LEGEND- hyaluronate sodium injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Boehringer Ingelheim Animal Health USA Inc.

Calea de administrare:

INTRA-ARTICULAR

Tip de prescriptie medicala:

PRESCRIPTION

Indicații terapeutice:

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.

Rezumat produs:

HOW SUPPLIED: LEGEND Injectable Solution is supplied in a carton of six 2 mL (20 mg) bottles. Approved by FDA under NADA # 140-883 Marketed by: Boehringer Ingelheim Animal Health USA Inc., Duluth, GA 30096

Statutul autorizaţiei:

New Animal Drug Application

Caracteristicilor produsului

LEGEND- HYALURONATE SODIUM INJECTION, SOLUTION
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
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LEGEND
(HYALURONATE SODIUM)
INJECTABLE SOLUTION
FOR INTRAVENOUS OR INTRA-ARTICULAR USE IN HORSES ONLY
2 ML
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 or intra-articular 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 2 mL (20 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
bacteri