Country: Frakkland
Tungumál: enska
Heimild: HMA (Heads of Medicines Agencies)
Bovine parainfluenza 3 virus 5 log10 CCID50, bovine respiratory syncytial virus 5 log10 CCID50, bovine viral diarrhoea virus inactivated 3 log2 titre
Pfizer
QI02AH
Powder and solvent for suspension for injection
Live and Inactivated viral vaccines
Cattle
2011-07-24
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Rispoval 3 BRSV Pi3 BVD Lyophilisate and suspension for suspension for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (4 ml) contains: ACTIVE INGREDIENT(S): _Lyophilised fraction _ Parainfluenza 3 virus, modified live strain RLB 103 10 5.0 to 10 8.6 CCID 50 Bovine Respiratory Syncytial Virus, modified live strain 375 10 5.0 to 10 7.2 CCID 50 _ _ _Liquid fraction _ Bovine Virus Diarrhoea Virus Type 1, inactivated strains 5960 (cytopathic) and 6309 (non-cytopathic), to induce a GMT seroneutralisation titre in guinea pigs of at least 3.0 log 2 ADJUVANT: Alhydrogel 2% 0.8 ml (equivalent to 24.36 mg of aluminium hydroxide) CCID 50 = Cell Culture Infectious Dose 50% For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of calves from 12 weeks of age to: - reduce virus excretion and the clinical signs caused by bovine Pi3 virus, - reduce virus excretion caused by BRSV infection, - reduce virus excretion and the severity of the leucopenia induced by BVDV type 1 infection. Onset of immunity: 3 weeks after vaccination Duration of immunity: 6 months (demonstrated by challenge studies) after vaccination for BRSV and BVDV Type 1. Duration of immunity has not been established for bovine Pi3 virus. Efficacy has not been demonstrated agains Lestu allt skjalið