ADEQUAN I.M.- polysulfated glycosaminoglycan injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) (POLYSULFATED GLYCOSAMINOGLYCAN - UNII:268AW7000T)

Available from:

American Regent, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Adequan® i.m. is recommended for the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses. There are no known contraindications to the use of intramuscular Polysulfated Glycosaminoglycan.

Product summary:

Adequan® i.m. solution, 500 mg/5 mL (100 mg/mL) in a 5 mL single dose glass vial. NDC 10797-995-70          5 mL Single Dose Vials          Packaged 7 vials per box AMERICAN REGENT, INC. ANIMAL HEALTH Shirley, NY 11967 (1-888-354-4857) Approved by FDA under NADA #140-901 Made in U.S.A. IN 99501 Rev. 9/2021 MG # 44455

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ADEQUAN I.M.- POLYSULFATED GLYCOSAMINOGLYCAN INJECTION, SOLUTION
AMERICAN REGENT, INC.
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ADEQUAN I.M.
polysulfated glycosaminoglycan
SINGLE DOSE
Solution 500 mg/5 mL
For Intramuscular Use In Horses
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
Each 5 milliliters of Adequan i.m. contains 500 mg 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
glycosaminoglycans in
articular cartilage matrix. PSGAG is a potent proteolytic enzyme
inhibitor and diminishes
or reverses the pathologic processes of traumatic or degenerative
joint disease which
result in a net loss of cartilage matrix components. PSGAG improves
joint function by
reducing synovial fluid protein levels and increasing synovial fluid
hyaluronic acid
concentration in traumatized equine carpal and hock joints.
INDICATIONS:
Adequan i.m. is recommended for the intramuscular treatment of
non-infectious
degenerative and/or traumatic joint dysfunction and associated
lameness of the carpal
and hock joints in horses.
DOSAGE AND ADMINISTRATION:
The recommended dose of Adequan i.m. in horses is 500 mg every 4 days
for 28 days
intramuscularly. The injection site must be thoroughly cleansed prior
to injection. Do not
mix Adequan i.m. with other drugs or solvents.
CONTRAINDICATIONS:
There are no known contraindications to the use of intramuscular
Polysulfated
®
®
®
®
®
Glycosaminoglycan.
WARNINGS:
Do not use in horses intended for human consumption. Not for use in
humans. Keep
this and all medications out of the reach of children.
PRECAUTIONS:
The safe use of Adequan i.m. in horses used for breeding purposes,
during
pregnancy, or in lactating mares has not been evaluated.
ANIMAL SAFETY:
Toxicity studies were conducted in horses. Doses as high as 2,500 mg
were
administered intramus