Bovilis BTV8 - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovilis BTV8 suspension for injection for cattle and sheep

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose (1 ml) 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 the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

Opalescent pink with resuspendable sediment.

4. CLINICAL PARTICULARS4.1 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)

In very rare cases 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.

In very rare cases hypersensitivity reactions may occur.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

• – common (more than 1 but less than 10 animals in 100 animals)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals )

• – rare (more than 1 but less than 10 animals in 10,000 animals)

• – very rare (less than 1 animal in 10,000 animals, including isolated reports)

• 4.7 Use during pregnancy, lactation or lay

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 bluetongue virus.

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

Subcutaneous use.

Sheep

Primary vaccination:

Sheep from 1 month of age: 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: 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.

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.

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

ATCvet code: Sheep: QI04AA02

Cattle: QI02AA08

Inactivated viral vaccine, to stimulate active immunity against bluetongue virus serotype 8.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Trometamol

Sodium chloride

Maleic acid

Simeticone emulsion

Aluminium hydroxide

Saponin

Water for injection

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 for 10, 20, 50 ml vials: 2 years Shelf life of the veterinary medicinal product as packaged for sale for 100, 200, 250, 500 ml vials: 1 year.

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

7. MARKETING AUTHORISATION HOLDER

Intervet International BV

Wim de Korverstraat 35

5831 AN Boxmeer

The NETHERLANDS

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/10/106/001–014

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 06/09/2010.

Date of last renewal: