NEXHA- hyaluronate sodium injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY)

Disponible desde:

Bioniche Animal Health USA, Inc.

Designación común internacional (DCI):

HYALURONATE SODIUM

Composición:

HYALURONATE SODIUM 10 mg in 1 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION

indicaciones terapéuticas:

NexHATM (hyaluronate sodium) 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. There are no known contraindications for the use of NexHATM (hyaluronate sodium) injectable solution in horses.

Resumen del producto:

NexHATM injectable solution is supplied in cartons containing twelve x 4 mL (40 mg) vials.

Estado de Autorización:

Abbreviated New Animal Drug Application

Ficha técnica

NEXHA- HYALURONATE SODIUM INJECTION, SOLUTION
BIONICHE ANIMAL HEALTH USA, INC.
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NEXHA
[HYALURONATE SODIUM]
INJECTABLE SOLUTION 10 MG/ML
FOR INTRAVENOUS USE IN HORSES ONLY
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
NexHA
(hyaluronate sodium) injectable solution is a clear, colorless
solution of low viscosity.
NexHA
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. NexHA
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-Dglucosamine 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 humor 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 the same structure and confi