Bovilis^® BTV8

Data Sheet

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovilis BTV8 suspension for injection for cattle and sheep

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml dose contains:

Active substance:
Bluetongue Virus Serotype 8 (prior to inactivation):500 Antigenic Units *.

(* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log₂)

Adjuvants
Aluminium hydroxide (as 100%) - 16.7 mg
Saponin - 0.31 mg

For a full list of excipients, see section 6.1.

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

Sheep
To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia*.
*(cycling value (Ct) >30 by a validated rRT-PCR method, indicating absence of infectious virus)

Cattle
To stimulate active immunity in cattle from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia*.
* (for details see section 4.4)

Onset of immunity: 3 weeks after vaccination.
Duration of immunity: 6 months

4.3 Contraindications
None

4.4 Special warnings for each target species

This vaccine has been shown to reduce but not prevent viraemia in cattle. The extent of this reduction has been shown by epidemiological modelling studies to be likely to reduce virus transmission to an extent that can limit the spread of an outbreak in a vaccinated population. This vaccine has been tested for safety in sheep and cattle. If used in other domestic and wild 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

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Vaccination may result in a slight rise in temperature (usually not more than 0.5°C, in individual cases up to about 2°C) for up to three days after vaccination, and temporary swellings at the injection site.
In sheep these swellings typically last for up to three weeks.
In cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of the vaccinated animals.

Occasional hypersensitivity reactions may occur.

4.7 Use during pregnancy, lactation or lay

The vaccine can be used during pregnancy and lactation.
The safety and efficacy of the vaccine has not been established in breeding males. In these categories of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or the national Competent Authorities, depending on the current vaccination policies against BTV.

4.8 Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

4.9 Amounts to be administered and administration route

Before using the vaccine allow it to reach ambient temperature (15 - 25°C).
Shake the bottle before use and periodically during use.
Use clean and sterile vaccination equipment and avoid the introduction of contamination.
It is recommended to use a multiject vaccination system.

Sheep

Primary vaccination:
Sheep from 1 month of age: subcutaneous injection of a single dose of 1 ml

Revaccination:
As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation

Cattle

Primary vaccination
Cattle from 6 weeks of age: subcutaneous injection of two doses of 1 ml, administered with an interval of approximately 3 weeks.

Revaccination:
As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No adverse reactions other than those described in section 4.6 were observed following administration of a double dose in cattle and sheep. However, the temperature rise may be 0.5°C higher and the swellings may be more pronounced and palpable for a longer period. In sheep, swellings may still be palpable after six weeks.

4.11   Withdrawal period(s)

Zero days.

5.  IMMUNOLOGICAL PROPERTIES

Inactivated viral vaccine, to stimulate active immunity against Bluetongue Virus Serotype 8

ATCvet code:  Sheep: QI04AA02
Cattle: QI02AA08

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Trometamol
Sodium chloride
Maleic acid
Simeticone emulsion
Aluminium hydroxide
Saponin
Water for injections

6.2 Incompatibilities

Do not mix with any other veterinary 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 temperatures above 37°C or contaminated.

6.4. Special precautions for storage

Store and transport refrigerated (2 °C – 8 °C)
Protect from light
Do not freeze.

6.5 Nature and composition of immediate packaging

PET vials of 10, 20, 50, 100, 200, 250 or 500 ml, with a rubber stopper and aluminium cap.
Pack size: cardboard box with 1 or 10 vials.
Not all pack sizes may be marketed.

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.

7. MARKETING AUTHORISATION HOLDER

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/../../...-...

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

DD/MM/YYYY

10. DATE OF REVISION OF THE TEXT

PROHIBITION OF SALE, SUPPLY AND/OR USE

The import, sale, supply and/or use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
Any person intending to import, sell, supply and/or use Bovilis BTV8 must consult the relevant Member State’s competent authority on the current vaccination policies prior to the import, sale, supply and/or use.