BSS Sterile Irrigating Solution

Generic Name: sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and sodium citrate
Dosage Form: ophthalmic solution

BSS®
Sterile Irrigating Solution
(balanced salt solution)

DESCRIPTION

BSS® 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 7.5. The osmolality is approximately 300 mOsm/Kg.

CLINICAL PHARMACOLOGY

BSS® 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 outer overwrap is intact, product is clear, seal is intact and bag is undamaged.

• Do not use if product is discolored or contains a precipitate.

• SINGLE patient use only. The contents of this bag 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 and edema following ocular surgery in which BSS® 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. Follow directions of the particular administration set to be used. Remove the outer overwrap. Clean and disinfect the rubber stopper by using a sterile alcohol wipe. Insert the spike aseptically into the bag through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before irrigation begins.

HOW SUPPLIED

BSS® Sterile Irrigating Solution is supplied in a clear polypropylene bag using a grey butyl stopper and aluminum seal packaged in a clear, multilayered plastic outer overwrap.

500 mL in a bag: NDC 0065-1795-04.

STORAGE: Store at 36° - 77°F (2° - 25°C). DO NOT FREEZE.

Rx Only

9003544-0409

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

© 2000-2007 Alcon, Inc.

Printed in USA

PRINCIPAL DISPLAY PANEL

SINGLE PATIENT USE ONLY

Rx Only                  NDC 0065-1795-04

BSS®

Sterile Irrigating Solution

(balanced salt solution)

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 7.5. The osmolality is approximately 300 mOsm/Kg.

NOT FOR I.V. USE

Read accompanying insert.

WARNINGS: NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless outer overwrap is intact, product is clear, seal is intact and bag is undamaged. Do not use if product is discolored or contains a precipitate. Discard unused contents. Do not use this bag for more than one patient. Do not use additives with this product. Tissue damage could result if other drugs are added to product. STORAGE: Store at 36° - 77°F (2° - 25°C). DO NOT FREEZE.

STERILE           500 mL

Alcon Laboratories, Inc.

Fort Worth, Texas 76134 USA

Printed in USA

© 2008 Alcon, Inc.

BSS 
balanced salt solution solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0065-1795
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 6.4 mg  in 1 mL
POTASSIUM CHLORIDE (POTASSIUM CATION) POTASSIUM CHLORIDE 0.75 mg  in 1 mL
CALCIUM CHLORIDE (CALCIUM CATION) CALCIUM CHLORIDE 0.48 mg  in 1 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION) MAGNESIUM CHLORIDE 0.3 mg  in 1 mL
SODIUM ACETATE (SODIUM CATION) SODIUM ACETATE 3.9 mg  in 1 mL
SODIUM CITRATE (SODIUM CATION) SODIUM CITRATE 1.7 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
WATER  
Packaging
# Item Code Package Description
1 NDC:0065-1795-04 500 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020742 03/28/1969
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Operations
Alcon Laboratories, Inc. 008018525 MANUFACTURE
Revised: 07/2011
 
Alcon Laboratories, Inc.
Hide
(web5)