Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

An inactivated adjuvanted liquid vaccine in single dose syringes for administration to pregnant mares.

Each single vaccine dose contains 1ml of an inactivated oil adjuvanted vaccine of Equine Rotavirus H2 strain, RP ≥ 1.0* per 1ml dose.

* Product is blended based on pre-inactivation titre but the blended and finished product must have a relative potency of at least 1.0.

Uses

For the vaccination of pregnant mares to provide passive transfer of antibodies to foals to reduce the risk of diarrhoea caused by Equine Rotavirus H2 serotype.

Mares are able to transfer the passive immunity to the foals 4 weeks after the third vaccination. Foals of the vaccinated mares show an increase in antibodies against Equine Rotavirus for approximately sixty days.

Dosage and administration

1.0 ml dose per mare to be administered by deep intramuscular injection.

Vaccination Schedule:

Pregnant mares should be given three doses of vaccine consisting of a single 1ml dose administered at the 8th, 9th and 10th month of each pregnancy.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not use in unhealthy animals.

Use of this vaccine in a mare can only aid the control of diarrhoea associated with rotavirus in its foal when the foal receives an adequate quantity of colostrum, shortly after birth. Both the mare's ability to respond by the production of antibodies in colostrum and the ability of the foal to ingest and absorb that colostrum is required for the vaccine to have an effect.

No information is available on the compatibility of this vaccine with any other. Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.

Adverse Reactions:

Mares may develop a small visible soft to firm swelling (≤3.5 x ≤2.5cm) lasting for generally only two days. The swelling may be painful for 1-2 days. Some mares may also develop a 1°C transient temperature rise, which may last for up to 2 days.

In most cases these small and transient injection site reactions resolve with no need for treatment.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

Operator Warning

In case of accidental self-injection/ingestion/spillage onto skin, seek medical advice immediately and show the package insert or label to the physician.

Withdrawal Period

Zero days.

Pharmaceutical precautions

Keep out of the reach and sight of children.

Store and transport refrigerated (2°C - 8°C).

Do not freeze. Protect from light.

Do not use after the expiry date printed on the syringe.

Legal category

POM-V

Packaging Quantities

Syringes are supplied in packs of 3, 10, 20 and 40 units.

Not all pack sizes may be marketed.

Further information

Disposal:

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

Marketing Authorisation Number

Vm 01596/4359