Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Infectious bursal disease virus, attenuated strain S706
Boehringer Ingelheim Vetmedica GmbH
QI01AD09
Infectious bursal disease virus, attenuated strain S706
.
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
2006-12-21
Health Products Regulatory Authority 15 July 2020 CRN009VN8 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT GALLIVAC IBD 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose contains: Active ingredient: Infectious Bursal Disease virus, attenuated strain S706, at least 10 4.0 CCID 50 Excipient: qs 1 dose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (broilers, future layers and broiler breeders). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of chickens to protect against mortality and to reduce lesions associated with Infectious Bursal (Gumboro) Disease. Immunity has been demonstrated 2 weeks after the first administration and has been shown under field conditions to persistthroughout the rearing period. 4.3 CONTRAINDICATIONS Do not vaccinate unhealthy birds. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Due to the spread of the vaccine virus, it is recommended to separate vaccinated and unvaccinated birds. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS During spray administration, the eyes must be protected by safety goggles and the nose and mouth by a dust mask. A helmet with filtered air circulation may be used instead of goggles and a mask.Care should be taken during reconstitution of the vaccine and drinking water application. Hands should be washed and disinfected after vaccinating. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Laboratory studies have shown that when the vaccine virus was experimentally passed from bird to bird, damage to the bursa increased. This was detected by histological examination of the bursae. However, this is not considered to result in an immunosuppressive effect. Health Products Regulatory Authority 15 July 2020 CRN009VN8 Page 2 of 4 4.7 USE DURING PREGNANCY, LACTATION OR L Đọc toàn bộ tài liệu