Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
bordetella bronchiseptica 0
Intervet Intenational BV
QI07AE
Nasal drops, solution
Dogs Non Food
2010-06-17
AN: 01119/2013 Revised: July 2013 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac KC (in AT, BE, DE, DK, LU and NO: Nobivac BbPi) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.4 ml vaccine reconstituted with diluent (water for injections): ACTIVE SUBSTANCES: 10 8.0 and 10 9.7 cfu 1 of live _Bordetella bronchiseptica_ bacteria strain B-C2 10 3.0 and 10 5.8 TCID 50 2 of live canine parainfluenza_ _virus strain Cornell 1 colony forming units 2 Tissue Culture Infective Dose 50% For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for nasal administration Lyophilisate: Off-white or cream-coloured pellet Solvent: clear colourless solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of dogs against _Bordetella bronchiseptica_ and canine parainfluenza virus for periods of increased risk to reduce clinical signs induced by _B. bronchiseptica_ and canine parainfluenza virus and to reduce shedding of canine parainfluenza virus. Onset of immunity: for _Bordetella bronchiseptica_: 72 hours after vaccination; for canine parainfluenza virus: three weeks after vaccination. Duration of immunity: 1 year AN: 01119/2013 Revised: July 2013 Page 2 of 5 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS Only healthy dogs should be vaccinated. 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Vaccinated animals can spread the _Bordetella br Read the complete document