ORTHOVISC is a sterile, non-pyrogenic solution of sodium
hyaluronate.
Sodium hyaluronate is a high molecular weight polysaccharide
composed of sodium glucuronate and N-acetylglucosamine. Sodium
hyaluronate is ubiquitously distributed throughout the tissues of
the body and is present in high concentrations in such tissues as
vitreous humor, synovial fluid, umbilical cord and dermis. Sodium
hyaluronate functions as a tissue lubricant and is thought to play
an important role in modulating the physical and mechanical
interactions between adjacent tissues. It can also act as a
visco-elastic support maintaining a separation between tissues.
ORTHOVISC is non-inflammatory, is non-pyrogenic and is well
tolerated. Sodium hyaluronate preparation has been shown to be
non-antigenic. ORTHOVISC does not interfere with normal wound
healing processes. |
ORTHOVISC is indicated for the symptomatic treatment of
temporomandibular joint dysfunction and osteoarthritis of the knee.
At the present time there are no known contraindications to the use
of ORTHOVISC when used in the symptomatic treatment of the joint
disease.
Individuals prone to chicken-or chicken-derived product allergies
could, conceivably, experience an adverse reaction to sodium
hyaluronate preparations. However, such reactions have not been
reported previously, despite wide usage of sodium hyaluronate in the
form of preparations identical to ORTHOVISC during other surgical
procedures. There are minimal risks associated with the procedure of
injecting substances into joints in general; primarily infection and
bleeding. Pre-existing infections of skin in the region of the
intended injection or known systemic bleeding disorders may
constitute relative or absolute contraindications.
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