Adequan Canine (Canada)

Company: American Regent

Polysulfated Glycosaminoglycan Sterile Injection 100 mg/mL

DIN 02052415

FOR VETERINARY USE ONLY

FOR INTRAMUSCULAR USE IN DOGS

Description

Each mL of Adequan^® Canine contains 100 mg Polysulfated Glycosaminoglycan (PSGAG), 0.009 mL benzyl alcohol as a preservative, and Water for Injection q.s. to 1 mL. Sodium hydroxide and/or hydrochloric acid added as necessary to adjust pH.

Pharmacology

Polysulfated Glycosaminoglycan (PSGAG) is chemically similar to the mucopolysaccharides of cartilaginous tissue. PSGAG diminishes the catabolic processes which lead to loss of cartilage matrix components. This effect is mediated by inhibition of proteolytic enzymes which degrade cartilage and which exacerbate inflammation in diseased joints. PSGAG also improves joint function by stimulating synovial membrane activity, reducing synovial inflammation, and increasing synovial fluid hyaluronic acid content. The net result is a decrease in articular pain and improvement in range of motion of arthritic joints. There is a preferential uptake of PSGAG into diseased joints compared to healthy joints. Therapeutic concentrations of PSGAG are maintained in the synovial fluid and in articular cartilage for 72 hours following intramuscular administration of 4.4 mg/kg in dogs.

Toxicology: In a subacute toxicity study dogs were treated with 5, 15 or 50 mg/kg PSGAG by intramuscular injection twice a week for 13 consecutive weeks. These doses represent approximately 1, 3, and 10 times the recommended dose of Adequan^® Canine for dogs and more than three times the maximum recommended number of injections. The only abnormality in the 5 mg/kg dose group was minor inflammation at injection sites. The number of injections administered during the study (26) probably contributed to this finding. Adverse drug effects on coagulation, kidney and liver function were observed in a dose-dependent manner in dogs treated with 15 and 50 mg/kg PSGAG.

At the recommended therapeutic dose and at double the recommended dose Adequan^® Canine has an excellent safety profile and injections are tolerated very well. Out of 123 dogs evaluated in clinical trials in Canada and the United States only six dogs (5%) experienced undesirable effects that might have been drug related. Mild diarrhoea developed in two dogs, one of which was treated with an antibacterial; transient listlessness or depression after one or more Adequan^® injections was observed in four dogs including one of the dogs with diarrhoea; and one dog was reported to have an increased appetite and stool volume. There was no evidence of a drug effect on coagulation, kidney or liver function based on clinical observations and serum biochemical, hematological, and platelet function tests.

Adequan Canine Indications

Adequan^® Canine is recommended for the treatment of non-infectious degenerative and/or traumatic arthritis and associated lameness of canine synovial joints.

Contraindications

Do not use Adequan^® Canine in dogs demonstrating hypersensitivity to PSGAG. PSGAG is a synthetic heparinoid. Do not use in dogs with known or suspected bleeding disorders.

Dosage and Administration

The recommended dose of Adequan^® Canine is 4.4 mg/kg (2 mg/lb) body weight by intramuscular injection twice a week (3 to 5 day intervals) for a maximum total of 8 injections over a four week period. Do not exceed the recommended dose or duration of treatment. Do not mix Adequan^® Canine with other drugs or solvents. Avoid inadvertent intravascular administration.

Cautions: Use in breeding animals and effects on canine fertility and reproductive function have not been studied. Use with caution in dogs with impaired renal and/or hepatic function, and in dogs which have been on long term nonsteroidal antiinflammatory drug therapy. Do not exceed the recommended dose or treatment duration. Avoid inadvertent intravascular administration.

Adverse Reactions

Although very rare*, the most frequently observed undesirable effects include vomiting, diarrhea, lethargy and anorexia. These signs are mild and transient and generally do not require cessation of treatment. In some cases death has been reported.

* Very rare: less than 1 animal in 10,000 animals (reporting rate: < 1).

To report suspected adverse drug events, or for technical assistance, contact American Regent, Inc. at 1-888-354-4857.

Warning

Keep out of the reach of children.

How Supplied

Adequan^® Canine, PSGAG 100 mg/mL, is available in 5 mL multiple dose vials packaged in boxes of 2.

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

MFG. BY: AMERICAN REGENT, INC., ANIMAL HEALTH, Shirley, N.Y. 11967

(1-888-354-4857)

IMP. BY: Central Sales Limited, 1-14 Regan Road, Brampton, ON, L7A 1B9, Canada

IN00502C

Rev. 03/2021C

MG #46018

CPN: 2107000.0