Equilis® Prequenza

Indicated for the active immunisation of healthy horses and ponies against influenza.

FOR ANIMAL USE ONLY

EQUILIS® PREQUENZA

Reg. No. G3775 (Act 36/1947)

Namibia Reg. No. V07/24.6/56 [NS0]

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.

COMPOSITION

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

Purified haemagglutinin/neuraminidase subunits from equine influenza viruses:

– A/equine-2/ South Africa/4/03:      50 AU*

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

Purified saponin (adjuvant):                  375 µg

* Antigenic units                             

STORAGE INSTRUCTIONS

  • Store in the dark between 2 °C – 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.
  • Do not use after the expiry date which is stated on the container label.

WARNINGS

  • 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.
  • In case of accidental self-injection, seek medical advice immediately and show the package leaflet to the physician.
  • 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.

PRECAUTIONS

  • Observe aseptic conditions. Ensure that vaccination equipment (needles, syringes, etc.) is clean and sterile prior to and during use.
  • Do not use disinfectants or antiseptics to sterilise any equipment.
  • It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
  • Adhere to the vaccination programme to obtain optimum results.
  • Do not eat, drink or smoke whilst handling the product.
  • Do not store partially used containers for future use and use the entire contents once opened.
  • Destroy any unused vaccine and dispose of all the empty vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
  • Do not contaminate rivers, dams or any water sources with containers or waste.
  • Allow the vaccine to reach room temperature (15 °C – 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 two 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).

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.

Local Regulations

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

Equilis® Prequenza 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 1, 5 or 10 x 1 mℓ pre-filled syringes (needle enclosed).

Not all pack sizes may necessarily be marketed.

REGISTRATION HOLDER                                                      

Intervet South Africa (Pty) Ltd.                                           

20 Spartan Road, Spartan                                                      

1619, RSA                                                                                          

Tel: +27 (0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za          

DATE OF PUBLICATION OF THIS PACKAGE INSERT 6 July 2017