HEALON® 5 (Sterile solution for injection)
(and dosage form):
HEALON® 5 (Sterile solution for injection)
Each mL contains 23 mg of sodium hyaluronate 5000 in a physiological buffer.
A.3 Connective Tissue Medicines.
Sodium hyaluronate is a visco-elastic polymer normally found in the aqueous and vitreous humour. Sodium hyaluronate occurs naturally on the corneal endothelium, bound to specific receptors. Sodium hyaluronate has a high affinity for the receptors.
The natural sodium hyaluronate layer on the corneal endothelium is reduced during irrigation, but can be restored by exogenous sodium hyaluronate. Sodium hyaluronate is degraded and eliminated by metabolism.
Sodium hyaluronate acts as a scavenger by neutralising the free radicals formed during cataract surgery using phacoemulsification (ultrasound).
The introduction of sodium hyaluronate creates and maintains a deep anterior chamber which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues.
Introduction of sodium hyaluronate into the anterior chamber keeps tissues separated during operative procedures and protects them from trauma from other tissues or instruments.
Sodium hyaluronate does not interfere with the healing process.
Sodium hyaluronate is eliminated in the same way as endogenous hyaluronate in the anterior chamber, i.e. via the trabecular meshwork. Upon entering the general circulation hyaluronate is rapidly eliminated by metabolising in the liver.
Surgical procedures in the anterior segment of the eye.
No known contra-indications to the use of HEALON® 5.
Interaction with other medicines has not been investigated in humans.
PREGNANCY AND LACTATION
The safety of HEALON® 5 for use in human pregnancy has not been established. Evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to the development of the embryo or foetus, the course of gestation and peri- and postnatal development.
DOSAGE AND DIRECTIONS FOR USE
HEALON® 5 is injected through a fine cannula into the eye. The amount varies with the type of surgery, repeated injections may be required. One syringe of 0,6 mL is usually sufficient in anterior chamber surgery.
HEALON® 5 should be thoroughly irrigated or aspirated out of the eye at the close of cataract surgery.
Special care should be taken to ensure complete removal of HEALON® 5 from the entire eye including the area behind the lens and the anterior chamber angles.
HEALON® 5 is easy to inject as the viscosity decreases considerably when expelled through a cannula.
Instructions for use
Press the vial downwards into the holder so that the needle perforates the membrane. Remove the plastic cap (syringe housing) and screw the plastic cap into the blue plunger. Connect the cannula and check for proper function. Refer to attached instruction sheet.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The following side effects have been reported and the frequencies are unknown:
A transient rise in intra-ocular pressure may be seen post-operatively. A transient myopic shift may occur if the product is not completely removed from the capsular bag.
Complete removal of HEALON® 5 is important to avoid intra-ocular pressure peaks post-operatively. Due to the greater viscosity and higher concentration of sodium hyaluronate in HEALON® 5, the rise in the post-operative may be higher with HEALON® 5 than if the same volume of other sodium hyaluronate visco-elastic products, with lower zero shear viscosity, is left in the anterior segment.
Prophylactic pressure-lowering treatment should always be considered in glaucoma patients.
In cases where HEALON® 5 has to be left in the eye for clinical reasons, prophylactic pressure-lowering treatment should also be considered.
Before initiating phacoemulsification, use irrigation/aspiration to create a fluid-filled space above the lens. This reduces the risk of initial visco-occlusion of the phaco tip or the irrigation line, which could cause phaco tip heating.
In-vitro studies have shown incompatibility, resulting in opalescence, between hyaluronate and solutions containing cationic components, e.g. detergents and benzalkonium chloride.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Glass syringe containing 0,6 mL of a clear, colourless and highly viscous liquid.
Glass cylinder sealed with a rubber diaphragm and an aluminium capsule with a rubber plunger. The glass cylinder is placed in a luer lock holder consisting of a syringe housing and a rod. A sterile single-use 25 G cannula is also supplied.
Store at 2°C - 8°C. Protect from freezing. Protect from light. HEALON® 5 must be allowed to reach room temperature (25°C) prior to use.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Genop Healthcare (Pty) Ltd
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
DATE OF PUBLICATION OF THE PACKAGE INSERT
7 December 2006
New addition to this site: September 2009
Source: Pharmaceutical Industry
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