Product Information

:   Healon GV is a sterile, non-pyrogenic, transparent viscoelastic preparation of a highly purified, noninflammatory, high molecular weight (average = 5 million daltons) fraction of sodium hyaluronate. Healon GV contains 14 mg/ml of sodium hyaluronate 7000, dissolved in a physiological sodium chloride-phosphate buffer (pH 7.0-7.5). This polymer consists of repeating disaccharide units of N-acetylglucosamine and sodium glucuronate linked by glycosidic bonds.

Sodium hyaluronate is a physiological substance that is widely distributed in the extracellular matrix of connective tissues in both animals and man. For example, it is present in the vitreous and aqueous humor of the eye, the synovial fluid, the skin and the umbilical cord. Sodium hyaluronate derived from various human or animal tissues do not differ chemically.

:   Healon GV is indicated for use in anterior segment ophthalmic surgical procedures.

Healon GV creates and maintains a deep anterior chamber, to facilitate manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. Healon GV also can be used to efficiently maneuver, separate and control ocular tissues.

Contraindications :   There are no known contraindications to the use of Healon GV when used as recommended.

Precautions :   Precautions normally considered during ophthalmic surgical procedure should be taken.

Postoperative intraocular pressure may be increased if Healon GV is left in the eye. Due to the greater viscosity of Healon GV, this increase in postoperative IOP may be higher than that caused by leaving the same amount of other sodium hyaluronate viscoelastic products, with lower zero shear viscosity, in the anterior chamber. Since rises in postoperative intraocular pressure, including cases of significant elevation and subsequent complications, have been reported, the following precautions are strongly recommended.

--Special care should be taken to ensure as complete removal as possible by continuing to irrigate/aspirate after you see displacement of the initial bolus of viscoelastic from the eye; continued irrigation/aspiration should facilitate removal of viscoelastic which may remain in the anterior segment.

--Pre-existing glaucoma, other causes of compromised outflow, higher preoperative intraocular pressure and complications in surgical procedures also may lead to increased intraocular pressure; consequently, extra care should be taken in patients with these conditions.

--Carefully monitor intraocular pressure, particularly during the early postoperative period.

--Treat with appropriate intraocular pressure lowering therapy, if required.

Healon GV is a highly purified fraction extracted from avian tissues which may contain minute amounts of protein. The potential risks associated with the injection of biological material should be considered.

Express a small amount of Healon GV from the syringe prior to use and carefully examine it during use to avoid injecting minute rubber particles which may be released when the syringe diaphragm is punctured.

Sodium hyaluronate solution may appear cloudy or form precipitates when it is injected. Based on in vitro laboratory studies, this phenomenon may be related to interactions with concomitantly used ophthalmic medications or detergents which remain in reused cannulas. Avoid reuse of cannulas.

Adverse Events:   Increased intraocular pressure has been reported after use of Healon GV:

--Increased intraocular pressure is likely to occur if Healon GV is not removed as completely as possible. Clinical judgment concerning the use of this product should be considered in cases where thorough removal may not be possible. The Precautions noted above should be taken to manage any increased postoperative intraocular pressure and to reduce the likelihood of occurence of related postoperative complications such as optic neuropathy, pupillary atonia and dilation, and iris atrophy.

Rarely, postoperative, inflammatory reactions (iritis, hypopyon, endophthalmitis) following the use of sodium hyaluronate, as well as incidents of corneal edema and corneal decompensation, have been reported. Their relationship to sodium hyaluronate has not been established.

How Supplied :   Healon GV is a sterile, non-pyrogenic viscoelastic preparation supplied in disposable 0.85 ml and 0.55 ml glass syringes. Each ml of Healon GV contains:

Healon GV syringes are terminally sterilized and aseptically packaged. A sterile single-use, 27 gauge cannula is included with each syringe.

Preparation and Storage

Refrigerated Healon GV should be held at room temperature for approximately 30 minutes before use. Protect from freezing and exposure to light.

Store between 2-8°C.

References :

1.Balazs, E.A.: Ultrapure hyaluronic acid and the use thereof. U.S. patent 4,141,973 (1979).

2.Fry L.L. & Yee R.W. (1993): Healon GV in extracapsular cataract extraction with intraocular lens implantation. Cataract Refract. Surg, 19:409-412.

3.Gaskel A. & Haining W. (1991): A double blind randomized multicentre clinical trial of "Healon GV," compared with "Healon" in ECCE with IOL implantation. Eur J. Implant Ref. Surg. 3:241.

Caution: Federal (US) law restricts this device to sale by or on the order of a physician.

Manufactured By:

Pharmacia AB

Sweden

Manufactured For:

Pharmacia & Upjohn Inc.

7000 Portage Road

Kalamazoo, MI 49001

U.S. patent 4,141,973, 1979.

Copyright© 1994 Pharmacia Inc. Ophthalmics

Healon GV is a trademark of Pharmacia Inc. Ophthalmics

All rights reserved.                                    February 1994.