Lyophilisate for suspension for injection in sheep

Presentation

Freeze-dried vaccine containing 10^5.0 -10^6.9 IFU live, attenuated ts 1B strain of Chlamydophila abortus per dose. The diluent Unisolve^® (Vm 01708/4269) is supplied with the vaccine.

Uses

For the active immunisation of susceptible breeding female sheep to reduce abortion caused by Chlamydophila abortus infection.

Challenge studies h ave demonstrated that protection against Enzootic abortion and excretion of Chlamydophila abortus post-challenge is undiminished for at least three years post vaccination with Enzovax.

Field studies in endemically infected flocks maintaining a policy of vaccinating incoming ewes with Enzovax indicate that enzootic abortion levels remain very low in ewes vaccinated 4 years previously.

Dosage and administration

Reconstitution

The vaccine is reconstituted with Unisolve immediately prior to use, allowing 2 ml of diluent per dose.

If using the vented transfer device push one end of the device through the centre of the vaccine vial using a firm, twisting action. Similarly, push the Unisolve vial onto the opposite end of the device taking care to ensure the spike penetrates the centre of the vial bung. Carefully allow diluent to flow into the vaccine vial without completely filling it. Ensure the powder plug is fully dissolved and then invert until all the vaccine solution drains into the diluent vial. Remove the empty vaccine vial and transfer spike from the diluent vial and place into an appropriate disinfectant solution.

Alternatively, 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, re-inject into the diluent vial and shake well. Great care should be taken not to generate an aerosol.

After reconstitution the vaccine should be kept cool and used as soon as possible (within 2 hours).

Administration

Dose: 2 ml by intramuscular or subcutaneous injection.

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.

Vaccination must take place at least 4 weeks before mating.

Injection equipment

To minimise the risk of self-injection the vaccine should be administered using disposable automatic syringes fitted with a guarded needle system according to the manufacturer's instructions. It is vital that a vented draw off tube is used with this equipment.

Regular checks should be made to ensure the syringes are properly calibrated.

Carefully attach the vial of reconstituted vaccine to the injection equipment and avoid creating aerosols during the priming process. It may be advisable to wear a visor while carrying out this operation.

Re-vaccination policy

Challenge studies have demonstrated that protection against enzootic abortion and excretion of Chlamydophila abortus post-challenge is undiminished for at least three lambings post vaccination with Enzovax.

Re-vaccination is recommended every 3-4 years depending on farm management practices and conditions.

Field studies in endemically infected flocks maintaining a policy of vaccinating incoming ewes with Enzovax indicate that enzootic abortion levels remain very low in ewes vaccinated 4 years previously.

Contra-indications, warnings, etc.

Do not vaccinate pregnant animals.

Do not vaccinate animals less than 4 weeks before mating.

Do not vaccinate animals which are being treated with antibiotics, particularly tetracyclines.

A transient temperature rise may be observed after vaccination (average of up to 1.5°C for a maximum of 3 days). 

No particular symptoms at ten times dose other than a transient pyrexic response similar to that seen after a single dose but up to 2˚C.

Safety/and or efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Toxovax (Vm 01708/4331).  However, it should be given at separate sites.

Do not mix with any other medicinal product except the solvent, Unisolve.

Operator warnings:

Operators should wear gloves when handling the vaccine.

Enzovax should not be handled by pregnant women or women of child-bearing age as the vaccine may cause abortion.

Enzovax should not be handled by persons who are immunodeficient (e.g. AIDS sufferers, persons undergoing chemotherapy or taking immunosuppressive drugs).

If in any doubt, you should consult your GP.

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 chlamydophila vaccine has occurred. Tetracycline therapy is the current recognised treatment for infection with Chlamydophila abortus in humans.

Withdrawal period:

Meat : 7 days.

FOR ANIMAL TREATMENT ONLY. KEEP OUT OF REACH AND SIGHT OF CHILDREN.

Pharmaceutical precautions

Store and transport refrigerated (2°C - 8°C). Do not freeze. Protect from light.

After dilution, the vaccine should be used as soon as possible (within 2 hours).

Disposal advice:

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant, in accordance with the local requirements.

Legal Category

POM-V                       To be supplied only on veterinary prescription.    

Package quantities

Carton with 1 vial of vaccine, 1 vial of Unisolve and one transfer kit.

Vials containing 10, 20 or 50 doses supplied together with Unisolve.

An administration kit including a vented transfer device for vaccine reconstitution and disposable automatic syringe with a guarded needle system is available.

Further information

Chlamydophila abortus is only one of the causes of abortion in sheep. If the abortion rate remains unchanged in flocks which have been vaccinated with Enzovax it is recommended that veterinary advice is sought.

The epidemiology of abortion due to Chlamydophila abortus in ewes involves a long incubation period. Ewes that abort in any lambing season have usually been infected at the previous lambing. Field trial data indicate that vaccinating incubating ewes will reduce the incidence of abortion, but a proportion can still go on to abort.

Care should be taken in handling such abortions as susceptible humans may be at risk of infection.

A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system. Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress.

Marketing Authorisation numbers

Enzovax Vm 01708/4523

Unisolve Vm 01708/4269

Marketing Authorisation holder

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

MK7 7AJ

Licensed distributor in Northern Ireland

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Date of text preparation:

May 2008.

Item code: 042073  V75463^.June2008