SUMMARY OF PRODUCT CHARACTERISTICS

HYLARTIL VET 10 mg/ml Solution for Injection

Each 2ml syringe contains:

Active substance:

Sodium Hyaluronate

(MrM, mean relative molecular mass ≥ 3.0 x106) 20.00 mg (10mg/ml)

For full list of excipients, see Section 6.1.

Solution for injection.

Horses.

Hylartil Vet (10mg/ml) is indicated for use in horses as follows:

None.

None known.

Please note the syringe is sealed with a membrane which must be ruptured prior to use (see directions in carton).

None known.

Directly after use of this product, hands and exposed skin should be washed thoroughly.

Transient swelling may occur at the injection site.

Hylartil Vet can, as far is known, be used during pregnancy and lactation.

None known.

For intra-articular use and direct injection into tendons.

Two ml (20 mg) of Hylartil Vet is given intra-articularly in small and medium size joints and can also be injected directly into tendons. In the treatment of larger joints/tendons the dosage may be increased to 4 ml (40 mg). The injection should be given under strict aseptic conditions. The treatment may be repeated at weekly intervals for a total of three treatments. Not more than two joints/tendons should be treated at the same time.

When performing intra-articular injections care should be taken not to scratch the cartilage surface, as this may result in diffuse swelling lasting for 24 to 48 hours. The transient swelling will have no effect on the ultimate clinical result. For best results the horse should be given a two day stall rest before gradually resuming normal activity.

The syringe must only be used once.

None known.

Do not use in horses intended for human consumption.

Treated horses may never be used for human consumption.

The horse must have been declared as not intended for human consumption under national horse passport legislation.

Hylartil Vet contains sodium hyaluronate. Sodium hyaluronate is a polysaccharide consisting of repeating units of N-acetylglucosamine and sodium glucuronate linked by glycosidic bonds. It is a natural substance, occurring in identical forms in all species.

ATCVet code:QM09AX01

Sodium Chloride

Sodium Phosphate Dihydrate

Sodium Acid Phosphate Dihydrate

Sodium hydroxide (pH adjustment)

Hydrochloric acid (pH adjustment)

Water for Injections

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Store in a refrigerator (2°C to 8°C). Do not freeze. Protect from light.

The product does not contain an antimicrobial preservative. Any product remaining in the syringe following administration of the required dose should be discarded.

A disposable single use 2ml prefilled parenteral syringe of colourless Type I glass, closed with a blue chlorobutyl rubber stopper. Supplied in cartons containing 1 or 20 syringes.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with national requirements.

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm:42058/4071

Date:6 March 2006

Date:April 2014

Approved: 30/04/2014