Hy-50 (Canada)

Hyaluronate sodium sterile injection 17 mg/mL (51 mg/3 mL)

Veterinary Use Only

For intra-articular or intravenous use in horses only

DIN 02238566

Description

HY-50 is a highly purified, sterile, pyrogen-free aqueous solution of hyaluronate sodium derived by a fermentation process using Streptococcus spp. and then purified to yield a product which is essentially free of protein and nucleic acids.

Each mL contains: hyaluronate sodium 17 mg; sodium chloride 7.57 mg; sodium phosphate dibasic 3.78 mg; sodium phosphate monobasic 0.45 mg; and water for injection q.s.

Chemistry:

Hyaluronate sodium is the sodium salt of hyaluronic acid, a highly polymerized, non-sulphated acid mucopolysaccharide or glycosaminoglycan composed of equimolar amounts of D-glucuronic acid and N-acetylglucosamine linked together by glycosidic bonds. Hyaluronate possesses a negative charge which enables it to bind readily to other substances such as water, ions, proteins and solutes. The hyaluronate produced by bacteria is structurally and chemically indistinguishable from mammalian hyaluronate.

Pharmacology

Hyaluronate is a naturally occurring substance present in connective tissue, skin, vitreous humour, synovial fluid and umbilical cord in all mammals. Hyaluronate is synthesized by synoviocytes and is responsible for the viscoelastic characteristic of synovial fluid. Synovial fluid hyaluronate functions as a lubricant of the intra-articular soft tissues, aids in providing nourishment and removing waste products from the avascular cartilage, and is an important constituent of the synovial membrane barrier. The surface of articular cartilage is coated by a thin amorphous layer of a protein-hyaluronate complex. Hyaluronate is also found in the superficial layers of the cartilage matrix where it exerts resistance to cartilage compression while retaining plasticity. Hyaluronate has biochemical activities which are distinct from its physical properties. It is a potent inhibitor of cell migration, a direct inhibitor of leucocyte activity, and it prevents the formation of excess fibrous tissue.

Hy-50 Indications

HY-50 is indicated for the intra-articular or intravenous treatment of carpal and fetlock joint dysfunction in horses due to acute or chronic non-infectious synovitis associated with equine osteoarthritis.

Contraindications

Do not administer to horses with a history of hypersensitivity to hyaluronate sodium. Do not administer when joint sepsis and/or fractures are suspected.

Dosage and Administration

Intravenous route: The recommended dose of HY-50 is 51 mg hyaluronate sodium (contents of one syringe) once a week for three consecutive weeks.

lntra-articular route: The recommended dose of HY-50 is 51 mg hyaluronate sodium (contents of one syringe) in small or medium sized joints (i.e. carpus, fetlock) by intra-articular injection. More than one joint may be treated at the same time. Treatment may be repeated after one or more weeks if necessary, but not to exceed four consecutive weekly injections in the same joint.

HY-50 should be administered using strict aseptic technique. The site should be surgically prepared to ensure removal of all dirt, hair, topical medicaments, and soapy residues. Intra-articular injections should not be made through skin that has been recently fired or blistered or that has been scurfed by the use of counterirritants. After introducing the needle into the joint, excess synovial fluid should be allowed to drain, or should be removed when possible, prior to attaching the syringe and injecting HY-50. Discard any unused portion of a syringe. A sterile dressing and clean bandage should be applied after injection, as appropriate for the particular joint treated. Hand walk for at least 2 days after treatment. Return to strenuous exercise will depend on the severity of each case and the regression of clinical signs.

Cautions:

In cases of severe acute lameness, radiographic evaluation should be carried out prior to intra-articular or intravenous HY-50 treatment to ensure that the joints are free from serious fractures. Observe strict aseptic technique. Intra-articular injections should not be made through skin that has been recently fired or blistered, or that has been scurfed by the use of counterirritants. The safety of HY-50 has not been established in breeding animals or in pregnant or lactating mares.

Adverse Reactions

In an open field trial, transient, localized post-injection swelling, edema and/or heat were observed in 2.7% of the joints treated with HY-50. These were usually mild and self-limiting, resolving spontaneously within 48 hours, and did not interfere with a successful therapeutic outcome. No adverse reactions and no systemic effects have been observed or reported as a result of treatment with intra-articular HY-50. No local or systemic adverse reactions were observed in experimental animals during safety and efficacy studies when HY-50 was administered intravenously.

Warnings

This drug is not to be administered to horses that are to be slaughtered for use in food.

Storage conditions:

Store refrigerated between 2-8°C. Protect from freezing. Discard any unused portion of a syringe.

How Supplied

HY-50 is supplied in 3 mL (51 mg) single dose glass syringes individually packaged in sealed plastic trays and outer cartons, and available in single units.

Dechra Ltd., Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, United Kingdom

Imported and distributed by: Dechra Veterinary Products Inc., 1 Holiday Avenue, East Tower, Suite 345, Pointe-Claire, Quebec, Canada, H9R 5N3

HY-50 is a registered trademark of Dechra Ltd.

F1472

CPN: 1786032.0