BSS- balanced salt solution solution

1. Description:
2. Clinical Pharmacology:
3. Indications And Usage:
4. Warnings:
5. Precautions:
6. Adverse Reactions
7. Dosage And Administration
8. How Supplied
9. Principal Display Panel
10. Description
11. Clinical Pharmacology
12. Indications And Usage
13. Warnings
14. Precautions

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 bag 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 and 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 rmly 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 LUER-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: November 2015

Alcon
A Novartis company

Distributed by:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134 USA

2000-2003, 2015 Novartis

W9012634-1115

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.
STORAGE: Store at 36 - 77 F (2 - 25 C).

STERILE 500 mL

Alcon

Alcon Laboratories, Inc.
Fort Worth, Texas 76134 USA

2012, 2015 Novartis

LOT:
EXP.:
MFD.:

9012630-1115

Storage: Store at 36 - 77 F (2 - 25 C).

Do not use unless outer overwrap is intact.

9012629-1115

BSS balanced salt solution solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0065-1795 Route of Administration OPHTHALMIC

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6.4 mg in 1 mL POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM CHLORIDE 0.75 mg in 1 mL CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CHLORIDE 0.48 mg in 1 mL MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CHLORIDE 0.3 mg in 1 mL SODIUM ACETATE (UNII: 4550K0SC9B) (Sodium Cation - UNII:LYR4M0NH37) SODIUM ACETATE 3.9 mg in 1 mL SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CITRATE 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:0065-1795-04 500 mL in 1 BAG; Type 0: Not a Combination Product 03/28/1969

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	Business Operations
Alcon Research Ltd		007672236	MANUFACTURE(0065-1795)

Revised: 3/2019 Document Id: e45faaef-3077-4b40-8227-7f80a9a36ac0 34391-3 Set id: 28488c7b-cf6a-4a03-916f-cc66b3afdc57 Version: 9 Effective Time: 20190329 Alcon Laboratories, Inc.

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.