Balanced Salt Solution

FDA Drug Information • Also known as: Bss

Brand Names: Bss
Route: OPHTHALMIC
Dosage Form: SOLUTION
Product Type: HUMAN PRESCRIPTION DRUG

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.

What Is Balanced Salt Solution Used For?

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.

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.

Side Effects (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.

Warnings and Precautions

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.

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

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.