Label: SODIUM CHLORIDE solution

  • NDC Code(s): 0338-0050-47
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated July 25, 2014

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  • 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

    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

    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.

  • CLINICAL PHARMACOLOGY

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

  • 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.

  • CONTRAINDICATIONS

    None known

  • 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.

  • 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.

  • ADVERSE REACTIONS

    None known

  • 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.

  • 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.
  • SPL UNCLASSIFIED SECTION

    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.

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Sodium Chloride Representative Container Label

    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 Carton Label

    2B7207

    4-3000 ML
    PLASTIC CONTAINER

    0.9% SODIUM CHLORIDE PROCESSING SOLUTION

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) YYMM00 (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303380050470

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0050
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0050-474 in 1 CARTON05/30/1980
    13000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01786705/30/1980
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation059140764MANUFACTURE(0338-0050) , STERILIZE(0338-0050) , PACK(0338-0050) , LABEL(0338-0050) , ANALYSIS(0338-0050)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation194684502ANALYSIS(0338-0050)