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.
Toxicity: 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.
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 controlled room temperature 18-25°C (64-77°F).
MFG. BY: AMERICAN REGENT, INC.
ANIMAL HEALTH
Shirley, NY 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