BOVALTO PASTOBOV

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mannheimia haemolytica type 1a antigen leucotoxin

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI02AB04

INN (International Name):

Mannheimia haemolytica type 1a antigen leucotoxin

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

POM (E): Prescription Only Exempt as defined in relevant national legislation

Therapeutic area:

pasteurella

Authorization status:

Authorised

Authorization date:

2000-02-01

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2018
CRN008RJX
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.
Health Products Regulatory Authority
14 December 2018
CRN008RJX
Page 2 of 5
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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
up to 5 cm diameter that regresses within 1-2 weeks. After
subcutaneous and
intramuscular injection granulomas up to 5 cm diameter may occur.
Vaccination (by
the subcu