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

Logo HEALON® GV (Sterile solution for injection)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

HEALON® GV (Sterile solution for injection)

COMPOSITION:
Each mL contains 14 mg
sodium hyaluronate in a physiological buffer.

PHARMACOLOGICAL CLASSIFICATION:
A 3 Connective tissue medicines

PHARMACOLOGICAL ACTION:
HEALON GVis a sterile, non-pyrogenic solution of a highly purified high molecular weight fraction of sodium hyaluronate extracted from animal tissue, dissolved in a physiological buffer. The average molecular weight of sodium hyaluronate, a visco-elastic polymer in HEALON
®GV is 5 million.

INDICATIONS:
Surgical procedures in the anterior segment of the eye, including intra-ocular lens insertion, intra and extra capsular lens extraction, glaucoma surgery, corneal graft and surgery for accidental trauma.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients.

DOSAGE AND DIRECTIONS FOR USE:
Cataract surgery
A sufficient volume of HEALON
®GV is gently introduced into the anterior chamber at an early stage during surgery prior to lens extraction to protect the tissues from trauma.
Intraocular lens insertion
HEALON
®GV 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®GV may be injected during surgery to replace any HEALON®GV lost.
Glaucoma filtration surgery
Prior to trabeculectomy HEALON
®GV is injected slowly through a corneal paracentesis to maintain the anterior chamber volume. Injection may be continued to allow HEALON®GV 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 GV. The donor graft is then placed on the bed of HEALON GV and sutured into place. HEALON GV 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 GV can be instilled to refill the anterior chamber of the eye, and avoid prolapse of the iris and synechiae formulation.
Blood contaminated HEALON GV should be replaced with new HEALON GV before closure.
Directions for use
Refer enclosed instruction sheet.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
A rise in intraocular pressure has been reported. Post-operative inflammatory reactions have been reported which are considered to be caused by surgical procedures.
The anterior chamber should not be over-filled with HEALON GV except in glaucoma surgery.
At the close of surgery some of the HEALON GV 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 GV is extracted from avian tissues, despite rigorous purification procedures minute amounts of protein are present, and thus the possibility of idiosyncratic reactions remains.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
None known.

IDENTIFICATION:
Syringe containing 0,55 mL or 0,85 mL of a clear, colourless and highly viscous sterile, non-pyrogenic solution.

PRESENTATION:
Carton with 1 sterile, aseptically packed syringe containing 0,55 mL or 0,85 mL of HEALON GV.

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

REGISTRATION NUMBER:
HEALON GV: 27/3/0061

NAME AND BUSINESS ADDRESS OF THE 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:
4 March 1993

Updated on this site: September 2009
Source: Pharmaceutical Industry

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