BALANCED SALT- sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and sodium citrate solution 
B. Braun Medical Inc.

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Balanced Salt Solution
Sterile Irrigating Solution

DESCRIPTION

Balanced Salt Solution Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl2·2H2O) 0.048%, magnesium chloride hexahydrate (MgCl2·6H2O) 0.03%, sodium acetate trihydrate (C2H3NaO2·3H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O7·2H2O) 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.

CLINICAL PHARMACOLOGY

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

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

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.

ADVERSE REACTIONS

Irrigation or any other trauma 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.

DOSAGE AND ADMINISTRATION

The irrigating solution should be used according to standard format for each surgical procedure. Note: Use an administration set with an air-inlet in the plastic spike since the bottle does not contain a separate airway tube. Follow directions of the particular administration set to be used. Remove the plastic cap of the Flip off closure. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.

HOW SUPPLIED

Balanced Salt Solution Sterile Irrigating Solution is supplied in a glass bottle using a gray butyl stopper and Flip off closure to close it.

NDC REF Size
 Balanced Salt Solution Sterile Irrigating Solution
 0264-2514-10 S2514-10 500 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.

Rx Only

Revised: November 2019

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Y36-002-943 LD-661-1

PRINCIPAL DISPLAY PANEL - 500 mL Label

Balanced Salt Solution

Sterile Irrigating Solution

REF S2514-10

NDC 0264-2514-10

500 mL

NOT FOR I.V. USE
SINGLE USE ONLY

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Each mL contains: sodium chloride 0.64%, potassium chloride  0.075%,
calcium chloride •2H2O 0.048%, magnesium chloride •6H2O  0.03%,
sodium acetate •3H2O 0.39%, sodium citrate •2H2O 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 product is clear, seal is intact, vacuum is present 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. Do no use additives with this product. Tissue
damage could result if other drugs are added to product.

See package insert.

STERILE              SINGLE DOSE UNIT

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.

Rx Only

Y37-002-524 LD-662-1

S2514-10 Container Label
 

BALANCED SALT 
sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and sodium citrate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0264-2514
Route of AdministrationIRRIGATION
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE6.4 mg  in 1 mL
POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE0.75 mg  in 1 mL
CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CHLORIDE0.48 mg  in 1 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CHLORIDE0.3 mg  in 1 mL
SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM ACETATE3.9 mg  in 1 mL
SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE1.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0264-2514-1012 in 1 CASE02/03/2010
1500 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09138702/03/2010
Labeler - B. Braun Medical Inc. (002397347)

Revised: 3/2021
Document Id: 13dc6558-1af4-41c1-8002-4e22cac44710
Set id: f47d4c31-8871-74dd-2e13-52af971a69e0
Version: 5
Effective Time: 20210308
 
B. Braun Medical Inc.