Healon 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 serves to maintaina deep anterior chamber during surgery, allowing for efficient manipulation with less trauma to the corneal endothelium and other surrounding tissues.

Furthermore, its viscoelasticity helps to push back the vitreous face and prevent formation of a postoperative flat chamber.

In posterior segment surgery Healon serves as a surgical aid to gently separate, maneuver and hold tissues. Healon creates a clear field of vision thereby facilitating intra- and postoperative inspection of the retina and photocoagulation.

Applications

Cataract Surgery-IOL Implantation

A sufficient amount of Healon is slowly, and carefully introduced (using a cannula or needle into the anterior chamber.

Injection of Healon 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 may also be used to coat surgical instruments and the IOL prior to insertion.

Additional Healon can be injected during surgery to replace any Healon lost during surgical manipulation(see PRECAUTIONS section).

Glaucoma Filtration Surgery

In conjunction with performing of the trabeculectomy, Healon is injected slowly and carefully through a corneal paracentesis to reconstitute the anterior chamber. Further injection of Healon 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. The donor graft can then be placed on top of the bed of Healon and sutured in place. Additional Healon maybe injected to replace the Healon lost as a result of surgical manipulation (see PRECAUTIONS section). Healon 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 is slowly introduced into the vitreouscavity. By directing the injection, Healon can be used to separate membranes (e.g. epiretinal membranes) away from the retina for safe excision and release of traction. Healon 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 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 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 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.

Caution

Federal law restricts this device to sale by or on the order of a physician.

REFERENCES

1. Richter, W., Ryde, M. Zetterstrom, O.: Nonimmunogenicity of a purified sodium hyaluronate preparation in man. Int Arch Appl Immun 59:45-48(1979).

2. Balazs, E. A.: Ultrapure hyaluronic acid and the use thereof. U.S. Patent 4,141, 973(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^®) in human anterior segment surgery. Ophthalmol 87 (1980) p 699-705.

6.Richter, W.: Non-immunogenicity of purified hyaluronic acid preparations tested by passive cutaneous anaphylaxis. Int Arch All 47119741 p 211-217.

Manufactured by
Pharmacia AB, Sweden
For: Pharmacia & Upjohn Company
A subsidiary of Pharmacia Corporation
Kalamazoo, MI 49001, USA

Revised: December 2002

Healon® is covered by
U.S. patent 4, 141, 973, (1979)
Copyright © 1996, Pharmacia Company.
All rights reserved

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