INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo HEALON® Sterile solution for injection

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

HEALON® Sterile solution for injection

COMPOSITION:
Each mL contains 10 mg of
sodium hyaluronate in a physiological buffer.

PHARMACOLOGICAL CLASSIFICATION:
A. 3 Connective tissue medicines

PHARMACOLOGICAL ACTION:
HEALON
® 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. HEALON® 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 degradedand eliminated by metabolism.
HEALON
® acts as a scavenger by neutralizing the free radicals formed during cataract surgery using phacoemulsification.
Introduction of HEALON
® into the anterior or posterior chamber keeps tissues separated during operative procedures and protects them from trauma from other tissues or instruments.
The anterior chamber depth is maintained and vitreous bulge can be reduced. HEALON
® protects corneal endothelial cells and other ocular structures, and may decrease the incidence of synechiae and adhesions.
HEALON
® does not interfere with the healing process.

INDICATIONS:
Surgical procedures on the eye, including intra-ocular lens insertion, intra and extra capsular lens extraction, glaucoma surgery, corneal graft, surgery for accidental trauma, retinal detachment and vitreal replacement procedures.

CONTRA-INDICATIONS:
None known.

DOSAGE AND DIRECTIONS FOR USE:
HEALON
® is injected through a fine cannula into the eye. The amount varies with the type of surgery, repeated injections may be required.
The total amount introduced is usually less than 1 mL in anterior segment surgery and 2-4 mL in posterior segment surgery.
A transient rise in intraocular pressure may be seen postoperatively. To minimise this risk it is recommended that HEALON
® is irrigated/aspirated out of the eye at the close of surgery.
Prophylactic pressure-lowering treatment should be considered in cases with glaucoma or in cases where HEALON
® for some reason is left in the eye.
HEALON
® is easy to inject as the viscosity decreases considerably when expelled through a cannula. HEALON® is easy to remove from the anterior segment.
Cataract surgery
A sufficient volume of HEALON
® is gently introduced into the anterior chamber at an early stage during surgery prior to lens extraction to protect the tissue from trauma.
Intraocular lens insertion
HEALON
® is introduced into the anterior chamber before lens extraction and is also used to coat the lens and instruments prior to insertion in the eye. Further HEALON® may be injected during surgery to replace any HEALON® lost.
Glaucoma filtration surgery
Prior to trabeculectomy HEALON
® is injected slowly through a corneal paracentesis to maintain the anterior chamber volume. Injection may be continued to allow HEALON® to flow through the sutured outer scleral flap to the conjunctival filtration site.
Corneal transplant surgery
After removal of the corneal button the anterior chamber is filled with HEALON
®. The donor graft is then placed on the bed of HEALON® and sutured into place. HEALON® may be put into the anterior chamber of the donor eye to protect the corneal endothelium cells of the graft.
Trauma
In various kinds of perforating trauma HEALON
® can be instilled to refill the anterior chamber of the eye, and avoid prolapse of the iris and synechiae formation.
Blood contaminated HEALON
® should be replaced with new HEALON® before closure.
Retinal detachment surgery
After draining the subretinal fluid, HEALON
® is slowly injected into the vitreous cavity to push back the retina and avoid a decrease in the intra-ocular pressure.
Vitrectomy
HEALON
® is injected into the vitreous cavity to replace the vitreous body.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
A transient rise in intraocular pressure has been reported. The peak of this pressure rise may be expected 4-8 hours postoperatively.
The anterior chamber should not be over-filled with HEALON
® except in glaucoma surgery.
At the close of surgery some of the HEALON
® should be removed by irrigation and/or aspiration (except in glaucoma surgery).
Intra-ocular pressure should be carefully monitored during the post-operative period and any excessive rises treated with appropriate therapy.
Because HEALON
® is extracted from avian tissues, despite rigorous purification procedures minute amounts of protein are present, and thus the remote possibility of idiosyncratic reactions remains.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF IT'S TREATMENT:
None known

IDENTIFICATION:
Syringe containing 0,4 mL or 0,55 mL of a clear sterile, non-pyrogenic solution.

PRESENTATION:
Box with 1 sterile, aseptically packed syringe containing 0,4 mL or 0,55 mL HEALON
®.

STORAGE INSTRUCTIONS:
Store at 2°C to 8°C. Protect from light and from freezing.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
H/3/292

NAME AND BUSINESS ADDRESS OF APPLICANT:
Genop Healthcare (Pty) Ltd
30 New Road (Entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
19 March 2003

Updated on this site: September 2009
Source: Pharmaceutical Industry

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