Bovilis Nasalgen-C Nasal Spray, Lyophilisate and Solvent for Suspension for Cattle

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Bovine coronavirus

متاح من:

MSD Animal Health UK Limited

ATC رمز:

QI02AD10

INN (الاسم الدولي):

Bovine coronavirus

الشكل الصيدلاني:

Nasal drops, lyophilisate and solvent for suspension

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Cattle

المجال العلاجي:

Live Viral Vaccine

الوضع إذن:

Authorized

تاريخ الترخيص:

2023-08-30

خصائص المنتج

Issued August 2023
AN: 03016/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis Nasalgen-C nasal spray, lyophilisate and solvent for
suspension for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) of reconstituted vaccine contains:
ACTIVE SUBSTANCE:
Live attenuated bovine coronavirus, strain CA25: 5.4 – 7.8 log
10
TCID
50
*
*Tissue culture infectious dose 50%
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate: white or off-white colour.
Solvent: clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of cattle from the day of birth onwards to
reduce clinical
signs of upper respiratory tract disease and nasal viral shedding from
infection with
bovine coronavirus.
Onset of immunity: 5 days.
Duration of immunity: 12 weeks.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Animals should preferably be vaccinated at least 5–7 days before a
period of stress
or increased infection pressure.
Issued August 2023
AN: 03016/2021
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Vaccinated cattle may excrete the vaccine strain nasally or orally
following
vaccination. Excretion has been observed for up to 9 days following
vaccination but
may persist longer. The vaccine strain can spread to other cattle.
Spread to other
species has not been investigated and cannot be excluded.
It is recommended to vaccinate all calves of the herd.
Appropriate biosecurity procedures to limit the risk of introduction
and spread of
bovine coronavirus infection in premises should be part of management
tools.
ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals.
Not applicable.
Special precautions for the protection of the environment:
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOU