Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
avian infectious bursal disease virus 0 mg
CEVA Animal Health
QI01AD09
Suspension for injection
avian infectious bursal disease virus (gumboro disease)
Chicken
2012-05-01
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CEVAC TRANSMUNE lyophilisate for suspension for injection with solvent for chicken 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One in ovo dose (0.05 ml) or subcutaneous dose (0.1 ml) contains: Live attenuated IBD virus, strain Winterfield 2512 at least 0.1 CID 50 * Excipients: BDA (bursal disease antibody) at least 90 VN titre** Other qs 1 dose Solvent qs 1 dose * CID 50 (Chicken Infective Dose 50%) ** VN titre (virus neutralisation titre) For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for suspension for injection with solvent Pale brown lyophilisate for reconstitution with a water-clear, colourless solvent provided for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens, 18-day-old embryonated broiler hatching eggs or 1-day-old broiler chickens, from hens vaccinated against IBD. 4.2 INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES For the active immunisation of chickens to reduce mortality, clinical disease, weight loss and acute lesions of bursa of Fabricius associated with infection caused by very virulent Avian Infectious Bursal Disease (IBD) viruses. The release of the vaccine virus from the complex (and therefore immunisation) is influenced by the natural decline of maternally derived antibodies (MDA), and has been found not to occur until MDA has reached relatively low levels. The onset of clinical protection depends on the initial MDA level. In vaccinated broilers it is achieved within 1 day after the Read the complete document