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POM-V Prescription Required

Syvazul BTV 3 Suspension for Injection for Sheep and Cattle

Active ingredient: Bluetongue virus

Form

Injection

Species

Cattle Sheep

Manufacturer

Laboratorios SYVA S.A.

VMD MA No.

31592/5006

What it's used for

Onset of immunity: 4 weeks after completion of the primary vaccination scheme. The duration of immunity has not been established. Cattle: For active immuni...

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

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Prescription required

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Clinical information

Syvazul BTV 3 Suspension for Injection for Sheep and Cattle — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.

Onset of immunity: 4 weeks after completion of the primary vaccination scheme.
The duration of immunity has not been established.
Cattle:

For active immunisation of cattle to reduce viraemia caused by bluetongue virus
serotype 3.
Onset of immunity: 3 weeks after completion of the primary vaccination scheme.
The duration of immunity has not been established.
Sheep:
Subcutaneous use.
Administer subcutaneously to sheep from 3 months of age, according to the following
scheme:
-
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:
-
Revaccination:
Not established.
None.
Sheep
Very common
(>1 animal / 10 animals treated):
- Injection site reaction*, Injection site
erythema
1,
*,
Injection site oedema
1,
*, Injection site
nodule
2,
*
- Elevated temperature
Rare
(1 to 10 animals / 10,000 animals
treated):
- Injection site abscess*
- Abortion, perinatal mortality, premature
parturition
- Apathy, recumbency, anorexia, lethargy
Very rare
(<1 animal / 10,000 animals
treated,
including isolated reports):
- Milk production decrease
- Paralysis, ataxia, blindness,
incoordination
- Pulmonary congestion, dyspnoea
- Rumen atony, bloated, hypersalivation
- Hypersensitivity reactions
- Death
* Most local reactions disappear or become residual (≤ 1 cm) before 70 days,
although residual nodules can persist after that time.
1. Mild to moderate, from 1 to 6 days after administration.
2. Painless, up to 3.8 cm diameter, after 2 to 6 days and diminishes progressively
over time.
3. Not exceeding 2.3 °C, during the 48 hours following vaccination.
4. Hypersalivation may occur with hypersensitivity reactions.
Cattle
Very common
(>1 animal / 10 animals treated):
- Injection site reaction*, Injection site
erythema
1,
*, Injection site oedema
1,*
,
Injection site nodule
2,
*
- Elevated temperature
Rare
(1 to 10 animals / 10,000 animals
treated):
- Injection site abscess*
-
- Anorexia
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
- Abortion, perinatal mortality, premature
parturition
- Apathy, recumbency, lethargy
-
-
incoordination
-
-
-
-
* Most local reactions disappear or become residual (≤ 1 cm) before 30 days,
although residual nodules can persist after that time.
1. Mild to moderate, from 1 to 6 days after administration.
2. Painless, up to 7 cm diameter, after 2 to 6 days and diminishes progressively over
time.
3. Not exceeding 2.3 °C, during the 48 hours following vaccination.
4. Hypersalivation may occur with hypersensitivity reactions.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary
medicinal product. Reports should be sent, preferably via a veterinarian, to either the
marketing authorisation holder or the national competent authority via the national
reporting system. See the package leaflet for respective contact details.
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 and cattle with
maternally-derived antibodies.

Special precautions for safe use in the target species:
Not applicable.
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.
Special precautions for the protection of the environment:
Not applicable.
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.
Store and transport refrigerated (2 C – 8 C).
Do not freeze.
Protect from light.
Store in the original package.
Zero days.

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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