Adequan Canine (Canada)

This page contains information on Adequan Canine for veterinary use.
The information provided typically includes the following:
  • Adequan Canine Indications
  • Warnings and cautions for Adequan Canine
  • Direction and dosage information for Adequan Canine

Adequan Canine

This treatment applies to the following species:
Manufacturer: Novartis

Polysulfated Glycosaminoglycan Sterile Injection

100 mg/mL

For Veterinary Use Only

DIN 02052415

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 the 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® 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, a problem which has not been observed in clinical practice. 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 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 not evidence of a drug effect on coagulation, kidney or liver function based on clinical observations and laboratory 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. Do not use in dogs with known or suspected bleeding disorders. Use with caution in dogs with impaired renal and/or hepatic function, and in dogs which have been on long term nonsteroidal anti-inflammatory drug therapy.

Dosage and Administration

The recommended dose of Adequan® Canine is 4.4 mg/kg (2 mg/lb.) of 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.

Precautions

Not intended for use in breeding animals as effects on canine fertility and reproductive function have not been studied. Do not exceed the recommended dose or treatment duration. Avoid inadvertent intravascular administration.

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 up to 25°C (77°F).

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

(1-800-458-0163)

DISTRIB. BY: Novartis Animal Health Canada Inc., 2000 Argentia Rd. Suite 400 Plaza 3, Mississauga, Ontario L5N 1V9

IN00502C

Rev. 4/09C

MG# 9855

NAC No.: 12311000

NOVARTIS ANIMAL HEALTH CANADA INC.
2000 ARGENTIA RD., SUITE 400, PLAZA 3, MISSISSAUGA, ON, L5N 1V9
Telephone:   800-387-6325
Order Desk:   800-387-6325
Fax:   905-567-0221
Fax Orders:   800-827-5782
Website:   www.ah.novartis.ca
Email:   ah.questions@novartis.com
Every effort has been made to ensure the accuracy of the Adequan Canine information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-09-05

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