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

1. Akornbalanced Salt Solution
2. Description
3. Clinical Pharmacology
4. Indications And Usage
5. Warnings
6. Precautions
7. Adverse Reactions
8. Dosage And Administration
9. How Supplied:

Akornbalanced Salt Solution  ⮝

Rx only

Description  ⮝

BALANCED SALT SOLUTION is a sterile physiological solution containing calcium chloride (CaCl2 2H2O), magnesium chloride (MgCl2 6H2O), potassium chloride (KCl), sodium acetate (C2H3NaO2 3H2O), sodium chloride (NaCl) and sodium citrate (C6H5Na3O7 2H2O). This solution is isotonic to ocular tissue and contains electrolytes required for normal cellular metabolic functions. Each 1 mL contains:

Calcium Chloride	(MW 147.02)	0.48 mg
Magnesium Chloride	(MW 203.31)	0.30 mg
Potassium Chloride	(MW 74.56)	0.75 mg
Sodium Acetate	(MW 136.08)	3.90 mg
Sodium Chloride	(MW 58.44)	6.40 mg
Sodium Citrate	(MW 294.10)	1.70 mg
Hydrochloric Acid and/or Sodium Hydroxide added to adjust pH.
Water for Injection 7.0 pH and 300 mosm/kg osmolality.

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, 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.

Prior to use, check the following: tip should be firmly in place, irrigating needle should be properly seated; squeeze out several drops before inserting into anterior chamber. The needle should be removed from the anterior chamber prior to releasing pressure to prevent suction.

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 to the corneal endothelium may result in corneal swelling or bullous keratopathy. Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

Dosage And Administration  ⮝

18 mL bottle: The adaptor plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the bottle as explained below. External irrigation may be done without the irrigating needle.

Method for Using Adaptor Plug for Ophthalmic Irrigating Needle:

1. Aseptically remove bottle from pouch by peeling backing.
2. Snap on surgeon's sterile irrigation needle. Push until firmly in place.
3. Test assembly for proper function before use.

How Supplied:  ⮝

NDC 17478-920-19 18 mL bottle

STORAGE: Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat and do not allow to freeze.

AKORN
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
BLA0N Rev. 10/16

Principal Display Panel Text for Container Label:

NDC 17478-920-19 Akorn Logo

BALANCED

SALT SOLUTION

Rx only

NOT FOR INJECTION

OR INTRAVENOUS USE.

18 mL Sterile Single Dose Bottle

Principal Display Panel Text for Carton Label:

NDC 17478-920-19 Akorn Logo

BALANCED SALT SOLUTION

30 Sterile Single Dose Bottles (18 mL each)

NOT FOR INJECTION OR INTRAVENOUS USE.

BALANCED SALT calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-920 Route of Administration OPHTHALMIC

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) Potassium Chloride 0.75 mg in 1 mL Sodium Acetate (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Acetate 3.90 mg in 1 mL Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride 6.40 mg in 1 mL Sodium Citrate (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Citrate 1.70 mg in 1 mL

Inactive Ingredients Ingredient Name Strength Hydrochloric Acid (UNII: QTT17582CB) Sodium Hydroxide (UNII: 55X04QC32I) Water (UNII: 059QF0KO0R)

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17478-920-19 1 in 1 POUCH 09/27/2006 1 18 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075503 09/27/2006

Labeler - Akorn, Inc. (062649876)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc.		155135783	MANUFACTURE(17478-920) , REPACK(17478-920) , ANALYSIS(17478-920) , LABEL(17478-920) , PACK(17478-920) , RELABEL(17478-920) , STERILIZE(17478-920)

Revised: 12/2016 Document Id: 7a763507-bb84-469b-985a-f083120a717a 34391-3 Set id: b691c782-98e8-4689-8ae3-e7bc30e46785 Version: 6 Effective Time: 20161208 Akorn, Inc.