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La información contenida en esta página está destinada a veterinarios y/o profesionales de salud animal con capacidad de prescripción y/o dispensación de medicamentos.

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– Entiendo que la información disponible en esta página se refiere exclusivamente a productos y autorizaciones en España. La información en otros países, debo consultarla a través de los medios oficiales disponibles en el destino específico o con el Departamento de Exportación.

Vaccine

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Syvazul® BTV suspension for injection

Inactivated vaccine against bluetongue as suspension for injection

1. Warning

The information available on this page complies with the legislation and texts in vigour in Spain. For all other countries, please refer to the specific local information or contact our Export Department for more information.

*The content of this page is purely informative. For a correct use of the products, please refer to the indications in the Summary of product characteristics..

Quick product information

Active ingredient(s)Route of administrationWaiting timePackaging

Inactivated Bluetongue Virus Serotype 1 (BTV-1), serotype 4 (BTV-4), serotype 8 (BTV-8)

Sheep: subcutaneous administration
Cattle: intramuscular administration

Zero days

80 ml

200 ml

Country Availability

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, United Kingdom.

If your country is not listed, please contact our export team.

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Active ingredient(s)

Inactivated bluetongue virus (BTV) RP** ≥ 1

* Maximum of two different inactivated bluetongue virus serotypes:

Inactivated Bluetongue Virus Serotype 1 (BTV-1), strain ALG2006/01 E1

Inactivated Bluetongue Virus Serotype 4 (BTV-4), strain BTV-4/SPA-1/2004

Inactivated Bluetongue Virus, Serotype 8 (BTV-8), strain BEL2006/01

**Relative potency determined by ELISA in relation to a reference vaccine whose efficacy has been demonstrated by challenge in the target species.

The number and type of strains included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label.

Indications

Sheep:

For active immunisation of sheep to prevent viraemia* and reduce clinical signs and by bluetongue virus serotypes 1 and/or 8 and to reduce lesions caused by bluetongue lesions caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).

*Below the level of detection by the validated RT-PCR method at 1.32 log10 TCID50/ml

Onset of immunity: 39 days after completion of the primary vaccination scheme.

Duration of immunity: one year after completion of the primary vaccination scheme.

Cattle:

For active immunisation of cattle to prevent viraemia* caused by serotypes 1 and/or 8 of the blue tonguevirus and to reduce viraemia* caused by bluetongue virus serotype 4 (combination of maximum 2 serotypes).

*Below the detection threshold with the RT-PCR validated method at 1.32 log10 DICT50/ml

Onset of immunity: 21 days after completion of the primary vaccination scheme.

Duration of immunity: one year after completion of the primary vaccination scheme.

Special precautions

Specific 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. People with known hypersensitivity to aluminium hydroxide, thiomersal or saponins must avoid all contact with the veterinary medicinal product.

Posology

Shake well before use.
Sheep:
Subcutaneous administration.
Administer subcutaneously to sheep from 3 months of age, according to the following schedule:
– Primary vaccination: administer a single 2 ml dose.
– Revaccination: administer one dose of 2 ml after 12 months.
Cattle:
Intramuscular administration.
Administer intramuscularly to cattle from 2 months of age in animals not treated previously or from 3 months of age in calves born to immunised cattle, according to the following schedule:
-Primary vaccination: administer two doses of 4 ml 3 weeks apart.
– Revaccination: administer one dose of 4 ml after 12 months.

Waiting time

Zero days.

Packaging

Containers with 80 and 200 ml.

With veterinary prescription.

Registry no.: EU/2/18/231/001-012