Bovalto Pastobov

Summary of Product characteristics

                                Revised: November 2018
AN: 01034/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovalto Pastobov
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
_Mannheimia haemolytica*_ type A1 antigen: leucotoxin minimum of 68
ELISA.U**
_* Mannheimia haemolytica_ was formerly called _Pasteurella
haemolytica_
** 1 ELISA.U: q.s. to obtain a _Mannheimia haemolytica_ antibody titre
of 1 ELISA unit in
mice after two administrations of vaccine
ADJUVANT(S):
Aluminium (as hydroxide)
........................................................................4.2
mg
EXCIPIENT(S):
Thiomersal
...............................................................................................0.2
mg
Excipient
............................................................................
q.s.p. 1 dose of 2 ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection – Milky beige
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of cattle to reduce clinical signs and lesions of
_ Mannheimia _
_haemolytica_* A1 induced respiratory disease.
4.3
CONTRAINDICATIONS
None
Revised: November 2018
AN: 01034/2018
Page 2 of 5
4.4
SPECIAL WARNINGS
None
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Shake well before use.
Apply usual aseptic procedures
Vaccinate only healthy animals
Apply usual procedures for the handling of the animals.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
In the case of accidental self-injection, seek medical advice
immediately and show the
package insert or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Vaccination by the subcutaneous route is followed by a limited 2-5 cm
local reaction
(oedema developing as a nodule) that regresses within 3 weeks.
Vaccination by the
intramuscular route can cause a transient, diffuse oedema and slight
local reaction u
                                
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