Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
INFECTIOUS BURSAL DISEASE VIRUS STRAIN LUKERT
Zoetis Ireland Limited
QI01AD09
INFECTIOUS BURSAL DISEASE VIRUS STRAIN LUKERT
Unknown
Lyophilisate for suspension
POM
Fowl - Chicken
Avian infectious bursal disease virus vaccine (Gumboro disease)
Immunological - Live Vaccine
Authorised
2015-09-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac Bursine 2 lyophilisate for suspension for spray vaccination or for use in drinking water for chickens. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES PER DOSE: Infectious bursal Disease virus strain Lukert: 10 4.3 – 10 5.5 TCID 50 EXCIPIENTS: For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for suspension. Brown to reddish brown lyophilisate. Upon reconstitution, light peach to a tan-brownish suspension depending on volume of water added. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (broilers and future layers/breeders). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunization of broilers, and future layers/breeders to reduce clinical signs caused by Infectious Bursal Disease virus. 4.3 CONTRAINDICATIONS Do not vaccinate unhealthy birds. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Maternally-derived antibodies (MDA) can interfere with the development of active immunity. Where it is likely that recent field infection or vaccination of the parent flock has stimulated a high antibody titre and consequently a high level of MDA, the timing of the vaccination programme should be planned accordingly. Very virulent Infectious Bursal Disease virus can breakthrough higher maternal antibody levels than vaccine virus. Field infection is capable therefore of reaching birds before vaccine has a chance to take. Only use as part of a complete Infectious Bursal Disease control programme involving hygiene, biosecurity, management, stocking density and disinfection, etc. Overwhelming levels of field virus may overcome vaccinal immunity. The virus of the vaccine will spread to unvaccinated birds. HEALTH PRODUCTS REGULATORY AUTHORITY ___________________ Lire le document complet