国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Gumboro disease virus strain D78
Intervet Ireland Limited
QI01AD09
Gumboro disease virus strain D78
.
Lyophilisate for oculonasal suspension/use in drinking water
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens
avian infectious bursal disease virus (gumboro disease)
Immunological - Live Vaccine
Authorised
2003-04-04
Health Products Regulatory Authority 05 April 2018 CRN000W0H Page 1 of 6 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis Gumboro D78 live lyophilisate for use in drinking water for chickens 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: PER DOSE Live Gumboro disease virus, (strain D78) ≥10 4.0 TCID 50 EXCIPIENTS: For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for use in drinking water. Vials: light brown/reddish brown-coloured pellet. Cups: light brown/reddish brown, predominantly spherical shaped. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens from 14 days of age 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of chickens to reduce mortality, clinical signs and/or lesions of Infectious Bursal Disease (Gumboro). Onset of immunity: 7 days. Duration of immunity: Data from the field shows that broilers are protected throughout the rearing period and breeder and layers birds are protected at least until the protection is boosted by use of an inactivated vaccine before the onset of lay. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. It is only necessary to apply the vaccine once to susceptible birds and this should be done as early as possible from 14 days of age. In the field, maternal antibodies will exist in the majority of chicks, therefore vaccination before 17 days for broiler-type birds and 21 days for replacement layers is not normally recommended where parent birds have been injected with an inactivated Gumboro vaccine. Health Products Regulatory Authority 05 April 2018 CRN000W0H Page 2 of 6 The properties of D78 are such that the vaccine virus will spread to in-contact birds and vaccine virus may increase in virulence on bird to bird passage. A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immuno- 阅读完整的文件