ADEQUAN I.M.- polysulfated glycosaminoglycan injection, solution

Adequan i.m. by

Drug Labeling and Warnings

Adequan i.m. by is a Animal medication manufactured, distributed, or labeled by American Regent, Inc., Daiichi Sankyo Altrich Sari. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Brand of Polysulfated Glycosaminoglycan (PSGAG)
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 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 intramuscularly to 6 horses twice a week for 12 weeks. 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 had any clinical or laboratory evidence of toxicity.

STORAGE CONDITIONS:

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). Discard unused portion. Dispose of spent needles in accordance with all federal, state and local environmental laws.

HOW SUPPLIED:

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
(631) 924-4000
(800) 458-0163

NADA #140-901, Approved by FDA

Made in U.S.A.

IN 99501
Rev. 1/19
MG #7560

Container Label

NDC: 10797-995-01

Adequan®  i.m.
POLYSULFATED GLYCOSAMINOGLYCAN

500 mg/5 mL          5 mL VIAL

FOR INTRAMUSCULAR USE IN HORSES

Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).

See package insert for full directions.

AMERICAN REGENT, INC.
ANIMAL HEALTH
Shirley, NY  11967

NADA # 140-901, Approved by FDA

Rev. 1/19

Carton Labeling

NDC: 10797-995-70

Adequan® i.m.

(Polysulfated Glycosaminoglycan)

SINGLE DOSE VIALS

7 Vials (5 mL each)

PSGAG injection

For intramuscular use in horses

• For the treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal joint in horses.

AMERICAN REGENT, INC.
ANIMAL HEALTH
Shirley, NY  11967
(800) 458-0163

INGREDIENTS AND APPEARANCE

ADEQUAN I.M. 
polysulfated glycosaminoglycan injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 10797-995
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) (POLYSULFATED GLYCOSAMINOGLYCAN - UNII:268AW7000T)	POLYSULFATED GLYCOSAMINOGLYCAN	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10797-995-70	7 in 1 CARTON
1	NDC: 10797-995-01	5 mL in 1 VIAL, SINGLE-USE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA140901	11/01/1989

Labeler - American Regent, Inc. (002033710)

Establishment
Name	Address	ID/FEI	Business Operations
American Regent, Inc.		002033710	ANALYSIS, MANUFACTURE, STERILIZE

Establishment
Name	Address	ID/FEI	Business Operations
Daiichi Sankyo Altrich Sari		262417595	API MANUFACTURE