Sodium Chloride

INDICATIONS AND USAGE 0.9% Sodium Chloride Processing Solution is indicated in processing blood cells. See directions accompanying blood cell processing device for complete instructions for use.

ADVERSE REACTIONS None known

CONTRAINDICATIONS None known

DESCRIPTION Sodium Chloride Processing Solution is a sterile, nonpyrogenic solution in single dose container for use in blood cell processing devices. It contains no antimicrobial agents. Composition, osmolarity, pH, and ionic concentration are shown in Table 1. Table 1 0.9% Sodium Chloride Processing Solution Size (mL) Composition (g/L) Osmolarity (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Sodium Chloride, USP (NaCl) Sodium Chloride 3000 9 308 5.5 (4.5 to 7.0) 154 154 The plastic 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-ethylhexylphthalate (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 tissue culture toxicity studies.

DOSAGE AND ADMINISTRATION As directed by a physician. See directions accompanying blood cell processing device. Processing Solutions should be inspected visually for particulate matter and discoloration prior to use.

WARNINGS This container should not be connected for direct intravenous administration. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of processing solution.

CLINICAL PHARMACOLOGY 0.9% Sodium Chloride Processing Solution has value as a physiological blood cell processing aid.

20140725

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Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER

NDA017867

Sodium Chloride

Sodium Chloride

0338-0050

HUMAN PRESCRIPTION DRUG

EXTRACORPOREAL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 3000 mL 2B7207 NDC 0338-0050-47 NOT FOR INJECTION 0.9% SODIUM CHLORIDE Processing Solution EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP NO ANTIMICROBIAL AGENT HAS BEEN ADDED pH 5.5 (4.5 TO 7.0) mEq/L SODIUM 154 CHLORIDE 154 OSMOLARITY 308 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER DOSAGE AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS ACCOMPANYING BLOOD CELL PROCESSING DEVICE FOR USE THIS CONTAINER SHOULD NOT BE CONNECTED FOR DIRECT INTRAVENOUS ADMINISTRATION CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT 0.9% Sodium Chloride NaCl Processing Solution VIAFLEX CONTAINER PL146 PLASTIC FOR PRODUCT INFORMATION 1-800-933-0303 Baxter Logo Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA Baxter VIAFLEX and PL 146 are trademarks of Baxter International Inc Sodium Chloride Representative Container Label

Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA ©Copyright 1983, 1990, 1995, Baxter Healthcare Corporation. All rights reserved. 07-19-73-065 Rev. May 2014 BAXTER, AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC.

Pediatric Use Safety and effectiveness in pediatric patients have not been established. Do not administer unless solution is clear and seal is intact.

Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Processing Solution. It is also not known whether 0.9% Sodium Chloride Processing Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Processing Solution should be given to a pregnant woman only if clearly needed.

Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Processing Solution. It is also not known whether 0.9% Sodium Chloride Processing Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Processing Solution should be given to a pregnant woman only if clearly needed.

HOW SUPPLIED 0.9% Sodium Chloride Processing Solution in Flexible Plastic Container is available as follows: Code Size (mL) NDC 2B7207 3000 0338-0050-47 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25º C); brief exposure up to 40º C does not adversely affect the product. To Open Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. Preparation for Use 1. Suspend container from eyelet support. 2. Remove plastic protector from outlet port at bottom of container. 3. Attach to blood cell processing device. Refer to complete directions accompanying blood cell processing device.

PRECAUTIONS Careful review and understanding of the use of this solution in conjunction with blood cell processing equipment is essential. Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Processing Solution. It is also not known whether 0.9% Sodium Chloride Processing Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Processing Solution should be given to a pregnant woman only if clearly needed. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Do not administer unless solution is clear and seal is intact.