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Name:Sodium Chloride
Manufacturer:Baxter Healthcare Corporation
Category:Prescription Marketed Drugs


Sodium Chloride Injection, USPin VIAFLEX Plastic Container

SODIUM CHLORIDE - sodium chloride injection 
Baxter Healthcare Corporation

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Sodium Chloride Injection, USP
in VIAFLEX Plastic Container

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.

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, Mutagenesis, 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 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
Rev. December 2005

BAXTER, VIAFLEX and PL 146 are trademarks of Baxter International Inc.

PACKAGE LABELING - PRINCIPAL DISPLAY PANEL

Sodium Chloride Injection Representative Container Label

Container Label

LOT
EXP

2B1302
NDC 0338-0049-18

0.9% Sodium Chloride Injection USP

100 mL

Single dose container Each 100
mL contains 900 mg Sodium
Chloride USP pH 5.0 (4.5 to 7.0)
mEq/100 mL Sodium 15 Chloride 15
Osmolarity 308 mOsmol/L (calc)
Sterile Nonpyrogenic Read
package insert for full information
Additives may be incompatible
Dosage Intravenously as directed
by a physician Cautions Must not
be used in series connectionsDo
not use unless solution is clear
Rx Only
VIAFLEX container
PL 146
Baxter VIALFEX and PL 146 are trademarks of
Baxter International Inc

Baxter  
Baxter Healthcare Corporation
Deerfiled IL 60015 USA
Made in USA

Sodium Chloride Injection Representative Carton Label

Carton Label

Lot: PXX
QTY: 96-100 mL

Exp: XX XX
Code: 2B1302
NDC: 0338-0049-18

0.9% SODIUM CHLORIDE INJ USP

(17) XXXX00 (10) PXX

(01) 50303380049184


SODIUM CHLORIDE 
sodium chloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0049
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 9 g  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0049-01 150 mL in 1 BAG None
2 NDC:0338-0049-02 250 mL in 1 BAG None
3 NDC:0338-0049-03 500 mL in 1 BAG None
4 NDC:0338-0049-04 1000 mL in 1 BAG None
5 NDC:0338-0049-10 4 BAG ( BAG) in 1 PACKAGE contains a BAG
5 25 mL in 1 BAG This package is contained within the PACKAGE (0338-0049-10)
6 NDC:0338-0049-41 1 BAG ( BAG) in 1 PACKAGE contains a BAG
6 50 mL in 1 BAG This package is contained within the PACKAGE (0338-0049-41)
7 NDC:0338-0049-11 4 BAG ( BAG) in 1 PACKAGE contains a BAG
7 50 mL in 1 BAG This package is contained within the PACKAGE (0338-0049-11)
8 NDC:0338-0049-31 16 BAG ( BAG) in 1 PACKAGE contains a BAG
8 50 mL in 1 BAG This package is contained within the PACKAGE (0338-0049-31)
9 NDC:0338-0049-48 1 BAG ( BAG) in 1 PACKAGE contains a BAG
9 100 mL in 1 BAG This package is contained within the PACKAGE (0338-0049-48)
10 NDC:0338-0049-18 4 BAG ( BAG) in 1 PACKAGE contains a BAG
10 100 mL in 1 BAG This package is contained within the PACKAGE (0338-0049-18)
11 NDC:0338-0049-38 16 BAG ( BAG) in 1 PACKAGE contains a BAG
11 100 mL in 1 BAG This package is contained within the PACKAGE (0338-0049-38)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016677 06/16/2010

SODIUM CHLORIDE 
sodium chloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0043
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 4.5 g  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-0043-03 500 mL in 1 BAG None
2 NDC:0338-0043-04 1000 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018016 06/16/2010

SODIUM CHLORIDE 
sodium chloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-1452
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 4.5 g  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0338-1452-48 100 mL in 1 BAG None
2 NDC:0338-1452-02 250 mL in 1 BAG None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018016 06/16/2010

Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare SA dba Baxter Healthcare of Puerto Rico 189326168 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 059140764 MANUFACTURE

Revised: 06/2010 Baxter Healthcare Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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