LEGEND- hyaluronate sodium injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Merial, Inc.

INN (International Name):

hyaluronate sodium

Composition:

hyaluronate sodium 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

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.

Product summary:

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.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

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