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

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

متاح من:

MSD Animal Health UK Limited

ATC رمز:

QI02AD07

INN (الاسم الدولي):

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

الشكل الصيدلاني:

Nasal spray, lyophilisate for suspension

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Cattle

المجال العلاجي:

Live Viral Vaccine

الوضع إذن:

Authorized

تاريخ الترخيص:

2019-06-20

خصائص المنتج

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