Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
hyaluronate sodium (UNII: YSE9PPT4TH) (hyaluronic acid - UNII:S270N0TRQY)
Merial, Inc.
hyaluronate sodium
hyaluronate sodium 10 mg in 1 mL
INTRAVENOUS
PRESCRIPTION
INDICATIONS: LEGEND Injectable Solution is indicated in the treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis. CONTRAINDICATIONS: There are no known contraindications for the use of LEGEND Solution in horses.
HOW SUPPLIED: LEGEND Injectable Solution is supplied in a carton of six 4 mL (40 mg) bottles. NADA 140-883, Approved by FDA Manufactured for: Merial, Inc., Duluth, GA 30096-4640, U.S.A.
New Animal Drug Application
LEGEND- HYALURONATE SODIUM INJECTION, SOLUTION MERIAL, INC. ---------- LEGEND (HYALURONATE SODIUM) INJECTABLE SOLUTION FOR INTRAVENOUS USE IN HORSES ONLY CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: LEGEND Injectable Solution is a clear, colorless solution of low viscosity. LEGEND Injectable Solution is pyrogen free, sterile and does not contain a preservative. It is administered by intravenous injection. Hyaluronic acid, the conjugate acid of hyaluronate sodium, is extracted from the capsule of _Streptococcus_ spp. and purified, resulting in a form which is essentially free of protein and nucleic acids. LEGEND Injectable Solution is supplied in 4 mL (40 mg) vials. Each mL contains 10 mg hyaluronate sodium, 8.5 mg sodium chloride, 0.223 mg sodium phosphate dibasic, and 0.04 mg sodium phosphate monobasic. The pH is adjusted to between 6.5 and 8.0 with sodium hydroxide or hydrochloric acid. CHEMISTRY: Hyaluronic acid, a glycosaminoglycan, can exist in the following forms depending upon the chemical environment in which it is found: as the acid, hyaluronic acid; as the sodium salt, sodium hyaluronate (hyaluronate sodium); or as the hyaluronate anion. These terms may be used interchangeably but in all cases, reference is made to the glycosaminoglycan composed of repeating subunits of D-glucuronic acid and N-acetyl- D-glucosamine linked together by glycosidic bonds. Since this product originates from a microbial source, there is no potential for contamination with dermatan or chondroitin sulfate or any other glycosaminoglycan. CLINICAL PHARMACOLOGY: Hyaluronic acid is a naturally occurring substance present in connective tissue, skin, vitreous humour and the umbilical cord in all mammals. High concentrations of hyaluronic acid are also found in the synovial fluid. It also constitutes the major component of the capsule of certain microorganisms. The hyaluronic acid produced by bacteria is of the same structure and configuration as that found in mammals. The Perskaitykite visą dokumentą