Adequan I.M. (Canada)

Company: American Regent

Polysulfated Glycosaminoglycan Injection 100 mg/mL

DIN 01910051

FOR VETERINARY USE ONLY

FOR INTRAMUSCULAR USE IN HORSES

Description

Each mL of Adequan^® I.M. contains 100 mg Polysulfated Glycosaminoglycan (PSGAG) and Water for Injection q.s. Sodium hydroxide and/or hydrochloric acid added as necessary to adjust pH. Sodium chloride may be added to adjust tonicity.

Pharmacology

Polysulfated Glycosaminoglycan is chemically similar to the mucopolysaccharides of cartilaginous tissue. It is a potent proteolytic enzyme inhibitor and diminishes or reverses the processes which result in the loss of cartilaginous mucopolysaccharides. PSGAG improves joint function by stimulating synovial membrane activity, reducing synovial protein levels and increasing synovial fluid viscosity in traumatized equine joints.

Toxicity: Toxicity studies were conducted in horses. Doses as high as 2,500 mg were administered intramuscularly to 6 horses twice a week for 12 weeks or a total of 21 injections. This dosage is 5 times the recommended dosage and approximately 3 times the recommended therapeutic regimen. Clinical observations revealed no soreness or swelling at the injection site or in the affected joint. No animal showed any evidence of abnormality that was related to Adequan^® I.M. treatment as determined by clinical observation and a battery of laboratory tests.

From 100,000 doses used clinically, the reported incidence of side effects is 0.001% (1 case). This reaction consisted of a transient joint flare, occurring within 24 hours of injection, and resolving within 24 hours with antiinflammatory therapy.

Adequan I.M. Indications

Adequan^® I.M. is recommended for the treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness in horses.

Contraindications

Do not use Adequan^® I.M. in horses demonstrating hypersensitivity to PSGAG.

Warnings

This drug is not to be administered to horses that are to be slaughtered for use in food. Keep out of the reach of children.

Dosage and Administration

The recommended dose of Adequan^® I.M. is 500 mg (1 vial) per 1000 lbs. body weight, given intramuscularly every 4 days for a total of 8 injections over a 28 day period. The injection site must be thoroughly cleansed prior to injection. Do not mix Adequan^® I.M. with other drugs or solvents. For intramuscular use only - avoid inadvertent intravascular administration.

Adverse Reactions

There are no known adverse reactions associated with the use of Adequan^® I.M.

Adequan I.M. Caution

Avoid inadvertent intravascular administration. Not intended for use in breeding animals as effects on fertility and reproductive function in mares and stallions have not been studied.

How Supplied

Adequan^® I.M., PSGAG 100 mg/mL, is available in 5 mL single dose vials packaged in boxes of 7.

Storage Conditions: Store at controlled room temperature 18-25°C (64-77°F). Discard unused portion.

AMERICAN REGENT, INC., ANIMAL HEALTH, Shirley, N.Y. 11967

(1-888-354-4857)

Imported by: Central Sales Limited, 1-14 Regan Road, Brampton, ON, L7A 1B9, Canada

IN99501C

Rev. 03/2021C

MG #15651

CPN: 2107001.0