BSS
Summary of product characteristics
Adverse Reactions
ADVERSE REACTIONS Irrigation or any other trauma to the corneal endothelium 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.
Description
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 (CaCl 2 •2H 2 O) 0.048%, magnesium chloride hexahydrate (MgCl 2 •6H 2 O) 0.03%, sodium acetate trihydrate (C 2 H 3 NaO 2 •3H 2 O) 0.39%, sodium citrate dihydrate (C 6 H 5 Na 3 O 7 •2H 2 O) 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.
Dosage And Administration
DOSAGE AND ADMINISTRATION The adapter plug is designed to accept an irrigating needle. Tissues may be irrigated by attaching the needle to the DROP-TAINER ® bottle as explained below. External irrigation may be done without the irrigating needle. Method of using Adapter Plug for LUER-LOK ® Hub Ophthalmic Irrigating Needle: 1. Aseptically remove DROP-TAINER bottle from blister by peeling paper backing. 2. Snap on surgeon's sterile irrigation needle. Push until firmly in place and twist slightly. 3. Test assembly for proper function before use. NOTE: LUER-LOK is a registered trademark of Becton, Dickinson and Company.
Indications And Usage
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
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. • This solution contains no preservative, unused contents should be discarded.
Clinical Pharmacology
CLINICAL PHARMACOLOGY BSS Sterile Irrigating Solution is an isotonic solution for use in irrigating tissues of the eyes.
Effective Time
20230526
Version
14
Spl Product Data Elements
BSS balanced salt solution SODIUM CHLORIDE SODIUM CATION POTASSIUM CHLORIDE POTASSIUM CATION CALCIUM CHLORIDE CALCIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION SODIUM ACETATE SODIUM CATION SODIUM CITRATE SODIUM CATION SODIUM HYDROXIDE HYDROCHLORIC ACID WATER carton label label carton Bottle Lable
Application Number
NDA020742
Brand Name
BSS
Generic Name
balanced salt solution
Product Ndc
0065-0795
Product Type
HUMAN PRESCRIPTION DRUG
Route
OPHTHALMIC
Package Label Principal Display Panel
PRINCIPAL DISPLAY PANEL NDC 0065-0795-15 BSS™ Sterile Irrigating Solution (balanced salt solution) ALCON CONTENTS: 3 doz. 15mL Single Dose Bottles STORAGE: Store at 36° - 77°F (2° - 25°C). Rx Only Alcon Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA 300048944-0521 NDC 0065-0795-15 BSS ® Sterile Irrigating Solution (balanced salt solution) ALCON ® a Novartis company CONTENTS: 3 doz. 15mL Single Dose Bottles STORAGE: Store at 36° - 77°F (2° - 25°C). Rx Only Alcon ® Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA © 2002, 2013, 2015 Novartis 9012635-1115 NDC 0065-0795-15 BSS ® Sterile Irrigating Solution (balanced salt solution) STERILE UNLESS PACKAGE OPEN OR BROKEN 15 mL DROP-TAINER ® Bottle, SINGLE DOSE UNIT With Adapter for LUER-LOK ® Hub Irrigating Needle A sterile balanced salt solution for extraocular and intraocular use during procedures with an expected maximum duration of less than 60 minutes. Read enclosed insert. WARNINGS: • NOT FOR INJECTION OR INTRAVENOUSINFUSION. • Do not use unless product is clear, seal is intact and container is undamaged. • Do not use if blister or paper backing is damaged or broken. • 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. Rx Only Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dihydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. STORAGE: Store at 36° - 77°F (2° - 25°C). NOTE: LUER-LOK is a registered trademark of Becton, Dickinson & Co. Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA Alcon 9017036-0119 NDC 0065-0795-15 BSS ® Sterile Irrigating Solution (balanced salt solution) STERILE UNLESS PACKAGE OPEN OR BROKEN 15 mL DROP-TAINER ® Bottle, SINGLE DOSE UNIT With Adapter for LUER-LOK ® Hub Irrigating Needle A sterile balanced salt solution for extraocular and intraocular use during procedures with an expected maximum duration of less than 60 minutes. Read enclosed insert. 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 blister or paper backing is damaged or broken. • 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. Rx Only Each mL contains: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dihydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH), and water for injection. STORAGE: Store at 36° - 77°F (2° - 25°C). NOTE: LUER-LOK is a registered trademark of Becton, Dickinson & Co. Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA ©2003, 2013,2015 Novartis Alcon ® a Novartis company 9012632-1115 NDC 0065-0795-15 BSS ® STERILE IRRIGATING SOLUTION (BALANCED SALT SOLUTION) UNIT DOSE 15 mL Rx Only ALCON LABORATRIES, INC. FORT WORTH TEXAS 76134 USA 289010-0902
How Supplied
HOW SUPPLIED In 15 mL and 30 mL sterile DROP-TAINER bottles (consisting of a polypropylene bottle and LEUR-LOK ™ adapter plug with a white polypropylene closure) in a blister package. 15 mL in a 15 mL bottle: NDC 0065-0795-15 30 mL in a 30 mL bottle: NDC 0065-0795-30 STORAGE: Store at 36° - 77°F (2° - 25°C). Revised: May 2021 Alcon Distributed by: Alcon Laboratories , Inc. 6201 South Freeway Fort Worth, Texas 76134 USA © 2021 Alcon Inc. W300048945-0521
Precautions
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 BSS Sterile Irrigating Solution was used as an irrigating solution.
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