PROVISC® Intraocular Viscoelastic Injection
SCHEDULING STATUS:
S4
PROPRIETARY NAME
(and dosage form):
PROVISC® Intraocular Viscoelastic Injection
COMPOSITION:
Each mL of PROVISC® contains 10,0mg sodium hyaluronate.
PHARMACOLOGICAL CLASSIFICATION:
A.3. Connective tissue medicines.
PHARMACOLOGICAL ACTION:
PROVISC (sodium hyaluronate) viscoelastic preparation is a sterile, nonpyrogenic, high molecular weight, non-inflammatory highly purified fraction of sodium hyaluronate, dissolved in physiological sodium chloride phosphate buffer.
Sodium hyaluronate is a naturally occurring, high molecular weight polysaccharide, composed of sodium glucuronate and N-acetyl-glucosamine which forms a repeating unit by linking alternately beta 1-3 and beta 1-4 glycosidic bonds. As a biologic polymer it is found in various vertebrate connective tissues including aqueous and vitreous humor of the eye, synovial fluid, skin and umbilical cord.
PROVISC (sodium hyaluronate) serves to maintain a deep anterior chamber during anterior segment surgery allowing reduced trauma to the corneal endothelium and surrounding ocular tissues. The viscoelastic properties of PROVISC (sodium hyaluronate) help to push back the vitreous face and prevent formation of a flat chamber postoperatively.
INDICATIONS:
PROVISC (sodium hyaluronate) is indicated for use as a surgical aid in anterior segment surgical procedures including cataract extraction with intraocular lens (IOL) implantation.
CONTRA-INDICATIONS:
Allergy to any components in this preparation.
WARNINGS:
• For Intraocular Use only.
• Single Use only.
DOSAGE AND DIRECTIONS FOR USE:
Cataract Surgery –IOL Implantation:
A cannula or needle is used to slowly and carefully inject a sufficient amount of PROVISC (sodium hyaluronate) into the anterior chamber. The injection may be performed before or after delivery of the crystalline lens.
Sodium hyaluronate may also be used to coat surgical instruments and the intraocular lens prior to implantation.
Additional sodium hyaluronate can be injected during surgery to replace any sodium hyaluronate lost during surgical manipulation (see Precautions).
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
A transient rise in intraocular pressure has been reported in some cases. Postoperative inflammatory reactions such as hypopyon and iritis have been reported with the use of ophthalmic viscoelastic preparations, as well as incidents of corneal oedema and decompensation. Their relationship to the use of PROVISC (sodium hyaluronate) has not been established.
Refrigerated PROVISC should be allowed to attain room temperature prior to use.
Precautions:
Precautions normally associated with the surgical procedure should be observed.
Postoperative increases in intraocular pressure have been reported with sodium hyaluronate products. The IOP should be carefully monitored and appropriate therapy instituted if significant increases occur. Remove PROVISC (sodium hyaluronate) by irrigation and/or aspiration at the close of surgery. Do not refill the anterior chamber.
PROVISC (sodium hyaluronate) is obtained from microbial fermentation by a highly purified proprietary process. The physician should be aware of potential allergic risks that can occur with the injection of any biological material.
Do not reuse cannulas or syringes.
Use only if solution is clear.
Avoid trapping air bubble.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
None known.
IDENTIFICATION:
PROVISC is a clear, colourless, viscoelastic solution.
PRESENTATION:
Supplied in a sterile disposable glass syringe delivering 0,4mL or 0,65mL of PROVISC solution. PROVISC syringes are aseptically packaged in blister pack and terminally sterilized.
STORAGE INSTRUCTIONS:
Store in refrigerator (2-8°C). Protect from freezing. Protect from light. The contents are sterile unless the package is opened or broken.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
X/3/408
NAME AND BUSINESS ADDRESS OF APPLICANT:
Alcon Laboratories (SA) Pty/Ltd
Surrey Avenue
RANDBURG
2194
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
31 August 1990
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