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 glass bottle using a grey butyl stopper and aluminum seal with a blue polypropylene flip-off cap. 250 mL in a 325 mL container: NDC 0065-0795-25. 500 mL in a 635 mL container: NDC 0065-0795-50. STORAGE: Store at 36° - 77° F (2° - 25°C).      9012631-1115 Alcon® A Novartis company                        Distributed by: Alcon Laboratories, Inc. Fort Worth, Texas 76134 USA © 2000-2003, 2015 Novartis

Authorization status:

New Drug Application

Summary of Product characteristics

BSS- BALANCED SALT SOLUTION SOLUTION
ALCON LABORATORIES, INC.
REFERENCE LABEL SET ID: 4BD4D59C-EB3B-4A5E-9EB7-AE95B0A92BEA
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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, vacuum is
present 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.
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 may result in corneal swelling or
bullous keratopathy.
Post-operative inflammatory reactions as well as incidents o