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CEVAC® CHLAMYDIA 50 Doses Reg. No. G3843 (Act 36/ 1947), N-SR 1514

A live, freeze-dried, attenuated vaccine for the prevention of enzootic abortion caused by Chlamydophila abortus infection.
Active ingredient: Live, attenuated, Chlamydophila abortus strain 1B
Dose: 2 mℓ of the reconstituted vaccine.
FOR ANIMAL USE ONLY
CEVAC^® CHLAMYDIA
Reg. No. G3843 Act 36/1947, N-SR 1514
INDICATIONS:
A live, freeze-dried, attenuated vaccine for the active immunisation of healthy, susceptible, breeding ewes as an aid in the prevention of enzootic abortion (Chlamydiosis) caused by Chlamydophila abortus infection.
STORAGE:
Store in a refrigerator at 2 – 8 °C. Do not freeze.
Protect from sunlight.
Improper storage of the vaccine may cause potency losses.
COMPOSITION:
This vaccine contains a live, attenuated, thermosensitive Chlamydophila abortus strain 1B.
Minimum titre per 2 mℓ dose is 10^5,0 Inclusion Forming Units (IFUs).
OPERATOR WARNINGS:
CEVAC^® CHLAMYDIA should not be handled by pregnant women or women of child-bearing age as the vaccine may cause abortion.
Immuno-suppressed persons (eg. people with AIDS, people undergoing chemotherapy or on immunosuppressive drugs) should also not handle this vaccine. Seek medical advice, if in any doubt.
Both gloves and a protective visor should be worn when handling this vaccine.
All precautionary measures should be taken to avoid self-injection. However, if this occurs, immediately consult a medical doctor and inform him/ her that self-injection with a live, Chlamydial vaccine has occurred and show this package insert. Treatment with Tetracyclines is the currently recognised therapy for Chlamydophila abortus infection in humans.
WARNINGS:
Do not slaughter sheep for human consumption for at least 7 days after vaccination.
Vaccinate healthy flocks only.
Do not vaccinate animals less than 4 weeks before mating.
Do not vaccinate pregnant animals.
Do not vaccinate any animals which are being treated with antimicrobials, particularly Tetracyclines.
A mild, temporary local reaction may occur at the site of injection but will disappear within a few days.
An average temperature increase of 0,5 – 1 ˚C may be observed in the flock for 2 – 3 days, after vaccination with CEVAC^® CHLAMYDIA .
Keep out of reach of children, uninformed persons and animals.
Chlamydiosis is only one of the causes of abortion in sheep. If the abortion rate remains unchanged in flocks that have been vaccinated with CEVAC^® CHLAMYDIA , then consult your veterinarian.
Do not administer any other live vaccine within 4 weeks of vaccination, after vaccination with CEVAC^® CHLAMYDIA .
Do not administer any other vaccine 14 days before or after vaccination with CEVAC^® CHLAMYDIA .
Destroy any unused vaccine by for example burning; dispose of all the vaccine containers safely when the vaccination is completed.
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:
Do not mix with any other vaccine.
Observe aseptic precautions. Ensure that all vaccination equipment (needles, syringes etc.) is clean and sterile prior to use.
Do not contaminate with disinfectant or spirits.
Once a bottle has been opened and reconstituted, its contents must be kept cool and used within 2 hours.
Only reconstitute the quantity of vaccine required and use immediately.
Do not store partially used bottles for future use.
It is good vaccination practice, when handling vaccines, to avoid contact with the eyes or mucous membranes, hands and clothing.
Wash and disinfect hands with a disinfectant, after vaccination.
DIRECTIONS FOR USE: Use only as directed.
CEVAC^® CHLAMYDIA is recommended for the active immunisation of healthy, susceptible, breeding ewes as an aid in the prevention of enzootic abortion (Chlamydiosis) caused by Chlamydophila abortus infection.
The ability of this vaccine to produce satisfactory results may depend on many factors, including, but not limited to, conditions of storage and handling by the user; administration of the vaccine and health and responsiveness of the flock. Directions for use should therefore be followed carefully .
RECONSTITUTION:
Reconstitute the vaccine with the diluent immediately prior to use, using 2 mℓ of diluent per dose.
Draw approximately 5 mℓ of the diluent from the diluent 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, re-inject into the diluent vial and shake well.
Do not generate a vaccine aerosol during this process.
Use within 2 hours of reconstitution.
ADMINISTRATION:
Care should be taken to avoid self-injection.
Dose: A single injection of 2 mℓ of the reconstituted vaccine must be administered by the subcutaneous or intramuscular route.
Injection sites: The preferred sites for subcutaneous injection are the sides of the neck or the low area on the rib cage, just behind the bare spot behind the front leg.
The preferred site for intramuscular injection is the heavy neck muscle, near the back of the head.
Time of vaccination: Ewe lambs 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.
Animals should be revaccinated after two years.
PRESENTATION:
Sealed glass vials containing 20 and 50 doses of vaccine. The vaccine is supplied with a sterile diluent (40 mℓ, and
100 mℓ, respectively), for reconstitution.
REGISTRATION HOLDER:
CEVA Animal Health (Pty) Ltd
Reg. No. 1973/016009/07
P O Box 7707
Halfway House 1685
011 312 4088