Toxovax Data Sheet
Presentation
Live, concentrated vaccine containing > 105 tachyzoites of the S48 strain of Toxoplasma gondii per dose. Unisolve® (Vm 01708/4269) is supplied as a diluent for dilution prior to use.
Uses
For the active immunisation of susceptible breeding female sheep to reduce the effects of infection by Toxoplasma gondii, namely early embryonic death, barrenness and abortion.
Vaccination with Toxovax is known to protect for at least two lambing seasons.
Dosage and administration
The vaccine is supplied as a liquid concentrate containing 20 or 50 doses. Immediately before use this is added to the diluent (Unisolve 40 or 100 ml, respectively), giving a dose volume of 2 ml.
Injection equipment
To minimise the risk of self-injection the vaccine should be administered using disposable automatic syringes fitted with the Sterimatic guarded needle system according to the manufacturer's instructions.
An administration kit including a vented transfer device for vaccine reconstitution and disposable automatic syringe with the Sterimatic guarded needle system is available from the company.
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.
Dilution
Protective gloves (impervious rubber or plastic such as disposable medical gloves or surgical gloves (EU guidelines)) and goggles or a face visor should be worn when reconstituting the vaccine.
If using the vented transfer device push one end of the device through the centre of the Unisolve vial using a firm, twisting action. Similarly, push the vaccine vial onto the opposite end of the device taking care to ensure the spike penetrates the centre of the vial bung. The vaccine concentrate will drain into the diluent vial. Remove the empty vaccine vial and transfer spike from the diluent vial and place into an appropriate disinfectant solution.
Alternatively, withdraw the entire contents of the vaccine concentrate vial using a sterile disposable 10 ml syringe and either a 16 g or 18 g sterile needle. Carefully expel any air from the syringe and inject the contents into the diluent vial. With the diluent vial upright withdraw 5‑10 ml of air prior to removing the needle. This maintains the vial under negative pressure and avoids spillage when the needle is removed.
After dilution the vaccine should be kept cool and away from light and used as soon as possible (within 2 hours). Ideally only dilute one vaccine vial at a time.
Administration
Dose: 2 ml by intramuscular injection.
Basic vaccination
Animals should be given a single dose at least 3 weeks prior to mating. 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.
Re-vaccination
After 2 years, a single dose at least 3 weeks prior to mating.
Contra-indications, warnings, etc.
Do not vaccinate animals less than 3 weeks before mating.
Do not use during pregnancy.
A transient temperature rise is normally observed (up to 41°C, returning to normal within 7-8 days of vaccination).
At 20 times dose no particular signs, other than a transient temperature increase similar to that seen with a single dose (although up to 41.5 - 42°C) have been observed.
Safety and/or efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Enzovax (Vm 01708/4523). However, it should be given at separate sites.
Do not mix with any other medicinal product except the diluent supplied, Unisolve.
Operator warnings
Toxovax should not be handled by pregnant women, or women of child-bearing age as the vaccine may interfere with normal foetal development.
Toxovax should not be handled by persons who are immunodeficient (e.g. AIDS sufferers; persons undergoing chemotherapy or taking immunosuppressive drugs).
Operators should wear gloves when handling the vaccine.
Living tachyzoites can cause disease in man.
Care should be taken to avoid self-injection and to avoid vaccine getting into the mouth or the eyes. In the case of self-injection, immediate medical advice should be sought and the doctor should be informed that self-injection with a living tachyzoite toxoplasma vaccine has occurred. Pyrimethamine therapy is the current recognised treatment for toxoplasmosis in humans.
Withdrawal period
Meat: 42 days
FOR ANIMAL TREATMENT ONLY. KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Pharmaceutical precautions
Store and transport refrigerated (2oC - 8oC). Protect from light. Do not freeze.
After dilution the vaccine should be kept cool and away from light and 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.
Not all pack sizes may be marketed.
An administration kit including a vented transfer device for vaccine reconstitution and disposable automatic syringe with a guarded needle system is available.
Further information
Nil.
Marketing Authorisation number
Vm 01708/4331
Distributed in Northern Ireland by:
Intervet Ireland Ltd.
Magna Drive
Magna Business Park
Citywest Road
Dublin 24
Date of text preparation:
May 2008.
Item code: 045631 V75464.June 2008
