Adequan I.M. (Canada)

Manufacturer: Luitpold

Polysulfated Glycosaminoglycan Injection 100mg/ml

For Veterinary Use Only

For Intramuscular Use In Horses

Description

Each milliliter of Adequan^® I.M. contains 100mg of Polysulfated Glycosaminoglycan (PSGAG) and Water for injection q.s. Sodium Hydroxide and/or Hydrochloric Acid added when 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 2,500mg 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 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). The reaction consisted of a transient joint flare, occurring within 24 hours of injection, and resolving within 24 hours with anti-inflammatory 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.

Warning

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

Adequan I.M. Dosage And Administration

The recommended dose of Adequan^® I.M. is 500mg (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. Cautions

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., 100mg/mL, is available as: 5mL glass vials, packaged in boxes of 4.

Storage Conditions

Store at controlled room temperature 18º-25ºC (64º-77ºF).

Discard unused portion.

LUITPOLD PHARMACEUTICALS, INC., Animal Health Division, Shirley, New York 11967

(800-458-0163)

REV. 6/90C

IN99501C

D.I.N. 01910051

Distributed by: Central Sales Ltd., Brampton, Ontario, Canada

Nac No.

11880020