"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Healon (sodium hyaluronate) is indicated for use as a surgical aid in cataract extraction (intra- and extracapsular), IOL implantation, corneal transplant, glaucoma filtration and retinal attachment surgery.
In surgical procedures in the anterior segment of the eye, instillation of Healon (sodium hyaluronate) serves to maintaina deep anterior chamber during surgery, allowing for efficient manipulation with less trauma to the corneal endothelium and other surrounding tissues.
In posterior segment surgery Healon (sodium hyaluronate) serves as a surgical aid to gently separate, maneuver and hold tissues. Healon (sodium hyaluronate) creates a clear field of vision thereby facilitating intra- and postoperative inspection of the retina and photocoagulation.
DOSAGE AND ADMINISTRATION
Cataract Surgery-IOL Implantation
A sufficient amount of Healon (sodium hyaluronate) is slowly, and carefully introduced (using a cannula or needle into the anterior chamber.
Injection of Healon (sodium hyaluronate) can be performed either before or after delivery of the lens. Injection prior to lens delivery will, however, have the additional advantage of protecting the corneal endothelium from possible damage arising from the removal of the cataractous lens.5 Healon (sodium hyaluronate) may also be used to coat surgical instruments and the IOL prior to insertion.
Additional Healon (sodium hyaluronate) can be injected during surgery to replace any Healon (sodium hyaluronate) lost during surgical manipulation(see PRECAUTIONS section).
Glaucoma Filtration Surgery
In conjunction with performing of the trabeculectomy, Healon (sodium hyaluronate) is injected slowly and carefully through a corneal paracentesis to reconstitute the anterior chamber. Further injection of Healon (sodium hyaluronate) can be continued allowing it to extrude into the subconjunctival filtration site and through and around the sutured outer scleral flap.
Corneal Transplant Surgery
After removal of the corneal button, the anterior chamber is filled with Healon (sodium hyaluronate) . The donor graft can then be placed on top of the bed of Healon (sodium hyaluronate) and sutured in place. Additional Healon (sodium hyaluronate) maybe injected to replace the Healon (sodium hyaluronate) lost as a result of surgical manipulation (see PRECAUTIONS section). Healon (sodium hyaluronate) has also been used in the anterior chamber of the donor eye prior to transplantation to protect the corneal endothelial cells of the graft 5 .
Retinal Attachment Surgery
Healon (sodium hyaluronate) is slowly introduced into the vitreouscavity. By directing the injection, Healon (sodium hyaluronate) can be used to separate membranes (e.g. epiretinal membranes) away from the retina for safe excision and release of traction. Healon (sodium hyaluronate) also serves to maneuver tissues into the desired position, e.g. to gently push back a detached retina or unroll a retinal flap. and aids in holding the retina against the sclera for reattachment.
Healon (sodium hyaluronate) is a sterile, nonpyrogenic, viscoelastic preparation supplied in disposable glass syringes, delivering 0.85 mL, 0.55 mL or 0.4 mL sodium hyaluronate MO mg/mL dissolved in physiological sodium chloride phosphate buffer( pH 7.0-7.5). Each mL of Healon contains 10 mg of sodium hyaluronate, 8.5 mg sodium chloride, 0.28 mg of disodium hydrogen phosphate dihydrate, 0.04 mg of sodium dihydrogen phosphate hydrate and q.s. water for injection U.S.P. Healon (sodium hyaluronate) syringes are terminally sterilized and aseptically packaged.
A sterile single - use 27 G cannula is enclosed in the 0.4 mL,0.55 mL, and 0.85 mL boxes.
Refrigerated Healon (sodium hyaluronate) should be allowed to attain room temperature (approximately 30 minutes) prior to use.
For intraocular use.
Store at 2 to 8 ° C (35 to 47 ° F).
Protect from freezing.
Protect from light.
Federal law restricts this device to sale by or on the order of a physician.
1. Richter, W., Ryde, M. Zetterstrom, O.: Nonimmunogenicity of a purified sodium hyaluronate preparation in man. Int Arch Appl Immun 59:45-48(1979).
3. Balazs, E. A., Miller, D & Stegmann, R.: Viscosurgery and the use of Na-hyaluronate in intraocular lens implantation. Lecture, Cannes, France(1979).
4. Miller, D.& Stegmann, R: Use of Na-hyaluronate in anterior segment eye surgery. Am Intra-Ocular Implant Soc J 6 (980b) p 13-15.
5. Pape, L. G.& Balazs, E. A.: The use of sodium hyaluronate (Healon (sodium hyaluronate) ®) in human anterior segment surgery. Ophthalmol 87 (1980) p 699-705.
Pharmacia AB, Sweden
For: Pharmacia & Upjohn Company
A subsidiary of Pharmacia Corporation
Kalamazoo, MI 49001, USA
Revised: December 2002
Healon (sodium hyaluronate) ® is covered by
U.S. patent 4, 141, 973, (1979)
Copyright © 1996, Pharmacia Company.
All rights reserved
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Healon Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.