Product Information
Description: 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.
Indications: 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.
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:
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:
14mg sodium hyaluronate 7000
8.5mg sodium chloride
0.28mg disodium hydrogen phosphate dihydrate
0.04mg sodium dihydrogen phosphate monohydrate
q.s. water for injection USP
Healon GV syringes are terminally sterilized and aseptically packaged. A sterile single-use, 27 gauge cannula is included with each syringe.
Refrigerated Healon GV should be held at room temperature for approximately 30 minutes before use. Protect from freezing and exposure to light.
For intraocular use. |
Store between 2-8°C.
References :
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.