Animal NDC 10797-995-01 Adequan I.m.

Polysulfated Glycosaminoglycan

Animal NDC Product Code 10797-995-01

Field Name Field Value
Animal NDC Code 10797-995-01
Proprietary Name Adequan I.m. What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Polysulfated Glycosaminoglycan What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name American Regent, Inc.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Polysulfated Glycosaminoglycan
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • WATER (059QF0KO0R)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA140901 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Adequan I.m. Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 boxAMERICAN REGENT, INC.ANIMAL HEALTHShirley, NY 11967(631) 924-4000(800) 458-0163NADA #140-901, Approved by FDAMade in U.S.A.IN 99501Rev. 1/19MG #7560

Container Label

NDC 10797-995-01Adequan®  i.m.POLYSULFATED GLYCOSAMINOGLYCAN500 mg/5 mL          5 mL VIALFOR INTRAMUSCULAR USE IN HORSESStore at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).See package insert for full directions.AMERICAN REGENT, INC.ANIMAL HEALTHShirley, NY  11967NADA # 140-901, Approved by FDARev. 1/19

Carton Labeling

  • NDC 10797-995-70
  • Adequan®
  • I.m.(Polysulfated Glycosaminoglycan)
  • SINGLE DOSE VIALS7 Vials (5 mL each)PSGAG injectionFor intramuscular use in horsesFor the treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal joint in horses.
  • AMERICAN REGENT, INC.ANIMAL HEALTHShirley, NY  11967(800) 458-0163

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.