polysulfated glycosaminoglycan

Manufacturer
American Regent, Inc. | Daiichi Sankyo Altrich Sari
Effective date
2024-10-07
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:45:56

Label at a glance#

ProductAdequan i.m.
Active ingredientPOLYSULFATED GLYCOSAMINOGLYCAN
Label structure15 sections

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.

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

polysulfated glycosaminoglycan

SINGLE DOSE

Solution 500 mg/5 mL
For Intramuscular Use In Horses

CAUTION:

SPL UNCLASSIFIED SECTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

DESCRIPTION SECTION

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:

CLINICAL PHARMACOLOGY SECTION

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:

INDICATIONS & USAGE SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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:

CONTRAINDICATIONS SECTION

There are no known contraindications to the use of intramuscular Polysulfated Glycosaminoglycan.

WARNINGS:

WARNINGS SECTION

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:

PRECAUTIONS SECTION

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:

SPL UNCLASSIFIED SECTION

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:

STORAGE AND HANDLING SECTION

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:

HOW SUPPLIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 LabelContainer Label

Carton Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
Carton Labeling

Serialization Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Serialization LabelSerialization Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1085962polysulfated glycosaminoglycan 100 MG/ML Injectable Solution [Adequan]SBD10
1085958polysulfated glycosaminoglycan 100 MG/ML Injectable SolutionSCD10
1085962Adequan 100 MG/ML Injectable SolutionSY10
1085962Adequan I.M. 100 MG per ML Injectable SolutionSY10

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeDataBar Limited(01)10310797995012GTIN-14: 10310797995012
GTIN storage (14 digits): 10310797995012
adequan-im-single-dose-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10797-995-01Adequan i.m.5 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION510
10797-995-70Adequan i.m.7 in 1 CARTONINJECTION, SOLUTION710

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
polysulfated glycosaminoglycanACTIVE INGREDIENT268AW7000T1
polysulfated glycosaminoglycanACTIVE MOIETY268AW7000T1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10797-99510797-995-01, 10797-995-70

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSULFATED GLYCOSAMINOGLYCAN268AW7000TACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92024-10-07full-release2026-06-01 02:43:34

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.