"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Those normally associated with the surgical procedure being performed.
Postoperative intraocular pressure may also be elevated as a result of pre-existing glaucoma, compromised outflow and by operative procedures and sequelae thereto, including enzymatic zonulysis, absence of an iridectomy, trauma to filtration structures, and by blood and lenticular remnants in the anterior chamber. Since the exact role of these factors is difficult to predict in any individual case, the following precautions are recommended:
. In posterior segment procedures in aphakic diabetic patients special care should be exercised to avoid using large amounts of Healon (sodium hyaluronate) .
Carefully monitor the intraocular pressure, especially during the immediate postoperative period. If significant rises are observed, treat with appropriate therapy.
Care should be taken to avoid trapping air bubbles behind Healon (sodium hyaluronate) .
Because Healon (sodium hyaluronate) is a highly purified fraction extracted from avian tissues and is known to contain minute amounts of protein, the physician should be aware of potential risks of the type that can occur with the injection of any biological material.
Because of reports of an occasional release of minute rubber particles, presumably formed when the diaphragm is punctured, the physician should be aware of this potential problem. Express a small amount of Healon (sodium hyaluronate) from the syringe prior to use, and carefully examine the remainder as it is injected.
Avoid reuse of cannulas. If reuse becomes necessary, rinse cannula thoroughly with sterile distilled water.
Sporadic reports have been received indicating that Healon (sodium hyaluronate) may become "cloudy" or form a slight precipitate following instillation into the eye. The clinical significance of these reports, if any, is not known since the majority received to date do not indicate any harmful effects on ocular tissues. The physician should be aware of this phenomenon and, should it be observed, remove the cloudy or precipitated material by irrigation and/or aspiration.
Use only if solution is clear.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Healon Information
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