Label: SODIUM CHLORIDE- sodium chloride injection, solution 

  • NDC Code(s): 0338-6304-02, 0338-6304-03, 0338-6304-04
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 09/13

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  • DESCRIPTION

    Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.5 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below:

    0.45% Sodium Chloride Injection, USP contains 4.5 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L chloride.

    0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.

    The flexible container is made with non-latex plastic materials specially designed for a wide range of parenteral drugs including those requiring delivery in containers made of polyolefins or polypropylene. For example, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of paclitaxel. In addition, the AVIVA container system is compatible with and appropriate for use in the admixture and administration of all drugs deemed compatible with existing polyvinyl chloride container systems. The solution contact materials do not contain PVC, DEHP, or other plasticizers.

    The suitability of the container materials has been established through biological evaluations, which have shown the container passes Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container system.

    The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration.

    The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and the other port has a medication site for addition of supplemental medication (See Directions for Use). The primary function of the overwrap is to protect the container from the physical environment.

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  • CLINICAL PHARMACOLOGY

    Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

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  • INDICATIONS AND USAGE

    Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

    0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.

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  • CONTRAINDICATIONS

    None known.

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  • WARNINGS

    Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

    In patients with diminished renal function, administration of Sodium Chloride Injection, USP may result in sodium retention.

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  • PRECAUTIONS

    General

    Do not connect flexible plastic containers of intravenous solutions in series connections. Such use could result in air embolism due to residual air being drawn from one container before administration of the fluid from a secondary container is completed.

    Pressurizing intravenous solutions contained in flexible plastic containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration.

    Use of a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

    Laboratory Tests

    Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

    Drug Interactions

    Caution must be exercised in the administration of Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

    Studies have not been conducted to evaluate additional drug/drug or drug/food interactions with Sodium Chloride Injection, USP.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    Studies with Sodium Chloride Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

    Pregnancy

    Teratogenic Effects

    Pregnancy Category C

    Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.

    Labor and Delivery

    Studies have not been conducted to evaluate the effects of Sodium Chloride Injection, USP on labor and delivery. Caution should be exercised when administering this drug during labor and delivery.

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sodium Chloride Injection, USP is administered to a nursing woman.

    Pediatric Use

    The use of Sodium Chloride Injection, USP in pediatric patients is based on clinical practice.

    Plasma electrolyte concentrations should be closely monitored in the pediatric population as this population may have impaired ability to regulate fluids and electrolytes.

    The infusion of hypotonic fluids (0.45% Sodium Chloride Injection, USP) together with the non-osmotic secretion of ADH may result in hyponatremia in patients with acute volume depletion. Hyponatremia can lead to headache, nausea, seizures, lethargy, coma, cerebral edema and death, therefore acute symptomatic hyponatremic encephalopathy is considered a medical emergency.

    Geriatric Use

    Clinical studies of Sodium Chloride Injection, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in the responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or drug therapy.

    This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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  • ADVERSE REACTIONS

    Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

    If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

    In addition to the above listed adverse reactions, the following has been reported for 0.45% Sodium Chloride Injection, USP (see Pediatric Use section).

    - Hyponatremia

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  • DOSAGE AND ADMINISTRATION

    As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact.

    All injections in AVIVA plastic containers are intended for intravenous administration using sterile equipment.

    Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

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  • HOW SUPPLIED

    The available sizes of each injection in AVIVA plastic containers are shown below:

    Code Size (mL) NDC Product Name
    6E1313
    6E1314
    6E1356
    500
    1000
    250
    0338-6333-03
    0338-6333-04
    0338-6333-02
    0.45% Sodium Chloride Injection, USP

    6E1322
    6E1323
    6E1324

    250
    500
    1000

    0338-6304-02
    0338-6304-03
    0338-6304-04

    0.9% Sodium Chloride Injection, USP

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C (104°F) does not adversely affect the product.

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  • DIRECTIONS FOR USE OF AVIVA PLASTIC CONTAINER

    To Open

    Tear overwrap down side at slit and remove solution container. Moisture and 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. If supplemental medication is desired, follow directions below.

    Preparation for Administration

    Caution: Do not use plastic containers in series connections.

    Caution: Use only with a non-vented set or a vented set with the vent closed.

    1. Suspend container from eyelet support.
    2. Remove protector from outlet port at bottom of container.
    3. Attach administration set. Refer to complete directions accompanying set.

    To Add Medication

    Additives may be incompatible.

    To add medication before solution administration

    1. Prepare medication site.
    2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
    3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly.

    To add medication during solution administration

    1. Close clamp on the set.
    2. Prepare medication site.
    3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
    4. Remove container from IV pole and/or turn to an upright position.
    5. Evacuate both ports by squeezing them while container is in the upright position.
    6. Mix solution and medication thoroughly.
    7. Return container to in-use position and continue administration.
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  • SPL UNCLASSIFIED SECTION

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Printed in USA

    *Bar Code Position Only
    071969742

    07-19-69-742 Rev. September 2013

    Baxter and AVIVA are trademarks of
    Baxter International Inc.

    For Product Information
    1-800-933-0303

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  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

    Package Label - Principal Display Panel - Container

    1000 mL 0.9% Sodium Chloride Injection USP

    LOT

    EXP

    6E1324

    NDC 0338-6304-04

    1000 mL

    0.9% Sodium Chloride Injection USP

    EACH 100 mL CONTAINS 900 mg SODIUM
    CHLORIDE USP pH 5.5 (4.5 TO 7.0) mEq/L
    SODIUM 154 CHLORIDE 154 OSMOLARITY 308
    mOsmol/L (CALC) STERILE NONPYROGENIC
    SINGLE DOSE CONTAINER ADDITIVES MAY BE
    INCOMPATIBLE CONSULT WITH PHARMACIST IF
    AVAILABLE WHEN INTRODUCING ADDITIVES USE
    ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT
    STORE DOSAGE INTRAVENOUSLY AS DIRECTED
    BY A PHYSICIAN SEE DIRECTIONS CAUTIONS
    SQUEEZE AND INSPECT INNER BAG WHICH
    MAINTAINS PRODUCT STERILITY DISCARD IF
    LEAKS ARE FOUND MUST NOT BE USED IN SERIES
    CONNECTIONS DO NOT USE UNLESS SOLUTION IS
    CLEAR Rx ONLY STORE AT ROOM TEMPERATURE
    (25°C/77°F) UNTIL READY TO USE AVOID
    EXCESSIVE HEAT SEE INSERT

    BAXTER AVIVA AND THE AVIVA CRESCENT DESIGN
    ARE TRADEMARKS OF BAXTER INTERNATIONAL INC

    BAXTER
    BAXTER HEALTHCARE CORPORATION
    DEERFIELD IL 60015 USA
    MADE IN USA

    FOR PRODUCT INFORMATION
    1-800-933-0303

    Package Label - Principal Display Panel - Carton

    15-1000 ML AVIVA CONTAINER

    6E-13-24

    15-1000 ML
    AVIVA CONTAINER

    0.9% SODIUM CHLORIDE
    INJECTION, USP

    EXP
    XXXXX

    SECONDARY BAR CODE
    (17) YYMM00 (10) XXXXX

    LOT
    XXXXX

    PRIMARY BAR CODE
    (01) 50303386304041

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  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 
    sodium chloride injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-6304
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 900 mg  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0338-6304-02 250 mL in 1 BAG
    2 NDC:0338-6304-03 500 mL in 1 BAG
    3 NDC:0338-6304-04 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA016677 12/09/1970
    Labeler - Baxter Healthcare Corporation (005083209)
    Registrant - Baxter Healthcare Corporation (005083209)
    Establishment
    Name Address ID/FEI Business Operations
    Baxter Healthcare Corporation 059140764 ANALYSIS(0338-6304), LABEL(0338-6304), MANUFACTURE(0338-6304), PACK(0338-6304), STERILIZE(0338-6304)
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