FrancophonIA/ELRC3.0 huggingface dataset:
English: Experience has shown that calves having no ELISA-titre of antibodies against BVD-virus may have a low (< 1:16) titre of virus-neutralising antibodies against BVD virus.
Danish: Erfaringen har vist, at kalve, der ikke har en ELISA-titer af antistoffer mod BVD-virus, kan have en lav (< 1:16) titer af virus-neutraliserende antistoffer mod BVD-virus.
English: - the Committee agreed that particular attention needs to be given to the inactivation used in irradiating foetal calf serum and that therefore additional guarantees are required to ensure that γ-irradiation of foetal calf serum will be performed in line with the European requirements.
Danish: - udvalget var enigt om, at der skal rettes særlig opmærksomhed mod den inaktiveringsmetode, der anvendes ved bestrålingen af føtalt kalveserum, og at der må kræves yderligere garantier for at sikre, at γ-bestrålingen af føtalt kalveserum bliver udført i overensstemmelse med EUbestemmelserne;
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING
English: 5.9 Special warnings for each target species
Danish: 5.9 Særlige advarsler for hver dyreart
English: The European Pharmacopoeia does not require testing for BVD virus or antibodies of the animals used in safety testing of the finished product of live IBR-vaccines.
Danish: Den Europæiske Farmakopé kræver ikke prøvning for BVD-virus eller antistoffer i dyr, der anvendes til sikkerhedsafprøvning af det færdige produkt af levende IBR-vacciner.
English: It is recommended to vaccinate all cattle of a herd."
Danish: Det anbefales at vaccinere alle kreaturer i besætningen.
English: Fetal Calf Serum γ-irradiated (25 - 42 kGy) serum
Danish: Føtalt kalveserum γ-bestrålet (25 - 42 kGy) Serum
English: BVD virus type 1 antibodies < 1:16 BVD virus type 2 antibodies < 1:16
Danish: BVD-virus type 1 antistoffer < 1:16 BVD-virus type 2 antistoffer < 1:16
English: No contamination of the working seeds WSV ELR522M1D and WCS-ELR510A125 / WCSELR510A127 with BVD-virus was found.
Danish: Der kunne ikke påvises kontaminering af working seed WSV ELR522M1D og WCS-ELR510A125 / WCS-ELR510A127 med BVD-virus.
English: 5.2 Contraindications
Danish: 5.2 Kontraindikationer
English: Both batches were originated from the same bulk of vaccine (77/V4392).
Danish: De to batcher stammede fra den samme vaccinebulk (77/V4392).
English: Three representative batches of vaccine of Bayovac IBR-Marker Vivum including the Working Seed Virus, the new Production Seed Virus, the Working Cell Seed, the new Production Cell Seed as well as the foetal calf serum were manufactured and tested according to the proposed modifications.
Danish: Tre repræsentative vaccinebatcher af Bayovac IBR-Marker Vivum, herunder working seed virus, den nye production seed virus, working cell seed, den nye production cell seed, samt føtalt kalveserum er blevet fremstillet og afprøvet i overensstemmelse med de foreslåede ændringer.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance(s)
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: - The establishment of new Production Seed Virus and Production Cell Seed free of BVD virus.
Danish: - Dannelse af ny production seed virus og production cell seed, der er fri for BVD-virus.
English: Batch of calf serum HyClone AFA4774 was formerly tested and certified as BVD virus free according to the EU Guidelines and USA Federal Regulations.
Danish: Kalveserumbatch HyClone AFA4774 var tidligere blevet afprøvet og attesteret som BVD-virusfri i overensstemmelse med EU-retningslinjerne og USA's regulativer.
English: The BVD virus genome content showed a clear decline over the production process as required.
Danish: BVD-virus-genomindholdet viste en klar nedgang i løbet af fremstillingsprocessen.
English: Store at +2°C to +8°C (refrigerated), protected from frost, heat or light.
Danish: Opbevares ved 2ºC-8ºC, beskyttet mod frost, varme og lys.
English: agents detectable cytopathic effect (cpe)
Danish: Cytopatisk effekt (cpe)
English: The original Immuno Peroxidase Linked Assay (IPLA) is well-described in an SOP and sufficiently validated.
Danish: Den første peroxidaseimmunanalyse (IPLA) er udtømmende beskrevet i en SOP og fyldestgørende valideret.
English: 4.2 Immunological properties
Danish: 4.2 Immunologiske egenskaber
English: So, no indication for multiplication of BVD virus was found.
Danish: Der blev således ikke fundet indicier på formering af BVD-virus.
English: NL (Colicensee)
Danish: NL (Medindehaver af tilladelsen)
English: Bayer Batch No.
Danish: Bayer Batch nr.
English: When inoculated parenterally in very rare cases minor, transient swelling may occur at the injection site.
Danish: Efter parenteral injektion kan der i meget sjældne tilfælde optræde mindre forbigående hævelser på injektionsstedet.
English: Striking clinical signs of disease were in the most typical and severe field cases: anorexia, drop in lactation, fever, nasal discharge, diarrhoea and mortality.
Danish: Signifikante kliniske sygdomstegn var i de mest typiske og alvorlige konkrete tilfælde appetitløshed, stærkt faldende mælkeproduktion, feber, næseflåd, diarré og større dødelighed.
English: - the Committee agreed that modifications of BVD virus testing are required;
Danish: - udvalget var enigt om, at det er nødvendigt at ændre BVD-virus-afprøvningen;
English: In addition the manufacturer is required to guarantee that the inactivation methods of all foetal calf serum used for the manufacture of virus seeds, cell seeds and finished products, for all vaccines listed in Annex II fully comply with the requirements of the European Pharmacopoeia and the EU Guideline ‘General requirements for the production and control of live mammalian bacterial and viral vaccines for veterinary use' (Volume 7 of The Rules Governing Medicinal Products in the European Union).
Danish: Derudover skal fremstilleren garantere, at de metoder, der anvendes til inaktivering af føtalt kalveserum, som anvendes til fremstilling af virusstammer (virus seeds), cellestammer (cell seeds) og færdigvarer, for så vidt angår de i bilag II anførte vacciner, fuldt ud opfylder kravene i Den Europæiske Farmakopé og EU-guidelinen vedrørende ‘General requirements for the production and control of live mammalian bacterial and viral vaccines for veterinary use' (bind 7 i bestemmelserne om lægemidler i Den Europæiske Union).
English: The present quality control appears to be insufficient to detect BVD virus.
Danish: Den nuværende kvalitetskontrol synes at være utilstrækkelig til at påvise BVD-virus.
English: BHV-1 gE-deletion mutants are immunogenic but show a reduced virulence.
Danish: BHV-1 gE-udrensede mutanter danner antistof, men udviser en reduceret virulens.
English: The only reported field case concerned in another EU-country (Italy) was suspected to relate to 1 batch of Rhinobovin Marker Vivum (02U056).
Danish: Det eneste indberettede tilfælde fra et andet EU-land (Italien) formodedes at stå i forbindelse med en batch af Rhinobovin Marker Vivum (02U056).
English: Only about 5% of these cases were evaluated as 'probable/possible related' to Bayovac IBR Marker Vivum or Rhinobovin Marker Vivum.
Danish: Kun omkring 5% af disse tilfælde blev vurderet som havende en "sandsynlig/mulig relation" til Bayovac IBR Marker Vivum eller Rhinobovin Marker Vivum.
English: the CVMP has recommended the variations of the Marketing Authorisations for all products listed in Annex II to include the new fully evaluated Polymerase Chain Reaction and Immuno Peroxidase Linked Assay, the additional screening of foetal calf serum on BVD virus and antibodies, the extension and intensification of the quality control on the absence of BVD virus on different levels of manufacture and the use of BVD-susceptible cattle in the batch safety-test.
Danish: anbefaler CVMP, at ændringerne af markedsføringstilladelserne for alle de i bilag II anførte produkter omfatter den nye fuldt evaluerede polymerasekædereaktion og peroxidaseimmunanalyse, supplerende screening af føtalt kalveserum for BVD-virus og antistoffer, udvidelse og intensivering af kvalitetskontrollen til sikring af fravær af BVD-virus på forskellige trin i fremstillingsprocessen og anvendelse af BVD-modtageligt kvæg i batchsikkerhedsafprøvningen.
English: No BVD virus was detected at any stage of the production.
Danish: Der påvistes ingen BVD-virus på noget trin i produktionsprocessen.
English: Limits
Danish: Grænser
English: Clinical features of the first field cases could be reproduced by vaccination of susceptible cattle with the contaminated (BVD virus type 2) batch of vaccine concerned.
Danish: Kliniske karakteristika fra de første konkrete tilfælde kunne reproduceres ved vaccination af modtageligt kvæg med den pågældende kontaminerede vaccinebatch (BVD-virus type 2).
English: - the Committee agreed that the safety problems were originated most probably from contaminated foetal calf serum used in the manufacture;
Danish: - udvalget var enigt om, at der var stor sandsynlighed for, at sikkerhedsproblemerne var forårsaget af kontamineret føtalt kalveserum, som var anvendt ved fremstillingen;
English: - the Committee agreed that the present quality control has been insufficient to detect BVD virus;
Danish: - udvalget var enigt om, at den nuværende kvalitetskontrol har været utilstrækkelig til at påvise BVD-virus;
English: Following infection the intensity and duration of clinical symptoms as well as the titre and duration of virus shedding are significantly reduced.
Danish: Ved en efterfølgende infektion vil de kliniske symptomer være signifikant reduceret både i intensitet og i varighed, ligesom titrene og perioden hvor der udskilles virus vil være signifikant reduceret.
English: The product induces in vaccinated cattle antibodies which are detected in the serumneutralisation test and in conventional ELISA tests.
Danish: Hos vaccinerede kreaturer inducerer vaccinen MLV antistoffer der kan påvises ved serumneutralisations test og ved konventionel ELISA test-metoder.
English: The first vaccination has to be applied intranasally, followed by the second vaccination intramuscularly.
Danish: Den første vaccination skal gives intranasalt, efterfulgt af den anden som gives intramuskulært.
English: Cattle over 3 months of age - e.g. fattening bulls, beef cattle, including pregnant heifers or cowsare vaccinated by two intramuscular inoculations, 3-5 weeks apart.
Danish: Kreaturer ældre end 3 måneder - f. eks. fedekalve, kødkvæg, drægtige kvier og køer vaccineres med 2 intramuskulære vaccinationer med 3-5 ugers mellemrum.
English: However, there was a timely coincidence of production of IBR Marker Vivum and BVDvaccine virus type 2, although in different, closely situated units with different personnel.
Danish: Der havde imidlertid været et tidsmæssigt sammenfald mellem fremstillingen af IBR Marker Vivum og BVD-vaccinevirus type 2, som var foregået i forskellige enheder, som ganske vist lå tæt ved hinanden, og med forskelligt personale.
English: In conclusion, the CVMP agrees that the safety problems in the field originated most probably from contaminated foetal calf serum used in the manufacture which may have arisen from the inadequacy of the applied inactivation used which therefore merit particular attention.
Danish: Konkluderende finder CVMP det sandsynligt, at de identificerede sikkerhedsproblemer i de omhandlede konkrete tilfælde var forårsaget af anvendelsen af forurenet føtalt kalveserum ved fremstillingen af vaccinerne, hvilken igen kan skyldes en inadækvat inaktiveringsmetode, som derfor skal vies særlig opmærksomhed.
English: (10 doses) (50 doses)
Danish: (10 doser) (50 doser)
English: PRODUCT BATCH RESULTS
Danish: PRODUKTBATCHRESULTATER
English: 5.11 Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: 5.11 Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Ingen
English: After further passages in bovine cell cultures a BHV-1 strain could be isolated by serial single plaque purifications that lacks the entire gene coding for the viral structural glycoprotein gE.
Danish: Efter yderligere passager i bovine cellekulturer kunne en BHV-1 stamme isoleres ved gentagne enkelt-lags oprensninger, hvor hele gen kodningen for det virus-strukturerede glykoprotein gE mangler.
English: Bayovac IBRMarker Vivum20 ml and 100 ml (respectively 10, 50 doses)
Danish: Bayovac IBRMarker Vivum20 ml og 100 ml (50 doser)
English: Seven out of 40 investigated batches of Bayovac IBR Marker Vivum originating from bulk of vaccine other than bulk 77/V4392 are mentioned, using IPLA, to be contaminated with BVD virus (< 10 virus particles per vial: only after a second passage on cell culture).
Danish: Syv ud af 40 undersøgte batcher af Bayovac IBR Marker Vivum fremstillet på basis af en anden vaccinebulk end 77/V4392 på grundlag af en IPLA karakteriseres som værende kontamineret med BVD-virus (< 10 viruspartikler pr. glas - kun efter en yderligere passage på cellekultur).
English: The vaccine is applied aseptically via the intramuscular route (2 ml) or sprayed into the nostrils (1 ml per nostril during aspiration) with the spray canula supplied in the package.
Danish: Vaccinen indgives aseptisk intramuskulært ( 2 ml ) eller sprayes ind i næsen ( 1 ml i hvert næsebor, under indånding ) med den vedlagte spray-applikator.
English: - the Committee agreed with the proposed modifications of the MAHs to decrease the risk of contamination and to increase the likelihood for detection of any possible contamination with BVD virus;
Danish: - udvalget tilsluttede sig de ændringer, der er foreslået af indehaverne af markedsføringstilladelserne med henblik på at mindske risikoen for kontaminering og øge sandsynligheden for at kunne påvise kontaminering med BVD-virus;
English: The SOPs describing the isolation and hygienic measures regarding the manufacturing units at the manufacturing site to avoid BVD virus cross-contamination of the products were supplied.
Danish: De standardoperationsprocedurer,, der beskriver de isolerings- og hygiejneforanstaltninger, der skal gennemføres af de enkelte produktionsenheder på produktionsstedet med henblik på at undgå krydskontaminering af produkterne med BVD-virus, blev forelagt udvalget.
English: Once resuspended the vaccine remains potent for max. 8 hours when product is withdrawn sterily and the vaccine is refrigerated.
Danish: Når vaccinen først er opløst, forbliver den effektiv i max. 8 timer, hvis produktet er trukket sterilt op og vaccinen opbevares afkølet.
English: Immunosuppressive substances, i.e. cortcosteroids, should be avoided in a period of 7 days prior to and after vaccination as this may impair the development of the immunity.
Danish: 5.6 Interaktionen med andre lægemidler og andre former for interaktion Brug af immunosuppressive substanser så som corticosteroider bør undgås i en periode på 7 dage før og 7 dage efter vaccinationen, da de kan indvirke på udviklingen af immunitet.
English: - The Committee agreed that the proposed modifications provide the necessary assurance that the risk for BVD virus contamination of the finished products is negligible:
Danish: - udvalget mener, at de foreslåede ændringer giver den nødvendige sikkerhed for, at risikoen for BVD-virus-kontaminering af færdigvarerne er minimal:
English: The first official reported Dutch field cases (12-13 herds) were related to 1 batch of Bayovac IBR Marker Vivum (WG4622) and this batch was the only batch of Bayovac IBR Marker Vivum marketed in the Netherlands at that time.
Danish: De første officielt indberettede konkrete tilfælde i Nederlandene (12-13 besætninger) blev sat i forbindelse med en batch af Bayovac IBR Marker Vivum (WG4622), og denne batch var den eneste batch af Bayovac IBR Marker Vivum, som blev markedsført i Nederlandene på daværende tidspunkt.
English: This batch of serum was used to establish 2 batches of Production Seed Virus (PSV), V4602 and P1641, as well as 6 batches of Production Cell Seed (PCS): all are employed for the production of the vaccines.
Danish: Denne serumbatch anvendtes til at danne to PSVbatcher, V4602 og P1641, samt 6 PCS-batcher, der alle anvendes til fremstilling af vacciner.
English: The dose for cattle, over 2 weeks of age, is 2 ml of the reconstituted vaccine for intranasal and/or intramuscular inoculation.
Danish: Dosis til kvæg ældre end 2 uger, er 2 ml færdig vaccine indgivet intranasalt eller intramuskulært.
English: DE Bayer AG Geschäftsbereich Tiergesundheit 51368 Leverkusen Tel no 02173-38 42 44 Fax no 02173-38 34 79
Danish: DE Bayer AG Geschäftsbereich Tiergesundheit 51368 Leverkusen Tlf nr. 02173-38 42 44 Fax nr. 02173-38 34 79
English: At post-mortem, macroscopic lesions were not reported or not specific and in other cases indicative for Bovine Viral Diarrhoea (BVD).
Danish: I forbindelse med post mortem-undersøgelser er der enten ikke rapporteret om makroskopiske læsioner eller læsionerne var ikke specifikke eller der blev rapporteret læsioner, der er specifikke for bovin virusdiarré (BVD).
English: Therefore the vaccine virus and the antibodies against it can be clearly differentiated from field strains or antibodies against the latter by its genomic profile and by serological methods, respectively.
Danish: Dette forhold er årsag til, at vaccine virus og de efter vaccination dannede antistoffer klart kan differentieres fra de naturligt forekomne virusstammer og deres antistoffer ved henholdsvis den genetiske profil og ved hjælp af serologiske metoder.
English: The SOPs of the quality control testing of batches of vaccine were provided.
Danish: Standardoperationsprocedurerne for kvalitetskontrol af vaccinebatcher blev forelagt.
English: Live, gE-deleted vaccin against IBR infectious bovine rhinotracheitis
Danish: Levende, gE-deleted vaccine mod IBR infektiøs bovin rhinotracheitis
English: No mycoplasma detectable
Danish: Ingen mycoplasma påviselig
English: 105 TCID50 (min)107TCID50 (max) Freeze-dried live virus vaccine with diluent for reconstitution
Danish: 105 TCID50 (min)107TCID50 (max) Frysetørret levende virusvaccine med fortyndingsmiddel til rekonstituering
English: In the production of vaccine bulk 77/V4392 from which batch WG4622, its sister-batches of Bayovac IBR-Marker Vivum and Rhinobovin Marker Attenuato batch 02U056 are originated, the PSV P1641 and PCS V4028 were used.
Danish: Ved fremstillingen af vaccinebulk 77/V4392, hvorfra batch WG4622, dens søsterbatcher af Bayovac IBR-Marker Vivum og Rhinobovin Marker Attenuato batch 02U056 stammer, anvendtes PSV P1641 og PCS V4028.
English: Batch No.
Danish: Batch nr.
English: To stimulate local immunity IBR infected cattle or cattle under risk of infection - including pregnant cattle - receive their first vaccination intranasally, the revaccination intramuscular.
Danish: For at stimulere lokal immunitet gives første vaccination intranasalt til IBR inficeret kvæg, eller kvæg i risiko for smitte - inklusive drægtige køer og kvierRevaccinationen gives intramuskulært.
English: Therefore, additional quality control testing using PCR and IPLA regarding BVD virus is deemed essential.
Danish: Udvalget finder det derfor nødvendigt, at der foretages en yderligere kvalitetskontrol på grundlag af PCR og IPLA med henblik på påvisning af BVD-virus.
English: The same inactivation procedure is used for all these products as for Bayovac IBR Marker Vivum / Rhinobovin Marker Vivum and this procedure was evaluated regarding BVD virus.
Danish: Det er den samme inaktiveringsmetode, der anvendes i forbindelse med alle disse produkter som i forbindelse med Bayovac IBR Marker Vivum / Rhinobovin Marker Vivum, og denne metode blev evalueret med hensyn til BVD-virus.
English: BVD virus PCR Last positive at dilution 10
Danish: BVD-virus PCR Sidst positiv ved fortynding 10 -2
English: The calves used in the safety test originated from a certified IBR-free cattle herd and this herd was routinely vaccinated against BVD.
Danish: De kalve, der blev anvendt til sikkerhedsafprøvningen, stammede fra en attesteret IBR-fri besætning, som rutinemæssigt blev vaccineret mod BVD.
English: Fax no 089-31 00 62 28
Danish: Fax nr. 089-31 00 62 28
English: Diseased cattle and cattle infested heavily by parasites should be excluded from the vaccination.
Danish: Syge dyr og dyr med en svær parasit-infestation bør ikke vaccineres.
English: Furthermore, only other inactivated products are made at the manufacturing site: Bayovac IBR Marker inactivatum/Rhinobovin Marker inactivatum, Baypamune and Foot and Mouth disease vaccines.
Danish: Der produceres udelukkende andre inaktiverede produkter på produktionsstedet - Bayovac IBR Marker inactivatum/Rhinobovin Marker inactivatum, Baypamune og mund- og klovsygevacciner.
English: Due to limited availability of Master Seed Virus (MSV) and Master Cell Seed (MCS), only the Working Seed Virus (WSV) and Working Cell Seed (WCS) of Bayovac IBR Marker Vivum and Rhinobovin Marker Vivum were retested for the absence of BVD virus, using IPLA and PCR.
Danish: Da det er vanskeligt at fremskaffe master seed virus (MSV) og master cell seed (MCS)*, blev kun working seed virus (WSV) og working cell seed (WCS) i Bayovac IBR Marker Vivum og Rhinobovin Marker Vivum omprøvet for fravær af BVD-virus på grundlag af IPLA og PCR.
English: Expiry Date
Danish: Udløbsdato
English: BE (Colicensee)
Danish: BE (Medindehaver af tilladelsen)
English: With the specific testkit .... these antibodies can be differentiated - due to the lack of antibodies against gE - from those of field virus infected animals or animals vaccinated with conventional vaccines.
Danish: Ved hjælp af et specifik testkit kan disse antistoffer differentieres pga mangel på antistof mod gE fra antistoffer fra naturligt inficerede dyr og antistoffer fra dyr vaccineret med konventionelle vacciner.
English: Intramuscular Intranasal
Danish: Intramuskulær Intranasal
English: max. 107.0 TCID50
Danish: Min. 105,0 - max. 107,0 TCID50.
English: Fax no 0297-284165
Danish: Fax nr. 0297-284165
English: Also one Italian field case was reported which was suspected to relate to Rhinobovin Marker Vivum.
Danish: Italien rapporterede om et konkret tilfælde, som formodedes at stå i forbindelse med Rhinobovin Marker Vivum.
English: - the Committee considered the lack of data regarding the secondly reported alleged Serious Adverse Drug reaction reports in The Netherlands ('case 2') and decided that evidence linking these ‘cases with the subject of the original referral was equivocal and that the Opinion of the CVMP will be confined to the original referral.
Danish: - udvalget har drøftet manglen på data vedrørende de alvorlige uønskede bivirkninger, der i anden omgang blev indberettet af Nederlandene ('case 2') og fastslået, at beviserne for en sammenhæng mellem disse og genstanden for den oprindelige indbringelse er usikre, og at CVMP's udtalelse udelukkende vil omhandle den oprindelige indbringelse.
English: The sequence of the BVD-vaccine virus type 2 appeared to be different from those of Bayovac IBR Marker Vivum BVD contaminant type 2, a BVD virus type 2 from a first Dutch field case and a reference BVD virus.
Danish: Sekvenseringen i BVD-vaccinevirus type 2 syntes at være forskellig fra sekvenseringen i Bayovac IBR Marker Vivum BVD-virus type 2, en BVD-virus type 2 fra et første konkret tilfælde i Nederlandene og en reference-BVD-virus.
English: test parameters limits lot No: X5737 lot No: X5883 lot No: X5958
Danish: Parti nr.: X5737 Parti nr: X5883 Parti nr.: X5958
English: Freeze-dried product, yellowish to white lyophilisate and solvent (aqua pro injectionem), clear colourless liquid for intranasal and/or intramuscular application
Danish: Frysetørret produkt, gulligt til hvidt lyophilisatogsolvens ( vand til injektionsvæske ) klar farveløs opløsning til intranasal og/eller intramuskulær anvendelse.
English: The Bovine Herpes Virus type 1 (BHV-1), strain Difivac (IBR-Marker Virus, gE-negative) was attenuated by multiple passages in bovine cell cultures.
Danish: Den Bovine Herpes virus type 1 (BHV-1), Difivac stamme (IBR-Marker virus, gE-negativ) er blevet svækket ved gentagne passager i bovine cellekulturer.
English: Virus herpétique bovin type 1 (BHV-1), souche Difivac (Virus IBR - Marker, gEnégatif), virus vivant atténué
Danish: Virus herpétique bovin type 1 (BHV-1), souche Difivac (Virus IBR - Marker, gEnégatif), levende, svækket virus