Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Infectious bronchitis virus
Ceva Animal Health Ltd
QI01AD07
Infectious bronchitis virus
Nebulisation solution
POM-V - Prescription Only Medicine – Veterinarian
Chickens
Live Viral Vaccine
Authorized
2016-05-26
Revised: October 2022 AN: 01551/2022 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CEVAC MASS L lyophilisate for oculonasal suspension for chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.2 ml) contains: ACTIVE SUBSTANCE: Live, attenuated infectious bronchitis virus (IBV), Massachusetts B-48 strain 10 2.8 - 10 4.3 EID 50 * *EID 50 = 50% embryo infective dose EXCIPIENTS For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate for oculonasal suspension. Yellowish pellet. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (broilers and future layers) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of broilers and future layers against infectious bronchitis (Massachusetts serotype), in order to reduce respiratory clinical signs, detrimental effect on the ciliary activity and presence of virus in the trachea. Protection was demonstrated by challenge with the Massachusetts M41 strain. Onset of immunity: 3 weeks following vaccination. Duration of immunity: 9 weeks following vaccination. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. Revised: October 2022 AN: 01551/2022 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinated chickens may excrete the vaccine strain for up to 28 days following vaccination. During this time, special precautions should be taken to avoid spreading of the vaccine strain to unvaccinated chickens and to other bird species, if any are close by. All chickens within the same farm should be vaccinated before or when entering the premises. Special precautions to be taken by the person administering the veterinary medicinal product to animals Care should be taken when reconstituting and administering the vaccine. Wash and disinfect hands and equipment after administration of the vaccine. When spraying the vaccine, personal protective equipment consisting of a mask with eye protectio Read the complete document