SUPRACOAT

Sodium Chondroitin Sulphate & Sodium Hyaluronate Ophthalmic Solution

DESCRIPTION:

SUPRACOAT is a sterile, non-pyrogenic, viscoelastic solution of a highly purified non- inflammatory medium molecular weight fraction of sodium chondroitin sulphate and sodium hyaluronate. SUPRACOAT solution is formulated to a viscosity of 20000 to 60000 cps (at shear rate of 2 sec.-1 25°C). Each mL of SUPRACOAT Solution contains not more than 40 mg sodium chondroitin sulphate and 17 mg sodium hyaluronate in a physiological buffer.
Sodium chondroitin sulphate and sodium hyaluronate are quite similar in regard to chemical and physical composition, as each occurs as a large, unbranched chain structure of medium to high molecular weight.

COMPOSITION:

Each ML Contains:

• Sodium chondroitin sulphate   USP ............40 mg
• Sodium hyaluronate     BP ............17 mg
• Aqueous Buffered Solution .............q.s.

INDICATION:

Viscoelastic Solution is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction. Ophthalmic viscoelastic solutions serve to maintain a deep anterior chamber during anterior segment surgery, thereby reducing trauma to the corneal endothelium and surrounding ocular tissues. They help to push back the vitreous face and prevent formation of a flat chamber postoperatively.

PHARMACOLOGICAL ACTION:

SUPRACOAT solution maintains a deep chamber during anterior segment surgeries, enhances visualization during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face, thus preventing formation of a postoperative flat chamber. The sugar moieties of these two compounds occur as repeating disaccharide subunits consisting of glucuronic acid in B 1-3 linkage with Nacetylglucosamine for sodium chondroitin sulphate and Nacetylglucosamine for sodium hyaluronate. The subunits are then combined by B 1-4 linkage of the amino sugar residue to the glucuronic residue of the next subunit to form large polymers. The two compounds differ in that sodium chondroitin sulphate possesses a sulphate group and a double, rather than a single, negative charge (as in the case of sodium hyaluronate) per repeating disaccharide subunit. Sodium chondroitin sulphate and sodium hyaluronate are biological polymers centered in the extra-cellular matrix of animals and humans. The cornea is the ocular tissue having the greatest concentration of sodium chondroitin sulphate, while the vitreous and aqueous humor contain the greatest concentration of sodium hyaluronate. SUPRACOAT solution is completely transparent and exhibits flow properties.

CONTRA-INDICATIONS:

There are no contra-Indications recorded on using SUPRACOAT, If Used as recommended. CLINICAL APPLICATIONS: In surgery involving the anterior segment, SUPRACOAT should be carefully and slowly injected into the anterior chamber using a sterile single-use Luer lock canula (in no case a reusable cannula should be used, even if it is well cleaned, rinsed and re-sterilized since it could release particles during injection) SUPRACOAT is injected before the capsulorhexis procedure, so that its protective effect will be optimized. At this stage of the surgery, SUPRACOAT protects the endothelium of the cornea from potential damage by surgical instruments. SUPRACOAT may be injected into the anterior chamber several times during surgery to replace the product lost during the surgical procedure. At the end of the surgery, SUPRACOAT should be aspiration with sterile irrigating solution.

DOSAGE AND DIRECTIONS FOR USE:

FOR INTRAOCULAR USE ONLY
FOR SINGLE USE ONLY
NOT FOR IV/IM INJECTION

SUPRACOAT should be allowed to attain room temperature prior to use. The syringe assembly is designed only for the injection of the SUPRACOAT viscoelastic solution it contains. Use of the syringe assembly for aspiration is not advised. When left in the eye, endothelial loss can be expected to be lower. For cataract surgery and intraocular lens implantation SUPRACOAT solution should be carefully introduced (using a 27-gauge cannula) into the anterior chamber. SUPRACOAT solution may be injected into the chamber prior to or following delivery of the crystalline lens. Instillation of SUPRACOAT solution prior to lens delivery will provide additional protection to the corneal endothelium. Instillation of the solution at this point is significant in that a coating of SUPRACOAT solution may protect the corneal endothelium from possible damage arising from surgical instrumentation during the cataract extraction surgery. SUPRACOAT solution may also be used to coat an intraocular lens as well as the tips of surgical instruments prior to implantation surgery. Additional solution may be injected during anterior segment surgery to fully maintain the chamber or replace any solution lost during the surgical procedure. At the end of the surgical procedure SUPRACOAT solution may be removed from the eye by thoroughly irrigating and aspirating with a balanced salt solution. Alternatively SUPRACOAT solution may be left in the eye, when used as directed.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

Atransient rise in intraocular pressure may be expected due to the presence of sodium hyaluronate which has been shown to effect such a rise. The intraocular pressure should be carefully monitored and appropriate therapy instituted if significant increases occur. In high risk patients tonometry should be performed on the first and second post-operative days. Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium chondroitin sulphate and sodium hyaluronate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material.

WARNINGS:

Do not use if package is damaged. Do not resterilize. Resterilization on this product has not been validated. Discard remaining solution after single use. Do not freeze. Physical, chemical and microbiological parameters may not be guaranteed if SUPRACOAT is reused

PRESENTATION:

SUPRACOAT solution is a sterile, non-pyrogenic, 1 mL, viscoelastic preparation supplied in a disposable syringe with a threaded luer. Lock. A sterile 27-gauge, disposable, bent, blunt-tip cannula is provided separately.

SHELF LIFE:

24 Months

STORAGE INSTRUCTIONS:

Store between 10°C-25°C. Protect from light. The contents are sterile unless the package is opened or broken. Do Not Freeze. Keep Out of the Reach of Children.

NOTE:

For Use during surgery Do not exert more pressure on the plunger prior to removing the cannula from the eye. This is to avoid aspiration of air Bubbles into the cannula.