Product Details - EQUILIS® PREQUENZA

Horses

Product Class

Reg. No. G3775 Act 36/1947
Reg.No. N-SR 1406


Indications

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.

Storage

  • 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.

Composition

Equilis® Prequenza is a vaccine suspension containing per 1ml:

  • Purified haemagglutinin/neuraminidase subunits from equine influenza viruses:

    • A/equine-1/Prague/1/56: 100 AU*

    • A/equine-2/Newmarket/1/93: 50 AU

    • A/equine-2/Newmarket/2/93: 50 AU

  • Purified saponin (adjuvant): 375 µg

* antigenic units

Warnings

  • Vaccinate healthy animals only.

  • Destroy any unused vaccine by, for example, burning and dispose of all vaccine containers after vaccination (including syringes and needles).

  • Do not mix the vaccine with other vaccines, or administer another vaccine shortly before or after vaccination with this product.

  • Accidental self-injection may lead to a severe local allergic reaction. Consult a physician immediately and show this package insert to the physician.

  • Do not store partially used containers for future use and use the entire contents when opened.

  • A transient swelling may occur after vaccination regressing within 2 days. In some cases fever may occur after vaccination.

  • Shake well before use.

  • Avoid intravenous injection.

  • KEEP OUT OF REACH OF CHILDREN AND UNINFORMED PERSONS.

  • 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.

Precautions

  • Observe aseptic conditions. Ensure that vaccination equipment (needles, syringes, etc.) is clean and sterile prior to 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 – 25 °C) before use.

Directions for use

  • USE ONLY AS DIRECTED.

  • Intramuscular injection of one dose (1 ml) per animal.

Vaccination schedule

Basic vaccination course

All horses not previously vaccinated should receive two vaccinations of one 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 (1st revaccination)

Revaccination

The first revaccination (third dose) is given five months after the basic vaccination course. The revaccination with Equilis® Prequenza Te or Equilis® Prequenza results in immunity to equine influenza for at least 12 months.

The second revaccination is given 12 months after the first revaccination.

Revaccination, at 12 month intervals of a suitable vaccine against equine influenza, such as Equilis® Prequenza or Equilis® Prequenza Te, both containing the strains A/equi 2/Newmarket-1/93 and A/equi 2/Newmarket-2/93, is recommended to maintain immunity levels against equine influenza.

Local Regulations

Although Equilis® Prequenza Te and Equilis® Prequenza 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 Te and Equilis® Prequenza 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.

Presentation

Cardboard box with 10 x 1 ml glass vials or cardboard box with 10, 5 or 1 x 1 ml pre-filled syringe (needle enclosed).

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd

Co. Reg. No. 1991/006580/07