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Date: Saturday, May 4, 2024 7:51

Release 3.63
Equip Artervac Emulsion for Injection for Horses and Ponies
 
Species: Horses and other equidae
Therapeutic indication: Immunological veterinary medical products: For horses
Active ingredient: Vaccine Antigens
Product:Equip® Artervac Emulsion for Injection for Horses and Ponies
Product index: Equip Artervac
Withdrawal notes: Horse: Zero days
Incorporating:
Presentation
Each dose of 1ml contains:
Active Substance
Inactivated Equine Arteritis Virus, Bucyrus strain 1.0 - 1.8 RP*
*Relative Potency compared to a reference vaccine
Adjuvant
Squalane 0.2% (v/v)
Pluronic L-121 0.1% (v/v)
Polysorbate 80 0.016% (v/v)
Uses
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 post primary vaccination.
Duration of immunity: 6 months.
Dosage and administration
1ml 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 vaccinations are recommended every 6 months.
Advice on correct administration
Shake well before use.
Contra-indications, warnings, etc
Special warnings for use in animals
Vaccinate healthy animals only.
Vaccination does not prevent infection.
Vaccination does not have an effect on the shedding of EAV by previously infected carrier stallions.
The effect of the vaccine on the fertility of breeding stallions has not been investigated. Under some national legislation EVA is a notifiable disease (UK). Please refer to the national product literature for recommendations on vaccination to comply with this legislation.
Equine viral arteritis (EVA) is a notifiable disease in the UK. Vaccinated horses will become seropositive and therefore it is recommended that they are blood tested prior to primary vaccination to demonstrate that they were previously seronegative. Details of blood testing and vaccination schedule should be recorded in the horse passport.
Pregnancy and lactation
Do not use in pregnant mares.
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.
Incompatibilities
Do not mix with any other veterinary medicinal product.
Adverse reactions
Minor transient (1 to 5 days) increase in body temperature (<40°C) and transient local reactions (for usually 2 to 3 days) may be very commonly observed in vaccinated horses. The swellings are usually less than 4cm in diameter but in one horse a swelling of 20cm lasting for 5 days was recorded. All swellings resolved.
Systemic reactions which includes depression and ocular and nasal discharge may be commonly observed. Urticaria and oedema of the legs, abdomen and scrotum may be rarely observed.
In the event of an allergic or anaphylactic reaction, adrenaline should be administered intramuscularly.
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).
Administration of a two-fold overdose has no influence on the systemic reactions to vaccination as described above. 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.
Operator warning
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Withdrawal period
Zero days.
Pharmaceutical precautions
Keep out of the sight and reach of children.
Store and transport refrigerated (2°C - 8°C).
Protect from light. Do not freeze.
Do not use this veterinary medicinal product after the expiry date stated on the carton and the syringe label after EXP.
Legal category
Legal category: POM-V
Packaging quantities
1 dose syringes are supplied in a cardboard box of 1, 2 and 10 units.
Not all pack sizes may be marketed.
Further information
Disposal: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Number
Vm 42058/4059
Significant changes
GTIN
GTIN description:1 x 1 dose:
GTIN:05414736041476