HYLARTIN V hyaluronate sodium injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

hyaluronate sodium (UNII: YSE9PPT4TH) (hyaluronic acid - UNII:S270N0TRQY)

Available from:

Zoetis Inc.

INN (International Name):

hyaluronate sodium

Composition:

hyaluronate sodium 10 mg in 1 mL

Prescription type:

PRESCRIPTION

Authorization status:

New Animal Drug Application

Summary of Product characteristics

HYLARTIN V- HYALURONATE SODIUM INJECTION
ZOETIS INC.
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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.
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