Ovilis® Enzovax

For the active immunisation of susceptible breeding female sheep as an aid in the prevention of abortion and stillbirth caused by Chlamydophila abortus infection.

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 Chlamydophila abortus infection.

COMPOSITION

Ovilis® Enzovax is a live, attenuated vaccine, containing ≥ 105,0 IFU of Chlamydophila 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 childbearing 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 within 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 vaccinate ewes which are being treated with antibiotics, particularly tetracyclines.
  • 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.
  • After reconstitution the vaccine should be kept cool and must be used within 2 hours. Do not store partially used containers for future use.
  • Vaccinators should be cleaned according to manufacturer’s recommendations prior to reuse.
  • 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.) are 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.
  • Withdraw 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, reinject 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 for breeding, may be vaccinated from 5 months of age. Shearlings and older ewes should be vaccinated during the 4-month period prior to mating.

PRESENTATION

Vial of Type I Ph. Eur. glass containing 20 doses (10 mℓ), sealed with a halobutyl rubber stopper and a colour coded aluminium cap.

Enclosed diluent (Unisolve): Type II glass or polyethylene terephthalate (PET) vial of 40 mℓ sealed with a rubber stopper and an aluminium cap.

Or
Vial of Type I Ph. Eur. glass containing 50 doses (10 mℓ), sealed with a halobutyl rubber stopper and a colour coded aluminium cap.

Enclosed diluent (Unisolve): Type II glass or polyethylene terephthalate (PET) vial of 100 mℓ sealed with a rubber stopper and an aluminium cap.

1 vial of the freeze-dried vaccine and 1 vial diluent are packed in an outer carton box.

Not all pack sizes may necessarily be marketed.

REGISTRATION HOLDER                                       MANUFACTURER

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

19 January 2010