Balanced Salt

ADVERSE REACTIONS Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy. Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

DESCRIPTION Balanced Salt Solution Sterile Irrigating Solution is a sterile balanced salt solution in 500 mL single-dose EXCEL ® flexible containers. Each mL contains sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl 2 ·2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 ·6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 ·3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 ·2H 2 O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. The pH is approximately 7.0. The osmolality is approximately 300 mOsm/Kg. The EXCEL ® plastic container is made from a multilayered film. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.

DOSAGE AND ADMINISTRATION The irrigating solution should be used according to standard format for each surgical procedure. Follow directions of the particular administration set to be used. Allow the fluid to flow and remove air from the tubing before irrigation begins.

INDICATIONS AND USAGE For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

WARNINGS NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless overwrap is intact, product is clear, seal is intact, and container is undamaged. Do not use if product is discolored or contains a precipitate. SINGLE patient use only. The contents of this container should not be used in more than one patient. This solution contains no preservative, unused contents should be discarded.

CLINICAL PHARMACOLOGY Balanced Salt Solution Sterile Irrigating Solution is an isotonic solution for use in irrigating tissues of the eyes.

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Balanced Salt Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate SODIUM CHLORIDE SODIUM CATION POTASSIUM CHLORIDE POTASSIUM CATION CALCIUM CHLORIDE CALCIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION SODIUM ACETATE SODIUM CATION SODIUM CITRATE SODIUM CATION SODIUM HYDROXIDE HYDROCHLORIC ACID WATER

ANDA091387

Balanced Salt

Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate

0264-1945

HUMAN PRESCRIPTION DRUG

IRRIGATION

PRINCIPAL DISPLAY PANEL - 500 mL Label Balanced Salt Solution Sterile Irrigating Solution NOT FOR INTRAVENOUS USE SINGLE USE ONLY REF L2514 NDC 0264-1945-10 500 mL EXCEL® CONTAINER Each mL contains sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl 2 ·2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 ·6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 .3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 ·2H 2 O) 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. pH: approximately 7.0; Osmolality: approximately 300 mOsm/Kg WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless overwrap is intact, product is clear, seal is intact, and container is undamaged. Do not use if product is discolored or contains a precipitate. Discard unused contents. Do not use this container for more than one patient. See package insert. Storage: Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from freezing. Not made with natural rubber latex, PVC or DEHP. Rx only Y94-003-436 LD-720-1 EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 500 mL Container Label 500 mL Container Label

Y36-003-042 LD-721-1 Package Insert EXCEL® CONTAINER Rx only

HOW SUPPLIED Balanced Salt Solution Sterile Irrigating Solution is supplied in sterile and nonpyrogenic 500 mL single-dose EXCEL ® flexible containers with clear overwrap, 24 per case. Not made with natural rubber latex, PVC or DEHP. NDC REF Size Balanced Salt Solution Sterile Irrigating Solution 0264-1945-10 L2514 500 mL

STORAGE Store at 20–25°C (68–77°F). Excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: August 2021 EXCEL ® is a registered trademark of B. Braun Medical Inc.

PRECAUTIONS Open under aseptic conditions only. 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 Balanced Salt Solution Sterile Irrigating Solution was used as an irrigating solution.