Product data

Presentation

A white emulsion of water in oil containing 2 x 108eb inactivated Chlamydophila abortus per dose, preserved with thiomersal 0.013% w/v.

Uses

For the active immunisation of susceptible breeding female sheep against Chlamydophila abortus infection as an aid in the prevention of abortion caused by this organism. Studies to date indicate that the protection afforded should exist for at least 771 days post initial vaccination.

Dosage & administration

Dose-1ml to be administered intramuscularly. The recommended injection site is a point 3”-4” in front of the shoulder in the middle of the neck.

Primary vaccination: Sheep should receive 1 dose of vaccine. Animals should be vaccinated approximately 1 month prior to mating or from 4 weeks after the ram is removed.

Booster vaccination: The primary vaccination should be repeated 771 days after the initial vaccination.

To facilitate injection the vaccine should be removed from the refrigerator on the morning of use and kept at room temperature. Unused vaccine must not be returned to the refrigerator. Shake the bottle well before withdrawing doses. Syringes and needles should be sterilised before use and the injection made through an area of clean, dry skin using aseptic techniques.

Contra-indications, warnings etc

Do not administer to unhealthy animals. Transient pyrexia and injection site inflammatory reactions may occur. The pyrexia is not associated with any change in appetite or general demeanour. The injection site reaction, which may be palpable as a nodule of approximately 30mm diameter, will normally resolve within 5 weeks. As with all vaccines, occasional hypersensitivity reactions may occur. In such cases appropriate treatment should be given, eg. an antihistamine or corticosteroid.

Some animals in any population may not respond to vaccination as a result of immunosuppression or for other reasons.

STORE ALL MEDICINES OUT OF REACH AND SIGHT OF CHILDREN. FOR ANIMAL TREATMENT ONLY

Mydiavac® may be administered simultaneously in a vaccination programme with a commercial Toxoplasma gondeii vaccine containing live tachyzoites of the S48 strain. Concomitant administration of Mydiavac® and such a commercial Toxoplasma gondeii vaccine does not significantly affect the serological effect to either vaccine or cause any ill effect provided different sites of injection, different syringes and needles are used. Mydiavac® must not be administered concomitantly with live Toxoplasma gondeii vaccines to pregnant animals. No other information is available on concomitant use.

Operator warning

To the user: This product contains a mineral oil-based compound. Accidental/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger or thumb if prompt medical attention is not given. Ensure that the method of restraint, handling and administration eg. by the use of guarded needles, minimises the risk of accidental self injection. If you are accidentally injected with the product, seek prompt medical advice even if only a very small amount is injected, and take the package insert with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the Physician: This product contains mineral oil. Even if very tiny amounts have been injected, accidental injection with this oil-based product can cause intense swelling which may, for example, result in ischaemic necrosis and the loss of a digit.

Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

This product contains mineral oil. Even if very tiny amounts have been injected, accidental injection with this oil-based product can cause intense swelling which may, for example, result in ischaemic necrosis and the loss of a digit.

Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

Withdrawal period

Zero days. However, if a live Toxoplasma gondeii vaccine has been administered concomitantly, the withdrawal period applicable to that vaccine should be observed.

Pharmaceutical precautions

Store between +2°C and +8°C. Do not freeze. Shake the container well before withdrawing a dose of vaccine. To facilitate injection the vaccine should be removed from the refrigerator on the morning of use and kept at room temperature. Unused vaccine must not be returned to the refrigerator. Once broached the contents of the vial must be used within, or discarded by the end of, that working day.

POM-V. To be supplied only on veterinary prescription.

Package quantities

20ml glass vials and 100ml collapsible polyethylene packs.

Further information

Abortion in sheep may have other causes. When the diagnosis is in doubt or when sheep vaccinated with Mydiavac® abort, it is strongly recommended that veterinary advice is sought.

Use medicines responsibly

The safety and efficacy of Mydiavac® administered to pregnant sheep has been studied in challenge experiments. These studies have demonstrated the safety of this practice. A reduction in abortion and infection was evident in pregnant ewes challenged following vaccination and in pregnant ewes vaccinated after challenge. On the basis of this evidence, Mydiavac® could be used as an aid in the control of Chlamydophila abortus infection, even in the face of an outbreak. Unused product and/or containers should be disposed of in accordance with advice from a local waste disposal authority.

Vm 43684/4000

Manufactured & distributed by:

Benchmark Vaccines Ltd, Braintree, CM7 2YW

Marketing authorisation holder

Benchmark Animal Health Ltd. Benchmark House, 8 Smithy Wood Drive, Sheffield, S35 1QN. Tel: 0845 009 3342. Made by Benchmark Animal Health Ltd in Braintree under licence from Novartis Animal Vaccines Ltd. Mydiavac® is the registered trade mark of Vericore Ltd.