Bovilis® BTV8
DATA SHEET
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Bovilis® BTV8
2. QUALITATIVE AND QUANTITATIVE COMPOSITON
Active substance:
A 1 ml dose contains at least 500 Antigenic Units/ml of Bluetongue Virus Serotype 8 prior to inactivation.
Adjuvant:
Aluminium hydroxide (as 100%)
Saponin
3. PHARMACEUTICAL FORM
Suspension for injection
4. CLINICAL PARTICULARS
4.1 Target species
Cattle and sheep
4.2 Indications for use, specifying the target species
To stimulate active immunity against Bluetongue Virus Serotype 8 in cattle and sheep to reduce viraemia.
Onset of immunity: 3 weeks after vaccination.
Duration of immunity: Not yet established
The efficacy of the vaccine has not been fully established
4.3 Contraindications
None
4.4 Special warnings
This vaccine has been tested for safety in sheep and cattle. If used in other ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination. The level of efficacy for other species may differ from that observed in sheep and cattle.
No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.
4.5 Special precautions for use
Special precautions for use in animals
Vaccinate healthy animals only.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
None
4.6 Adverse reactions (frequency and seriousness)
Immunisation may result in a slight rise in temperature (up to about 1°C) for up three days after vaccination and temporary swellings at the injection site. In sheep these swellings typically last for up to three weeks while in cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of vaccinates.
4.7 Use during pregnancy or lactation
The safety of use of the veterinary medicinal product in pregnant or lactating animals has not yet been established.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the compatibility of this vaccine with any other. Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
4.9 Amounts to be administered and administration route
Sheep
Sheep from 1 month of age: a single 1 ml dose by subcutaneous injection. The timing for administering booster vaccinations has not yet been established but it is recommended that animals are re-vaccinated at least 2 weeks before each risk period.
Cattle
Cattle from 1 month of age: Two 1 ml doses administered with an approximately 3 weeks interval by subcutaneous injection. The timing for administering booster vaccinations has not yet been established but it is recommended that animals are re-vaccinated at least 2 weeks before each risk period.
Before using the vaccine allow it to reach ambient temperature (15 - 25°C).
Shake the bottle vigorously before use and periodically during use.
Make sure that vaccination equipment is clean and sterile before use.
It is recommended to use a multiject vaccination system.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No reaction other than described in point 4.6 have been observed following administration of an overdose. However, in sheep, swellings may still be palpable for at least six weeks.
4.11 Withdrawal period
Zero days.
5. IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against Bluetongue Virus Serotype 8
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Trometamol; sodium chloride, maleic acid, antifoam, water for injection
6.2 Incompatibilities
Do not mix with any other medicinal product.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 12 months
Shelf-life after first opening the immediate packaging: 8 hours, provided the product is not subject to extreme temperatures or contaminated.
6.4. Special precautions for storage
Store and transport at 2°C - 8°C, protected from light. Do not freeze.
6.5 Nature and composition of immediate packaging
Sterile PET or Type II glass vials of 10, 20, 50, 100, 250 and 500 ml
Package size:
Cardboard box with 1 vial
Cardboard box with 10 vials
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements.