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Syvazul BTV Suspension for Injection for Sheep and Cattle

Active ingredient: Bluetongue virus

Form

Injection

Species

Cattle Sheep

Manufacturer

Laboratorios SYVA S.A.

VMD MA No.

31592/5000

What it's used for

Sheep: For active immunisation of sheep to prevent viraemia* and reduce clinical signs and lesions caused by bluetongue virus serotypes 1 and/or 8 and/or t...

Full indications, dosage and side effects ↓
View official SPC (PDF)

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Paying less for Bluetongue virus

  1. 1

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  2. 2

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Prescription required

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Clinical information

Syvazul BTV Suspension for Injection for Sheep and Cattle — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.

Sheep:
For active immunisation of sheep to prevent viraemia* and reduce clinical signs and
lesions caused by bluetongue virus serotypes 1 and/or 8 and/or to reduce viraemia* and
clinical signs and 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 bluetongue virus
serotypes 1 and/or 8 and/or to reduce viraemia* 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: 21 days after completion of the primary vaccination scheme.
Duration of immunity: one year after completion of the primary vaccination scheme.
Shake well before use.
Sheep:
Subcutaneous use.
Administer subcutaneously to sheep from 3 months of age, according to the following
scheme:
- Primary vaccination: administer a single 2 ml dose.
- Revaccination: administer one dose of 2 ml after 12 months.
Cattle:
Intramuscular use.
Administer intramuscularly to cattle from 2 months of age in naïve animals or from 3
months of age in calves born to immune cattle, according to the following scheme:
- Primary vaccination: administer two doses of 4 ml 3 weeks apart.
- Revaccination: administer one dose of 4 ml after 12 months.
None.
The development of local reactions is very common at the site of injection after
vaccination.
Erythema associated with mild to moderate oedema is very common from 1 to 6 days after
the administration.
A painless nodule that may reach up to 3.8 cm diameter in sheep and 7 cm diameter in
cattle develops very commonly after 2 to 6 days and diminishes progressively over time.
An abscess may appear on rare occasions.
Most local reactions disappear or become residual (≤ 1 cm) before 70 days in sheep and
30 days in cattle, although residual nodules can persist after that time.
A transient increase in rectal temperature, not exceeding 2.3 °C, during the 48 hours
following vaccination, is very common.
The following might be observed on rare occasions in sheep and on very rare occasions in
cattle:
- Reproductive system disorders: abortion, perinatal mortality or premature parturition
- Systemic disorders: apathy, recumbency, fever, anorexia or lethargy.
The following might be observed on very rare occasions in sheep and cattle:
- Reduction in milk production
- Neurological disorders: paralysis, ataxia, blindness or incoordination
- Respiratory tract disorders: pulmonary congestion, dyspnoea
- Digestive tract disorders: rumen atony or bloating
- Hypersensitivity reactions: with hypersalivation
- Death.
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).

Issued: October 2025
Exceptional case
Vaccinate healthy animals only.
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 sheep with maternally-derived
antibodies.
No information is available on the use of the vaccine containing BTV4 serotype in cattle
with maternally-derived antibodies.

Special precautions for use in animals
Not applicable.

Issued: October 2025
Exceptional case
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.
People with known hypersensitivity to aluminium hydroxide, thiomersal or saponins should
avoid contact with the veterinary medicinal product.
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.
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Inactivated bluetongue virus vaccines for sheep.
ATCvet code: QI04AA02.
To stimulate active immunity of sheep and cattle against bluetongue virus serotypes 1, 4
and/ or 8 related to those contained in the vaccine (combination of maximum 2 serotypes).

This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.

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