HYVISC- 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:

Boehringer Ingelheim Animal Health USA Inc.

Administration route:

INTRA-ARTICULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Hyvisc (hyaluronate sodium) Injection is recommended for the treatment of joint dysfunction in horses due to non-infectious synovitis associated with equine osteoarthritis. There are no known contraindications to the use of Hyvisc (hyaluronate sodium) Injection.

Product summary:

Hyvisc (hyaluronate sodium) Injection, 11 mg/mL, is available in 2 mL prefilled, disposable syringes individually packaged.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

HYVISC- HYALURONATE SODIUM INJECTION
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
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HYVISC®
(HYALURONATE SODIUM)
STERILE INJECTION, 11 MG/ML
For intra-articular injection in horses only
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION:
Hyvisc® (hyaluronate sodium) Injection is a clear, colorless, viscous
fluid contained in a
5 mL disposable syringe, as a single 2 mL dose. Chemically, hyaluronic
acid is a high
molecular weight mucopolysaccharide composed of repeating disaccharide
units, each
unit consisting of D-glucuronic acid and N-acetyl-D-glucosamine. Each
mL of Hyvisc
Injection contains 11 mg of hyaluronate sodium and 8.47 mg of sodium
chloride, USP, in
sterile water for injection, USP, q.s.
ACTIONS:
Hyaluronate sodium is a natural constituent of connective tissue and
synovial fluid in
both man and animals. In synovial fluid, hyaluronate sodium confers
viscoelastic as well
as lubricating properties
. In connective tissue, hyaluronate sodium specifically
interacts with cartilage proteoglycans to form stable aggregates
. The mechanism of
action by which exogenous hyaluronate sodium exerts its therapeutic
effect in arthritic
joints is not known at this time.
INDICATIONS:
Hyvisc (hyaluronate sodium) Injection is recommended for the treatment
of joint
dysfunction in horses due to non-infectious synovitis associated with
equine
osteoarthritis.
DOSAGE AND ADMINISTRATION:
The recommended dose of Hyvisc (hyaluronate sodium) Injection is 2 mL
(22 mg) given
to horses intra-articularly in small and medium-sized joints (carpal,
fetlock). In larger
joints (hock), the dosage is 4 mL (44 mg). Treatment may be repeated
at weekly
intervals for a total of three treatments. As with any intra-articular
injection, aseptic
technique is used. The following are suggested use directions
regardless of the type of
joint to be treated.
1.
1,2
3,4,5
Carefully diagnose each case using routine methods. The origin of
lameness should
2.
3.
4.
5.
As with any intra-articular in