Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Infectious bursal disease virus
Ceva Animal Health Ltd
QI01AD09
Infectious bursal disease virus
Lyophilisate for Oral Suspension
POM-V - Prescription Only Medicine – Veterinarian
Chickens
Live Viral Vaccine
Authorized
2012-11-07
Revised: October 2022 AN: 01549/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cevac IBD 2512 L lyophilisate for oral suspension for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose contains: ACTIVE SUBSTANCE: Live infectious bursal disease (IBD) virus strain, Winterfield 2512, G-61 2.0 log10 to 3.2 log10 EID50*/dose * EID50 (embryo infectious dose 50%) EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for oral suspension. Blue freeze-dried powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (broilers) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunization of broiler chickens from 10 days of age with maternally- derived antibodies against avian infectious bursal disease (IBD, Gumboro disease), to reduce mortality, clinical symptoms, weight loss and acute lesions in bursa of Fabricius, caused by very virulent infectious bursal disease virus. Onset of immunity: 14 days post-vaccination. Duration of immunity: 27 days post-vaccination. 4.3 CONTRAINDICATIONS Do not use in infected flocks with clinical symptoms. Do not use for immunisation of flocks without maternally derived antibodies (MDA). (See section 4.5.). Revised: October 2022 AN: 01549/2022 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The vaccine contains an “intermediate-plus” virus strain that is known to cause immunosuppression and bursal damage when inoculated into birds without MDA (see sections 4.5, 4.6 and 5.). Consequently, the vaccine is only indicated for immunisation of chicken having maternal antibodies and exposed to very virulent IBD virus strains. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate healthy birds only. It is not recommended to vaccinate birds younger than 10 days of age, regardless of the level of maternally derived antibodies (see section 4.9). The vaccine contains an “intermediate-plus” virus strain, causing significant immunosuppressio Read the complete document