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 (serotype G3 P12) , 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.

For the vaccination of pregnant mares to provide passive transfer of antibodies to foals to reduce the risk of diarrhoea caused by equine rotavirus G3 P12 serotypes.

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.

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

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.

Vaccinate healthy animals only.

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 within 24 hours after birth and a continuous intake of milk derived from the vaccinated mare is ensured. 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.

Can be used during pregnancy.

The safety of the veterinary medicinal product has not been established during lactation.

No information is available on the safety and efficacy of this vaccine with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Do not mix with any other veterinary medicinal product.

In mares a transient increase (up to 1.8°C) in rectal temperature which may last up to 2 days following vaccination may be very commonly observed.

A small visible soft to firm swelling (2.5 ≤ x ≤ 3.5 cm) lasting generally for only two days may be commonly observed. The swelling may be painful for 1 - 2 days.

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

The frequency of adverse reactions is defined using the following convention:

Adverse events observed after administration of a double dose are similar to those following administration of a single dose as listed above.

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

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Zero days.

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.

Keep out of the sight and reach of children.

For animal treatment only.

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

Not all pack sizes may be marketed.

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

Vm 42058/4063