Sodium Chloride

0.9% Sodium Chloride Irrigation, USP in the Baxter Sterile Container System is a sterile, nonpyrogenic, isotonic solution for the preparation of slushed solution. It contains no antimicrobial agents. Composition, osmolarity, pH and ionic concentration are shown in Table 1.

The Baxter Sterile Container System is designed to provide a slush container with a sterile exterior surface for use within the surgical field. Within the overwrap, the unit is packaged in a dispensing bag which maintains the sterility of this surface.

The flexible plastic slush container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by culture toxicity studies.

Slushed solution is used to induce regional hypothermia in conditions such as certain open heart and kidney surgical procedures by direct application of slushed solution. The objective of regional hypothermia is to reduce cellular metabolic activity so that body tissues can tolerate a period of total or relative ischemia thereby inhibiting the formation and buildup of destructive autolytic enzymes and anaerobic by-products usually produced and accumulated in ischemic tissues.

Slushed solution is used to create regional hypothermia in order to reduce and minimize manifestations of warm-temperature ischemia. Temperature probes may be used to determine requirements for replacement or addition of slushed solution.

None known

Not for injection. For use in slush preparation for regional hypothermia.

No serious adverse reactions are known.

The volume of slushed solution required will vary with patient’s age, clinical condition, cooling effect desired and duration of cooling effect desired, according to physician’s instructions.

.9% Sodium Chloride Irrigation, USP in the Baxter Sterile Container System is supplied as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Avoid freezing except during controlled slushing procedure. It is recommended that this product be stored at room temperature (25ºC); brief exposure up to 40ºC does not adversely affect this product.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

Distributed in Canada by
Baxter Corporation
Mississauga, ON L5N OC2

07-19-00-0323
Rev. April 2018

Baxter is a registered trademark of Baxter International Inc.

1000 mL
2B7231

NDC 0338-0051-44
Din 00786160

NOT FOR INJECTION

0.9% Sodium Chloride
Irrigation, USP
Baxter Sterile Container System

EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE
USP pH 5.0 (4.5 TO 7.0) mEq/L SODIUM 154
CHLORIDE 154 OSMOLARITY 308 mOsmol/L (CALC)
STERILE NONPYROGENIC SINGLE DOSE CONTAINER

FOR USE ONLY IN SLUSH PREPARATION
FOR REGIONAL HYPOTHERMIA

SEE ACCOMPANYING DIRECTIONS FOR USE
DOSAGE AS DIRECTED BY A PHYSICIAN
CAUTION RX ONLY

Baxter Logo
Baxter Healthcare Corporation
Deerfield IL 60015 USA

Made in USA

Distributed in Canada by
Baxter Corporation
Misissauga ON L5N 0C2

PL 146 Plastic

Baxter and PL 146 are trademarks of Baxter International Inc