Equilis West Nile - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Equilis West Nile suspension for injection for horses

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release :

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The NETHERLANDS

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Equilis West Nile suspension for injection for horses

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each dose of 1 ml contains:

Inactivated chimeric flavivirus strain YF-WN

Iscom-Matrix containing:

Purified saponin

Cholesterol

Phosphatidylcholine

1 Antigenic units

Opalescent suspension.

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.

5. CONTRAINDI­CATIONS

None.

In laboratory studies and field trials:

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).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Horses.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

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.

• 9. ADVICE ON CORRECT ADMINISTRATION

None.

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

• 12. SPECIAL WARNING(S)

Special warnings for each target species: Vaccinate healthy animals only.

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.

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction:

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.

Major incompatibilities:

Do not mix with any other veterinary medicinal product.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

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

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED