Bovilis BVD Product Data Sheet

Presentation
Bovilis BVD is an inactivated vaccine containing 50 ELISA units (EU) and inducing at least 4.6 log2 VN units per dose of cytopathogenic BVD virus strain C86. The virus is grown in cell culture, inactivated with beta-propiolactone, and adsorbed onto an aluminium salts adjuvant. The vaccine contains methyl parahydroxybenzoate as a preservative and traces of antibiotics and calf serum as remnants from the antigen production.
 
Uses
For active immunisation of cows and heifers to protect the foetus against transplacental infection with Bovine Viral Diarrhoea virus.
 
Dosage and administration
Bovilis BVD may be given to cattle from eight months of age onwards. Each animal should be given 2 ml of vaccine by intramuscular injection. The vaccine may be administered to pregnant cattle.
Recommended vaccination programme:
 
Primary immunisation
Two vaccinations 4 weeks apart. Foetal protection can be expected if the primary immunisation course has been completed 4 weeks before the start of the gestation. Animals which are vaccinated less than 4 weeks before gestation or during early gestation, may not be protected against foetal infection.
Revaccination
One vaccination. Foetal protection can be expected if the vaccine is administered 4 weeks before the start of the next gestation.
For whole herd vaccination, 6 monthly vaccinations may be advised (see Further information) to ensure that all animals fulfil these requirements.
 
Contra-indications, warnings, etc
Do not use in debilitated animals. A slight swelling may be observed for 14 days at the site of injection. Transient, mild pyrexia may occur.
No information is available on the safety and efficacy of the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product. Do not mix with any other medicinal product.
Withdrawal period
Zero days
For animal treatment only. Keep out of the reach and sight of children.
 
Pharmaceutical precautions
Store at +2° to +8°C. Do not freeze.
Allow the vaccine to reach ambient temperature (15 – 25°C) before use.
Shake the bottle well before use. Use sterile injection equipment.
Use broached vials within 10 hours.
Any unused product or waste material should be disposed of in accordance with national requirements.
 
Legal category
POM-V
 
Packaging Quantities
5, 10 or 25 dose vials
 
Further information
Foetal protection has been demonstrated at 6 months post vaccination and can therefore be expected if the primary immunisation has been completed 4 weeks before the start of the gestation. If a herd is vaccinated on the same day, then individuals that are not about 4 weeks pre-gestation may not be protected against foetal infection. Where this is the case, whole herd re-vaccination should be undertaken every 6 months.
BVD challenge data in non-pregnant animals shows protection against cell-free viraemia 12 months after primary vaccination.
A good immune response is reliant upon the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine will be reduced by poor storage or inappropriate administration. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.
 
Marketing authorisation number
Vm 06376/4025.