BSS PLUS

Alcon Laboratories, Inc.
Alcon Laboratories, Inc.

STERILE INTRAOCULAR IRRIGATING SOLUTION

FULL PRESCRIBING INFORMATION: CONTENTS*

• BSS PLUS DESCRIPTION SECTION
• CLINICAL PHARMACOLOGY SECTION
• INDICATIONS & USAGE SECTION
• BSS PLUS CONTRAINDICATIONS SECTION
• WARNINGS SECTION
• PRECAUTIONS SECTION
• BSS PLUS ADVERSE REACTIONS SECTION
• OVERDOSAGE SECTION
• DOSAGE & ADMINISTRATION SECTION
• HOW SUPPLIED SECTION
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

DESCRIPTION SECTION

BSS PLUS® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extracapsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery.

Part I: Part I is a sterile 480 mL solution in a 500 mL single-dose bottle to which the Part II concentrate is added. Each mL of Part I contains: sodium chloride 7.44 mg, potassium chloride 0.395 mg, dibasic sodium phosphate 0.433 mg, sodium bicarbonate 2.19 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

Part II: Part II is a sterile concentrate in a 20 mL single-dose vial for addition to Part I. Each mL of Part II contains: calcium chloride dihydrate 3.85 mg, magnesium chloride hexahydrate 5 mg, dextrose 23 mg, glutathione disulfide (oxidized glutathione) 4.6 mg, in water for injection.

After addition of BSS PLUS Part II to the Part I bottle, each mL of the reconstituted product contains: sodium chloride 7.14 mg, potassium chloride 0.38 mg, calcium chloride dihydrate 0.154 mg, magnesium chloride hexahydrate 0.2 mg, dibasic sodium phosphate 0.42 mg, sodium bicarbonate 2.1 mg, dextrose 0.92 mg, glutathione disulfide (oxidized glutathione) 0.184 mg, hydrochloric acid and/or sodium hydroxide (to adjust pH), in water for injection.

The reconstituted product has a pH of approximately 7.4. Osmolality is approximately 305 mOsm.

CLINICAL PHARMACOLOGY SECTION

None of the components of BSS PLUS are foreign to the eye, and BSS PLUS has no pharmacological action. Human perfused cornea studies have shown BSS PLUS to be an effective irrigation solution for providing corneal detumescence and maintaining corneal endothelial integrity during intraocular perfusion. An in vivo study in rabbits has shown that BSS PLUS is more suitable than normal saline or Balanced Salt Solution for intravitreal irrigation because BSS PLUS contains the appropriate bicarbonate, pH, and ionic composition necessary for the maintenance of normal retinal electrical activity. Human in vivo studies have demonstrated BSS PLUS to be safe and effective when used during surgical procedures such as pars plana vitrectomy, phacoemulsification, cataract extraction/lens aspiration, anterior segment reconstruction. No differences have been observed between adults and pediatric patients following use of this drug product.

INDICATIONS & USAGE SECTION

BSS PLUS is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.

CONTRAINDICATIONS SECTION

There are no specific contraindications to the use of BSS PLUS; however, contraindications for the surgical procedure during which BSS PLUS is to be used should be strictly adhered to.

WARNINGS SECTION

For IRRIGATION during ophthalmic surgery only. Not for injection or intravenous infusion. Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged. Do not use if product is discolored or contains a precipitate.

PRECAUTIONS SECTION

DO NOT USE BSS PLUS UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. BSS PLUS does not contain a preservative; therefore, do not use this container for more than one patient. Do not use additives other than BSS PLUS Concentrate Part II (20 mL) with this product. Tissue damage could result if other drugs are added to product. DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed.

There have been reports of corneal clouding or edema following ocular surgery in which BSS PLUS was used as an irrigating solution. As in all surgical procedures appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

Preparation: Reconstitute BSS PLUS® Intraocular Irrigating Solution just prior to use in surgery. Follow the same strict aseptic procedures in the reconstitution of BSS PLUS as is used for intravenous additives. Remove the blue flip-off seal from the BSS PLUS Part I (480 mL) bottle. Remove the blue flip-off seal from the BSS PLUS Part II (20 mL) vial. Clean and disinfect the rubber stoppers on both containers by using sterile alcohol wipes. Transfer the contents of the Part II vial to the Part I bottle using a BSS PLUS Vacuum Transfer Device (provided). An alternative method of solution transfer may be accomplished by using a 20 mL syringe to remove the Part II solution from the vial and transferring exactly 20 mL to the Part I container through the outer target area of the rubber stopper. An excess volume of Part II is provided in each vial. Gently agitate the contents to mix the solution. Place a sterile cap on the bottle. Remove the tear-off portion of the label. Record the time and date of reconstitution and the patient's name on the bottle label.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS SECTION

Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the use of BSS PLUS has not been established.

OVERDOSAGE SECTION

The solution has no pharmacological action and thus no potential for overdosage. However, as with any intraocular surgical procedure, the duration of intraocular manipulation should be kept to a minimum.

DOSAGE & ADMINISTRATION SECTION

The solution should be used according to the standard technique employed by the operating surgeon. Use an administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow the directions for the particular administration set to be used. Insert the spike aseptically into the bottle through the center target area of the rubber stopper. Allow the fluid to flow to remove air from the tubing before intraocular irrigation begins. If a second bottle is necessary to complete the surgical procedure, ensure that the vacuum is vented from the second bottle BEFORE attachment to the administration set.

HOW SUPPLIED SECTION

BSS PLUS is supplied in two packages for reconstitution prior to use: a 500 mL glass bottle containing 480 mL (Part I) and a 20 mL glass vial (Part II); both using grey butyl stoppers and aluminum seals with polypropylene flip-off caps. See the PRECAUTIONS section regarding reconstitution of the solution.

NDC 0065-0800-50.

Storage: Store Part I and Part II at 2° - 25°C (36° - 77°F). DO NOT FREEZE. Discard prepared solution after six hours.

Rx Only

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA
©2002-2003 Alcon, Inc.
340252-0803

BSS PLUS®
STERILE INTRAOCULAR IRRIGATING SOLUTION
(balanced salt solution enriched with bicarbonate, dextrose, and glutathione)

RECONSTITUTION INSTRUCTIONS

DIRECTIONS: Use Aseptic Technique