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.
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.
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:
|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.
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
Liebel-Flarsheim Company LLC
Raleigh, NC 27616
Made in USA
PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 125 mL Syringe
For Intravascular Use
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.
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
|SODIUM CHLORIDE sodium chloride injection|
|Labeler — Liebel-Flarsheim Company LLC (057880002)|
|Avantor Performance Materials, Inc.||152791026||API MANUFACTURE (0019-1188)|
|LIEBEL-FLARSHEIM COMPANY LLC||109024984||ANALYSIS (0019-1188), MANUFACTURE (0019-1188)|
Revised: 12/2022 Liebel-Flarsheim Company LLC
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