BOVALTO RESPI INTRANASAL, nasal spray, lyophilisate and solvent for suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bovine respiratory syncytial virus, live, Bovine parainfluenza virus 3 attenuated

Available from:

Merial Animal Health Limited

ATC code:

QI02AD07

INN (International Name):

Bovine respiratory syncytial virus, live, Bovine parainfluenza virus 3 attenuated

Dosage:

.

Pharmaceutical form:

Nasal spray, lyophilisate and solvent for suspension

Prescription type:

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

Therapeutic group:

Cattle

Therapeutic area:

bovine respiratory syncytial virus + bovine parainfluenza virus

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2018-04-13

Summary of Product characteristics

Health Products Regulatory Authority
19 April 2018
CRN000W73
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
BOVALTO RESPI INTRANASAL, nasal spray, lyophilisate and solvent for
suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (2 ml) contains:
​
​
LYOPHILISATE:
​
​
ACTIVE SUBSTANCES:
​
​
Bovine parainfluenza 3 virus (PI3V), modified live virus, strain Bio
23/A
​10
5.0
– 10
7.5
TCID
50
​
Bovine respiratory syncytial virus (BRSV), modified live virus,
strain Bio 24/A
​10
4.0
– 10
6.0
TCID
50
​
TCID
50
– a 50% infectious dose for tissue cultures
​
​
SOLVENT:
​
​
Phosphate buffered saline
​2 ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, lyophilisate and solvent for suspension
Appearance before reconstitution:
The lyophilisate has a porous structure, off-white or yellowish
colour.
The solvent is clear, colourless.
Appearance after reconstitution: opalescent liquid of yellowish to
pinkish colour.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of calves from the age of 10 days against
bovine
respiratory syncytial virus (BRSV) and bovine parainfluenza 3 virus
(PI3V), to reduce
the quantity and duration of nasal excretion of both viruses.
Onset of immunity: 10 days after vaccination
Duration of immunity: 12 weeks after vaccination.
Health Products Regulatory Authority
19 April 2018
CRN000W73
Page 2 of 5
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The laboratory efficacy studies have demonstrated that the presence of
maternally
derived antibodies at the time of vaccination had no impact on vaccine
efficacy in
young animals.
Vaccinate healthy animals only.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinated calves can excrete the vaccine strains BRSV and PI3V for up
to 6 days
after vaccination. Therefore, the spread of the vaccine virus from
vaccinated to
unvaccinated calves cannot be