Bovilis INtranasal RSP Live, Nasal Spray, Lyophilisate and Solvent for Suspension for Cattle

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

MAH:

MSD Animal Health UK Limited

ATC_code:

QI02AD07

INN:

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

pharmaceutical_form:

Nasal spray, lyophilisate for suspension

prescription_type:

POM-V - Prescription Only Medicine – Veterinarian

therapeutic_group:

Cattle

therapeutic_area:

Live Viral Vaccine

authorization_status:

Authorized

authorization_date:

2019-06-20

SPC

Unlimited renewal: June 2023
AN: 00420/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis INtranasal RSP Live, nasal spray, lyophilisate and solvent for
suspension for
cattle
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.
Unlimited renewal: June 2023
AN: 00420/2023
Page 2 of 6
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.
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
t