VISCOAT® Intraocular Viscoelastic Injection
(and dosage form):
VISCOAT® Intraocular Viscoelastic Injection
VISCOAT is a sterile, non-pyrogenic, viscoelastic solution of a highly purified non-inflammatory medium molecular weight fraction of sodium chondroitin sulphate and sodium hyaluronate. VISCOAT solution is formulated to a viscosity of 40000 ± 20000 cps (at shear rate of 2 sec.-1 25°C). Each mL of VISCOAT Solution contains not more than 40 mg sodium chondroitin sulphate and 30 mg sodium hyaluronate in a physiological buffer. The osmolality of VISCOAT solution is 325 mOsm. ± 40 mOsm; the pH is 7,2 ± 0,2.
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. Sodium chondroitin sulphate has a mean molecular weight of approximately 22 500 daltons, while sodium hyaluronate exhibits a molecular weight of over 500 000 daltons.
A. 3 Conductive Tissue Medicines.
VISCOAT 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 ß 13 linkage with N-acetylglucosamine for sodium chondroitin sulphate and N-acetylglucosamine for sodium hyaluronate. The subunits are then combined by ß 14 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.
VISCOAT solution is completely transparent and exhibits flow properties.
VISCOAT solution is indicated for use as a surgical aid in anterior segment procedures including cataract extraction and intraocular lens implantation.
Sensitivity to any of the components.
DOSAGE AND DIRECTIONS FOR USE:
FOR INTRAOCULAR USE ONLY
BOTH VISCOAT AND CANNULA ARE FOR SINGLE USE ONLY
VISCOAT should be allowed to attain room temperature prior to use.
The syringe assembly is designed only for the injection of the VISCOAT 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 VISCOAT solution should be carefully introduced (using a 27-gauge cannula) into the anterior chamber.
VISCOAT solution may be injected into the chamber prior to or following delivery of the crystalline lens. Instillation of VISCOAT 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 VISCOAT solution may protect the corneal endothelium from possible damage arising from surgical instrumentation during the cataract extraction surgery. VISCOAT 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 VISCOAT solution may be removed from the eye by thoroughly irrigating and aspirating with a balanced salt solution. Alternatively, VISCOAT solution may be left in the eye, when used as directed.
For Directions for Use, see below.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
A transient 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 hyaluronate and sodium chondroitin sulphate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects above.
CONDITIONS OF REGISTRATION:
Advertising to the professionals only.
VISCOAT is a colourless, transparent viscoelastic solution.
VISCOAT solution is a sterile, non-pyrogenic, 0,5 mL, viscoelastic preparation supplied in a disposable syringe with a threaded luer tip. A sterile 27-gauge, disposable, bent, blunt-tip cannula is provided separately. The cannula sheath should be used to firmly attach the cannula to the syringe.
Store between 2°8°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
NAME AND BUSINESS ADDRESS OF APPLICANT:
Alcon Laboratories (S.A.) (Pty) Ltd
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
DIRECTIONS FOR USE - SYRINGE ACTIVATION
NOTICE: THIS VISCOAT® DELIVERY SYSTEM IS NOT DESIGNED OR INTENDED TO BE ATTACHED TO REUSABLE (METAL-HUBBED) INSTRUMENTS OR TO DISPOSABLE INSTRUMENTS OTHER THAN THE ONE PROVIDED WITH THE PRODUCT.
1. PEEL LID FROM BLISTER PACK UNDER ASEPTIC CONDITIONS.
2. .REMOVE CAP FROM SYRINGE TIP (CAP IS ON TIGHTLY).
3. INJECT VISCOAT INTO THE CANNULA HUB UNTIL IT IS 3/4 FULL.
CANNULA (WITH PLASTIC SHEATH STILL IN PLACE) .
4. INSTALL THE STERILE 27-GAUGE CANNULA TWIST INTO PLACE AS TIGHTLY AS POSSIBLE.
5. REMOVE PLASTIC SHEATH FROM CANNULA.
6. GENTLY PUSH PLUNGER ROD TO EXPEL AIR BUBBLES FROM SYRINGE TIP AND CANNULA.
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