Bovilis INtranasal RSP Live, nasal spray, lyophilisate and solvent for suspension for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bovine respiratory syncytial virus (live) strain Jencine-2013; Bovine parainfluenza virus type 3 (live) strain INT2-2013

Available from:

Intervet Ireland Limited

ATC code:

QI02AD07

INN (International Name):

Bovine respiratory syncytial virus (live) strain Jencine-2013; Bovine parainfluenza virus type 3 (live) strain INT2-2013

Dosage:

.

Pharmaceutical form:

Lyophilisate and solvent for suspension for nasal administration

Prescription type:

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

Therapeutic area:

bovine respiratory syncytial virus + bovine parainfluenza virus

Authorization status:

Authorised

Authorization date:

2019-06-14

Summary of Product characteristics

June 2022
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis INtranasal RSP Live, nasal spray, lyophilisate and solvent for
suspension for cattle
AT, DE: Bovilis IntraNasal RSP Live
DK, NO: Bovilis RSP Live Vet
FI, SE: Bovilis RSP live vet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 2 ml contains:
ACTIVE SUBSTANCES:
Live bovine respiratory syncytial virus (BRSV), strain Jencine-2013:
5.0 – 7.0 log
10
TCID
50
*
Live bovine parainfluenza virus type 3 (PI3), strain INT2-2013:4.8 –
7.3 log
10
TCID
50
*
*50% tissue culture infective dose
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, lyophilisate and solvent for suspension
Lyophilisate: off-white or cream-coloured cake.
Solvent: clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of calves from the day of birth onwards to
reduce clinical signs of respiratory
disease and viral shedding from infection with BRSV and PI3.
_ _
Onset of immunity:
BRSV:
6 days (for calves vaccinated from the day of birth onwards)
5 days (for calves vaccinated from the age of 1 week onwards)
PI3:
1 week
Duration of immunity:
12 weeks
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Animals should be preferably vaccinated at least 5 – 7 days before a
period of stress or increased
infection pressure.
June 2022
3
The efficacy against BRSV may be reduced by presence of maternally
derived antibodies.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinated calves may excrete the vaccine strains up to 12 days
following vaccination.
It is recommended to vaccinate all calves of the herd.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
_ _
A mild and transient nasal discharge may very commonly occur during
two days following
vac