FOR ANIMAL USE ONLY
Reg. No. G3775 (Act 36/1947)
Namibia Reg.No. V07/24.6/56 NS0
Equilis® Prequenza is indicated for the active immunisation of healthy horses and ponies against equine influenza to reduce severity and duration of clinical signs and to reduce the amount and duration of viral shedding after infection.
Equilis® Prequenza is a vaccine suspension containing per 1 mℓ:
- A/equine-2/ South Africa/4/03 : 50 AU*
- A/equine-2/ Newmarket/2/93 : 50 AU
Purified saponin (adjuvant) : 375 µg
* Antigenic units
- Store in the dark between 2 °C and 8 °C.
- Do not freeze.
- Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
- Protect from direct sunlight.
- Keep the vial in the outer carton, in order to protect from light.
- Vaccinate healthy animals only.
- Avoid intravenous injection.
- A transient swelling may occur after vaccination regressing within 2 days. In some cases, fever may occur after vaccination.
- Do not mix Equilis® Prequenza with other vaccines, or administer another vaccine shortly before or after vaccination with Equilis® Prequenza.
- Accidental self-injection may lead to a severe local allergic reaction. Consult a physician immediately and show this package insert to him/her.
- Do not store partially used containers for future use and use the entire contents once opened.
- Dispose of any unused vaccine as well as all empty vaccine containers and vaccination equipment according to local waste disposal regulations.
- KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS. Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.
- Observe aseptic conditions. Ensure that vaccination equipment (needles, syringes, etc.) is clean and sterile prior to and during use.
- It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
- Allow the vaccine to reach room temperature (15 °C to 25 °C) before use.
DIRECTIONS FOR USE - USE ONLY AS DIRECTED
- Shake well before use.
- Intramuscular injection of 1 dose (1 mℓ) per animal.
VACCINATION SCHEDULE Basic vaccination course
All horses not previously vaccinated should receive 2 vaccinations of 1 dose with a 4-week interval. The basic vaccination course results in immunity to equine influenza lasting at least 5 months. Foals should be vaccinated from the age of 6 months. If vaccination is performed before 6 months of age full protection can be expected after the third vaccination (first revaccination).
The first revaccination (third dose) is given 5 months after the basic vaccination course. The revaccination with Equilis® Prequenza or Equilis® Prequenza Te results in immunity to equine influenza for at least 12 months.
The second revaccination is given 12 months after the first revaccination.
The alternate use, at 12-month intervals, of Equilis® Prequenza is recommended to maintain immunity levels for the influenza component.
Although Equilis® Prequenza and Equilis® Prequenza Te results in immunity for 12 months, local Jockey Club and Horse Society regulations should be adhered to. These often recommend a 6-month vaccine interval. In this case the alternate use of Equilis® Prequenza and Equilis® Prequenza Te is recommended.
PREGNANCY AND LACTATION
Can be used in pregnant mares, but handling of such animals, particularly in the latter stage of pregnancy, is not without risk and care should be taken to avoid stress.
Cardboard box with 10 x 1 mℓ glass vials or cardboard box with 1, 5 or 10 x 1 mℓ pre-filled syringes (needle enclosed).
REGISTRATION HOLDER MANUFACTURER
Intervet South Africa (Pty) Ltd. Intervet International B.V.
20 Spartan Road, Spartan 35 Wim de Körverstraat
1619, RSA Boxmeer, The Netherlands
Tel: +27 (0) 11 923 9300 Fax: +27 (0) 11 392 3158
DATE OF PUBLICATION OF PACKAGE INSERT
6 July 2017