Bovilis Blue-8 - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Bovilis Blue-8 suspension for injection for cattle and sheep

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Intervet International BV

Wim de Korverstraat 35,

5831 AN Boxmeer

The NETHERLANDS

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bovilis Blue-8 suspension for injection for cattle and sheep

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each ml of vaccine contains:

Bluetongue virus inactivated, serotype 8

Aluminium hydroxide

Purified saponin (Quil A)

Thiomersal

(* equivalent to titre prior to inactivation)

Sheep

For the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.

(Cycling value (Ct) > 36 by a validated RT-PCR method, indicating no presence of viral genome)

Onset of immunity: 20 days after the second dose.

Duration of immunity: 1 year after the second dose.

Cattle

For the active immunisation of cattle from 2.5 months of age to prevent viraemia caused by bluetongue virus serotype 8.

*(Cycling value (Ct) > 36 by a validated RT-PCR method, indicating no presence of viral genome)

Onset of immunity: 31 days after the second dose.

Duration of immunity: 1 year after the second dose.

5. CONTRAINDI­CATIONS

None.

An average increase in body temperature varying between 0.5 and 1.0 °C is a common reaction observed in sheep and cattle. It lasted not longer than 24 to 48 hours. Transient fever was observed in rare cases. Temporary local reactions can occur very rarely at the injection site in the form of a nodule of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears within 14 days, at the latest and which may be painful. Loss of appetite can occur in very rare cases. Hypersensitivity reactions are very rarely observed.

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

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

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

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

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

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

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Sheep and cattle.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Subcutaneous use.

Primary vaccination:

Sheep from 2.5 months of age:

Administer two doses of 2 ml subcutaneously with a 3 week interval.

Cattle from 2.5 months of age:

Administer two doses of 4 ml subcutaneously with a 3 week interval.

Revaccination:

1 dose per year.

Any revaccination scheme should be agreed by the competent authority or by the responsible veterinarian, taking into account the local epidemiological situation.

ADVICE ON CORRECT ADMINISTRATION

Shake well before use. Avoid multiple vial broaching. Avoid introduction of contamination.

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 °C – 8 °C).

Do not freeze.

Protect from light.

Do not use this veterinary medicinal product after the expiry date which is stated on the label/carton. Shelf life after first opening the container: 10 hours.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Vaccinate healthy animals only.

Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine.

No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies.

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.

Pregnancy and lactation:

Can be used during pregnancy. There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.

Fertility:

The safety and efficacy of the vaccine has not been established in breeding males (sheep and cattle). In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National competent authorities on the current vaccination policies against bluetongue virus (BTV).

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.

Overdose (symptoms, emergency procedures, antidotes):

Occasionally a slight increase of the temperature (0.5 °C – 1.0 °C) is observed for 24–48 hours after the administration of a double dose of the vaccine. Painless swellings occur occasionally with a size up to 2 cm in sheep and up to 4.5 cm in cattle after administration of a double dose.

Incompatibili­ties:

Do not mix with any other veterinary medicinal product.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED {DD/MM/YYYY} Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency

• 15. OTHER INFORMATION