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ARTERVAC – Emulsion for Injection for Horses

1 Timoney PJ et al. Equine Viral Arteritis. Veterinary Clinics of North America: Equine Practice (1993) 9 (2) 295-309.

Description

Each dose of 1 ml contains:

Active Substances:
Inactivated equine arteritis virus, Bucyrus strains:RP*=1.0-1.8
Adjuvants:
SP oil0.05 ml
Excipients
Eagles Hepes (0.05% LAH) Mediumqs to 1.0 ml
Trace of neomycin27 mcg
* Relative Potency compared to a reference vaccine

INDICATIONS

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.

CONTRAINDICATIONS

Do not use in sick animals.
Do not use in pregnant mares.

ADVERSE REACTIONS

Minor transient (1 to 5 days) increases in body temperature (<40°C) were observed in both clinical studies and field trials in approximately 20% of horses vaccinated. Transient local reactions (for usually 2 to 3 days) were observed in up to 20% of horses vaccinated. The swellings were usually less than 4 cm in diameter, but the swelling (lasting for 5 days) in one horse was recorded as being 20 cm. All swellings resolved. Systemic reactions were observed which included depression (1%), ocular and nasal discharge (8%), urticaria (<1%) and oedema of legs, abdomen or scrotum (<1%).

TARGET SPECIES

Ponies and horses from the age of nine months.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

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 vaccinations are recommended every 6 months.
Onset of immunity: 3 weeks.
Duration of immunity: 6 months post primary vaccination
Overdose
Administration of a twofold overdose has no influence on the systemic reactions to vaccination (as described in 5.4). 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.

WITHDRAWAL PERIOD

Zero days.

SHELF LIFE

Shelf life of the veterinary product as packaged for sale: 24 months.

SPECIAL STORAGE PRECAUTIONS

Store and transport refrigerated (2°C - 8°C).
Protect from light.
Do not freeze.

SPECIAL WARNINGS

Do not use in pregnant mares.
Do not mix with other vaccine/immunological product.
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 from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with this product.
In the event of an allergic or anaphylactic reaction, adrenaline should be administered intramuscularly.
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.
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 insert or the label to the physician.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

OTHER INFORMATION

ATCv code: QI05 AA07
Nature and composition of immediate packaging
Single-dose (1ml)
Container: Sterile single-use polypropylene syringes closed with rubber tips
Pack sizes:
- box containing 1 sachet of 1 syringe of 1 dose
- box containing 10 sachets of 1 syringe of 1 dose
Not all pack sizes may be marketed.

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