Reg. No. G2758 (Act 36/1947)
Namibia Reg No. V03/24.4/249 S0
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.
- Store between 2ºC – 8ºC . Do not freeze.
- Protect from light.
- Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
Ovilis® Enzovax is a live, attenuated vaccine, containing > 105.0 IFU of Chlamydia abortus, strain ts 1B, per dose.
- 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 immuno-deficient (e.g. people with AIDS, persons undergoing chemotherapy or taking immuno-suppressive 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 recognised treatment for chlamydia in humans.
- 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 vaccinate ewes which are being treated with antibiotics, particularly tetracyclines.
- After dilution the vaccine should be kept cool and must be used within 2 hours. Do not store partially used containers for future use.
- Do not mix with other vaccines or medications.
- Other live vaccines should not be administered within 4 weeks of the administration of Ovilis Enzovax.
- Discard any unused vaccine, empty containers and place all used equipment (gloves, syringes and needles used for mixing the vaccine etc.) into disinfectant. Disposable items should be incinerated and vaccinator equipment cleaned according to manufacturer’s recommendations prior to re-use.
- Do not open and reconstitute the vaccine until ready to start vaccination.
- 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.
- Observe aseptic precautions. Ensure that the vaccination equipment (needles, syringes, etc.) are clean and sterile prior to use.
- Ensure that all equipment is kept clean and sterile during vaccination.
- 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
- The vaccine 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 vaccine solution from the vial, reinject into the diluent vial and shake well. Take care not to generate an aerosol by ensuring there are no air bubbles in the syringe before reinjecting into the vial.
- The dose is a single injection of 2 ml of reconstituted vaccine by subcutaneous or intramuscular injection. Animals should be re-vaccinated after 2 years.
- Ewe lambs, where it is intended to breed from them, may be vaccinated from 5 months of age. Shearlings and older ewes should be vaccinated during the 4 month period prior to mating.
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).
Intervet South Africa (Pty) Ltd
20 Spartan Road, Spartan, 1619, RSA
Tel: +27 (0) 11 923 9300 Fax: +27 (0) 11 392 3158
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21 January 2010