RISPOVAL 3-BRSV-Pi3-BVD
Country: United Kingdom
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
08-12-2012
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Active ingredient:
Bovine parainfluenza 3 virus 5 log10 CCID50, bovine respiratory syncytial virus 5 log10 CCID50, bovine viral diarrhoea virus inactivated 3 log2 titre
Available from:
Pfizer
ATC code:
QI02AH
Pharmaceutical form:
Powder and solvent for suspension for injection
Therapeutic group:
Live and Inactivated viral vaccines
Therapeutic area:
Cattle
Authorization date:
2011-07-24
Summary of Product characteristics
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
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