Each dose of 1 ml contains:

Inactivated chimeric flavivirus strain YF-WN ≥ 492 AU1

1Antigenic units determined by ELISA.

Iscom-matrix containing:

Purified saponin 250 micrograms

Cholesterol 83 micrograms

Phosphatidylcholine 42 micrograms

For the full list of excipients, see section “Pharmaceutical particulars”.

Suspension for injection.

Opalescent suspension.

Horses.

Active immunisation of horses against West Nile virus (WNV) to reduce clinical signs of disease and lesions in the brain and to reduce viraemia.

Onset of immunity: 2 weeks after primary vaccination course of two injections.

Duration of immunity: 12 months.

None.

Vaccinate healthy animals only.

Not applicable.

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

After vaccination a mild transient swelling may very commonly develop at the injection site (max. 3 cm in diameter). This swelling normally resolves within 1 to 5 days.

A mild body temperature increase (max. 1.5 °C) may very commonly occur for 1 to 2 days.

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).

Use during pregnancy or lactation

Can be used during pregnancy and lactation.

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.

Intramuscular use.

Vaccination schedule: Administer one dose (1 ml) by intramuscular injection, according to the following schedule:

Primary vaccination: first injection from 6 months of age onwards, second injection 3 to 5 weeks later.

Revaccination: a yearly booster injection of one dose (1 ml) should be sufficient to achieve a reduction of fever, lesions in the brain and viraemia.

Following the administration of a double dose of vaccine, no side-effects other than those described under section 4.6 have been observed.

Zero days

ATCvet code: QI05AA10.

Immunologicals for Equidae, inactivated viral vaccines.

The vaccine stimulates active immunity against West Nile virus in horses.

Sodium chloride

Potassium chloride

Disodium hydrogen phosphate dihydrate

Potassium dihydrogen phosphate

Water for injections

Do not mix with any other veterinary medicinal product.

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

Store in a refrigerator (2 °C – 8 °C). Do not freeze.

Protect from light.

Type I glass vials of 1 ml (1 dose) closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.

Type I glass pre-filled syringes of 1ml (1 dose), containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.

Cardboard box with 10 glass vials of 1 ml (1 dose).

Plastic box with 10 glass vials of 1 ml (1 dose).

Cardboard box with 5 or 10 pre-filled syringes of 1 ml (1 dose).

Plastic box with 5 or 10 pre-filled syringes of 1 ml (1 dose).

Not all pack sizes may be marketed.

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

UK(NI): Intervet International B.V., The Netherlands

UK(GB): Vm 01708/5035

UK(NI): EU/2/13/151/001-003

06 June 2013.

03 October 2018.

For animal treatment only.

Keep out of the sight and reach of children.