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Name:Sodium Chloride
Manufacturer:Hospira, Inc.
Category:Prescription Marketed Drugs


0.9% SodiumChlorideInjection, USP

SODIUM CHLORIDE - sodium chloride injection, solution 
Hospira, Inc.

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0.9% Sodium
Chloride
Injection, USP

Hospira

Plastic THERMOJECT®

Unit of Use System

For Thermodilution

Measurement of

Cardiac Output

Rx only

DESCRIPTION

0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution of sodium chloride in water for injection. It is administered via a thermodilution catheter for measuring cardiac output.

Each mL contains sodium chloride 9 mg. Osmolar concentration is 0.308 mOsmol/mL (calc). pH is 5.8 (4.5 to 7.0). Electrolyte content: Na+ 0.154 mEq/mL; Clˉ 0.154 mEq/mL. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose thermodilution agent. When smaller amounts are required the unused portion should be discarded.

Used as directed, the Thermoject Unit of Use System provides for aseptic delivery of cardiac output injectate. The solution may be used iced or at room temperature for injection of measured boluses from 1 to 10 mL as required.

0.9% Sodium Chloride Injection, USP in the Thermoject System for cardiac output monitoring may be classified as a thermodilution diagnostic aid.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder, freely soluble in water.

The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

CLINICAL PHARMACOLOGY

Used as a thermodilution agent for measuring cardiac output, 0.9% Sodium Chloride Injection, USP usually involves volumes too small to affect electrolyte or water balance except possibly in neonates or very small infants.

INDICATIONS AND USAGE

0.9% Sodium Chloride Injection, USP in the Thermoject System is indicated for measurement of cardiac output by the thermodilution method. Use only for Thermodilution as directed.

CONTRAINDICATIONS

This solution is not intended and should not be used for injection by the usual parenteral routes of administration, including infusion via intravenous administration sets.

WARNINGS

Use Aseptic Technique. See PRECAUTIONS.

PRECAUTIONS

Do not use unless the solution is clear and container undamaged. Discard unused portion. Use only for Thermodilution as directed. The solution should be inspected visually for particulate matter and discoloration prior to use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with 0.9% Sodium Chloride Injection in Plastic Vials have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy Category C.

Animal reproduction studies have not been conducted with sodium chloride. It is also not known whether sodium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride 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 in 0.9% Sodium Chloride Injection in Plastic Vials is administered to a nursing mother.

Pediatric Use

The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

ADVERSE REACTIONS

Reactions which may occur because of the solution or the technique of administration include febrile response, tissue necrosis or infection, local or systemic.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient and institute appropriate countermeasures.

OVERDOSAGE

In a small volume container, the solution is unlikely to pose a threat of solute or fluid overload except possibly in neonates or very small infants.

DOSAGE AND ADMINISTRATION

The volume of bolus injection (1 to 10 mL) varies depending on patient condition and requirements to produce an adequate thermodilution cardiac output curve. Usually the smallest volume necessary to produce an adequate curve is used so as to limit fluid dosage.

When cardiac output measurement is desired, the vial and injector are connected as shown under HOW SUPPLIED. Prime the injector. The injector is connected securely to the side port of a 3-way stopcock attached to the RA proximal port of a thermodilution catheter using the male luer lock. The hand should be used to cradle the stopcock and Thermoject Syringe so a smooth, quick injection can be made.

CAUTION: Handle vial as little as possible to prevent change in temperature.

TO ADD SUBSEQUENT VIALS: Properly position the 3-way stopcock and disconnect the unit. Remove the empty vial by rotating counterclockwise. Attach replacement vial as before, i.e., rotate vial clockwise three times. Prime the injector and reconnect the unit to the stopcock.

The final vial used in a series of injections should be left in the injector so the system remains closed in case subsequent cardiac output measurements are made.

HOW SUPPLIED

Product

Contents

Syringe Kit

List No. 1081

Qty.

10 mL Thermoject Vials,

0.9% Sodium Chloride

Injection, USP

4

10 mL Thermoject

Injector

1

Empty Vial (For

Temperature Probe)

1

Carrying Tray

1

USE ASEPTIC TECHNIQUE

  1. Open carton using tear strip, remove carrying tray and contents.

  2. Remove injector from tray; if iced injectate is desired, submerge tray into ice bath without submerging the yellow vial caps.

  3. Remove purple cap from empty vial, fill vial with desired solution, replace cap and place injectate probe through hole in cap into solution (tip should be submerged at least 3 cm).

DISPENSING

CAUTION: Do not connect injector and vial until ready to use.

  1. When desired solution temperature is reached, remove cap from injector and one vial.

    Image from Drug Label Content

  2. Insert vial into injector and rotate clockwise (about three turns) until medication enters needle.

    Image from Drug Label Content

    CAUTION: Handle vial as little as possible to prevent change in solution temperature.

  3. Twist and pull luer cover to remove.

    Image from Drug Label Content

  4. Hold vial and injector in vertical position with vial below injector and prime the injector to remove all air from vial and injector. Connect injector securely to the side port of a 3-way stopcock attached to the RA proximal port of a thermodilution catheter.

  5. TO ADD SUBSEQUENT VIALS. Properly position the 3-way stopcock and disconnect the unit. Remove the empty vial by rotating counterclockwise. Attach replacement vial and rotate vial clockwise three times. Prime the injector and reconnect the unit to the stopcock.

  6. Leave the last vial in the series in the injector to prevent contamination of the needle and fluid path.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Hospira

Hospira, Inc.

Lake Forest, IL 60045 USA

©Hospira 2005

EN-0951

Printed in USA


SODIUM CHLORIDE 
sodium chloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1081
Route of Administration INTRAVENOUS DEA Schedule     
INGREDIENTS
Name (Active Moiety) Type Strength
Sodium Chloride (Sodium Chloride) Active 9 MILLIGRAM  In 1 MILLILITER
Water Inactive  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 0409-1081-51 25 CARTON In 1 CASE contains a CARTON
1 4 VIAL In 1 CARTON This package is contained within the CASE (0409-1081-51) and contains a SYRINGE, PLASTIC
1 10 mL (MILLILITER) In 1 SYRINGE, PLASTIC This package is contained within a CARTON and a CASE (0409-1081-51)

Revised: 08/2006 Hospira, Inc.



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


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