BALANCED SALT- sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and trisodium citrate dihydrate solution

Balanced Salt by

Drug Labeling and Warnings

Balanced Salt by is a Prescription medication manufactured, distributed, or labeled by Akorn, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Balanced Salt Solution is a sterile physiological solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (CaCl22H2O) 0.048%, magnesium chloride hexahydrate (MgCl26H2O) 0.03%, sodium acetate trihydrate (C2H3NaO23H2O) 0.39%, sodium citrate dihydrate (C6H5Na3O72H2O) 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 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

• 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.
• SINGLE patient use only. The contents of this bottle should not be used in more than one patient.
• This solution contains no preservative, unused contents should be discarded.

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

This 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 flip-off cap. 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 grey butyl stopper and aluminum seal with a polypropylene flip-off cap.

NDC: 17478-921-95          500 mL in a 570 mL container.

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DO NOT FREEZE.

AKORN

Manufactured for: Akorn, Inc.
Lake Forest, IL 60045

Made in Austria

BSA0N Rev. 10/16

Principal Display Panel Text for Container Label:

NDC: 17478-921-95

Balanced Salt Solution

Sterile Irrigating Solution

NOT FOR INTRAVENOUS USE SINGLE-DOSE UNIT

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.

The pH is approximately 7.0.

The osmolality is approximately 300 mOsm/Kg.

STERILE 500 mL Rx Only

INGREDIENTS AND APPEARANCE

BALANCED SALT 
sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and trisodium citrate dihydrate solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 17478-921
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
sodium chloride (UNII: 451W47IQ8X) (chloride ion - UNII:Q32ZN48698, sodium cation - UNII:LYR4M0NH37)	sodium chloride	6.4 mg  in 1 mL
potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152, chloride ion - UNII:Q32ZN48698)	potassium chloride	0.75 mg  in 1 mL
calcium chloride (UNII: M4I0D6VV5M) (calcium cation - UNII:2M83C4R6ZB, chloride ion - UNII:Q32ZN48698)	calcium chloride	0.48 mg  in 1 mL
magnesium chloride (UNII: 02F3473H9O) (magnesium cation - UNII:T6V3LHY838, chloride ion - UNII:Q32ZN48698)	magnesium chloride	0.3 mg  in 1 mL
sodium acetate (UNII: 4550K0SC9B) (acetate ion - UNII:569DQM74SC, sodium cation - UNII:LYR4M0NH37)	sodium acetate	3.9 mg  in 1 mL
trisodium citrate dihydrate (UNII: B22547B95K) (anhydrous citric acid - UNII:XF417D3PSL)	anhydrous citric acid	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: 17478-921-95	1 in 1 BOTTLE	11/27/2014
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	ANDA075503	11/27/2014

Labeler - Akorn, Inc. (062649876)