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Amvisc Plus (Bausch & Lomb)
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Description: AMVISC® PLUS is a sterile nonpyrogenic solution of sodium hyaluronate.
AMVISC® PLUS contains 16 mg/mL of sodium hyaluronate dissolved in a physiological sodium chloride phosphate buffer solution (pH 6.8 - 7.6). In the limit of zero shear rate (1), the viscosity is 132,000 cP (132 Pa s) at 25°C and the osmolality is approximately 340 milliosmoles.
Characteristics: Sodium hyaluronate is a high molecular weight polysaccharide composed of sodium glucuronate and N-acetylglucosamine. Sodium hyaluronate is ubiquitously distributed throughout the tissues of the body and is present in high concentrations in such tissues as vitreous humor, synovial fluid, umbilical cord and the dermis of rooster combs. Sodium hyaluronate functions as a tissue lubricant (1,2) and it is thought to play an important role in modulating the interactions between adjacent tissues. It can also act as a viscoelastic support maintaining a separation between tissues. Sodium hyaluronate prepared from different materials may have different molecular weights but is thought to have the same chemical structure. Sodium hyaluronate is also elaborated by certain bacteria as a protective substance. Those bacteria may be cultured by fermentation process to yield sodium hyaluronate. The sodium hyaluronate in AMVISC® PLUS is prepared from the dermis of rooster combs (2). It has a molecular weight greater than 1,000,000, is reported to be nonantigenic (3,4), does not cause foreign body reactions, is nonpyrogenic and is well tolerated in human eyes (5). AMVISC® PLUS does not interfere with normal wound healing processes.
Indications: AMVISC® PLUS is indicated for use as a surgical aid in ophthalmic anterior (6) and posterior (5) segment procedures including · extraction of a cataract · implantation of an intraocular lens (IOL) · corneal transplantation surgery · glaucoma filtering surgery · surgical procedures to reattach the retina.
Because of its lubricating and viscoelastic properties, transparency and ability to protect corneal endothelial cells (7), AMVISC® PLUS helps maintain anterior chamber depth and visibility, minimizes interaction between tissues, and acts as a tamponade and vitreous substitute during retina reattachment surgery. AMVISC® PLUS also preserves tissue integrity and good visibility when used to fill the anterior and posterior segments of the eye following open sky procedures.
Contraindications: At the present time there are no contraindications to the use of AMVISC® PLUS when used as a surgical aid in ophthalmic surgical procedures.
Precautions: Those precautions normally considered during anterior segment and retina reattachment procedures are recommended.
There may be increased intraocular pressure following surgery (8) caused by preexisting glaucoma or by the surgery itself. For these reasons the following precautions should be considered.
Adverse Reactions: Sodium hyaluronate is a natural component of the tissues of the body and is extremely well tolerated in human eyes. Transient postoperative inflammatory reactions were reported in clinical trials (5) and oral and topical steroid preparations were administered. AMVISC® PLUS is tested in animals to determine that each batch is essentially noninflammatory. Since sodium hyaluronate molecules are noninflammatory, any phlogistic response is considered to be caused by the surgical procedures. The best index of the degree of phlogistic response is the postoperative clarity of the vitreous cavity. As outlined above transient postoperative increase in intraocular pressure has been observed following the use of sodium hyaluronate in anterior segment surgery. On rare occasions postoperative reactions including inflammation, corneal edema and corneal decompensation have been reported. The relationship to the use of AMVISC® PLUS has not been established.
Adverse Reaction Reporting: Adverse reactions and/or potentially sight-threatening complications that may be reasonably regarded as AMVISC® PLUS related and that were not previously expected in nature, severity or degree of incidence should be reported to Bausch & Lomb Surgical at 800-338-2020 or 909-971-5100. Outside the USA call your customer service affiliate.
How Supplied: AMVISC® PLUS is a sterile viscoelastic preparation supplied in a disposable glass syringe delivering either 0.5 mL or 0.8 mL of sodium hyaluronate dissolved in physiological sodium chloride phosphate buffer solution. Each mL of AMVISC® PLUS contains 16 mg of sodium hyaluronate. Sodium hydroxide and/or hydrochloric acid are added to adjust pH (if necessary). AMVISC® PLUS is sterile filtered and aseptically transferred to syringes. The filled syringes are sealed and final package sterilized (R). Contents of unopened and undamaged pouches are sterile. Refrigerated AMVISC® PLUS should be allowed to reach room temperature (approximately 20 to 45 minutes, depending on volume) prior to use.
For Intraocular Use: Store at 2-8°C. Protect from freezing.
Caution: Federal U.S. law restricts this device to sale by or on the order of a physician.
Bausch & Lomb Incorporated
Rochester, NY 14609 U.S.A.
EU Authorised Representative: Bausch & Lomb Incorporated
Regent Park · Kingston Road
Leatherhead KT22, 7PQ UK
®/ Trademarks of Bausch & Lomb Incorporated
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PO11-602-01 PIN 555-200 Rev. 12/96