Introduction

FDAH

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

An inactivated adjuvanted liquid vaccine in single dose syringes for administration to horses and ponies.

Each single dose contains 1 ml of an inactivated SP oil adjuvanted vaccine of equine arteritis virus (EAV), Bucyrus strain, RP* 1.0 – 1.8. Contains trace amounts of neomycin (27 micrograms) and 0.05 ml SP oil as adjuvant.

*Relative Potency compared to reference vaccine.

Uses

For the active immunisation of horses and ponies against equine arteritis, to reduce clinical signs and shedding of virus in nasal secretions after infection.

The vaccine is recommended for use in healthy horses and ponies from 9 months of age.

The onset of immunity is from 3 weeks after the second dose.

The duration of immunity is from 6 months post primary vaccination.

Dosage and administration

Shake well before use.

Administer a 1 ml dose by intramuscular injection.

Primary Vaccination Course

One 1 ml dose per horse followed by a second 1 ml dose 3 to 6 weeks later.

Following completion of the primary course, a single dose of Artervac should be administered every 6 months.

Contra-indications, warnings, etc

Do not use in unhealthy animals.

Do not use in pregnant mares.

Minor transient increases in body temperature (<40°C) lasting 1-5 days and transient local reactions lasting 2-3 days (usually <4 cm) may be observed in approximately 20% of horses vaccinated. In one case a swelling of 20 cm and lasting 5 days was observed. Systemic reactions such as depression (1%), ocular and nasal discharge (8%), urticaria (<1%) and oedema of the legs, abdomen and scrotum (<1%) were observed.

Administration of a twofold overdose has no influence on the systemic reactions to vaccination. 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.

Animals that have received immunosuppressive drugs (e.g. glucocorticoids) should not be vaccinated until an interval of at least 4 weeks has elapsed.

No data are available on the safety and efficacy of concurrent administration 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 Artervac.

Do not mix with other vaccines / immunological products.

In case of an allergic or anaphylactic reaction, administer adrenalin by intramuscular injection.

Vaccination does not prevent infection, nor does it 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.

UK Only:

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.

Withdrawal period

Zero days.

Operator warning

In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician.

Pharmaceutical precautions

The vaccine should be stored and transported between 2ºC and 8ºC (in a refrigerator). Do not freeze. Protect from light. Do not use after the expiry date printed on the packaging and label.

Keep out of reach of children.

Disposal

Any unused medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements.

Legal category

POM-V

Packaging Quantities

Box containing 1 sachet of 1 single dose (1.0 ml) syringe.

Box containing 10 sachets of 1 single dose (1.0 ml) syringe.

Not all pack sizes may be marketed.

Further information

In any animal population there will be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine and the animal’s ability to respond. Immune competence can be influenced by genetic factors, intercurrent infection, age, nutritional status, concurrent drug therapy, stress, etc. In addition, successful vaccination is dependent on correct administration and storage of the vaccine.

Ireland Only:

Artervac must not be imported, sold or administered except in accordance with a licence granted by the Minister for Agriculture and Food, Maynooth Business Campus, Maynooth, County Kildare under The Diseases of Animals Act, 1966 (Control on Animal and Poultry Vaccines) Order 2002 (SI No. 528 of 2002).