Summary of Product Characteristics (SmPC) - Equilis West Nile
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Equilis West Nile suspension for injection for horses
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
Active substance:
Inactivated chimeric flavivirus strain YF-WN > 492 AU1
Adjuvant:
Iscom-Matrix containing:
Purified saponin 250 micrograms
Cholesterol 83 micrograms
Phosphatidylcholine 42 micrograms
1 Antigenic units determined by ELISA.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection.
Opalescent suspension.
4. CLINICAL PARTICULARS
4.1 Target species
Horses.
4.2 Indications for use, specifying the target species
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.
4.3 Contraindications
None.
4.4 Special warnings for each target species
Vaccinate healthy animals only.
4.5 Special precautions for use
Special precautions for use in animals
Not applicable.
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)
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).
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
4.8 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.
4.9 Amounts to be administered and administration route
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of a double dose of vaccine, no side-effects other than those described under section 4.6 have been observed.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines.
ATCvet code: QI05AA10.
The vaccine stimulates active immunity against West Nile virus in horses.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Potassium chloride
Disodium hydrogen phosphate dihydrate
Potassium dihydrogen phosphate
Water for injections
6.2 Major 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 in a refrigerator (2 °C - 8 °C).
Do not freeze.
Protect from light.
6.5 Nature and composition of immediate packaging
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.
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.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Intervet International B.V. Wim de Korverstraat 35 5831 AN Boxmeer The NETHERLANDS
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/13/151/001-003
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 06/06/2013.
Date of last renewal: 16/04/2018
10. DATE OF REVISION OF THE TEXT
{MM/YYYY}
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
PROHIBITION OF SALE, SUPPLY AND/OR USE
Any person intending to manufacture, import, possess, sell, supply and use Equilis West Nile must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.