FrancophonIA/ELRC3.0 huggingface dataset:
English: o The safety and efficacy data provided by the applicant were sufficient to consider that the overall benefit-risk balance for the product is positive.
Danish: o De sikkerheds- og virkningsdata, som ansøgeren har fremlagt, var tilstrækkelige til at antage, at det generelle risk/benefit-forhold for produktet er positivt.
English: During the mutual recognition procedure concerns were raised by Belgium that the benefit/risk balance of Poulvac Bursa Plus might be considered unfavourable.
Danish: Under den gensidige anerkendelsesprocedure gav Belgien udtryk for bekymring over, at benefit/riskforholdet for Poulvac Bursa Plus kunne anses for at være ugunstigt.
English: • The vaccine strain is able to spread to incontact chickens, but is very unlikely to increase in virulence.
Danish: • Vaccinestammen kan sprede sig ved kontakt mellem kyllinger, men det er meget usandsynligt, at dens virulens vil øges.
English: The valid Summary of Product Characteristics, Labelling and Package Leaflet are the final versions achieved during the Coordination group procedure.
Danish: De gældende tekster til produktresumé, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen.
English: Prevention of mortality and reduction of bursal lesions were demonstrated.
Danish: Forebyggelse af dødelighed og reduktion af bursa-skader blev påvist.
English: Layer chicks are clinically more sensitive than broilers
Danish: Læggehøns er klinisk mere følsomme end slagtekyllinger
English: • These types of product are for use in specific cases where there is evidence of vvIBD and where the level of bursal damage incurred is a necessary risk to achieve the protection provided against vvIBD.
Danish: • Disse produkttyper skal anvendes i specifikke tilfælde, hvor der foreligger tegn på vvIBD, og hvor omfanget af de bursa-skader, der måtte opstå, er en nødvendig risiko for at opnå beskyttelsen mod vvIBD.
English: Field data confirm the benefits of vaccination under practical conditions on sites which have experienced ongoing problems with vvIBD where intermediate products have not been successful at controlling the vvIBD problem.
Danish: Feltdata bekræfter fordelene ved vaccination under praktiske betingelser på steder, der har oplevet vedvarende problemer med vvIBD, hvor intermediære produkter ikke har kunnet kontrollere vvIBDproblemet.
English: Therefore, the benefits of the product have been adequately demonstrated and that any risks associated with residual virulence is a recognised risk associated with this type of product, which is only recommended for use in an environment contaminated with vvIBD.
Danish: Fordelene ved produktet er således blevet tilstrækkeligt påvist, og enhver risiko forbundet med residual virulens er en anerkendt risiko i tilknytning til denne type produkt, der kun anbefales til brug i et miljø forurenet med vvIBD.
English: • A study to assess the potential immunosuppression linked to administration of the vaccine was carried out according to the recommendations of the Ph. Eur.
Danish: • En undersøgelse, der skulle vurdere den potentielle immunosuppression i tilknytning til administration af vaccinen, blev gennemført i henhold til anbefalingerne i Den Europæiske Farmakopé (SPF-kyllinger).
English: • The SPC reflects the results of the various safety studies.
Danish: • Produktresuméet afspejler resultaterne af de forskellige feltundersøgelser.
English: Therefore, the CVMP recommended the granting of the Marketing Authorisations for Poulvac Bursa Plus for which the Summary of Product Characteristics, Labelling and Package Leaflet set out in Annex III of the CVMP Opinion.
Danish: CVMP anbefalede derfor, at der udstedes markedsføringstilladelse for Poulvac Bursa Plus, for hvilket produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III til CVMP's udtalelse.
English: Risks
Danish: Risici
English: The Marketing Authorisation Holder (MAH) provided 5 pivotal studies, 7 supportive studies and 3 field studies in order to assess safety of the vaccine.
Danish: Indehaveren af markedsføringstilladelsen fremlagde 5 pivotale undersøgelser, 7 understøttende undersøgelser og 3 feltundersøgelser til vurdering af vaccinens sikkerhed.
English: Assessment of Poulvac Bursa Plus
Danish: Vurdering af Poulvac Bursa Plus
English: • Since the product has been authorised, the reported incidence of adverse reactions is zero which indicates that the safety profile is acceptable.
Danish: • Siden produktet blev godkendt, er der ikke blevet indberettet nogen bivirkninger, hvilket indikerer, at sikkerhedsprofilen er acceptabel.
English: o The SPC provides adequate information to the end user to enable the appropriate use of the product, including a recommendation to only use the product where vvIBD was present.
Danish: o Produktresuméet indeholder tilstrækkelig information til slutbrugeren til at muliggøre en korrekt anvendelse af produktet, herunder en anbefaling om kun at anvende produktet, hvor der findes vvIBD.
English: Poulvac Bursa Plus is a live vaccine against Infectious Bursal Disease Virus (IBDV), also known as Gumboro disease.
Danish: Poulvac Bursa Plus er en levende vaccine mod infektiøs bursitisvirus (IBDV), også kendt som Gumboro-syge.
English: • Poulvac Bursa Plus has a negative impact on the serological response induced by vaccination against NDV.
Danish: • Poulvac Bursa Plus har en negativ indvirkning på den serologiske respons fremkaldt af vaccination mod NDV.
English: Given its residual pathogenicity, the vaccine strain, V877, is classified as “intermediate plus” and also known as a “hot” strain.
Danish: På grund af vaccinestammen V877's residuale patogenicitet klassificeres den som "intermediær plus"-type og er også kendt som en "varm" stamme.
English: A detailed analysis of the data provided concluded that Poulvac Bursa Plus is able to overcome Infectious Bursal Disease ELISA titres of ≥ 500.
Danish: En detaljeret analyse af de fremlagte data førte til den konklusion, at Poulvac Bursa Plus kan overvinde Infectious Bursal Disease med ELISA-titre på ≥ 500.
English: monograph 01/2008:0587 is not directly applicable, the vaccine strain was shown to be compliant with its section 2.4.1 “safety”.
Danish: Selv om Den Europæiske Farmakopés monografi 01/2008:0587 ikke finder direkte anvendelse, viste vaccinestammen sig at opfylde afsnit 2.4.1 "sikkerhed" heri.
English: • Efficacy of the vaccine in the presence of a range of MDA titres (mean titre of around 500 ELISA Units as recommended) was also shown under laboratory conditions: significant reduction of the bursal lesions was shown at 14 and 32 days post challenge.
Danish: • Vaccinens virkning ved tilstedeværelsen af en række MDA-titer (gennemsnitstiter på omkring 500 ELISA-enheder som anbefalet) blev påvist under laboratoriebetingelser: En væsentlig reduktion af bursa-skader blev påvist henholdsvis 14 og 32 dage efter eksponeringen.
English: This allows the accurate dosing of the virus which, the MAH states, is not possible in very young birds by the oral route.
Danish: Dette muliggør en nøjagtig dosering af virusset, hvilket indehaveren af markedsføringstilladelsen har anført ikke er muligt hos meget unge fugle ad en oral vej.
English: monograph concerning the section 2.4.2 since higher than acceptable damage to the bursa of Fabricius was observed.
Danish: • Vaccinen overholder ikke Den Europæiske Farmakopés monografi med hensyn til afsnit 2.4.2, da en højere end acceptabel skade på Bursa Fabricii blev observeret.
English: The results showed that the vaccine strain notably reduced the serological response induced by vaccination against Newcastle Disease Virus (NDV) observed in chickens previously vaccinated using Poulvac Bursa Plus.
Danish: Det fremgik af resultaterne, at vaccinestammen navnlig nedbragte den serologiske respons på vaccination mod Newcastle Disease Virus (NDV) observeret hos kyllinger, der tidligere er blevet vaccineret med Poulvac Bursa Plus.
English: However, the monograph is only intended for classical strains and bursal damage is expected to be associated with intermediate plus vaccine strains.
Danish: Monografien er kun beregnet på traditionelle stammer, og bursa-skader forventes at hænge sammen med vaccinestammer af "intermediær plus"-typen.
English: Benefit/risk balance
Danish: Benefit/risk-forholdet
English: This reduced serological response against NDV was however not translated into a reduction of the clinical protection against a virulent challenge.
Danish: Denne reducerede serologiske respons mod NDV resulterede dog ikke i en reduktion af den kliniske beskyttelse mod en virulent eksponering.
English: The risk of bursal damage and limited immunosuppression are clearly stated on the SPC (as is the need to restrict the use of the product to case of outbreaks of very virulent IBDV strains) and form part of the risk benefit assessment conducted by the veterinarian when deciding to use this product.
Danish: Risikoen for bursa-skader og begrænset immunosuppression fremgår klart af produktresuméet (og det samme gør behovet for at begrænse brugen af produktet til tilfælde af udbrud af vvIBDV-stammer) og udgør en del af den benefit/risk-vurdering, dyrlægen foretager, når han/hun beslutter at anvende produktet.
English: o It was accepted that the immunosuppression seen was an acknowledged risk associated with the product, which was offset against the demonstrated ability to provide protection against vvIBD in the face of MDA levels as specified in the SPC.
Danish: o Det accepteredes, at den påviste immunosuppression var en anerkendt risiko i tilknytning til produktet, som blev opvejet af den påviste evne til at yde beskyttelse mod vvIBD på baggrund af maternelle antistofniveauer som anført i produktresuméet.
English: The vaccine is indicated for the active immunisation of chickens with maternal antibody levels of ≤ 500 ELISA units, to reduce mortality and bursal lesions of Gumboro disease.
Danish: Vaccinen er indiceret til aktiv immunisering af kyllinger med antistofniveauer fra moderen på ≤ 500 ELISA-enheder for at nedbringe dødeligheden og bursa-skader forårsaget af Gumboro-syge.
English: • When administered to SPF chickens using a 10 times overdose, the vaccine does not cause clinical signs or mortality.
Danish: • Når vaccinen gives til SPF-kyllinger i en dosis 10 gange stærkere end den anbefalede, forårsager den ingen kliniske symptomer eller dødelighed.
English: monograph (01/2008:0587) for classical IBDV vaccines, in that there was bursal damage and an interference on the serological response to NDV, it was acknowledged that there was no requirement to comply with this monograph because the product was classified as an intermediate plus strain.
Danish: o Selv om produktet ikke overholdt Den Europæiske Farmakopés monografi (01/2008:0587) for traditionelle IBDV-vacciner, da der forekom bursa-skade og en interferens med den serologiske respons på NDV, anerkendtes det, at der ikke foreligger noget krav om, at denne monografi skal overholdes, fordi produktet var klassificeret som en "intermediær plus"stamme.
English: Efficacy studies have been carried out both under laboratory conditions, in SPF and commercial chickens with MDA, and under field conditions.
Danish: Virkningsundersøgelser blev foretaget både på laboratoriebetingelser af SPF-kyllinger og kommercielle kyllinger med maternelle antistoffer og på feltbetingelser.
English: The breakthrough titre has been supported, which underpins the proposed recommendation for use and confirms the ability of the product to be used to overcome MDA (present at levels as specified in the SPC), an issue which typically causes problems for intermediate vaccines.
Danish: Gennembrudstiteren er blevet underbygget, hvilket støtter den anbefalede brug og bekræfter produktets evne til at overvinde maternelle antistoffer (der er til stede i niveauer som anført i produktresuméet), noget, der typisk forårsager problemer for intermediære vacciner.
English: • With respect to the level of bursal damage seen in SPF birds vaccinated with Poulvac Bursa Plus it is noted that the results of independent confirmatory testing of Poulvac Bursa Plus conducted by Germany and presented during the current procedure indicate that the level of bursal lesions seen are in line with those seen following vaccination with similar products which are already authorised in many Member States and therefore used widely within the European Union.
Danish: • Med hensyn til omfanget af bursa-skader hos SPF-fugle vaccineret med Poulvac Bursa Plus bemærkes det, at resultaterne af uafhængige bekræftende tests af Poulvac Bursa Plus udført af Tyskland og fremlagt under den aktuelle procedure, viser, at omfanget af bursa-skader svarer til det, der ses efter vaccination med tilsvarende produkter, der allerede er godkendt i mange medlemsstater og derfor anvendes bredt inden for EU.
English: The level of bursal lesions seen in independent confirmatory testing of Poulvac Bursa Plus is in line with those seen following vaccination with similar products which are already authorised in several Member States and used within the EU.
Danish: Omfanget af de bursa-skader, der er påvist i uafhængige bekræftende tests af Poulvac Bursa Plus, ligger på linje med det, der ses efter vaccination med tilsvarende produkter, der allerede er godkendt i adskillige medlemsstater og anvendes i EU.
English: There is no requirement to demonstrate better protection than existing products, nevertheless it has been shown under field conditions that Poulvac Bursa Plus is able to restore performance lost due to vvIBD which has broken through the protection provided by classical vaccines containing mild or intermediate strains.
Danish: Der findes ikke noget krav om, at det skal påvises, at produktet giver en bedre beskyttelse end eksisterende produkter, men det er dog under feltbetingelser blevet påvist, at Poulvac Bursa Plus er i stand til at genoprette ydelser, der er gået tabt, fordi vvIBD har gennembrudt den beskyttelse, som traditionelle vacciner indeholdende milde eller intermediære stammer yder.
English: • Under field conditions it was shown that Poulvac Bursa Plus was able to restore performance lost due to vvIBD which had broken through the protection provided by classical vaccines containing mild or intermediate strains.
Danish: • Under feltbetingelser blev det påvist, at Poulvac Bursa Plus var i stand til at genoprette tabt ydelse som følge af vvIBD, der var brudt igennem den beskyttelse, som traditionelle vacciner indeholdende milde eller intermediære stammer giver.
English: The effect on serology is adequately reflected in the SPC.
Danish: Virkningen på serologien fremgår på passende vis af produktresuméet.
English: The MAH provided 2 pivotal studies, 7 supportive studies and 4 field studies.
Danish: Indehaveren af markedsføringstilladelsen fremlagde 2 pivotale undersøgelser, 7 understøttende undersøgelser og 4 feltundersøgelser.
English: • Efficacy of the vaccine (minimum titre) has been shown using SPF chickens of the minimum age recommended: reduction of the bursal lesions and prevention of the mortality caused by a vvIBDV was achieved in those animals.
Danish: • Vaccinens virkning (minimumstiter) er blevet påvist hos SPF-kyllinger i den anbefalede minimumsalder: En reduktion af bursa-skader og forebyggelse af dødelighed forårsaget af vvIBDV blev opnået hos disse dyr.
English: • Although no compatibility is claimed, serological data have been provided to support an absence of a negative interaction between Poulvac Bursa Plus and other vaccines.
Danish: • Selv om ingen uforligeligheder gøres gældende, er der blevet fremlagt serologiske data til støtte for fraværet af en negativ interaktion mellem Poulvac Bursa Plus og andre vacciner.
English: However, this effect did not affect the ability of the Newcastle Disease vaccine to protect against challenge with virulent NDV.
Danish: Denne virkning påvirkede dog ikke Newcastle Disease-vaccinens evne til at beskytte mod eksponering for virulent NDV.
English: Efficacy of the vaccine has been adequately demonstrated in the laboratory, sufficient to confirm prevention of mortality and reduction of bursal lesions caused by vvIBDV using SPF chickens.
Danish: Vaccinens effektivitet er blevet påvist i laboratoriet i tilstrækkelig grad til at bekræfte forebyggelse af dødelighed og reduktion af bursa-skader forårsaget af vvIBDV ved hjælp af SPF-kyllinger.
English: An onset and duration of protection of respectively 14 and 32 days have been demonstrated.
Danish: En beskyttelse, der indtræder efter 14 dage og varer 32 dage, blev påvist.
English: In view of the fact that no compatibility statement is claimed it is considered that sufficient information has been provided to support an absence of a negative interaction between Poulvac Bursa Plus and other vaccines.
Danish: Da der ikke er gjort nogen uforligeligheder gældende, menes der at være fremlagt tilstrækkelig information til støtte for fraværet af en negativ interaktion mellem Poulvac Bursa Plus og andre vacciner.
English: The vaccine has a negative effect on the level of the serological response to NDV vaccination, however there was no affect on the ability of NDV vaccine to induce a protective response capable of resisting challenge with virulent NDV.
Danish: Vaccinen har en negativ indvirkning på den serologiske respons på NDV-vaccination, men der var dog ingen virkning på NDV-vaccinens evne til at fremkalde en beskyttelse, der kunne modstå eksponering for en virulent NDV.
English: From the studies that were presented in the safety part of the dossier, the following conclusions can be drawn:
Danish: Følgende konklusioner kan drages af de undersøgelser, der blev fremlagt i dossierets sikkerhedsdel:
English: This is an acceptable risk associated with the protection provided against vvIBD in the face of MDA.
Danish: Dette er en acceptabel risiko i tilknytning til beskyttelsen mod vvIBD på baggrund af de maternelle antistoffer.
English: From the studies that were provided in the efficacy part of the dossier, the following conclusions can be drawn:
Danish: Følgende konklusioner kan drages af de undersøgelser, der blev fremlagt i dossierets virkningsdel:
English: Until the emergence of those strains the common practice in broiler production was to vaccinate hens just before laying in order to induce a high level of passive immunity in the chicks which could protect them up to an age when infection by IBDV was less detrimental with regards to immunosuppression.
Danish: Sådanne meget virulente vilde stammer har forekommet i Europa siden slutningen af 1980'erne Indtil fremkomsten af disse stammer var det almindelig praksis i slagtekyllingeproduktionen at vaccinere hønsene lige før æglægningen for at give kyllingerne en høj passiv immunitet, som kunne beskytte dem frem til en alder, hvor IBDV-infektion var mindre skadelig med hensyn til immunosuppression.
English: The Netherlands
Danish: Nederlande ne
English: monograph 01/2008:0587 showed that this vaccine strain causes significant damages to the Bursa of Fabricius, which in turn result in immunosuppression.
Danish: Belgien hævdede, at den undersøgelse, som ansøgeren havde gennemført i henhold til Den Europæiske Farmakopés monografi 01/2008:0587, viste, at denne vaccinestamme forårsager betydelige skader på Bursa Fabricii, som igen resulterer i immunosuppression.
English: Benefits
Danish: Fordele
English: The onset and duration of immunity has been confirmed in commercial broiler chicks in a similar laboratory study in the presence of MDA.
Danish: Immunitetens indtræden og varighed er blevet bekræftet hos kommercielle slagtekyllinger i en tilsvarende laboratorieundersøgelse under tilstedeværelse af maternelle antistoffer.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF POULVAC BURSA PLUS
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF PULVAC BURSA PLUS 1.
English: Under laboratory conditions, efficacy against vvIBDV was shown using SPF chickens.
Danish: Effektiviteten mod vvIBDV blev påvist ved hjælp af SPF-kyllinger under laboratoriebetingelser.
English: These benefits have been shown in the field in circumstances where the product is intended to be used and in the face of MDA levels which must necessarily be considered typical.
Danish: Disse fordele er blevet påvist i felten under de betingelser, som produktet er beregnet til og med maternelle antistofniveauer, der nødvendigvis må anses for at være typiske.
English: The onset and duration of immunity has also been confirmed in commercial broiler chicks in a similar laboratory study in the presence of MDA levels as specified in the SPC.
Danish: Immunitetens indtræden og varighed er også blevet bekræftet hos kommercielle slagtekyllinger i en tilsvarende laboratorieundersøgelse under tilstedeværelse af maternelle antistofniveauer som anført i produktresuméet.
English: Pharmaceutical form
Danish: Lægemiddelfor
English: These have been under practical conditions, in flocks with levels of MDA which necessarily should be considered typical of situations where the product would be used.
Danish: Disse data er opnået under praktiske betingelser i flokke, hvor niveauet af maternelle antistoffer nødvendigvis må anses for at være typisk for de situationer, hvor produktet vil blive anvendt.
English: At that time, because the hypervirulent strains were able to breakthrough high maternally derived antibodies (MDA) levels, live vaccination of broilers became necessary.
Danish: På det tidspunkt blev levende vaccination af slagtekyllinger nødvendig, fordi de hypervirulente stammer var i stand til at gennembryde høje maternelle antistofniveauer.
English: For Poulvac Bursa Plus, the optimum day of vaccination recommended in the Summary of Product Characteristics (SPC) needs to be calculated using the Kouwenhoven's formula; the target maximum MDA levels at the time of vaccination is 500 ELISA Units using a commercially available kit, but whatever the vaccination day calculation reaches, it is contra-indicated to vaccinate chickens less than 10 days of age.
Danish: De maksimale målniveauer for maternelle antistoffer på tidspunktet for vaccinationen er 500 ELISA-enheder, idet der anvendes et kommercielt tilgængeligt kit, men uanset hvilken vaccinationsdag beregningen resulterer i, er det kontraindiceret at vaccinere kyllinger, der er under 10 dage gamle.
English: Efficacy
Danish: Virkning
English: The potential advantage of using “intermediate plus” or “hot” strains, such as the one contained in Poulvac Bursa Plus is that they could break through higher maternally derived antibodies (MDA) levels than milder strains can do.
Danish: Den potentielle fordel ved at anvende virusstammer af "intermediær plus"-typen eller den "varme" type som den, der er indeholdt i Poulvac Bursa Plus, er, at de kan gennembryde højere maternelle antistofniveauer, end mildere stammer kan. Et af problemerne med at vurdere vaccinationens effektivitet hos kommercielle slagtekyllinger (med maternelle antistoffer) under laboratorieforhold er imidlertid, at de normalt ikke berøres klinisk af eksponering for vvIBDV, sådan som specifikt patogenfrie (SPF) kyllinger gør.
English: Germany Fort Dodge Animal Health
Danish: Tyskland Fort Dodge Animal Health
English: Ireland Fort Dodge Animal Health
Danish: Irland Fort Dodge Animal Health
English: Belgium Fort Dodge Animal Health
Danish: Belgien Fort Dodge Animal Health
English: Latvia Fort Dodge Animal Health
Danish: Letland Fort Dodge Animal Health
English: Bulgaria Fort Dodge Animal Health
Danish: Bulgarien Fort Dodge Animal Health
English: Lithuania Fort Dodge Animal Health
Danish: Litauen Fort Dodge Animal Health
English: Denmark Fort Dodge Animal Health
Danish: Danmark Fort Dodge Animal Health
English: Estonia Fort Dodge Animal Health
Danish: Estland Fort Dodge Animal Health
English: Hungary Fort Dodge Animal Health
Danish: Ungarn Fort Dodge Animal Health
English: Slovenia Fort Dodge Animal Health
Danish: Slovenien Fort Dodge Animal Health
English: Poland Fort Dodge Animal Health
Danish: Polen Fort Dodge Animal Health
English: Slovakia Fort Dodge Animal Health
Danish: Slovakiet Fort Dodge Animal Health
English: Spain Fort Dodge Animal Health
Danish: Spanien Fort Dodge Animal Health
English: Greece Fort Dodge Animal Health
Danish: Grækenland Fort Dodge Animal Health
English: Romania Fort Dodge Animal Health
Danish: Rumænien Fort Dodge Animal Health