sodium chloride (Sodium Chlorideinjection 
sodium chloride injection (Sodium Chlorideinjection 
[Baxter Healthcare Corporation]

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 pH is 5.0 (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 VIAFLEX 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-ethylhexyl phthalate (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

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.

The intravenous administration of Sodium Chloride Injection, USP can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutive states is inversely proportional to the electrolyte concentration of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the injections.

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

GENERAL PRECAUTIONS

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.

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

Carcinogenesis and Mutagenesis and Impairment of Fertility

Studies have not been performed with Sodium Chloride Injection, USP to evaluate the potential for carcinogenesis, mutagenesis, or impairment of 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.

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 mother.

Pediatric Use

Safety and effectiveness of Sodium Chloride Injection, USP in pediatric patients have not been established by adequate and well controlled trials, however, the use of sodium chloride solutions in the pediatric population is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.

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 responses between the 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.

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

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.

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.

All injections in VIAFLEX 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 VIAFLEX plastic containers are shown below:

Code Size (mL) NDC Product Name
2B1313 500 0338-0043-03 0.45% Sodium Chloride Injection, USP
2B1314 1000 0338-0043-04
2B1355 100 0338-1452-48
2B1356 250 0338-1452-02
2B1300 25
Quad Pack
0338-0049-10 0.9% Sodium Chloride Injection, USP
50
2B1306 Single pack 0338-0049-41
2B1301 Quad pack 0338-0049-11
2B1308 Multi pack 0338-0049-31
100
2B1307 Single pack 0338-0049-48
2B1302 Quad pack 0338-0049-18
2B1309 Multi pack 0338-0049-38
2B1321 150 0338-0049-01
2B1322 250 0338-0049-02
2B1323 500 0338-0049-03
2B1324 1000 0338-0049-04

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 VIAFLEX PLASTIC CONTAINER

WARNING

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

To Open

Tear overwrap down side at slit and remove solution container. 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

1. Suspend container from eyelet support.

2. Remove plastic protector from outlet port at bottom of container.

3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication

WARNING

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

07-19-49-761


Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0049 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 0.9 GRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0049-10 4 BAG In 1 CARTON contains a BAG
1 25 MILLILITER In 1 BAG This package is contained within the CARTON (0338-0049-10)

Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-1452 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 450 MILLIGRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-1452-48 100 MILLILITER In 1 BAG None
2 0338-1452-02 250 MILLILITER In 1 BAG None

Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0043 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 450 MILLIGRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0043-03 500 MILLILITER In 1 BAG None
2 0338-0043-04 1000 MILLILITER In 1 BAG None

Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0049 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 0.9 GRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0049-41 1 BAG In 1 CARTON contains a BAG
1 50 MILLILITER In 1 BAG This package is contained within the CARTON (0338-0049-41)

Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0049 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 0.9 GRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0049-11 4 BAG In 1 CARTON contains a BAG
1 50 MILLILITER In 1 BAG This package is contained within the CARTON (0338-0049-11)

Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0049 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 0.9 GRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0049-31 16 BAG In 1 CARTON contains a BAG
1 50 MILLILITER In 1 BAG This package is contained within the CARTON (0338-0049-31)

Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0049 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 0.9 GRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0049-48 1 BAG In 1 CARTON contains a BAG
1 100 MILLILITER In 1 BAG This package is contained within the CARTON (0338-0049-48)

Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0049 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 0.9 GRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0049-18 4 BAG In 1 CARTON contains a BAG
1 100 MILLILITER In 1 BAG This package is contained within the CARTON (0338-0049-18)

Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0049 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 0.9 GRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0049-38 16 BAG In 1 CARTON contains a BAG
1 100 MILLILITER In 1 BAG This package is contained within the CARTON (0338-0049-38)

Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0049 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 0.9 GRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0049-01 150 MILLILITER In 1 BAG None

Sodium Chloride Injection (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0049 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 0.9 GRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0049-02 250 MILLILITER In 1 BAG None

Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0049 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 0.9 GRAM  In 100 MILLILITER
Water for Injection Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0049-03 500 MILLILITER In 1 BAG None

Sodium Chloride (Sodium Chloride)
PRODUCT INFO
Product Code 0338-0049 Dosage Form INJECTION
Route Of Administration INTRAVENOUS DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (sodium chloride) Active 0.9 GRAM  In 100 MILLILITER
Water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0338-0049-04 1000 MILLILITER In 1 BAG None

Revised: 02/2006 Baxter Healthcare Corporation