Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
bordetella bronchiseptica 0 %
Pfizer
QI07AE01
Powder and solvent for solution for injection
Bordetella vaccine
Dogs
2011-08-23
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BRONCHI-SHIELD, lyophilisate and solvent for suspension for nasal drops for dogs . 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1 ml) of vaccine contains : _1. LYOPHILIZED FRACTION: _ Active substance: _Bordetella bronchiseptica_, live, strain 92B 2.1 x 10 6 to 5.5 x 10 8 CFU (*) (*) CFU: colony forming unit Excipients: For a full list of excipients, see section 6.1. _2. SOLVENT_: Water for injections 1 ml 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for nasal drops. Uniform cream colour cake. 4. CLINICAL PARTICULARS 4.1 Target Species Dogs. 4.2 Indications for use, specifying the target species In dogs: - For active immunization of dogs of 8 weeks of age or o lder to reduce coughing caused by _Bordetella _ _bronchiseptica_. Duration of immunity: 1 year. Onset of immunity: from 5 days after vaccination . 4.3 Contraindications Do not vaccinate sick/unhealthy animals. Do not vaccinate animals undergoing antibacterial or immunosuppressive treatment. See section 4.6. 4.4 Special warnings for each target species The product contains live bacteria and must be administere d by the intranasal route only. Parenteral administration can generate abscesses and cellulitis. If any antib iotic is used within 2 weeks after vaccination, vacc ination should be repeated after co mpletion of the an Read the complete document