Label: ADEQUAN I.M.- polysulfated glycosaminoglycan injection, solution
- NDC Code(s): 10797-959-01
- Packager: American Regent, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated October 9, 2023
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- SPL UNCLASSIFIED SECTION
- DESCRIPTION:
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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:
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DOSAGE AND ADMINISTRATION:
Practice aseptic techniques in withdrawing each dose to decrease the possibility of post-injection bacterial infections. Adequately clean and disinfect the stopper prior to entry with a sterile needle and syringe. Use only sterile needles, and use each needle only once.
The vial stopper may be punctured a maximum of 10 times.
The recommended dose of Adequan® i.m. Multi-Dose 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. Multi-Dose with other drugs or solvents.
- CONTRAINDICATIONS:
- WARNINGS:
- PRECAUTIONS:
- SAFETY AND EFFICACY:
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ANIMAL SAFETY:
Animal Safety studies utilizing Adequan® i.m. Multi-Dose were not performed. Safety studies were conducted in horses using the single dose formulation. 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.
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STORAGE CONDITIONS:
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). Avoid prolonged exposure to temperatures ≥ 40°C (104°F).
Use within 28 days of first puncture and puncture a maximum of 10 times. Dispose of spent needles in accordance with all federal, state and local environmental laws.
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HOW SUPPLIED:
Adequan® i.m. Multi-Dose solution, 5,0000 mg/50 mL (100 mg/mL) in 50 mL multi-dose glass vials.
NDC 10797-959-01 50 mL Multi-Dose Vials Packaged 1 vial per boxAMERICAN REGENT, INC.
ANIMAL HEALTH
Shirley, NY 11967
(1-888-354-4857)Made in U.S.A.
IN959
Rev. 9/2021
MG# 44453Approved by FDA under NADA #140-901
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Container Label
NDC 10797-959-01
Adequan i.m.®
polysulfated glycosaminoglycanMulti-Dose
100 mg/mL
50 mL Preserved Multiple Dose VialFor Intramuscular Use in Horses Only. Not for Intra-Articular Use.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.Use within 28 days of first puncture.
WARNING: Do not use in horses intended for human consumption.
Store at 20° to 25°C (68° to 77°F). Avoid prolonged exposure to temperatures ≥ 40°C (104°F).
See package insert for full directions.
AMERICAN REGENT, INC.
ANIMAL HEALTH
Shirley, NY 11967Approved by the FDA under NADA # 140-901
Rev. 09/2021
- Carton Labeling
- Serialization Label
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INGREDIENTS AND APPEARANCE
ADEQUAN I.M.
polysulfated glycosaminoglycan injection, solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:10797-959 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 BENZYL ALCOHOL (UNII: LKG8494WBH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10797-959-01 1 in 1 CARTON 1 50 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA140901 12/20/2009 Labeler - American Regent, Inc. (002033710) Establishment Name Address ID/FEI Business Operations American Regent, Inc. 002033710 analysis, manufacture