Each 1 ml dose contains:

Inactivated West Nile virus, strain VM-2, 1.0 - 2.2 RP*

SP Oil 4.0% - 5.5% (v/v)

* Relative potency by in vitro method, compared to a reference vaccine that was shown efficacious in horses.

For the active immunisation of horses of 6 months of age or older against West Nile virus (WNV) disease by reducing the number of viraemic horses after infection with WNV lineage 1 or 2 strains and to reduce duration and severity of clinical signs against WNV of lineage 2 strains.

Onset of immunity: 3 weeks after primary vaccination course.

Duration of immunity: 12 months after primary vaccination course for WNV lineage 1 strains. For WNV lineage 2 strains the duration of immunity has not been established.

Administer the entire content of the syringe (1 ml), by deep intramuscular injection in the neck region, according to the following schedule:

First injection from 6 months of age, second injection 3-5 weeks later.

A sufficient degree of protection should be achieved after an annual booster injection with a single 1 ml dose although this schedule has not been fully validated.

Vaccinate healthy animals only.

Vaccination may interfere with existing sero-epidemiological surveys. However, since the IgM response following vaccination is infrequent, a positive IgM-ELISA test result is a strong indicator of natural infection with West Nile virus. If infection is suspected as a result of a positive IgM response, additional testing would need to be conducted to conclusively determine whether the animal was infected or vaccinated.

No specific studies have been conducted to demonstrate absence of interferences from maternally derived antibodies on vaccine take. It is therefore recommended not to vaccinate foals of less than 6 months of age.

Horses:

Rare (1 to 10 animals / 10,000 animals treated):	Hypersensitivity reaction (including vomiting, incoordination, lethargy, and laboured breathing)1
Very rare (<1 animal / 10,000 animals treated, including isolated reports)	Hyperthermia2 Injection site swelling (sometimes associated with injection site pain and mild depression)3

1As with any vaccine rare, occasional hypersensitivity reactions may occur. If such a reaction occurs, appropriate treatment should be administered without delay.

2Resolves within 2 days.

3Transient local reactions in the form of a mild, local swelling at the injection site post vaccination (maximum 1 cm in diameter) that resolves spontaneously within 1 to 2 days.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.

Can be used during pregnancy and lactation.

No specific efficacy studies were conducted in pregnant mares. As a consequence, it cannot be excluded that transient immunodepression that may be observed during pregnancy could interfere with vaccine uptake.

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.

Do not mix with any other veterinary medicinal product.

Zero days.

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

Store and transport refrigerated (2 °C - 8 °C).

Do not freeze.

Protect from light.

For animal treatment only.

Keep out of the sight and reach of children.

Single-dose (1 ml) pre-filled type I glass syringe closed with bromobutyl rubber tip.

Packaging: box of 2, 4 or 10 single-dose syringes with needles.

Not all pack sizes may be marketed.

Medicines should not be disposed of via wastewater.

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

UK(GB): Vm 42058/5023