Your browser does not support JavaScript! BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.]
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BALANCED SALT (sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and sodium citrate) solution
[B. Braun Medical Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

DESCRIPTION

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

Balanced Salt Solution Sterile Irrigating 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 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.

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

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

Balanced Salt Solution Sterile Irrigating Solution is supplied in a glass bottle using a gray butyl stopper and aluminum closure with a tear tab.

NDCREFSize
Balanced Salt Solution Sterile Irrigating Solution
0264-2514-10S2514-10500 mL

STORAGE

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.

 

Rx Only

Issued: November 2009

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

Y36-002-712

PRINCIPAL DISPLAY PANEL - 500 mL Label

Balanced Salt Solution

Sterile Irrigating Solution

NDC 0264-2514-10
REF S2514-10

500 mL

NOT FOR I.V. USE
SINGLE USE ONLY

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

PRINCIPAL DISPLAY PANEL - 500 mL Label
BALANCED SALT 
sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and sodium citrate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0264-2514
Route of AdministrationIRRIGATIONDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Chloride (SODIUM CATION) Sodium Chloride6.4 mg  in 1 mL
Potassium Chloride (POTASSIUM CATION) Potassium Chloride0.75 mg  in 1 mL
Calcium Chloride (CALCIUM CATION) Calcium Chloride0.48 mg  in 1 mL
Magnesium Chloride (MAGNESIUM CATION) Magnesium Chloride0.3 mg  in 1 mL
Sodium Acetate (SODIUM CATION) Sodium Acetate3.9 mg  in 1 mL
Sodium Citrate (SODIUM CATION) Sodium Citrate1.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Hydroxide 
Hydrochloric Acid 
Water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0264-2514-1012 in 1 CASE
1500 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09138702/03/2010
Labeler - B. Braun Medical Inc. (002397347)
Establishment
NameAddressID/FEIBusiness Operations
B Braun Medical Inc037425308MANUFACTURE

Revised: 1/2011
 
B. Braun Medical Inc.

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