Pneumovac suspension for injection for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bovine Respiratory Syncytial Virus, Strain Bio-24 Inactivated; Bovine parainfluenza 3 virus, strain bio-23, inactivated; Mannheimia Haemolytica, serotype A1 strain dsm 5283, inactivated

Available from:

Animal Health Distributors Limited

ATC code:

QI02AL04

INN (International Name):

Bovine Respiratory Syncytial Virus, Strain Bio-24 Inactivated; Bovine parainfluenza 3 virus, strain bio-23, inactivated; Mannheimia Haemolytica, serotype A1 strain dsm 5283, inactivated

Dosage:

. relative potency/dose

Pharmaceutical form:

Suspension for injection

Prescription type:

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

Therapeutic area:

bovine parainfluenza virus + bovine respiratory syncytial virus + pasteurella

Authorization status:

Authorised

Authorization date:

2021-01-08

Summary of Product characteristics

Health Products Regulatory Authority
15 January 2021
CRN00C41D
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pneumovac suspension for injection for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2ml) contains:
ACTIVE SUBSTANCES:
Bovine respiratory syncytial virus inactivated, strain BIO 24 RP ≥
1*
Bovine parainfluenza 3 virus inactivated, strain BIO 23 RP ≥ 1*
_Mannheimia haemolytica_ inactivated,
Strain DSM 5283, serovar 1A RP ≥ 1*
*RP - Relative Potency (ELISA) 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 mg
Quillaja saponin (Quil A) 0.4mg
EXCIPIENTS:
Thiomersal 0.2 mg
Formaldehyde 35% solution max 1 mg
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection. Rosy 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 against:
Bovine parainfluenza 3 virus, to reduce the quantity and duration of
virus excretion.
Bovine respiratory syncytial virus, to reduce the quantity and
duration of virus excretion.
_Mannheimia haemolytica _Serotype 1A, to reduce clinical signs and
lung lesions.
_Onset of immunity:_
3 weeks after primary vaccination course
_Duration of immunity:_
6 months after primary vaccination course
4.3 CONTRAINDICATIONS
None
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Health Products Regulatory Authority
15 January 2021
CRN00C41D
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
i) Special precautions for use in animals
The efficacy of vaccination has not been demonstrated in the presence
of antibodies. The level of antibody response
may be reduced by the presence of maternal antibodies. In the presence
of maternal antibodies timing of the initial
vaccination of calves should be planned accordingly.
ii) Special prec