Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Live attenuated infectious bronchitis coronavirus, (strain CR88121) (793B)
Merial Animal Health Limited
QI01AD07
Live attenuated infectious bronchitis coronavirus, (strain CR88121) (793B)
4.0-5.3 log 10 50% embryo infective dose/dose
Powder for nebuliser suspension
POM: Prescription Only Medicine as defined in relevant national legislation
Chickens
avian infectious bronchitis virus
Immunological - Live Vaccine
Authorised
2003-06-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT GALLIVAC IB88. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains: Attenuated Infectious Bronchitis coronavirus, strain CR88121 (793B), at least 4.0 log 10 EID 50 Excipient q.s. 1 dose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for nebuliser suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Broiler chickens from 14 days of age. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Reduces clinical signs and lesions of respiratory disease caused by the coronavirus variant, strain CR88 (793B) in broiler chickens. Immunity has been demonstrated 17 days after vaccination, and the duration of immunity is at least 5 weeks. 4.3 CONTRAINDICATIONS In the absence of trial data, furure layers or breeders and chickens in lay must not be vaccinated. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Gallivac IB88 vaccination does not replace the vaccination schedule against classical Infectious Bronchitis. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _5_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _2_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _2_ _7_ _9_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Only healthy birds should be vaccinated. The vaccine virus can spread to non-vaccinated birds, but no trend towards reversion to virulence was demonstrated in laboratory trials. Nevertheless, care should be taken to preve Read the complete document