Description: Healon®5 is a sterile, non-pyrogenic, transparent viscoelastic preparation of a highly purified, noninflammatory, high molecular weight (average molecular weight 4 million) of sodium hyaluronate. Healon5 contains 23 mg/mL of sodium hyaluronate 5000, dissolved in 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 hyaluronates derived from various human or animal tissues do not differ chemically.
The fraction of sodium hyaluronate in Healon5 is reported to be nonantigenic 1,3 and does not cause inflammatory 2 or foreign body reactions.
The graph below represents the flow curve (shear viscosity versus shear rate).
The viscosity of Healon5 at rest (at zero shear rate) is about 7 million mPas, a viscosity higher than Healon and HealonGV. At high shear rates, such as during injection, the viscosity of Healon5 decreases dramatically due to high pseudoplasticity, facilitating injection through a 25G cannula.
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Indications: Healon5 is intended for use in anterior segment ophthalmic surgical procedures of the human eye. Healon5 is designed to create and maintain a deep anterior chamber which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. 4 Healon5 also can be used to efficiently separate and control ocular tissues.
Healon5 is not designed to have any pharmacological effect.
Contraindications: There are no known contraindications to the use of Healon5 when used as recommended.
Precautions: Precautions normally considered during ophthalmic surgical procedures should be taken.
Special care should be taken to ensure complete removal of Healon5 from the entire eye including behind the lens and the chamber angles. Complete removal of Healon5 is important to avoid intraocular pressure peaks postoperatively. Due to the greater viscosity and higher concentration of sodium hyaluronate in Healon5, the rise in the postoperative intraocular pressure may be higher with Healon5 than if the same volume of other sodiumhyaluronate viscoelastic products, with lower zero shear viscosity, is left in the anterior segment of the eye.
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. Prophylactic pressure-lowering treatment should always be considered and especially in cases where Healon5 has to be left in the eye for clinical reasons.
Both the Rock'n Roll technique and the "Behind the Lens" or the Two Compartment Technique (TCT) were evaluated during the clinical trial. The table below reflects IOPs >/=30 mm Hg at 5 hours postoperatively in association with removal technique.
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As a result of clinical experience, the following removal technique (TCT) is recommended to ensure efficient removal of Healon5:
Use a standard I/A tip, 0.3 mm, with effectual flow of 20-25 ml/min and vacuum of 250-300 mmHg with a potential maximum setting at 500 mmHg. When using a machine with a peristaltic pump, use the upper limits of the suggested settings. When using a Venturi pump use the lower limits of the suggested settings. Bottle height should be 60-70 cm above eye level.
An alternative technique to remove Healon5 is to create maximum turbulene to makeHealon®5 fracture into large pieces. This can be accomplished by using the Rock'n Roll technique (described below) with standard I/A tip, 0.3 mm, with high settings; flow rates should be 25-30 ml/min and vacuum 350-500 mmHg, depending on the type of pump. If a peristaltic pump is used, the vacuum should be set towards the higher limit.
If a venturi pump is used, the vacuum should be set towards the lower limit. Bottle height should be 60-70 cm above eye level. Today's phaco machines often use linear control. The suggested machine settings can only be achieved if the surgeon operates the phaco machine with fully depressed foot pedal.
Healon5 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 Healon5 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. In-vitro studies have shown incompatibility, resulting in opalescence, between sodiumhyaluronate and solutions containing cationic components, e.g., detergents and benzalkonium chloride.
Reprocessed cannulas should not be used.
Do not use if the blister package has been damaged.
Do not resterilize.
Healon5 is for single use.
Adverse Events: Increased intraocular pressure has been reported after use of sodium hyaluronate solutions.
Increased intraocular pressure is likely to occur if Healon5 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 occurrence 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.
A clinical trial of Healon5 was initiated on August 23 rd , 1999. A total of 359 patients were included. 187 patients with a mean age of 74.1 years were randomized into the Healon5 group and 172 into the Healon group with a mean age of 73.2 years.
The intraocular pressure (IOP) was assessed at 5 hours after surgery, since the expected IOP peak time period is 4-6 hours after surgery. The IOP was measured also at 24 hours and 7 days. No anti-glaucoma medication was permitted until after the 5-hour IOP assessment.
Eleven percent of the Healon5 patients and 10% of the Healon patients experienced IOP spikes >/=30 mmHg at 5 hours postoperatively.
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There was no difference seen between the two groups with regard to the mean IOP at 5 hours after surgery and no difference in mean change. The increase was of the same magnitude in both groups. At 7 days postoperatively, the mean IOP was at pre-operative levels in both study groups.
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The specified complications were similar for both groups. All of the complications are commonly seen after cataract surgery. Blurred vision, scratchy sensation, foreign body sensation, itching, burning, tenderness, coreal oedema, represented most of the complications recorded in both groups.
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Iritis was equally distributed between the two groups.
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Two Healon5 events were scored as possibly device related by the investigators.
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The difference in percent change in endothelial cell counts between the Healon5 and Healon has been investigated in another clinical study. The endothelial cell count evaluation included 81 patients in the Healon5 group and 78 in the Healon group. The mean age in the Healon5 group was 69.9 years and in the Healon group 68.9 years.
No difference was observed between the treatment groups with regard to the change from pre-operative values to the values determined at 3 months after surgery. The percentage cell loss in the Healon5 group was 9.4 and in the Healon group 11.2%.
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How Supplied: Healon5 is sterile, non-pyrogenic, viscoelastic preparation supplied in disposable 0.6 mL glass syringe. Each mL of Healon5 contains:
23 mg sodium hyaluronate 5000
8.5 mg sodium chloride
0.28 mg disodium hydrogen phosphate dihydrate
0.04 mg sodium dihydrogen phosphate monohydrate
q.s. water for injection
Healon5 syringes are terminally steam sterilized and aseptically packaged.
A sterile single-use, 25 gauge cannula is included with each syringe.
Refrigerated Healon5 should be held at room temperature for approximately 30 minutes before use. Store between 2° to 8°C (35°-47°F). Protect from freezing and exposure to light.
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= Exp. date:
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= Lot No.:
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= For single use only.
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= Method of sterilization using steam or dry heat.
Rx only
Caution: Federal (US) law restricts this device to sale by or on the order of a physician.
Manufactured by:
Pharmacia & Upjohn AB
SWEDEN
Manufactured for:
Pharmacia & Upjohn Company
Kalamazoo, MI 49001 USA
Revised: June 2000
Patent Pending PCT SE98/00 401
Healon5 is a trademark of Pharmacia & Upjohn AB.
All rights reserved.