Target species
Sheep and cattle.
Indications for use for each target species
Sheep:
For active immunisation of sheep to reduce viraemia, mortality, clinical signs and lesions caused by bluetongue virus serotype 3.
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.
Contraindications
None.
Special warnings
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 use
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.
Adverse Events
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 3 |
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, hypersalivation4 - Hypersensitivity reactions4 - Death |
* Most local reactions disappear or become residual (≤ 1 cm) before 70 days, although residual nodules can persist after that time.
1Mild to moderate, from 1 to 6 days after administration.
2Painless, up to 3.8 cm diameter, after 2 to 6 days and diminishes progressively over time.
3Not exceeding 2.3 °C, during the 48 hours following vaccination.
4Hypersalivation 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 3 |
Rare (1 to 10 animals / 10,000 animals treated): | - Injection site abscess* - Milk production decrease - Anorexia |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | - Abortion, perinatal mortality, premature parturition - Apathy, recumbency, lethargy - High somatic cell count - Paralysis, ataxia, blindness, incoordination - Pulmonary congestion, dyspnoea - Rumen atony, bloated, hypersalivation4 - Hypersensitivity reactions4 - Death |
* Most local reactions disappear or become residual (≤ 1 cm) before 30 days, although residual nodules can persist after that time.
1Mild to moderate, from 1 to 6 days after administration.
2Painless, up to 7 cm diameter, after 2 to 6 days and diminishes progressively over time.
3Not exceeding 2.3 °C, during the 48 hours following vaccination.
4Hypersalivation 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.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy and 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-bycase basis.
Symptoms of overdose (and where applicable, emergency procedures antidotes)
The safety of an overdose has not been established.
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 competent authority on the current vaccination policies, as these activities may be prohibited in the whole or part of its territory pursuant to national legislation.
Administration routes and dosage
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.
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 2 ml 3 weeks apart.
Revaccination:
Not established.