Target Species
Sheep and Cattle
Indications for use for each target species
Sheep
For active immunisation of sheep to reduce the viraemia, mortality and clinical signs caused by the serotype 3 of the bluetongue virus.
Onset of immunity: 3 weeks after completion of the primary vaccination scheme.
Duration of immunity: not established.
Cattle
For active immunisation of cattle to reduce the viraemia against the serotype 3 of the bluetongue virus.
Onset of immunity: 3 weeks after completion of the primary vaccination scheme.
Duration of immunity: not established
Contraindications
None
Special warnings
Vaccinate healthy animals only.
No information is available on the use of the vaccine in seropositive sheep and cattle, including those with maternal antibodies.
Special precautions for use
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.
Special precautions for the protection of the environment: Not applicable.
Adverse events
Sheep
Very common (>1 animal / 10 animals treated): | Injection site swelling1 Injection site nodule2 |
Common (1 to 10 animals / 100 animals treated): | Elevated temperature3 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Loss of appetite Hypersensitivity reaction |
1Painless, diameter up to 4 cm, for up to 9 days, transforms into a nodule.
2Painless, diameter up to 4 cm, recedes within 14 days.
3Up to 1 ºC, for up to 72 hours.
Cattle
Very common (>1 animal / 10 animals treated): | Injection site swelling1 Injection site nodule2 |
Rare (1 to 10 animals / 10,000 animals treated): | Elevated temperature3 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Loss of appetite Hypersensitivity reaction |
1Painless, diameter up to 9 cm, for up to 6 days, transforms into a nodule.
2Painless, diameter 0.5 to 9 cm, recedes in 25% of animals within 21 days.
3Up to 1 ºC, for up to 24 hours.
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.
Use during pregnancy, lactation or lay
Pregnancy: Can be used during pregnancy in ewes and cows.
Lactation: No negative impact on the milk-yield using the vaccine in lactating ewes and cows is expected.
Fertility: The safety of the vaccines has not been established in breeding males. 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 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.
Administration routes and dosage
Shake well before use. Avoid multiple vial broaching. Avoid introduction of contamination.
Subcutaneous use.
Primary vaccination
Sheep from 2 months of age: Administer two doses of 2 mL subcutaneously 3 weeks apart.
Cattle from 2 months of age: Administer two doses of 4 mL subcutaneously 3 weeks apart.
Revaccination
Not established
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
After the administration of a double dose, no adverse reactions other than those described in section 3.6 were observed.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Any person intending to manufacture, import, possess, distribute, sell, supply and use this veterinary medicinal product must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Withdrawal periods
Zero days.