Introduction

Company name: Genitrix Ltd

Address: Genitrix House

Daux Road

Billingshurst

West Sussex

RH14 9SJ

Telephone: 01403 786345

Fax: 01403 786346

Email: mail@genitrix.co.uk

Website: www.genitrix.co.uk

Presentation

Pre-filled 3ml syringes containing 50 mg highly purified, sterile, non-pyrogenic, sodium hyaluronate in an aqueous solution.

Uses

For intra-articular treatment of lameness caused by joint dysfunction associated with non-infectious synovitis.

Hyaluronic acid is a natural constituent of connective tissues in all mammals and its chemical structure is the same in all species. Vitreous humour, umbilical cord and synovial fluid are especially rich in hyaluronic acid. Hyaluronic acid is also found in the articular cartilage matrix.

Hyaluronic acid has biochemical activities which are distinct from its physical and rheological properties. It is an effective free radical scavenger, a potent inhibitor of leucocyte and macrophage migration and aggregation, and enhances healing of connective tissue.

Intra-articularly administered HY-50 Vet alleviates aseptic joint inflammation and enhances joint function.

Dosage and administration

For single intra-articular injection: 3ml (50 mg or 1 syringe) for carpal, fetlock and tibiotarsal joints. Smaller joints such as the intertarsal, tarsometatarsal and interphalangeal joints can be treated with 1.5 mL (25 mg). More than one joint may be treated at the same time. Excess synovial fluid should be removed whenever possible prior to injection.

Remove product from refrigerator approximately 10 minutes before performing intra-articular injection. The injection should be administered under strict aseptic conditions. Ensure removal of dirt, hair, topical medicaments and soap/antiseptic residues. Intra-articular injections should not be made through overlying skin that is infected, blistered, scurfed or otherwise compromised. A sterile dressing and clean bandage should be applied after injection, as appropriate for the particular joint treated.

Contra-indications, warnings, etc

Withdrawal periods

Zero days

Transient mild swelling and/or heat has been reported in treated joints (2.7%). These self-limiting local signs resolve spontaneously within 48 hours, and do not negate a successful therapeutic outcome.

Pharmaceutical precautions

Any unused portion of a syringe is to be discarded. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority

Store between 2° and 8°C. Do not freeze.

Keep out of the reach of children.

Legal category

POM-V

Packaging Quantities

3 ml single-dose glass syringes.

Further information

The sodium hyaluronate in HY-50 Vet is produced by a bacterial fermentation process. It is extremely pure and is free of any animal proteins or pyrogens.

Radiographic evaluation should be carried out in cases of acute, severe lameness to ensure that the joints are free from serious fractures.

Marketing authorisation number

Vm 19785/4000.