an untreated group of birds.
Danish: Behandlingen udryddede ikke fuldstændigt alle bakterierne i åndedrætssystemet, og visse kyllinger havde stadig sygdomssymptomer, men antallet af smitteramte dyr var betydeligt mindre end i ubehandlede grupper af kyllinger.
English: Why is Aivlosin approved?
Danish: Hvorfor er Aivlosin blevet godkendt?
English: The withdrawal period is the time required after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter lægemidlets indgivelse, før dyret kan slagtes og kødet kan anvendes til konsum.
English: Aivlosin is available as a premix for medicated feeding stuff and as an oral powder for pigs, and as granules for use in drinking water for pigs, chickens, turkeys and pheasants.
Danish: Aivlosin fås som premix til foderlægemiddel og som oralt pulver til svin samt som granulat til anvendelse i drikkevandet til svin, kyllinger, kalkuner og fasaner.
English: When mixing Aivlosin into feed or drinking water or handling the medicated feed or water, direct contact with eyes, skin and mouth should be avoided and protective equipment should be worn, e.g. overalls, gloves and face masks (respirator).
Danish: Ved iblanding af Aivlosin i foderet eller drikkevandet og ved håndtering af det medicinerede foder eller vand bør man undgå, at dette kommer i direkte kontakt med øjne, hud og mund, og man bør bruge værnemidler som overtrækstøj, handsker og beskyttelsesmaske (åndedrætsværn).
English: What is the risk associated with Aivlosin?
Danish: Hvilken risiko er der forbundet med Aivlosin?
English: Other information about Aivlosin:
Danish: Andre oplysninger om Aivlosin
English: In chickens and pheasants, it is used for treatment or metaphylaxis of lung infections caused by a bacterium Mycoplasma gallisepticum.
Danish: Hos kyllinger og fasaner anvendes det til behandling eller metafylakse af lungeinfektioner forårsaget af bakterien Mycoplasma gallisepticum.
English: However, if Aivlosin is accidentally consumed by a person, immediate medical advice should be sought and the package leaflet or label shown to the doctor.
Danish: Har en person utilsigtet indtaget Aivlosin, bør der straks søges lægehjælp, og indlægssedlen eller etiketten vises til lægen.
English: People who have had reactions when handling Aivlosin or similar products should avoid any contact with Aivlosin.
Danish: Har man tidligere haft reaktioner ved håndtering af Aivlosin eller lignende lægemidler, bør man undgå kontakt med Aivlosin.
English: Since the composition of the pig feed might affect the effectiveness of Aivlosin, it should only be used in dry feed.
Danish: Svinefoderets sammensætning kan have indflydelse på virkningen af Aivlosin, som derfor kun bør anvendes i tørt foder.
English: The effectiveness of Aivlosin was similar to that of other medicines of the same class already authorised for this disease in chickens.
Danish: Aivlosins virkning svarer til virkningen af andre lægemidler i samme klasse, som allerede er godkendt til denne sygdom hos kyllinger.
English: These included a dose confirmation study in turkey poults (young turkeys) artificially infected with a lung virus (avian pneumovirus) and Ornithobacterium rhinotracheale, to simulate a complicated infection.
Danish: Disse omfattede en undersøgelse til bekræftelse af dosis hos kalkunkyllinger, som var blevet kunstigt inficeret med en lungevirus (aviær pneumovirus) og Ornithobacterium rhinotracheale, for at simulere en kompliceret infektion.
English: The oral powder is mixed into pig feed by the pig owner and is used to treat individual pigs.
Danish: Det orale pulver blandes i svinefoderet af dyrets ejer og anvendes til behandling af individuelle dyr.
English: The withdrawal period for eggs from chickens treated with Aivlosin is zero days.
Danish: Tilbageholdelsestiden for æg fra kyllinger, der behandles med Aivlosin, er nul dage.
English: In turkeys, it is used to treat lung infections caused by a bacterium, Ornithobacterium rhinotracheale, which can cause illness when it is complicated by other viral and bacterial infections.
Danish: Hos kalkuner anvendes det til behandling af lungeinfektioner forårsaget af bakterien Ornithobacterium rhinotracheale, som kan medføre sygdom, hvis den kompliceres af andre virus- eller bakterieinfektioner.
English: A further set of studies investigated Aivlosin in diseased chickens and pheasants as well as in very young chicks that hatched from eggs, which came from flocks where the disease was present.
Danish: En række yderligere undersøgelser så nærmere på Aivlosin hos kyllinger og fasaner, der allerede havde sygdommen, og hos meget unge kyllinger udklækket af æg fra hold, hvor sygdommen var til stede.
English: The studies showed that pigs treated with Aivlosin showed less severe signs of disease than untreated animals.
Danish: Undersøgelserne viste, at svin, som blev behandlet med Aivlosin, udviste færre alvorlige tegn på sygdommen end ubehandlede dyr.
English: The withdrawal period for meat from pigs treated with Aivlosin given in the feed is two days and one day with Aivlosin given via drinking water.
Danish: Tilbageholdelsestiden for kød fra svin, der behandles med Aivlosin, er to dage, og én dag, når det gives via drikkevandet.
English: The withdrawal period for meat from chickens, turkeys and pheasants treated with Aivlosin given via drinking water is two days.
Danish: Tilbageholdelsestiden for kød fra kyllinger, kalkuner og fasaner, der behandles med Aivlosin via drikkevandet, er to dage.
English: Poults either received treatment with Aivlosin or no treatment three days later.
Danish: Tre dage senere blev kalkunkyllingerne enten behandlet med Aivlosin eller blev ikke behandlet.
English: In pigs, it is used to treat or for metaphylaxis of a number of infectious diseases that are caused by bacteria that affect the lungs (i.e. swine enzootic pneumonia) or the intestinal tract (swine dysentery or porcine proliferative enteropathy).
Danish: Det anvendes hos svin til behandling eller metafylakse af en række bakterielle infektionssygdomme i lungerne (dvs. enzootisk pneumoni hos svin) eller fordøjelsessystemet (svinedysenteri eller proliferativ enteropati hos svin).
English: Chickens and pheasants treated with Aivlosin showed less severe signs of disease than untreated animals.
Danish: Kyllinger og fasaner, som blev behandlet med Aivlosin, udviste færre alvorlige tegn på sygdommen end ubehandlede dyr.
English: Skin that has been in contact with Aivlosin or medicated feed or drinking water should be washed.
Danish: Har man fået Aivlosin eller medicineret foder eller drikkevand på huden, bør det pågældende område vaskes.
English: What benefits of Aivlosin have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Aivlosin?
English: How is Aivlosin used?
Danish: Hvordan anvendes Aivlosin?
English: How does Aivlosin work?
Danish: Hvordan virker Aivlosin?
English: The treatment success with Aivlosin was similar to the effectiveness of other medicines of the same class authorised for such diseases in pigs.
Danish: Aivlosin gav lige så gode behandlingsresultater som andre veterinærlægemidler, der tilhører samme klasse og er godkendt til behandling af de pågældende sygdomme hos svin.
English: For more information about treatment with Aivlosin animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Aivlosin, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Aivlosin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Aivlosin, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Aivlosin improves the health and weight of the animals, but may not eliminate completely the bacteria that caused lung infection.
Danish: Metafylakse består i samtidig behandling af både sygdomsramte dyr og af klinisk sunde dyr, som er i tæt kontakt med dem. Aivlosin forbedrer dyrenes sundhedstilstand og vægt, men udrydder ikke nødvendigvis fuldstændigt de bakterier, der har forårsaget lungeinfektionen.
English: The main measure of effectiveness was damage to lungs and air sacs, which was less for the Aivlosin-treated turkeys than for the untreated group.
Danish: Beskadigelsen var mindre hos de kalkuner, der fik Aivlosin, end hos den ubehandlede gruppe.
English: This later diagnosis is not any more listed in the DSM-IV-TR.
Danish: Denne senere diagnose er ikke længere opført i DSM-IV-TR.
English: Available data is in fact indicative of such causal relationship.
Danish: De tilgængelige data peger faktisk på en sådan årsagssammenhæng.
English: The number of patients could be considered sufficient in 4 studies (146, 203, 155 and 324 patients) and small in 2 studies (50 and 49 patients).
Danish: Antallet af patienter kunne anses for tilstrækkeligt i 4 undersøgelser (146, 203, 155 og 324 patienter) og lille i 2 undersøgelser (50 og 49 patienter).
English: The duration of these studies was short (2 or 3 months) considering the chronic indication approved.
Danish: Varigheden af disse undersøgelser var kort (2 eller 3 måneder) i betragtning af den godkendte kroniske indikation.
English: Patients included in most of these studies presented various very different symptoms without standardised diagnosis.
Danish: Patienter, der indgik i de fleste af disse undersøgelser, udviste diverse meget forskellige symptomer uden standardiseret diagnose.
English: Only one study (Vinckier study) mentioned a small group of patients suffering from associated systemic disease.
Danish: Kun én undersøgelse (Vinckier-undersøgelsen) nævnte en lille gruppe patienter, der led af tilknyttet systemisk sygdom.
English: The seriousness of such adverse effects and their possible fatal outcome is underlined.
Danish: Alvorligheden af sådanne bivirkninger og deres mulige dødelige udfald understreges
English: There seemed to be a benefit of treatment in approximately 5575% of patients but the CHMP concluded that these results are in fact difficult to interpret from a clinical point of view and not reliable due to the methodological limitations of the studies.
Danish: Der syntes at være en fordel ved behandlingen for ca. 55-75 % af patienterne, men CHMP konkluderede, at disse resultater i virkeligheden er vanskelige at fortolke ud fra et klinisk synspunkt og ikke er pålidelige på grund af undersøgelsernes metodiske begrænsninger.
English: Results were heterogeneous and there was no consistency across studies.
Danish: Resultaterne var heterogene, og der var ingen sammenhæng på tværs af undersøgelserne.
English: The reliability and the clinical relevance of the study results was therefore questionable and preclude any conclusion on the efficacy of the product.
Danish: Pålideligheden og den kliniske relevans af undersøgelsens resultater var derfor tvivlsom og udelukker enhver konklusion om produktets virkning.
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC the CHMP recommends:
Danish: Derfor anbefaler CHMP i overensstemmelse med artikel 116 i Direktiv 2001/83/EF:
English: As a note, one of the above mentioned three cases of fibrosis was reported in 2009 (i.e. after finalisation of the previous referral) which shows that the risk minimisation measures that were imposed at that point in time are not sufficient to exclude the risk.
Danish: Som en bemærkning, var et af ovenstående tre tilfælde af fibrose blevet indberettet i 2009 (dvs. efter afslutningen af den foregående indbringelsesprocedure), som viser, at de foranstaltninger til risikominimering, der blev indført på det tidspunkt, ikke er tilstrækkelige til at udelukke risikoen.
English: The CHMP was therefore requested to give its opinion on whether the marketing authorisations for ergot derivatives containing medicinal products should be maintained, varied, suspended or withdrawn in relation to the below mentioned indications:
Danish: CHMP blev derfor anmodet om at afgive udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler, der indeholder ergotderivater bør opretholdes, ændres, suspenderes eller tilbagekaldes i forhold til de nedenfor nævnte indikationer:
English: A review of all other available data (i.e. literature data, pre-clinical data, and other clinical data including epidemiological studies) that were relevant to evaluate the risk of fibrosis was provided where possible.
Danish: En gennemgang af alle andre tilgængelige data (dvs. data fra litteraturen, prækliniske data og andre kliniske data, herunder epidemiologiske undersøgelser), der var relevante for at vurdere risikoen for fibrose, blev leveret, hvor det var muligt.