DailyMed Label: Balanced Salt

DailyMed Label: Balanced Salt

2024

DailyMed Prescription

Balanced Salt

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

B. Braun Medical Inc.

NDC: 0264-1945

NDC: 0264-1945

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.

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.

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.

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.

Irrigation or any other trauma to the corneal endothelium may result in corneal swelling or bullous keratopathy.

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

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

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 Y94-003-436 Y94-003-436