Introduction

Company name: Intervet / Schering-Plough Animal Health

Address: Walton Manor

Walton

Milton Keynes

MK7 7AJ

Telephone: 01908 685685 (Customer Support Centre)

Telephone: 0370 060 3380 (Switchboard)

Fax: 01908 685555

Email: support.uk@intervet.com

Website: www.intervet.co.uk

Presentation

A white oily emulsion vaccine prepared from louping-ill virus grown in tissue culture, inactivated with formalin, concentrated by ultra filtration and emulsified with a mineral oil. Contains liquid paraffin/Montanide as adjuvant and thiomersal as preservative.

Uses

For the active immunisation of sheep to stimulate a serological response to the Louping III virus.

Onset of immunity is within 4 weeks of vaccination and duration as shown by an anamnestic response is at least 18 months.

Dosage and administration

Dose

1 ml.

Administration

Administer a 1 ml dose by subcutaneous injection on the side of the neck.

To facilitate injection, the vaccine should be removed to a warm room a few hours before use.

Pre-warming of the vaccine should not exceed 37 degrees C (blood temperature) for 30 minutes or 25 degrees C for 8 hours.

Shake the container well before withdrawing the doses.

Animals should be revaccinated after 2 years, at least 4 weeks prior to the period of greatest infection risk.

Use during pregnancy and lactation

No information is available from laboratory studies on the safety of this vaccine administered during early to mid pregnancy, although experience of use in the field suggests that problems are unlikely to occur. Animals should not be vaccinated within the last month of gestation.

Contra-indications, warnings, etc

Warnings

Occasional hypersensitivity reactions may occur. In such case, appropriate treatment such as adrenaline should be administered without delay.

Lambs born from vaccinated ewes acquire passive antibody, via the colostrum, for the first few weeks of life.

Syringes and needles should be steralised before use and the injection made through an area of clean, dry skin. In view of the oily nature of the vaccine, very strict precautions against contamination should be taken, since abscess formation may prevent satisfacotory immunization.

Part-used containers of the vaccine should be disposed of safely at the end of the day's operations, as under field conditions it may be difficult to avoid accidental contamination.

To the user:

This product contains mineral oil. Accidental injection/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 if prompt medical attention is not given.

If you are accidentally injected with this 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 small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even 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.

Adverse reactions

Local reactions at the injection site are anticipated in the majority of animals after vaccination due to the oil adjuvant in the vaccine. Non-painful dermal thickening and swelling may produce a local reaction of up to 5 x 10 cm approximately 2-3 weeks after vaccination. The reaction will persist but slowly resolve over a 4-5 week period. Some loss of wool may occur at the injection site. No information on microscopic features of the injection site reactions is available. Note: These observations were noted after administration of a double dose (2 ml) of vaccine.

Interaction with other medicinal products

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other. It is therefore recommended that no other vaccines should be administered within 14 days before or after vaccination with the product.

Withdrawal Period:

Zero days.

Pharmaceutical precautions

Store between +2°C and +8°C, protected from light. Do not freeze. Protect from light.

After first opening the containers, the contents should be used immediately.

Do not mix with any other medicinal product.

Keep out of the reach and sight of children.

Disposal advice

Any unused veterinary medicinal product or waste material derived from such products should be disposed of in accordance with local requirements.

Legal category

POM-VPS

Packaging Quantities

20 ml glass bottles.

Further information

In any animal population there may be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine together with the animal's ability to respond. This can be influenced by such factors as genetic constitution, intercurrent infection, age, the presence of maternally-derived antibodies, nutritional status, concurrent drug therapy and stress.

Marketing authorisation number

Vm 00201/4206.

Significant Changes

Use in cattle and goats deleted