Label: ADEQUAN I.M.- polysulfated glycosaminoglycan injection, solution

  • NDC Code(s): 10797-995-01, 10797-995-70
  • Packager: American Regent, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated October 10, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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 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); (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
    (1-888-354-4857)

    Approved by FDA under NADA #140-901

    Made in U.S.A.

    IN 99501
    Rev. 9/2021
    MG # 44455

  • Container Label

    NDC 10797-995-01

    Adequan®  i.m.
    polysulfated glycosaminoglycan

    500 mg/5 mL
    (100 mg/mL)

    For Intramuscular Use In Horses


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

    AMERICAN REGENT, INC. ANIMAL HEALTH
    Shirley, NY  11967

    Container Label

  • Carton Labeling

    NDC 10797-995-70

    Adequani.m.®
    polysulfated glycosaminoglycan

    PSGAG Injection

    500 mg/5 mL (100 mg/mL)

    For the intramuscular use in horses.

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

    SINGLE DOSE VIALS

    7 Vials (5 mL each)

    AMERICAN REGENT, INC., ANIMAL HEALTH
    Shirley, NY  11967
    (1-888-354-4857)

    Approved by FDA under NADA # 140-901

    Carton Labeling
  • Serialization Label

    Serialization Label

  • INGREDIENTS AND APPEARANCE
    ADEQUAN I.M. 
    polysulfated glycosaminoglycan injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:10797-995
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) (POLYSULFATED GLYCOSAMINOGLYCAN - UNII:268AW7000T) POLYSULFATED GLYCOSAMINOGLYCAN100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10797-995-707 in 1 CARTON
    1NDC:10797-995-015 mL in 1 VIAL, SINGLE-USE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14090111/01/1989
    Labeler - American Regent, Inc. (002033710)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Regent, Inc.002033710analysis, manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Daiichi Sankyo Altrich Sari262417595api manufacture