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.

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:

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

Authorization status:

New Drug Application

Summary of Product characteristics

BSS- BALANCED SALT SOLUTION SOLUTION
ALCON LABORATORIES, INC.
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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 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.
2
2
2
2
2
3
2
2
6
5
3
7
2
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