Target Species: Sheep and cattle.
Indications for use for each target species:
Sheep:
Active immunisation to reduce viraemia and to prevent clinical signs caused by bluetongue virus (BTV) serotype 3.
Onset of immunity: 3 weeks after the primary vaccination course.
Duration of immunity: has not been established.
Cattle:
Active immunisation to prevent viraemia and to prevent clinical signs caused by bluetongue virus (BTV) serotype 3.
Onset of immunity: 3 weeks after the primary vaccination course.
Duration of immunity: has not been established.
Contraindications: None.
Special warnings:
Vaccinate healthy animals only.
Basic immunisation should be started in time so that protection has fully developed by the beginning of the risk period for the animal (related to the appearance of the main vectors of the disease – biting midges).
No data are available concerning the impact of maternally derived antibodies on the response to vaccination.
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:
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:
Common (1 to 10 animals / 100 animals treated): Elevated temperature1 Injection site swelling2
Very rare (< 1 animal / 10 000 animals treated, including isolated reports): Anaphylactoid reaction3
1 For up to 3 days. 2 Diameter up to 2 cm, recedes within a maximum of 3 weeks. 3 Symptomatic treatment should be given.
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 to the national competent authority via the national reporting system.
Use during pregnancy, lactation or lay:
Pregnancy:
Can be used during pregnancy.
Lactation
The safety of the veterinary medicinal product has not been established during lactation.
Fertility:
The safety of the vaccine 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 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.
Administration routes and dosage:
Subcutaneous use in sheep and intramuscular use in cattle. Apply usual aseptic procedures.
Shake gently immediately before use. Avoid bubble formation, as this can be irritating at the site of injection. The entire content of the vial should be used immediately after broaching and during the same procedure. Avoid multiple broaching of vials. Before use the vaccine should be warmed to 15 - 25 °C.
Administer one dose of 1 ml, subcutaneously in sheep, intramuscularly in cattle, according to the following vaccination scheme:
Primary vaccination:
In sheep: one injection from 1 month of age in naive animals.
In cattle: 1st injection: from 1 month of age in naive animals & 2nd injection: 3 weeks after the first injection.
Revaccination: Not established.
Symptoms of overdose (and where applicable, emergency procedures and antidotes): Not applicable.