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CLINICAL PHARMACOLOGY 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.

Find Lowest Prices on PROVISC® (1% Sodium Hyaluronate) Viscoelastic Preparation DESCRIPTION PROVISC® (sodium hyaluronate) Viscoelastic Preparation 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 contains active 10.0mg sodium hyaluronate; 0.56mg dibasic sodium phosphate, anhydrous; 0.04mg monobasic sodium phosphate; 8.4mg sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH and water for injection.

INDICATIONS PROVISC (sodium hyaluronate) Viscoelastic Preparation is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction and intraocular lens (IOL) implantation. PROVISC (sodium hyaluronate) Viscoelastic Preparation 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) Viscoelastic Preparation help to push back the vitreous face and prevent formation of a flat chamber postoperatively. DOSAGE AND ADMINISTRATION No information provided. HOW SUPPLIED PROVISC (sodium hyaluronate) is a sterile, non-pyrogenic, viscoelastic preparation(sodium hyaluronate, 10mg/mL, dissolved in physiological sodium chloride phosphate buffer) supplied in disposable glass syringes delivering 0.55mL or 0.85mL. Each mL of PROVISC Viscoelastic Preparation contains 10mg sodium hyaluronate; 0.56mg dibasic sodium phosphate, anhydrous; 0.04mg monobasic sodium phosphate; 8.4mg sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH and QS water for injection. PROVISC (sodium hyaluronate) syringes are aseptically packaged in blister packs and terminally sterilized. STORAGE RECOMMENDATIONS Store in refrigerator (2° †? 8°C, 36° †? 46°F). Protect from freezing. Protect from light. Refrigerated PROVISC (sodium hyaluronate) Viscoelastic Preparation should be allowed to attain room temperature prior to use (approximately 20 †? 40 minutes depending on quantity).

PATIENT INFORMATION No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

OVERDOSE No information provided. CONTRAINDICATIONS At present there are no known contraindications to the use of PROVISC (sodium hyaluronate) Viscoelastic Preparation when used as recommended; care should be used in patients with hypersensitivity to any components in this material (see Precautions).

SIDE EFFECTS PROVISC (sodium hyaluronate) Viscoelastic Preparation is extremely well-tolerated after injection into human eyes during ophthalmic surgical procedures. As with most viscoelastic ophthalmic preparations, 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 edema and corneal decompensation. Their relationship to the use of sodium hyaluronate (PROVISC (sodium hyaluronate) ) has not been established. DRUG INTERACTIONS No information provided.