SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Equip Artervac Emulsion for Injection for Horses and Ponies

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose of 1 ml contains :

Active substance

Inactivated Equine Arteritis Vaccine, Bucyrus strain RP*=1.0-1.8

* Relative Potency compared to a reference vaccine

Adjuvant

Squalane* 1.61 mg

*As component of MetaStim (that also contains Pluronic L-121 and Polysorbate 80)

Excipient

Eagles Hepes (0.05 % LAH) Medium qs to 1.0 ml

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Emulsion for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Horses and ponies from the age of 9 months.

4.2 Indications for use, specifying the 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 post primary vaccination
Duration of immunity: 6 months

4.3 Contraindications

Do not use in sick animals.

4.4 Special warnings for each target species

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.

4.5 Special precautions for use

i. Special precautions for use in animals

None.

ii. 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.

4.6 Adverse reactions (frequency and seriousness)

Minor transient (1 to 5 days) increase in body temperature (<40°C) was 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%).

In the event of an allergic or anaphylactic reaction, adrenaline should be administered intramuscularly.

4.7 Use during pregnancy, lactation or lay

Do not use in pregnant mares.

4.8 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.

4.9 Amounts to be administered and administration route

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Administration of a twofold overdose has no influence on the systemic reactions to vaccination as described in section “Adverse Reactions”. 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.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Inactivated viral vaccines

ATCvet code: QI05AA07

The vaccine induces an active immunity against equine arteritis virus, strain Bucyrus in horses and ponies

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Eagles Hepes (0.05 % LAH) Medium

Phosphate Buffered Saline

Pluronic L-121

Squalane

Polysorbate 80

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

6.4. Special precautions for storage

Store and transport refrigerated (2 C – 8 C).

Protect from light.

Do not freeze.

Container: Sterile single-use polypropylene syringes closed with rubber tips

Content: 1 Dose (1 ml)

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.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Ltd

5th Floor, 6 St Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm42058/4059

9. DATE RENEWAL OF THE AUTHORISATION

Date:23 March 2010

10. DATE OF REVISION OF THE TEXT

Date:June 2013

Approved: 20/06/2013