País: Regne Unit
Idioma: anglès
Font: VMD (Veterinary Medicines Directorate)
Bordetella bronchiseptica
Zoetis UK Limited
Bordetella bronchiseptica
Lyophilisate for Oral Suspension
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Live Bacterial Vaccine
Authorized
2019-08-21
Revised: December 2020 AN: 00300/2020 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus Bb Oral Lyophilisate and Solvent for Oral Suspension for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCE: Lyophilisate: _Live attenuated Bordetella bronchiseptica_, strain 92B 1.4 x 10 8 - 5.5 x 10 9 CFU*/dose * CFU: colony forming unit EXCIPIENT: Solvent: Purified water 1 ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for oral suspension. Lyophilisate: Uniform off-white colour freeze-dried powder. Solvent: clear colourless liquid 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunization of dogs of 8 weeks of age or older to reduce clinical signs and excretion following infection with _Bordetella bronchiseptica._ Onset of immunity: 3 weeks Duration of immunity: 12 months 4.3 CONTRAINDICATIONS None Revised: December 2020 AN: 00300/2020 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The product contains live bacteria and must be administered by the oral route only. Parenteral administration can generate abscesses and cellulitis. Vaccinated dogs may shed the vaccine strain of _Bordetella bronchiseptica _for up to 35 days oronasally and for at least 70 days in faeces. Due to the attenuated nature of the vaccine strain it is not necessary to keep unvaccinated dogs separate from vaccinated animals, however during this time it is advised that any immunocompromised dogs should avoid contact with vaccinated dogs. The _Bordetella bronchiseptica_ in the vaccine has been shown to be safe in pigs exposed to the vaccine strain (e.g. from contact with vaccinated dogs)._ _Cats exposed to the vaccine strain (e.g. from contact with vaccinated dogs) may show moderate clinical signs such as sneezing, nasal and ocul Llegiu el document complet