Target species
Horses and ponies.
Indications for use for each target species
For the active immunisation of horses and ponies against equine arteritis in order to reduce clinical signs and shedding of virus in nasal secretion after infection.
Onset of immunity: 3 weeks
Duration of immunity: 6 months
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Vaccination does not prevent infection.
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.
Other precautions:
Vaccination does not have an effect on the shedding of EAV by previously infected carrier stallions.
The effect of the veterinary medicinal product on the fertility of breeding stallions has not been investigated.
Adverse events
Horses and ponies:
Very common (>1 animal / 10 animals treated): | Injection site swelling1 Elevated temperature2 |
Common (1 to 10 animals / 100 animals treated): | Ocular discharge Nasal discharge Depression |
Rare (1 to 10 animals / 10,000 animals treated): | Allergic reaction3, Anaphylactic-type reaction3, Localised allergic oedema (oedema of the legs, abdominal oedema, scrotal oedema)3, Urticaria3 |
1Transient, usually lasting for 2 to 3 days. The swellings are usually less than 4 cm in diameter but in one horse a swelling of 20 cm lasting for 5 days was recorded. All swellings resolved.
2Minor transient (1 to 5 days) increase in body temperature (<40°C).
3If such reactions occur, adrenaline should be administered intramuscularly.
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 its local representative 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:
Do not use (during the whole or part of the pregnancy).
Interaction with other medicinal products and other forms of interaction
Animals that have received immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.
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.
1 ml dose per horse to be administered by intramuscular injection.
Primary course:
A single dose should be administered two times with an interval of 3-6 weeks from an age of nine months onwards.
Booster vaccination:
Booster vaccinations are recommended every 6 months.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Administration of a twofold overdose has no influence on the systemic reactions to vaccination as described in section “Adverse events”. Local swellings (< 4 cm in size) were observed in 80% of horses administered two doses of vaccine, these swellings were observed for one day only.
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 competent authority on the current
vaccination policies, as these activities may be prohibited in a country on the whole or part of its territory pursuant to national legislation.
Withdrawal periods
Zero days.