Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
hyaluronate sodium (UNII: YSE9PPT4TH) (hyaluronic acid - UNII:S270N0TRQY)
Zoetis Inc.
hyaluronate sodium
hyaluronate sodium 10 mg in 1 mL
PRESCRIPTION
New Animal Drug Application
HYLARTIN V- HYALURONATE SODIUM INJECTION ZOETIS INC. ---------- HYLARTIN V SODIUM HYALURONATE INJECTION 10 mg/mL PRODUCT INFORMATION CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: HYLARTIN V is a sterile pyrogen-free solution of a highly purified, specific fraction of the sodium salt of hyaluronic acid extracted from rooster combs. HYLARTIN V is supplied in disposable glass syringes, each of which contains 20 mg (10 mg/mL) of sodium hyaluronate in 2.0 mL physiological sodium chloride-phosphate buffer with a pH of 7.0-7.5. CHEMISTRY: Sodium hyaluronate is a high molecular weight polymer made up of repeating disaccharide units of N- acetylglucosamine and sodium glucuronate linked by beta 1-3 and beta 1-4 glycosidic bonds. HYLARTIN V contains only traces of protein. PHARMACOLOGY: Sodium hyaluronate is a natural, physiological substance which occurs extracellularly in connective tissue in both animals and man and is chemically identical in different species. High concentrations (>0.2 mg/mL) of hyaluronate are found in the synovial fluid, the vitreous of the eye and the umbilical cord. Sodium hyaluronate is a normal component of connective tissue matrix and it is injected therapeutically only in compartments where it constitutes a normal component, specifically the joint cavity. TOXICOLOGY: Acute, sub-acute and chronic toxicity studies in mice, rats, rabbits, dogs, monkeys and horses have not demonstrated any significant adverse reactions or sensitization. In an acute toxicity study in horses, HYLARTIN V was injected intra-articularly at dosages corresponding to five times the recommended dose per animal (200 mg total). In a sub-acute study, horses were injected intra-articularly with the recommended dose per joint (20 mg) at weekly intervals for nine weeks. The results of both investigations showed that hematological and blood chemistry values remained within normal ranges. In mice, the intravenous LD was found to be of the order of 50 mg/kg body weight. Th Belgenin tamamını okuyun