Equilis West Nile
inactivated chimaeric flavivirus strain YF-WN
Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Wim de Körverstraat 35 5831 AN Boxmeer
The NETHERLANDS
Equilis West Nile suspension for injection for horses
Each dose of 1 ml contains:
Inactivated chimeric flavivirus strain YF-WN ≥ 492 AU1 Iscom-Matrix containing:
Purified saponin 250 micrograms
Cholesterol 83 micrograms
Phosphatidylcholine 42 micrograms
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.
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.
Horses.
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.
None.
Zero days.
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.
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.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
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The vaccine stimulates active immunity against West Nile virus in horses. Package sizes:
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.