BOVALTO Respi 4 suspension for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Inactivated bovine respiratory syncytial virus, strain bio-24, Inactivated bovine parainfluenza 3 virus, strain bio-23, Inactivated mannheimia haemolytica serotype a1 strain dsm 5283, Inactivated bovine viral diarrhoea virus, strain bio-25

Available from:

Merial Animal Health Limited

ATC code:

QI02AL

INN (International Name):

Inactivated bovine respiratory syncytial virus, strain bio-24, Inactivated bovine parainfluenza 3 virus, strain bio-23, Inactiva

Dosage:

.

Pharmaceutical form:

Suspension for injection

Prescription type:

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

Therapeutic group:

Cattle

Therapeutic area:

Inactivated viral and inactivated bacterial vaccines

Therapeutic indications:

Immunological - Inactivated Vaccine

Authorization status:

Authorised

Authorization date:

2016-02-26

Summary of Product characteristics

Health Products Regulatory Authority
27 February 2018
CRN000XS0
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
BOVALTO Respi 4 suspension for injection
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 bovine viral diarrhoea virus, strain BiO-25
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)
0.4 mg
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
Health Products Regulatory Authority
27 February 2018
CRN000XS0
Page 2 of 5
- bovine viral diarrhoea virus, to reduce virus excretion due to
infection
- _Mannheimia haemolytica _serotype A1, to reduce clinical signs and
lung lesions.
Onset of immunity: 3 weeks
Duration of immunity: 6 months
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Vaccinate healthy animals only.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Safety and efficacy studies were performed in sero-negative calves.The
efficacy of the
vaccination has not been demonstrated in presence of antibodies. The
level of
antibody response may be reduced by the presence of maternal
antibodi