Animal NDC 10797-959-01 Adequan I.m.

Polysulfated Glycosaminoglycan

Animal NDC Product Code 10797-959-01

Field Name Field Value
Animal NDC Code 10797-959-01
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)
  • BENZYL ALCOHOL (LKG8494WBH)
  • WATER (059QF0KO0R)
  • BENZYL ALCOHOL (LKG8494WBH)
  • 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

Description:

Each mL contains Polysulfated Glycosaminoglycan 100 mg, Benzyl Alcohol 0.9% v/v as a preservative, and Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid added when necessary to adjust pH. The solution is clear, colorless to slightly yellow.

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. Multi-Dose 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:

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:

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. Multi-Dose in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated.

Safety And Efficacy:

Safety and efficacy studies utilizing Adequan® i.m. Multi-Dose were not performed. Adequan® i.m. Multi-Dose was approved based on the conclusion that the safety and effectiveness of Adequan® i.m. Multi-Dose will not differ from that demonstrated for the original formulation of Adequan® i.m.

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.

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.

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 HEALTHShirley, NY 11967(631) 924-4000800-458-0163Made in U.S.A.IN959Rev. 1/19MG# 28493
NADA #140-901, Approved by FDA

Container Label

NDC 10797-959-01
Adequan® i.m. Multi-Dose
(POLYSULFATED GLYCOSAMINOGLYCAN)
100 mg/mL
     50 mL Preserved Multiple Dose Vial
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
For Intramuscular Use in Horses Only. Not for Intra-Articular Use.
Use within 28 days of first puncture.WARNING: Do not use in horses intended for human consumption.
Store at 20°-25°C (68°-77°F).  Avoid prolonged exposure to temperatures ≥ 40°C (104°F).See package insert for full directions.AMERICAN REGENT, INC.ANIMAL HEALTHShirley, NY 11967
NADA 140-901, Approved by FDA
Rev. 1/19

Carton Labeling

NDC 10797-959-01
Adequan® i.m.
(POLYSULFATED GLYCOSAMINOGLYCAN)
MULTI-DOSE
100 mg/mL
(5000 mg/50 mL)
PSGAG injection for intramuscular use in horses only. Not for intra-articular use.
Contains one 50 mL Preserved Multiple Dose Vial
AMERICAN REGENT, INC.ANIMAL HEALTHShirley, NY 11967
(800) 458-0163
NADA 140-901, Approved by FDA

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

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