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Sodium Hyaluronate (ProVisc)
PROVISC® viscoelastic material is a sterile, non-pyrogenic,
high molecular weight, noninflammatory highly purified fraction of sodium
hyaluronate, dissolved in physiological sodium chloride phosphate buffer.
Each mL of PROVISC® viscoelastic material contains active
10.0 mg sodium hyaluronate; 0.56 mg dibasic sodium phosphate, anhydrous;
0.04 mg monobasic sodium phosphate; 8.4 mg sodium chloride; hydrochloric
acid and/or sodium hydroxide to adjust pH and water for injection.
Characteristics Sodium hyaluronate is a high molecular weight polysaccharide, composed
of sodium glucuronate and N-acetyl-glucosamine which forms a repeating
disaccharide unit by linking alternately beta 1-3 and beta 1-4 glycosidic
bonds. The 1 % viscous and transparent material, PROVISC®,
is a specific fraction of sodium hyaluronate, developed as an aid in ophthalmic
surgery. It acts as a space occupying fluid that is replaced by the body’s
natural fluids.
PROVISC® viscoelastic material is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction and intraocular lens (IOL) implantation. Ophthalmic viscoelastic materials serve to maintain a deep anterior chamber during anterior segment surgery allowing reduced 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.
Cataract Surgery - IOL Implantation A cannula or needle is used to slowly and carefully inject a sufficient amount of PROVISC® material into the anterior chamber. The injection may be performed before or after removal of the crystalline lens. PROVISC® viscoelastic material may also be used to coat surgical instruments and the intraocular lens prior to implantation. Additional PROVISC® viscoelastic material can be injected during surgery to replace any PROVISC® viscoelastic material lost during surgical manipulation (see Precautions section). HOW SUPPLIED PROVISC® is a sterile, non-pyrogenic, viscoelastic material (sodium hyaluronate, 10 mg/mL, dissolved in physiological sodium chloride phosphate buffer) supplied in disposable glass syringes delivering 0.4 mL, 0.55 mL or 0.85 mL. Each mL of PROVISC® material contains 10.0 mg sodium hyaluronate; 0.56 mg dibasic sodium phosphate, anhydrous; 0.04 mg monobasic sodium phosphate; 8.4 mg sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH and OS water for injection. PROVISC® syringes are aseptically packaged in blister packs and terminally sterilized. Refrigerated PROVISC® viscoelastic material should be allowed to attain room temperature prior to use (approximately 20-40 minutes depending on quantity). Store in refrigerator (2- 8° C, 36- 46° F). CAUTION: Federal (USA) law restricts this device to sale by or
on the order of a physician.
(a) PROVISC® material is tolerated after injection into human eyes during ophthalmic surgical procedures. As with most viscoelastic ophthalmic materials, a transient rise in intraocular pressure has been reported in some cases. (b) Postoperative inflammatory reactions such as hypopyon and iritis have been reported with the use of ophthalmic viscoelastic materials, as well as incidents of corneal edema and corneal decompensation. Their relationship to the use of sodium hyaluronate (PROVISC®) has not been established.
No information provided.
No information provided.
(a) Precautions normally associated with anterior segment surgical procedures should be observed. (b) 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. (c) It is recommended that PROVISC® material be removed by irrigation and/or aspiration at the close of surgery. Do not overfill the anterior chamber. (d) PROVISC® material is obtained from microbial fermentation by a purified proprietary process. Although precautions have been taken to make this device protein-free and it has been tested in animals for allergenic response, this device, used in susceptible persons, may produce allergenic responses. (e) In addition to the above, the following precautions should be observed:
(f) This Product Contains Dry Natural Rubber.
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