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0.9% Sodium Chloride Processing Solution in Flexible Plastic Container Not for injection | Sodium Chloride [Baxter Healthcare Corporation] | BioPortfolio

13:48 EST 27th January 2019 | BioPortfolio

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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.

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.

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 Processing Solution 3000 9 308 5.5
(4.5 to 7.0)
154 154

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

0.9% Sodium Chloride Processing Solution is indicated in processing blood cells.

See directions accompanying blood cell processing device for complete instructions for use.

None known

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.

Careful review and understanding of the use of this solution in conjunction with blood cell processing equipment is essential.

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.

Safety and effectiveness in pediatric patients have not been established.

Do not administer unless solution is clear and seal is intact.

None known

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.

0.9% Sodium Chloride Processing Solution in Flexible Plastic Container is available as follows:

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.

Code Size (mL) NDC
2B7207 3000 0338-0050-47

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.

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.

3000 mL

2B7207NDC 0338-0050-47

NOT FOR INJECTION

0.9%SODIUM CHLORIDEProcessing Solution

EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USPNO ANTIMICROBIAL AGENT HAS BEEN ADDED pH 5.5 (4.5 TO 7.0)mEq/L SODIUM 154 CHLORIDE 154 OSMOLARITY 308mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSECONTAINER

DOSAGE AS DIRECTED BY A PHYSICIAN SEE DIRECTIONSACCOMPANYING BLOOD CELL PROCESSING DEVICE FOR USE THISCONTAINER SHOULD NOT BE CONNECTED FOR DIRECT INTRAVENOUSADMINISTRATION

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINSPRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USEUNLESS 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 ChlorideNaClProcessing Solution

VIAFLEX CONTAINER

PL146 PLASTIC FOR PRODUCT INFORMATION

1-800-933-0303

Baxter Logo Baxter Healthcare CorporationDeerfield, IL 60015 USA

Made in USA

Baxter VIAFLEX andPL 146 are trademarks of Baxter International Inc

2B7207

4-3000 MLPLASTIC CONTAINER

0.9% SODIUM CHLORIDE PROCESSING SOLUTION

EXPXXXXX

SECONDARY BAR CODE(17) YYMM00 (10) XXXXX

LOTXXXXX

PRIMARY BAR CODE(01) 50303380050470

Manufacturer

Baxter Healthcare Corporation

Active Ingredients

Source

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