SUMMARY OF PRODUCT CHARACTERISTICS

Equip Rotavirus emulsion for injection for horses

Each dose of 1 ml contains:

Active substance:

Inactivated equine rotavirus H2 strain (serotype G3 P12) RP ≥ 1.0*

(7.4 x 106 to 7.4 x 107 FAID50**)

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

** Fluorescent antibody infectivity dose 50%.

Adjuvants:

SP Oil Adjuvant:

Pluronic L121 1 mg

Squalane 2 mg

Tween 80 (Polysorbate 80) 0.16 mg

Phosphate buffered saline to 0.05 ml.

Excipients:

For the full list of excipients, see section 6.1.

Emulsion for injection

Reddish/pinkish liquid

Horses (pregnant mares)

For 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.

None.

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.

Special precautions for use in animals

Vaccinate healthy animals only.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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

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:

- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

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 when used 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.

Intramuscular use

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 1 ml dose administered at the 8th, 9th and 10th month of each pregnancy.

Adverse events observed after administration of a double dose are similar to those following administration of a single dose as listed in section 4.6.

Zero days.

Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines for horses.

ATC vet code: QI05AA09.

HEPES diluent:

Eagle’s Earle’s MEM growth medium

HEPES acid

Sodium hydrogen carbonate

Water for injections

Hydrochloric acid

Sodium hydroxide

Do not mix with any other veterinary medicinal product.

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.

Protect from light.

Sterile single-use polypropylene syringes (Ph. Eur. 3.2.8) containing one dose each, and closed with rubber tips (Ph. Eur. 3.2.9).

Syringes are supplied in cardboard 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.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm 42058/4063

9. DATE OF FIRST AUTHORISATION

05 September 2008

October 2016

Approved: 18/10/2016