BSS- balanced salt solution solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838), SODIUM ACETATE (UNII: 4550K0SC9B) (Sodium Cation - UNII:LYR4M0NH37), SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37)

Available from:

Alcon Laboratories, Inc.

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 6.4 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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). Alcon Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA © 2021 Alcon, Inc.

Authorization status:

New Drug Application

Summary of Product characteristics

BSS - BALANCED SALT SOLUTION SOLUTION
ALCON LABORATORIES, INC.
----------
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 (CaCl
•2H O) 0.048%, magnesium chloride hexahydrate (MgCl
•6H O)
0.03%, sodium acetate trihydrate (C H NaO •3H O) 0.39%, sodium
citrate dihydrate
(C H Na O •2H 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.
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.
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.
™
™
2
2
2
2
2
3
2
2
6
5
3
7
2
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
decomp