BALANCED SALT- sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and trisodium citrate dihydrate solution Akorn, Inc. ------M080082/00 US BALANCED SALT SOLUTION sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and sodium citrate solution
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 (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 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 BALANCED SALT sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and trisodium citrate dihydrate solution
Product Information Product T ype HUMAN PRESCRIPTION DRUG Ite m Code (Source ) NDC:17478 -9 21
Route of Administration OPHTHALMIC
Active Ingredient/Active Moiety Basis of Ingredient Name Strength Strength so dium chlo ride (UNII: 451W47IQ8 X) (chlo ride io n - UNII:Q32ZN48 6 9 8 , so dium catio n - 6 .4 mg so dium chlo ride UNII:LYR4M0 NH37) in 1 mL po ta ssium chlo ride (UNII: 6 6 0 YQ9 8 I10 ) (po tassium catio n - UNII:29 5O53K152, chlo ride io n - po tassium 0 .75 mg UNII:Q32ZN48 6 9 8 ) chlo ride in 1 mL ca lcium chlo ride (UNII: M4I0 D6 VV5M) (calcium catio n - UNII:2M8 3C4R6 ZB, chlo ride io n - 0 .48 mg calcium chlo ride UNII:Q32ZN48 6 9 8 ) in 1 mL ma g nesium chlo ride (UNII: 0 2F3473H9 O) (magnesium catio n - UNII:T6 V3LHY8 38 , chlo ride io n - magnesium 0 .3 mg UNII:Q32ZN48 6 9 8 ) chlo ride in 1 mL so dium a ceta te (UNII: 4550 K0 SC9 B) (acetate io n - UNII:56 9 DQM74SC, so dium catio n - 3.9 mg so dium acetate UNII:LYR4M0 NH37) in 1 mL anhydro us citric 1.7 mg triso dium citra te dihydra te (UNII: B22547B9 5K) (anhydro us citric acid - UNII:XF417D3PSL) acid in 1 mL
Inactive Ingredients Ingredient Name Strength so dium hydro xide (UNII: 55X0 4QC32I) hydro chlo ric a cid (UNII: QTT1758 2CB) wa ter (UNII: 0 59 QF0 KO0 R) Packaging Marketing Start Marketing End # Item Code Package Description Date Date NDC:17478 -9 21- 1 1 in 1 BOTTLE 11/27/20 14 9 5 50 0 mL in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n 1 Pro duct
Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date ANDA ANDA0 7550 3 11/27/20 14
Labeler - Akorn, Inc. (117696770)
Registrant - Akorn Operating Company LLC (117693100)
Revised: 10/2020 Akorn, Inc.