Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED/STORAGE AND HANDLING .9% Sodium Chloride Irrigation, USP in the Baxter Sterile Container System is supplied as follows: Code Size (mL) NDC DIN 2B7231 1000 0338-0051-44 786160 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.; PRINCIPAL DISPLAY PANEL - PACKAGING LABELING 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 Representative Container Label for 0.9% Sodium Chloride Irrigation USP
- HOW SUPPLIED/STORAGE AND HANDLING .9% Sodium Chloride Irrigation, USP in the Baxter Sterile Container System is supplied as follows: Code Size (mL) NDC DIN 2B7231 1000 0338-0051-44 786160 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.
- PRINCIPAL DISPLAY PANEL - PACKAGING LABELING 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 Representative Container Label for 0.9% Sodium Chloride Irrigation USP
Overview
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. Table 1 Size (mL) Composition (g/L) Osmolarity (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Sodium Chloride, USP (NaCl) Sodium Chloride 0.9 % Sodium Chloride Irrigation, USP 1000 9 308 5.0 (4.5 to 7.0) 154 154 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.
Indications & Usage
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.
Dosage & Administration
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.
Warnings & Precautions
WARNINGS Not for injection. For use in slush preparation for regional hypothermia.
Contraindications
None known
Adverse Reactions
No serious adverse reactions are known.
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