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Bluevac BTV8 (bluetongue virus inactivated, serotype...) – Package leaflet - QI04AA02

Updated on site: 08-Feb-2018

Medication name: Bluevac BTV8
ATC: QI04AA02
Substance: bluetongue virus inactivated, serotype 8
Manufacturer: CZ Veterinaria S.A.

PACKAGE LEAFLET FOR:

BLUEVAC BTV8 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

Marketing authorisation holder and manufacturer responsible for batch release:

CZ Veterinaria, S.A. La Relva s/n

36400 Porriño SPAIN

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

BLUEVAC BTV8 suspension for injection for cattle and sheep

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

Each ml of vaccine contains:

106.5 CCID50*

Bluetongue virus inactivated, serotype 8

Aluminium hydroxide

6 mg

Purified saponin (Quil A)

0.05 mg

Thiomersal

0.1 mg

(*)equivalent to titre prior to inactivation (log10)

 

4.INDICATION(S)

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.

6.ADVERSE REACTIONS

An average increase in body temperature varying between 0.5 and 1.0 ºC is a common reaction observed in sheep and cattle. It lasts not longer than 24 to 48 hours. Transient fever was observed in rare cases. In very rare cases, temporary local reactions occur at the injection site in the form of a normally painless 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. In very rare cases loss of appetite can occur.

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

-very common (more than 1 in 10 animals displaying adverse reactions 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).

If you notice any serious effects or other effects not mentioned in this package leaflet, 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.

9.ADVICE ON CORRECT ADMINISTRATION

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

10.WITHDRAWAL PERIOD

Zero days.

11.SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store and transport refrigerated (2 ºC – 8 ºC).

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:

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.

Special precautions for use in animals:

Vaccinate healthy animals only.

Pregnancy and lactation:

Can be used during pregnancy in ewes and cows. 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 ºC – 1.0 ºC) 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 to protect the environment.

14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).

15.OTHER INFORMATION

Immunological properties

Pharmacotherapeutic group: bluetongue virus vaccine, inactivated.

ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle).

BLUEVAC BTV8 stimulates active immunity against bluetongue virus, serotype 8.

Pack sizes:

Box of 1 bottle of 52 ml

Box of 1 bottle of 100 ml

Box of 1 bottle of 252 ml.

Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

United Kingdom

Intervet UK Ltd.

Walton Manor

Walton

Milton Keynes

MK7 7AJ

UK

Tel: +44 (0)1908 685685

CZ Veterinaria, S.A. La Relva s/n

36400 Porriño Spain

Tel: +34 986330400

Ireland and Northern Ireland

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Ireland

Tel: +353 (0)1 2970220

CZ Veterinaria, S.A. La Relva s/n

36400 Porriño Spain

Tel: +34 986330400

Deutschland

Intervet Deutschland GmbH

Feldstraße 1a

D-85716 Unterschleißheim

Tel: +49(0)89 456 14 499

CZ Veterinaria, S.A. La Relva s/n

36400 Porriño Spanien

Tel: +34 986330400

Nederland

Intervet Nederland B.V. Wim de Körverstraat 35 5831 AN Boxmeer Tel: +31.485.587652

CZ Veterinaria, S.A. La Relva s/n

36400 Porriño Spanje

Tel: +34 986330400

España

Vetia Animal Health, S.A. Calle Teide nº 4

28703 San Sebastián de los Reyes, Madrid

España

Tel: +34 619292771

CZ Veterinaria, S.A. La Relva s/n

36400 Porriño España

Tel: +34 986330400

België/Belgique/Belgien, Luxembourg/Luxemburg, Република България, Magyarország, Česká republika, Malta, Danmark, Norge, Eesti, Österreich, Ελλάδα, Polska, Portugal, France, România, Slovenija, Ísland, Slovenská republika, Italia, Suomi/Finland, Κύπρος, Sverige, Latvija, Lietuva, Hrvatska

CZ Veterinaria, S.A. La Relva s/n

36400 Porriño Spain

Tel: +34 986330400

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