FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse event reports with signs typical of bovine neonatal pancytopenia in herds in which Pregsure BVD was one of the vaccines used varies across affected Member States and in some Member States, e.g. Germany and United Kingdom, has increased markedly since 2009.
Danish: Hyppigheden af indberetninger om utilsigtede hændelser med typiske tegn på bovin neonatal pancytopeni hos besætninger, hvor Pregsure BVD var en af de anvendte vacciner, er forskellig i de berørte medlemsstater, og i nogle medlemsstater, f.eks. Tyskland og Det Forenede Kongerige, er den steget markant siden 2009.
English: The product has also a claim of partial cross protection against BVDV type 2.
Danish: En anden af lægemidlets virkningsangivelser er, at det giver delvis krydsbeskyttelse mod BVDV type 2.
English: Germany is the Member State where most adverse events of bovine neonatal pancytopenia have been reported.
Danish: Tyskland er den medlemsstat, hvor der er indberettet flest utilsigtede hændelser i form af bovin neonatal pancytopeni.
English: The potential risk of bovine neonatal pancytopenia following use of the product was not considered to be acceptable in comparison to the benefits provided by the product.
Danish: Den potentielle risiko for bovin neonatal pancytopeni efter brugen af lægemidlet blev ikke anset for at være acceptabel i forhold til de fordele, som lægemidlet giver.
English: Since March 2009, over 400 adverse events of bovine neonatal pancytopenia (involving over 2,000 animals) have been reported within eleven European Union (EU) Member States where the product is authorised.
Danish: Siden marts 2009 er der blevet indberettet over 400 utilsigtede hændelser i form af bovin neonatal pancytopeni (der omfattede over 2.000 dyr) i 11 EU-medlemsstater, hvor lægemidlet er godkendt.
English: Scientific conclusions and grounds for suspension of the marketing authorisations
Danish: Faglige konklusioner og begrundelser for suspendering af markedsføringstilladelserne
English: Product name Pharmaceutical form
Danish: Lægemiddelform Styrke
English: It was noted that in Member States where Pregsure BVD was not marketed or in herds where Pregsure BVD had not been used, bovine neonatal pancytopenia appears to be reported as isolated events and may be compatible with so-called idiopathic bovine neonatal pancytopenia.
Danish: Det blev bemærket, at i medlemsstater, hvor Pregsure BVD ikke var markedsført, eller hos besætninger, hvor Pregsure BVD ikke var blevet anvendt, er bovin neonatal pancytopeni tilsyneladende indberettet som isolerede tilfælde og kan være forenelig med såkaldt idiopatisk bovin neonatal pancytopeni.
English: The possibility of the vaccine triggering the production of allo- or auto-antibodies cannot be excluded and may explain the rapid onset of the disorder in calves that have recently ingested colostrum from vaccinated dams.
Danish: Muligheden for, at vaccinen udløser produktionen af allo- eller autoantistoffer, kan ikke udelukkes, og det kan forklare sygdommens hurtige indtræden hos kalve, der kort tid forinden havde indtaget kolostrum fra vaccinerede moderdyr.
English: The data evaluated suggest that Pregsure BVD may be one of the contributing factors for bovine neonatal pancytopenia although investigations are currently ongoing to determine all the factors associated with the disorder and the underlying cause.
Danish: De evaluerede data tyder på, at Pregsure BVD kan være en af de faktorer, der bidrager til bovin neonatal pancytopeni, selv om der i øjeblikket er undersøgelser i gang for at bestemme alle de faktorer, der er associeret med sygdommen, og den underliggende årsag.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that the pharmacovigilance data (adverse event reports) indicated a general trend between reported events of bovine neonatal pancytopenia and the temporal and geographical distribution of Pregsure BVD sales, including the number of doses sold in the different EU Member States.
Danish: Udvalget for Veterinærlægemidler (CVMP) var af den opfattelse, at lægemiddelovervågningsoplysningerne (indberetningerne af utilsigtede hændelser) tydede på en generel sammenhæng mellem de indberettede tilfælde af bovin neonatal pancytopeni og den tidsmæssige og geografiske distribution af Pregsure BVD, herunder det antal doser, der er solgt i de forskellige EU-medlemsstater.
English: A number of laboratory studies identified the ingestion of colostral antibodies from vaccinated dams as a potential risk factor.
Danish: I en række laboratorieundersøgelser identificerede man indtagelsen af antistoffer fra kolostrum fra vaccinerede moderdyr som en potentiel risikofaktor.
English: For the suspension to be lifted the marketing authorisation holders should provide the national competent authorities with scientific evidence to demonstrate that the administration of the vaccine to dams, according to the recommendations of the summary of product characteristics, does not lead to an increased risk of bovine neonatal pancytopenia or propose management measures to mitigate this risk and to demonstrate a favourable benefit-risk balance for the product.
Danish: For at suspenderingen kan ophæves, skal indehaverne af markedsføringstilladelsen give de nationale kompetente myndigheder videnskabelig dokumentation for, at indgivelsen af vaccinen til moderdyr, i henhold til anbefalingerne i produktresuméet, ikke fører til en øget risiko for bovin neonatal pancytopeni, eller foreslå risikohåndteringsforanstaltninger for at nedsætte denne risiko og påvise et positivt benefit/risk-forhold for lægemidlet.
English: The overall incidence for bovine neonatal pancytopenia events reported following use of the product was estimated to be over 0.016% across the EU, based on a single dose, between 2004 and 2009.
Danish: Den samlede incidens for indberettede bovin neonatal pancytopeni-hændelser efter brugen af lægemidlet blev anslået til at være over 0,016 % i hele EU mellem 2004 og 2009, baseret på en enkelt dosis.
English: • the CVMP concluded that the benefit-risk balance for Pregsure BVD is unfavourable under the authorised conditions of use;
Danish: • CVMP konkluderede, at benefit/risk-forholdet for Pregsure BVD er negativt med de godkendte anvendelsesbetingelser;
English: Pribinova 25
Danish: Pfizer AH Pribinova 25
English: Pregsure BVD is an inactivated vaccine for the immunisation of female cattle to prevent bovine viral diarrhoea virus (BVDV) type 1 (cytopathogenic strain 5960) transplacental infection and the birth of BVDV type 1 persistently infected calves.
Danish: Pregsure BVD er en inaktiveret vaccine til immunisering af køer, der skal forhindre transplacental infektion med bovin viral diarrévirus (BVDV) type 1 (cytopatogenisk stamme 5960) og fødslen af kalve, der er persistent inficeret med BVDV type 1.
English: The Committee reviewed the list of ongoing or planned research studies supported by the marketing authorisation holder to investigate bovine neonatal pancytopenia and the potential relation with Pregsure BVD.
Danish: Udvalget gennemgik listen over igangværende eller planlagte forskningsundersøgelser iværksat af indehaveren af markedsføringstilladelsen for at undersøge bovin neonatal pancytopeni og den potentielle forbindelse til Pregsure BVD.
English: • the aetiology of bovine neonatal pancytopenia is unknown and the risk factors associated with the disorder have yet to be determined;
Danish: • Ætiologien af bovin neonatal pancytopeni erukendt, og de risikofaktorer, der er forbundet med sygdommen, er stadig ikke blevet fastlagt;
English: Following the evaluation of adverse event reports of bovine neonatal pancytopenia after the use of Pregsure BVD, and epidemiological data and findings from research projects on bovine neonatal pancytopenia, the German authority (Paul-Ehrlich Institut (PEI)) questioned the benefit-risk balance for the product.
Danish: På baggrund af evalueringen af indberetningerne om utilsigtede hændelser i form af bovin neonatal pancytopeni efter brugen af Pregsure BVD og på baggrund af epidemiologiske data og resultater fra forskningsprojekter om bovin neonatal pancytopeni satte den tyske myndighed (Paul-Ehrlich Institut (PEI)) spørgsmålstegn ved lægemidlets benefit/risk-forhold.
English: The CVMP concluded that the overall benefit-risk balance of the product is unfavourable under the authorised conditions of use.
Danish: CVMP konkluderede, at det overordnede benefit/risk-forhold for lægemidlet er negativt med de godkendte anvendelsesbetingelser.
English: Although considered by the marketing authorisation holder, an association between the occurrence of bovine neonatal pancytopenia and the release of particular batch(es) of the product has not been found nor any indication for circovirus contamination of the product.
Danish: Selv om dette blev taget i betragtning af indehaveren af markedsføringstilladelsen, blev der ikke konstateret en sammenhæng mellem forekomsten af bovin neonatal pancytopeni og frigivelsen af særlig(e) batch(er) af lægemidlet, og der var heller ingen tegn på kontaminering af lægemidlet med circovirus.
English: • adverse events of bovine neonatal pancytopenia reported after the use of Pregsure BVD appear to indicate an association with the product.
Danish: • utilsigtede hændelser med bovin neonatal pancytopeni, som er indberettet efter brugen af Pregsure BVD, indikerer tilsyneladende en sammenhæng med lægemidlet.
English: In addition to the pharmacovigilance data, the CVMP also took into account epidemiological and experimental studies that provided further evidence to suggest an association between Pregsure BVD and bovine neonatal pancytopenia.
Danish: Foruden lægemiddelovervågningsoplysningerne tog CVMP også højde for epidemiologiske og eksperimentelle undersøgelser, som gav yderligere evidens, der tydede på en forbindelse mellem Pregsure BVD og bovin neonatal pancytopeni.
English: Slovak republic Pfizer Luxembourg SARL o.z.
Danish: Pfizer Luxembourg SARL o.z.
English: Belgium Pfizer Animal Health Rue Laid Burniat 1
Danish: Pfizer Animal Health Rue Laid Burniat 1
English: The aetiology of bovine neonatal pancytopenia is unknown at present and the potential association with Pregsure BVD is the focus of ongoing research.
Danish: Ætiologien af bovin neonatal pancytopeni er på nuværende tidspunkt ukendt, og der er fokus på den potentielle sammenhæng med Pregsure BVD i den igangværende forskning.
English: Pfizer Animal Health Rue Laid Burniat 1 1348 - Louvain-laNeuve
Danish: Pfizer Animal Health S.A. Rue Laid Burniat 1 B-1348 - Louvain-laNeuve
English: In addition, unpublished data from a study involving negative control farms to investigate management factors potentially associated with bovine neonatal pancytopenia identified a history of Pregsure BVD vaccination at the herd level as a potential risk factor for bovine neonatal pancytopenia.
Danish: Desuden viste ikke-offentliggjorte data fra en undersøgelse, der omfatter negative kontrollandbrug med henblik på at undersøge håndteringsfaktorer, der potentielt er forbundet med bovin neonatal pancytopeni, at tidligere Pregsure BVD-vaccination på besætningsniveau var en potentiel risikofaktor for bovin neonatal pancytopeni.
English: Evaluation of the potential association between the occurrence of bovine neonatal pancytopenia in calves and vaccination of dams using Pregsure BVD and associated names
Danish: Evaluering af den potentielle sammenhæng mellem forekomsten af bovin neonatal pancytopeni hos kalve og vaccination af moderdyrene med Pregsure BVD og tilknyttede navne
English: Preliminary epidemiological findings report an association between bovine neonatal pancytopenia calves and a vaccination history, at the herd level, involving Pregsure BVD.
Danish: Ifølge de foreløbige epidemiologiske resultater er der en sammenhæng mellem bovin neonatal pancytopeni hos kalve og en vaccinationshistorie på besætningsniveau, der involverer Pregsure BVD.
English: From the data evaluated to date, there is evidence to suggest a potential association between vaccination of dams using Pregsure BVD and the occurrence of bovine neonatal pancytopenia in calves.
Danish: Fra evalueringsdatoen og indtil nu er der evidens for en potentiel sammenhæng mellem vaccination af moderdyr med Pregsure BVD og forekomsten af bovin neonatal pancytopeni hos kalve.
English: Pfizer Healthcare Ireland trading as Pfizer Animal Health Ringaskiddy County Cork IRELAND
Danish: Pfizer Healthcare Ireland trading as Pfizer Animal Health
English: Strength
Danish: Ringaskiddy
English: PFIZER HELLAS S.A 243 Messogeion Ave. Neo Psychiko GR-154 51
Danish: Grækenland PFIZER HELLAS S.A 243 Messogeion Ave.
English: Target animal species
Danish: Dyrearter
English: Laboratórios Pfizer Lda Lagoas Park - Edifício
Danish: Laboratórios Pfizer Lda Lagoas Park - Edifício 10 2740-244 Porto Salvo PORTUGAL
English: Administration of Pregsure BVD to female cattle allows prevention of BVDV type 1 transplacental infection and the birth of BVDV type 1 persistently infected calves and laboratory scale investigations have also demonstrated that vaccination can reduce fertility losses due to BVDV type 1 infection in the early stage of gestation.
Danish: Indgivelse af Pregsure BVD til køer gør det muligt at hindre transplacental infektion med BVDV type 1 samt fødslen af kalve, der er persistent inficeret med BVDV type 1.
English: 1348 - Louvain-la
Danish: 1348 - Louvain-la-Neuve BELGIUM
English: Although the definitive aetiology of bovine neonatal pancytopenia is at present unknown, it appears to be a multi-factorial disorder and the possibility that it may be immune-mediated is consistent with available epidemiological data and is becoming a focus of research efforts to identify the causal factor(s) for calves developing bovine neonatal pancytopenia.
Danish: Muligheden for, at den er immunmedieret, er i overensstemmelse med de tilgængelige epidemiologiske data, og der bliver nu sat fokus på dette i forskningsindsatsen for at identificere årsagsfaktor(erne) for kalve, der udvikler bovin neonatal pancytopeni.
English: SLOVAK REPUBLIC
Danish: Slovakiet
English: Pfizer Animal Health BV Rivium Westlaan 142 2909 LD Capelle a/d Ijssel
Danish: Nederlandene Pfizer Animal Health BV Rivium Westlaan 142
English: Route of administration
Danish: Doseringshyppighed og indgivelsesvej
English: Whilst acknowledging the limitations of the pharmacovigilance data and the lack of appropriate control animals in some of laboratory studies, having evaluated the data available, the CVMP concluded the above-mentioned findings provide evidence to suggest a potential association between the occurrence of bovine neonatal pancytopenia and Pregsure BVD.
Danish: Efter at have evalueret de foreliggende data konkluderede CVMP dog, at ovennævnte resultater giver evidens for en potentiel sammenhæng mellem forekomsten af bovin neonatal pancytopeni og Pregsure BVD.
English: (Invented) name Strength Pharmaceutical form
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration
English: The publications on clinical data are old (from 1971 up to 1995).
Danish: Publikationerne af kliniske data er gamle (fra 1971 op til 1995).
English: The scales used were largely based on subjective assessment rather than formal testing.
Danish: De anvendte skalaer var hovedsagelig baseret på subjektiv vurdering frem for formel testning.
English: Therefore, the CHMP maintained its opinion of 27 June 2013 and therefore, in accordance with Article 116 of Directive 2001/83/EC the CHMP recommends:
Danish: fastholdt CHMP sin udtalelse af 27. juni 2013 og anbefaler derfor i overensstemmelse med artikel 116, i direktiv 2001/83/EF:
English: All these old studies suffered from methodological flaws.
Danish: Alle disse gamle undersøgelser var behæftet med metodologiske mangler.
English: Overall summary of the scientific evaluation of dihydroergotoxine containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder dihydroergotoxin (se bilag I)
English: It therefore remains uncertain whether the studied population in the selected clinical studies is representative of the proposed indication.
Danish: Det er derfor fortsat uvist, om den undersøgte population i de valgte kliniske undersøgelser er repræsentativ for den foreslåede indikation.
English: Thus the demonstrated benefit for patients in the proposed indication does not outweigh the above identified risk.
Danish: Den påviste fordel for patienterne ved den foreslåede indikation overstiger derfor ikke den ovenfor omhandlede risiko.
English: The primary mechanism of action of dihydroergotoxine and other ergoloids is unclear at the present time.
Danish: Den primære virkningsmekanisme af dihydroergotoxin og andre ergoloider er på nuværende tidspunkt uklar.
English: In addition, the CHMP convened another meeting of the scientific advisory group (SAG) that took place on 16 October 2013.
Danish: Udvalget indkaldte til endnu et møde i den videnskabelige rådgivende gruppe, som fandt sted den 16. oktober 2013.
English: In others, only certain points of the scale to assess efficacy were significantly improved.
Danish: I andre var der kun væsentlig forbedring af visse punkter på skalaen til vurdering af virkning.
English: The seriousness of such adverse effects and their possible fatal outcome is underlined.
Danish: Alvorligheden af sådanne bivirkninger og deres mulige fatale udfald understreges,
English: The Cochrane review is not relevant for the assessment as it focuses on dementia and symptoms consistent with dementia.
Danish: Cochrane-gennemgangen er ikke relevant for vurderingen, da den fokuserer på demens og symptomer forenelige med demens.
English: Therefore, concerns about heterogeneity of the studied population remain.
Danish: Der er derfor fortsat betænkeligheder omkring ensartetheden af den undersøgte population.
English: Issues such as a high dropout level, unclear or subjective evaluation criterions and low number of patients also preclude a conclusion on efficacy based on these data.
Danish: Problemer såsom høj frafaldsprocent, uklare eller subjektive vurderingskriterier og lavt patientantal udelukker ligeledes en konklusion om virkning på grundlag af disse data.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products in the concerned indications.
Danish: • udvalget fulgte proceduren i henhold til artikel 31 i direktiv 2001/83/EF for lægemidler indeholdende ergotderivater til de pågældende indikationer,
English: No reports of ergotism were stated, however, the CHMP questioned the appropriateness of the data collection method (i.e. non exhaustive and thus inconclusive).
Danish: Der blev ikke indberettet ergotisme, man CHMP betvivlede egnetheden af dataindsamlingsmetoden (dvs. ikke udtømmende og derfor inkonklusiv).
English: • Orthostatic hypotension
Danish: • Ortostatisk hypotension
English: The outcome in the different components included in these assessment tools vary considerably between the studies and no general conclusions can be drawn neither on the size of possible effects nor on the clinical relevance.
Danish: Resultatet for de forskellige komponenter, der indgår i disse vurderingsværktøjer, afviger betydeligt mellem undersøgelserne, og der kan ikke drages generelle konklusioner om størrelsen af mulige virkninger eller deres kliniske relevans.
English: Diagnostic and determination of the origin of cognitive impairments are difficult tasks for the modern medicine.
Danish: Diagnostik og årsagsbestemmelse af kognitiv funktionsnedsættelse er vanskelige opgaver for den moderne medicin.
English: In addition, both included a small number of patients (n=48 and n=62), both were short-term studies (1-5 months and 8 months, respectively) which short term duration is considered inappropriate to evaluate the outcome of slow progressing diseases.
Danish: Begge undersøgelser omfattede endvidere kun et lille antal patienter (n=48 og =62), og begge var kortvarige (hhv. 1-5 måneder og 8 måneder) og derfor uegnede til at vurdere udfaldet af en langsomt fremadskridende sygdom.
English: Moreover, three out of the nine cases were reported during the French Pharmacovigilance survey that was conducted in 2011 which shows that the risk minimisation measures that are currently in place are not sufficient to prevent the risk of fibrotic reactions.
Danish: Tre ud af de ni tilfælde blev desuden indberettet under den franske undersøgelse af lægemiddelovervågning, der blev foretaget i 2011, hvilket viser, at de nuværende risikominimeringsforanstaltninger ikke er tilstrækkelige til at forhindre udvikling af fibrotiske reaktioner.
English: These studies were of poor methodological quality: uncontrolled, open designed and without any well-defined primary efficacy endpoint.
Danish: Disse undersøgelser var af ringe metodologisk kvalitet: ukontrollerede, med åbent design og uden veldefineret primært endepunkt for virkning.
English: Furthermore, the fact that these studies have been performed many years ago raises methodological concerns given advances in clinical research methods and the changes in the definition of dementia/ pre-dementia conditions over time.
Danish: Det forhold, at disse undersøgelser er udført for mange år siden, giver desuden anledning til metodologiske betænkeligheder i betragtning af fremskridtene i kliniske forskningsmetoder og de ændringer, der med tiden er sket i definitionen af demens og prædemens.
English: Indeed, the heterogeneity of the studies submitted is such that no firm conclusions can be drawn.
Danish: De forelagte undersøgelser er således så uensartede, at der ikke kan drages faste konklusioner.
English: In the 19 clinical studies that are argued to be supportive of this restricted indication, and which included heterogeneous populations, some did not show significant effects of dihydroergotoxine.
Danish: Af de 19 kliniske undersøgelser, der hævdes at støtte denne begrænsede indikation, og som omfattede heterogene populationer, var der nogle, der ikke viste nævneværdige virkninger af dihydroergotoxin.
English: The two comparative studies described by the MAH (Orma, 1958 and Vannas, 1958) were of poor methodological quality; moreover no information is available about the exact design or randomisation in the different groups tested.
Danish: De to sammenlignende undersøgelser, der beskrives af indehaveren af markedsføringstilladelsen MAH (Orma, 1958, og Vannas, 1958) var af ringe metodologisk kvalitet; desuden foreligger der ingen oplysninger om det eksakte design eller randomiseringen i de forskellige undersøgte grupper.
English: In order to lift the suspension, MAHs must identify a specific patient population for which the benefits of the medicinal product outweigh the risk.
Danish: For at suspenderingen kan ophæves, skal indehaverne af markedsføringstilladelse udpege en konkret patientpopulation, for hvilken fordelene ved lægemidlet er større end risikoen.
English: Although some of the proposed measures could help identify patients with preexisting fibrosis, relevant concomitant medication and increased risk, the Committee pointed out that they are insufficient to avoid that some patients develop fibrosis and ergotism during treatment.
Danish: Skønt nogle af de foreslåede foranstaltninger kan medvirke til at identificere patienter med præeksisterende fibrose, relevant samtidig medicinering og forhøjet risiko, understregede udvalget, at de ikke er tilstrækkelige til at undgå udvikling af fibrose og ergotisme hos nogle patienter under behandlingen.
English: The majority of the papers are not relevant (publications not submitted, studies were open-label, not placebo-controlled and/or with intravenous use of dihydroergotoxine mesilate).
Danish: Størstedelen af artiklerne er ikke relevante (ikke indsendt til publikation, åbne undersøgelser, ikke placebokontrollerede og/eller med intravenøs anvendelse af dihydroergotoxinmesilat).
English: Following the adoption of the CHMP opinion during the June 2013 CHMP meeting, a re-examination request was received from one of the MAH involved in the procedure.
Danish: Efter vedtagelsen af CHMP's udtalelse på udvalgets møde i juni 2013 modtoges en anmodning om fornyet overvejelse fra en af de markedsføringstilladelsesindehavere, som var involveret i proceduren.