Cattle and 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).

To stimulate active immunity in cattle from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia*.

* (for details see section Special warnings for each target species).

Onset of immunity: 3 weeks after vaccination.

Duration of immunity: 6 months.

None.

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.

Vaccinate healthy animals only.

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

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.

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.

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.

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.

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

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.

No adverse reactions other than those described in section "Adverse Reactions" 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.

Zero days.