Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Avian infectious bursal disease virus, live
GENERA Inc
QI01AD09
Avian infectious bursal disease virus, live
.
Lyophilisate for oculonasal suspension/use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
avian infectious bursal disease virus (gumboro disease)
Authorised
2019-01-07
Health Products Regulatory Authority 17 January 2019 CRN000WS3 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Avishield IBD INT, lyophilisate for oculonasal suspension/use in drinking water, for chickens 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose contains ACTIVE SUBSTANCE: Attenuated live Infectious Bursal Disease virus, IM strain VMG 91 10 4.0 to 10 5.0 TCID 50 * *TCID 50 = 50% tissue culture infective dose EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for oculonasal suspension/use in drinking water Cream to reddish coloured lyophilisate 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of chickens (broilers, future layers and breeders), with maternally derived antibodies, to prevent mortality and clinical disease, due to infection caused by Avian Infectious Bursal Disease viruses. Onset of immunity: 2 weeks after vaccination Duration of immunity: 4 weeks after vaccination 4.3 CONTRAINDICATIONS None. Health Products Regulatory Authority 17 January 2019 CRN000WS3 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Please refer to section 4.9. Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The vaccine strain can spread to susceptible, unvaccinated chickens for at least 10 days following vaccination. The vaccine virus has shown the potential to increase in virulence on bird to bird passage and may cause immunosuppression but does not induce clinical signs of disease. It is very important to take measures to ensure that the vaccine strain does not spread to unvaccinated chickens. It is possible that the vaccine viruses can be spread to non-target susceptible species. Care should be taken to ensure that the vaccine virus does not spread to unvaccinated birds. Therefore, all birds in a flock should be vaccinated at the same time to reduce the risk of bi Lire le document complet