ADEQUAN I.M.- polysulfated glycosaminoglycan injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) (POLYSULFATED GLYCOSAMINOGLYCAN - UNII:268AW7000T)

Available from:

American Regent, Inc.

INN (International Name):

POLYSULFATED GLYCOSAMINOGLYCAN

Composition:

POLYSULFATED GLYCOSAMINOGLYCAN 100 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

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

Product summary:

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 box AMERICAN REGENT, INC. ANIMAL HEALTH Shirley, NY 11967 (1-888-354-4857) Made in U.S.A. IN959 Rev. 9/2021 MG# 44453 Approved by FDA under NADA #140-901

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ADEQUAN I.M.- POLYSULFATED GLYCOSAMINOGLYCAN INJECTION, SOLUTION
AMERICAN REGENT, INC.
----------
ADEQUAN I.M.®
POLYSULFATED GLYCOSAMINOGLYCAN
MULTI-DOSE
Solution 100 mg/mL in a 50 mL Preserved Multi-Dose Vial
For 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.
DESCRIPTION:
Each mL contains Polysulfated Glycosaminoglycan (PSGAG) 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 i