Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T) (POLYSULFATED GLYCOSAMINOGLYCAN - UNII:268AW7000T)
American Regent, Inc.
POLYSULFATED GLYCOSAMINOGLYCAN
POLYSULFATED GLYCOSAMINOGLYCAN 250 mg in 1 mL
INTRA-ARTICULAR
PRESCRIPTION
Adequan is recommended for the treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal joint in horses. Do not use in horses showing hypersensitivity to Polysulfated Glycosaminoglycan. Do not administer Adequan in the face of joint sepsis.
Adequan solution, 250 mg/mL is available as: NDC 10797-991-72 1 mL single dose vials Packaged in boxes of 6 Store at controlled room temperature up to 25°C (77°F) (See USP).
New Animal Drug Application
ADEQUAN I.A.- POLYSULFATED GLYCOSAMINOGLYCAN INJECTION, SOLUTION AMERICAN REGENT, INC. ---------- ADEQUAN I.A. (POLYSULFATED GLYCOSAMINOGLYCAN) (PSGAG) Solution 250 mg/mL For intra-articular (I.A.) use in horses DESCRIPTION Each milliliter of Adequan contains 250 mg of Polysulfated Glycosaminoglycan and Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid added when necessary to adjust pH. PHARMACOLOGY Polysulfated Glycosaminoglycan is chemically similar to the mucopolysaccharides of cartilaginous tissue. It is a potent proteolytic enzyme inhibitor and diminishes or reverses the processes which result in the loss of cartilaginous mucopolysaccharides. PSGAG improves joint function by stimulating synovial membrane activity, reducing synovial protein levels and increasing synovial fluid viscosity in traumatized equine carpal joints. TOXICITY Toxicity studies were conducted in horses. Doses as high as 1,250 mg were administered intracarpally to 6 horses once a week for 18 weeks. This dosage is 5 times the recommended dosage and 3.6 times the recommended therapeutic regimen. Clinical observations revealed soreness and swelling in 1.8% (2 of 109 animals) at the injection site which was mild, self limiting and lasted less than one day. There was a dose related evaluation on partial thromboplastin time, creatinine and glucose. No animal had any clinical illness during the trial and none showed clinical evidence of toxicity except transient swelling at the injection site, possibly due to mechanical invasion of the joint. INDICATIONS Adequan is recommended for the treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal joint in horses. CONTRAINDICATIONS Do not use in horses showing hypersensitivity to Polysulfated Glycosaminoglycan. Do not administer Adequan in the face of joint sepsis. WARNING Do not use in horses intended for human consumption. DOSAGE AND ADMINISTRATION The recommended dose of Adequan in horses is 250 mg (1 vial) once a week for five Прочитать полный документ