Target species
Sheep and cattle.
Indications for use, specifying the target species
Sheep:
For active immunisation of sheep to prevent viraemia* and reduce clinical signs and lesions caused by bluetongue virus serotype 8.
*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 serotype 8
*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.
Contraindications
None.
Special warnings for each target species
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.
Special precautions for use
Special precautions for use in animals
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.
Adverse reactions (frequency and seriousness)
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).
Use during pregnancy, lactation or lay
Pregnancy:
Can be used during pregnancy.
Lactation:
Can be used during lactation.
Fertility:
The safety and the efficacy of the vaccine have 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.
Amounts to be administered and administration route
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
After administration of a double dose, no other adverse reactions different to those mentioned in section 'Adverse Events' were observed.