Target species
Horses.
Indications for use for each target species
For active immunisation of horses to reduce clinical signs due to infection with Equine Herpesvirus 1 and 4 and to reduce abortion caused by EHV-1 infection.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
The vaccine may not be effective in animals incubating the disease at the time of vaccination.
In the event of an allergic or anaphylactic reaction, immediate treatment should be given with a soluble glucocorticoid intravenously (e.g. dexamethasone sodium phosphate), adrenaline intramuscularly or antihistamine intramuscularly. Animals that have received immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.
Syringes and needles should not have been sterilised chemically or be above ambient temperature. Do not use chemicals to disinfect or sterilise the skin.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Not applicable.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Horses:
Very common (>1 animal / 10 animals treated): | Injection site swelling1 |
Common (1 to 10 animals / 100 animals treated): | Elevated temperature2 |
Rare (1 to 10 animals / 10,000 animals treated): | Stiff gait Anorexia, Lethargy |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Hypersensitivity reaction3 |
1 Transient. Up to 5 cm in diameter, disappearing within a few to 6 days post vaccination.
2 Transient. Up to 2 days following dosing not exceeding 1.7°C.
3 Appropriate treatment is recommended / treat symptomatically.
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.
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
One dose per horse to be administered by deep intramuscular injection.
Primary course: A single dose should be administered from 5 months of age followed by a second injection after an interval of 4 to 6 weeks.
In the event of increased infection risk, for example when a foal had consumed insufficient colostrum or there is a risk of early exposure to field infections with EHV-1 or EHV-4, earlier vaccination may be given. In these circumstances, the foal should receive a single dose from 3 months of age followed by the above mentioned full primary vaccination course.
Booster: Following completion of the primary course, a single dose should be administered every 6 months.
Use in pregnant mares: To reduce abortion due to EHV-1 infection, pregnant mares should be vaccinated during the 5th, 7th, and 9th month of pregnancy with a single 1.5 ml dose on each occasion.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse reactions exceeding those discussed in section "Adverse events" were recorded following administration of an overdose.
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
Not applicable.
Withdrawal periods
Zero days.