FDA Label for Bss
View Indications, Usage & Precautions
Bss Product Label
The following document was submitted to the FDA by the labeler of this product Alcon Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 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.
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.
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.
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.
How Supplied
In 15 mL and 30 mL sterile DROP-TAINER bottles (consisting of a polypropylene bottle and LEURLOK® 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: November 2015
Alcon®
A Novartis company
Distributed by:
Alcon Laboratories , Inc.
6201 South Freeway
Fort Worth, Texas 76134 USA
©2000-2003, 2015 Novartis
9012634-1115
Principal Display Panel
NDC 0065-0795-15
BSS®
Sterile Irrigating Solution
(balanced salt solution)
ALCON®
a Norvartis 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 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
* Please review the disclaimer below.