August 24, 2016
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Healon

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Healon

Indications
Dosage
How Supplied

INDICATIONS

Uses

The Healon OVD 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 the Healon OVD serves to maintain a 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 the Healon OVD serves as a surgical aid to gently separate, maneuver and hold tissues.The Healon OVD creates a clear field of vision thereby facilitating intra- and post-operative inspection of the retina and photocoagulation.

DOSAGE AND ADMINISTRATION

Applications

Cataract Surgery - IOL Implantation

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

Injection of the Healon OVD 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 lens5.The Healon OVD may also be used to coat surgical instruments and the IOL prior to insertion.

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

Glaucoma Filtration Surgery

In conjunction with performing of the trabeculectomy, the Healon OVD is injected slowly and carefully through a corneal paracentesis to reconstitute the anterior chamber. Further injection of the Healon OVD 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 the Healon OVD.The donor graft can then be placed on top of the bed of Healon OVD and sutured in place.Additional Healon OVD may be injected to replace the Healon OVD lost as a result of surgical manipulation (see PRECAUTIONS section).The Healon OVD has also been used in the anterior chamber of the donor eye prior to trepanation to protect the corneal endothelial cells of the graft5.

Retinal Attachment Surgery

The Healon OVD is slowly introduced into the vitreous cavity. By directing the injection, the Healon OVD can be used to separate membranes (e.g. epiretinal membranes) away from the retina for safe excision and release of traction.The Healon OVD 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.

Instructions

Sterile Opening Technique

Tear off the paper covering.

Bend the plastic backwards at the central indentation so as to fully expose the white plastic rod.

Dislodge syringe and place onto sterile field.

Dislodge syringe and place onto sterile field - Illustration1

Assembly

Assembly - Illustration1

Press the vial completely into the holder so that the needle perforates the membrane.

Important

Perforate the membrane before screwing on the plastic rod.

Perforate the membrane before screwing on the plastic rod - Illustration1

Remove the plastic rod.

Remove the plastic rod - Illustration1

Screw the plastic rod into the blue plunger.

Screw the plastic rod into the blue plunger  - Illustration1

Connect the cannula and check for proper function.

Store at 2 to 8°C (36 to 46°F). For single use only

HOW SUPPLIED

The Healon OVD is a sterile, nonpyrogenic, viscoelastic preparation supplied in disposable glass syringes, delivering 0.85 mL, 0.55 mL or 0.4 mL sodium hyaluronate (10 mg/mL) dissolved in physiological sodium chloride phosphate buffer (pH 7.0-7.5). Each mL of Healon OVD 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 dihydrate and q.s. water for injection U.S.P.The Healon OVD 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 OVD should be allowed to attain room temperature (approximately 30 minutes) prior to use.

For intraocular use.

Store at 2 to 8°C (36 to 46°F).
Protect from freezing.
Protect from light.

Caution

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

Definition of symbols on cannula, syringe-, blister label and carton.

Definition of symbols on cannula, syringe-, blister label and carton  - Illustration1

REFERENCES

1. Richter,W., Ryde, M. & Zetterström, 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 (1980b) 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 47 (1974) p 211-217.

Manufactured by: AMO Uppsala AB, Rapsgatan 7, Box 6406, SE-751 36 Uppsala, Sweden. Revised: May 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 8/16/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

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