Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) (POLYSULFATED GLYCOSAMINOGLYCAN - UNII:268AW7000T)
American Regent, Inc.
POLYSULFATED GLYCOSAMINOGLYCAN
POLYSULFATED GLYCOSAMINOGLYCAN 100 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION
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.
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
New Animal Drug Application
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 Läs hela dokumentet