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SODIUM CHLORIDE injection, solution
[Baxter Healthcare Corporation]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL New Drug Application
Drug Label Sections

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.

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.

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.

CONTRAINDICATIONS

None known.

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.

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.

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

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.

HOW SUPPLIED

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

CodeSize (mL)NDCProduct 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.

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.

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

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

SODIUM CHLORIDE 
sodium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0338-6304
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE900 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-6304-02250 mL in 1 BAG
2NDC:0338-6304-03500 mL in 1 BAG
3NDC:0338-6304-041000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01667712/09/1970
Labeler - Baxter Healthcare Corporation (005083209)
Registrant - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare Corporation059140764ANALYSIS(0338-6304), LABEL(0338-6304), MANUFACTURE(0338-6304), PACK(0338-6304), STERILIZE(0338-6304)

Revised: 9/2013
 
Baxter Healthcare Corporation

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