Product Details - OVILIS® ENZOVAX

GoatsSheep

Product Class

FOR ANIMAL USE ONLY

OVILIS® ENZOVAX
Reg. No. G2758 (Act 36/1947)
Namibia Reg No. V03/24.4/249 NS0

INDICATIONS
Ovilis® Enzovax is indicated for the active immunisation of susceptible breeding female sheep as an aid in the prevention of abortion and stillbirth caused by Chlamydia abortus infection.

COMPOSITION
Ovilis® Enzovax is a live, attenuated vaccine, containing ≥ 105.0 IFU of Chlamydia abortus, strain TS 1B, per dose.

STORAGE

  • Store between 2 °C and 8 °C.
  • Do not freeze.
  • Protect from light.
  • Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.

OPERATOR WARNINGS

  • Ovilis® Enzovax should not be handled by pregnant women or women of child bearing age as the vaccine may cause abortion.
  • The vaccine should not be handled by persons who are immunodeficient (e.g. people with AIDS, persons undergoing chemotherapy or taking immunosuppressive drugs). If in any doubt, seek medical advice.
  • Operators should wear gloves when handling the vaccines.
  • Care should be taken to avoid self-injection, but if this occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred. Tetracycline therapy is the current recognized treatment for chlamydiosis in humans.

WARNINGS

  • Withdrawal period: Animals should not be slaughtered for human consumption before 7 days after vaccination.
  • Vaccinate healthy animals only.
  • Do not vaccinate animals less than 4 weeks before mating.
  • Do not vaccinate pregnant animals.
  • Do not administer any other vaccine 14 days before or after vaccination with this product.
  • Do not open and reconstitute the vaccine until ready to start vaccination.
  • Do not mix Ovilis® Enzovax with other vaccines or medications.
  • Other live vaccines should not be administered within 4 weeks of the administration of Ovilis® Enzovax.
  • Dispose of any unused vaccine as well as all empty vaccine containers and vaccination equipment (e.g. gloves, needles and syringes used for mixing) according to local waste disposal regulations.
  • KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
  • Although this remedy has been extensively tested under a wide 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 precautions. Ensure that the 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.

DIRECTIONS FOR USE - USE ONLY AS DIRECTED

DOSAGE AND ADMINISTRATION
Ovilis® Enzovax should be reconstituted with Unisolve.
Remove approximately 5 mℓ of Unisolve from the vial with a syringe and needle. Inject into the vaccine vial and shake well until the powder plug is fully dissolved. Remove the solution from the vial, re-inject into the diluent vial and shake well. Take care not to generate an aerosol by ensuring that there are no air bubbles in the syringe before re-injecting into the vial.
The dose is a single injection of 2 mℓ of reconstituted vaccine by subcutaneous or intramuscular injection. Animals should be revaccinated after 2 years.
Ewe lambs, where it is intended to breed from, may be vaccinated from 5 months of age. Shearlings and older ewes should be vaccinated during the 4 month period prior to mating.

PRESENTATION
Vials containing 20 doses or 50 doses, to be used together with the appropriate diluent, Unisolve 40 mℓ (20 doses) or 100 mℓ (50 doses).

REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
Fax: +27 (0) 11 392 3158
www.msd-animal-health.co.za

MANUFACTURER
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands

DATE OF PUBLICATION OF THIS PACKAGE INSERT
21 January 2010

ZA/OVI/0217/0001