País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Live Infectious Bursal Disease Virus, strain GM97
Laboratorios Hipra S.A.
QI01AD09
Live Infectious Bursal Disease Virus, strain GM97
.
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
2015-05-29
Health Products Regulatory Authority 10 December 2019 CRN009DWR Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRAGUMBORO-G97 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Composition per dose: ACTIVE SUBSTANCE: - Live Infectious Bursal Disease Virus, strain GM97: 10 2 - 10 3 EID 50 (embryo infective dose 50%). EXCIPIENTS AND ADJUVANTS WHERE KNOWLEDGE OF THIS IS ESSENTIAL FOR THE SAFE ADMINISTRATION OF THE MEDICINAL PRODUCT: None. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for oral suspension. Appearance: reddish tablet. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Species: Chickens. Category: Broilers. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of broilers with insignificant levels of maternally derived antibodies (ELISA of 500 or below) to reduce mortality, clinical signs and bursal lesions of Gumboro disease. Such birds can be vaccinated from one day of age. The onset of immunity is 14 days post vaccination and the duration 43 days post vaccination. 4.3 CONTRAINDICATIONS Do not vaccinate sick birds. Do not use in infected flocks showing clinical signs. Since no studies to demonstrate the safety of this vaccine when it is administered to layers and breeders have been carried out, its use is not recommended for these categories of the target species (see section 4.7). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Use only in flocks with low levels of maternal antibodies (mean ELISA titres ≤500). The optimum day of vaccination of broilers with maternal antibodies is calculated according to the Kouwenhoven’s formula (see section 4.9 posology). Due to its residual pathogenicity to the bursa the vaccine should be used only in areas contaminated with vvIBDV, except for infected flocks showing clinical signs. See section 4.3. Health Products Regulatory Authority 10 December 2019 CRN009DWR Page 2 of 4 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS - Do not use water with chlorine Leer el documento completo