SODIUM CHLORIDE (Page 2 of 2)

8.5 Geriatric Use

No clinical studies of Sodium Chloride Injection USP 0.9% were conducted. Other reported clinical experience with sodium chloride injection 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 other drug therapy.

10 OVERDOSAGE

Use of Sodium Chloride Injection USP 0.9% may pose a threat of overdose marked by electrolyte disturbance and/or fluid overload, particularly in pediatric patients and patients with compromised renal or cardiac function. In the event of overdosage, discontinue the infusion, reevaluate the patient and institute appropriate corrective action.

11 DESCRIPTION

Sodium Chloride Injection USP 0.9% is a formulation of sodium chloride in Water for Intravascular Injection. No preservative, antimicrobial agent or buffer is added. Sodium Chloride Injection USP 0.9% is provided as a sterile, nonpyrogenic, clear, colorless, odorless solution.

Molecular formula = NaCl MW = 58.44

Each mL of Sodium Chloride Injection USP 0.9% contains 9 mg of sodium chloride. The pH is 4.5 to 7.0. The osmolarity is 308 mOsm/L (calc.).

Sodium Chloride Injection USP 0.9% is provided in a 125 mL syringe with a 125 mL fill. The syringes are for single patient use and are disposable and not meant for reuse.

12 CLINICAL PHARMACOLOGY

Sodium Chloride Injection USP 0.9% has an osmotic pressure similar to plasma.

16 HOW SUPPLIED/STORAGE AND HANDLING

Sodium Chloride Injection USP 0.9% is a clear, colorless, odorless solution containing 9 mg/mL of sodium chloride. Sodium Chloride Injection USP 0.9% is supplied in 125 mL prefilled syringes containing 125 mL of solution. Each syringe is sealed with rubber closures and the contents are sterile. The 125 mL syringe is supplied with a luer locknut adapter which is cleared for manufacture and distribution as a device under 510(K) number 862653. The syringes are contained in shipping cartons with the following configurations:

Volume Packaging NDC
125 mL in plastic syringes 20 syringes per carton 0019-1188-81
125 mL in plastic RFID-Tagged Syringes* 20 syringes per carton 0019-1188-27
*Radio Frequency Identification (RFID) Technology

RFID-Tagged Syringe Description

This information is for Ultraject® syringes containing Sodium Chloride Injection USP 0.9% that has been labeled with a Radio Frequency Identification (RFID) tag. When used with an RFID-enabled Optivantage Injector, this tag allows for the exchange of product information such as lot number, expiration, concentration, and identification of the syringe as being unused prior to use and used after product administration. Patient information is not utilized in any form with this RFID technology. Sodium Chloride Injection USP 0.9% product quality is not impacted with the use of this RFID tag. Sodium Chloride Injection USP 0.9% RFID syringes require no special handling and should be stored at the conditions listed for the drug product.

RFID-Tagged Syringe Directions for Use

For the RFID technology to function, the syringe must be used with an Optivantage Injector with RFID technology. Function of the RFID technology is not dependent on syringe orientation as it is placed in the injector. Instructions for use of the injector are provided on the injector interface screens and operator’s manual.

If the RFID tag is damaged or otherwise non-functional, the injector will notify the user. Should this occur, the Sodium Chloride Injection USP 0.9% syringe with the non-functional RFID tag may still be used but no data will be transferred to the injector.

Regarding interference with medical devices, the RFID tag and injector system meet the IEC 60601-1-2 requirements for emission and immunity standards for medical devices. Follow all manufacturers’ guidelines and do not operate any part of the Optivantage Injector System and RFID-tagged syringes within 6 inches (15 cm) of a pacemaker and/or defibrillator.

Storage

Store Sodium Chloride Injection USP 0.9% syringes and RFID-tagged syringes at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

PROTECT FROM FREEZING

Manufactured by:

Liebel-Flarsheim Company LLC

Raleigh, NC 27616

Made in USA

GBT 11880919

Issued: 9/19

Guerbet

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 125 mL Syringe

For Intravascular Use

Sterile Solution

NDC 0019-1188-81

125 mL

Sodium Chloride Injection USP 0.9%

MEDICATION AND FLUID PATHWAY ARE STERILE.

OUTSIDE OF SYRINGE IS NOT STERILE.

SINGLE DOSE UNIT, DISCARD UNUSED PORTION.

EXPEL AIR BEFORE USE.

PROTECT FROM FREEZING.

Rx only

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each mL contains 9 mg sodium chloride.

Dosage: See package insert.

Discard if syringe seal is broken or leakage is observed.

Manufactured by: Liebel-Flarsheim Company LLC

Raleigh, NC 27616

Guerbet

12070916

Principal Display Panel
(click image for full-size original)
Carton
(click image for full-size original)
SODIUM CHLORIDE sodium chloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0019-1188
Route of Administration INTRAVASCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE .9 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0019-1188-81 20 BOX in 1 CARTON contains a BOX
1 1 SYRINGE, PLASTIC in 1 BOX This package is contained within the CARTON (0019-1188-81) and contains a SYRINGE, PLASTIC
1 125 mL in 1 SYRINGE, PLASTIC This package is contained within a BOX and a CARTON (0019-1188-81)
2 NDC:0019-1188-27 20 BOX in 1 CARTON contains a BOX
2 1 SYRINGE, PLASTIC in 1 BOX This package is contained within the CARTON (0019-1188-27) and contains a SYRINGE, PLASTIC
2 125 mL in 1 SYRINGE, PLASTIC This package is contained within a BOX and a CARTON (0019-1188-27)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021569 09/01/2012
Labeler — Liebel-Flarsheim Company LLC (057880002)
Establishment
Name Address ID/FEI Operations
Avantor Performance Materials, Inc. 152791026 API MANUFACTURE (0019-1188)
Establishment
Name Address ID/FEI Operations
LIEBEL-FLARSHEIM COMPANY LLC 109024984 ANALYSIS (0019-1188), MANUFACTURE (0019-1188)

Revised: 12/2022 Liebel-Flarsheim Company LLC

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