Target species
Horses.
Indications for use, specifying the target species
Active immunisation of horses from 5 months of age against West Nile disease by reducing the number of viraemic horses. If clinical signs are present, their duration and severity are reduced.
Onset of immunity: 4 weeks after the first dose of the primary vaccination course. In order to achieve full protection, the full vaccination course of two doses must be given.
Duration of immunity: 1 year after a full primary vaccination course of two injections.
Contraindications
None.
Special warnings for each target species
Vaccinate only healthy animals.
Special precautions for use
Special precautions for use in animals
The safety of the vaccine has been demonstrated in foals from 5 months of age. However, the vaccine has shown to be safe in a field study including animals of 2 months of age.
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.
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.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions (frequency and seriousness)
Horses:
Common (1 to 10 animals / 100 animals treated): | Injection site swelling1 |
Rare (1 to 10 animals / 10,000 animals treated): | Injection site pain, increased skin temperature Elevated temperature2 Apathy3, decreased appetite4 Hypersensitivity reaction5 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site abscess |
1 max. diameter 5 cm, which resolves within 4 days.
2 max. 1.5 °C, for 1 day, exceptionally 2 days.
3 usually resolving within two days.
4 the day after vaccination.
5 which may require appropriate symptomatic treatment.
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 the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
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 product. A decision to use this vaccine before or after any other product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
For intramuscular use.
Shake the vaccine gently before use.
Administer one dose of 1 ml, by intramuscular injection, preferably in the neck region, according to the following schedule:
Primary vaccination course: first injection from 5 months of age, second injection 4-6 weeks later.
Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single dose although this schedule has not been fully validated.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions other than those already mentioned under 'Adverse reactions (frequency and seriousness)' have been observed after the administration of more than 10 doses.
Withdrawal period
Zero days.