Label: BALANCED SALT- sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and trisodium citrate dihydrate solution
- NDC Code(s): 17478-921-95
- Packager: Akorn, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated February 2, 2015
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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
- INDICATIONS AND USAGE
- 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.
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
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.
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.
Principal Display Panel Text for Container Label:
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
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)