BOVALTO RESPI 3 SUSPENSION FOR INJECTION FOR CATTLE

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
BOVALTO Respi 3 suspension for injection for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (2 ml) contains:
ACTIVE SUBSTANCES:
Inactivated bovine respiratory syncytial virus, strain BIO-24
RP
1*
Inactivated bovine parainfluenza 3 virus, strain BIO-23
RP
1*
Inactivated_ Mannheimia haemolytica_, serotype A1 strain DSM 5283
RP
1*
* Relative potency (RP) in comparison with the reference serum
obtained after vaccination of guinea pigs with a
vaccine batch that has successfully passed the challenge test in the
target animals.
ADJUVANTS:
Aluminium hydroxide
8.0 mg
Quillaja saponin (Quil A)
0.4mg
EXCIPIENTS:
Thiomersal
0.2 mg
Formaldehyde
1.0 mg at most
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
Appearance: Pinkish liquid with sediment.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of cattle in the absence of maternally derived
antibodies against:
- parainfluenza 3 virus, to reduce virus excretion due to infection
- bovine respiratory syncytial virus, to reduce virus excretion due to
infection
-_ Mannheimia haemolytica_ serotype A1, to reduce clinical signs and
lung lesions.
_Onset of immunity (demonstrated by challenge):_
3 weeks after primary vaccination
_Duration of immunity (demonstrated by challenge):_
6 months after primary vaccination
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