Label: BALANCED SALT- sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and sodium citrate solution
- NDC Code(s): 0264-2514-10
- Packager: B. Braun Medical Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 18, 2018
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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
- INDICATIONS AND USAGE
- NOT FOR INJECTION OR INTRAVENOUS INFUSION.
- Do not use unless 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 bottle should not be used in more than one patient.
- The use of additives with this solution may cause corneal decompensation.
- This solution contains no preservative, unused contents should be discarded.
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
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 aluminum tab. 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
PRINCIPAL DISPLAY PANEL - 500 mL Label
Balanced Salt Solution
Sterile Irrigating Solution
NOT FOR I.V. USE
SINGLE USE ONLY
B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA
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
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.
INGREDIENTS AND APPEARANCE
sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and sodium citrate solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0264-2514 Route of Administration IRRIGATION Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6.4 mg in 1 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 0.75 mg in 1 mL CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CHLORIDE 0.48 mg in 1 mL MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CHLORIDE 0.3 mg in 1 mL SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM ACETATE 3.9 mg in 1 mL SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE 1.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROCHLORIC ACID (UNII: QTT17582CB) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0264-2514-10 12 in 1 CASE 02/03/2010 1 500 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091387 02/03/2010 Labeler - B. Braun Medical Inc. (002397347)