PASTOBOV
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
20-03-2012
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Active ingredient:
mannheimia haemolytica (pasteurella) 68 ELISA.U
Available from:
Merial
ATC code:
QI02AB04
Pharmaceutical form:
Suspension for injection
Therapeutic group:
Pasteurella
Therapeutic area:
Cattle
Authorization date:
2012-01-25
Summary of Product characteristics
June 2007
Page 1 of 31
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SUMMARY OF PRODUCT CHARACTERISTICS
June 2007
Page 2 of 31
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
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
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.
3 of 31
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL
PRODUCT TO ANIMALS
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