SODIUM CHLORIDE by is a Prescription medication manufactured, distributed, or labeled by Liebel-Flarsheim Company LLC, Avantor Performance Materials, Inc., LIEBEL-FLARSHEIM COMPANY LLC. Drug facts, warnings, and ingredients follow.
To report SUSPECTED ADVERSE REACTIONS, contact Liebel-Flarsheim Company LLC at 1-855-266-5037 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
NOTE: Exterior of syringe is not sterile.
Remove syringe from carton and inspect the area around the tip cap and outside of piston for signs of leakage. Do not use if leakage is observed. Load syringe into power injector.
To remove tip cap from syringe, push in and twist off, then discard.
Attach luer locknut to syringe by holding dust cover and screwing to the stop.
Remove all air from the syringe and associated tubing prior to injection to avoid air embolus with the associated risk of stroke, organ ischemia and/or infarction, and death.
Use of a damaged syringe or failure to maintain aseptic technique may result in infection, sepsis and death [see Dosage and Administration (2)].
Sodium Chloride Injection USP 0.9% may cause fluid overload in patients with congestive heart failure, severe renal insufficiency, and in clinical states with edema, sodium retention, or hypernatremia.
Consider each patient’s age, body weight, fluid status, concomitant medical conditions and planned radiological procedure to determine if use of Sodium Chloride Injection USP 0.9% is appropriate.
Extravasation of the Sodium Chloride Injection USP 0.9% may cause mechanical compression of neurovascular structures. Extravasation of contrast agent may result in tissue injury by osmolar and direct cytotoxicity (see package inserts of specific contrast agents). Establish intravascular catheter patency prior to the administration of Sodium Chloride Injection USP 0.9%.
Reported adverse reactions include:
Administration of Sodium Chloride Injection USP 0.9% is not known to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Sodium Chloride Injection USP 0.9.%
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Appropriate administration of Sodium Chloride Injection USP 0.9% is not known to cause harm to a breastfed infant.
Safety and effectiveness of Sodium Chloride Injection USP 0.9% administered by power injection in pediatric patients have not been established. Administration of Sodium Chloride Injection USP 0.9% to pediatric patients by power injection is not recommended. When performing manual injection of Sodium Chloride Injection USP 0.9% to pediatric patients, take into account the patient’s weight, fluid status, and concomitant medical conditions to determine if use of Sodium Chloride Injection USP 0.9% is appropriate.
The safety of manual injection of Sodium Chloride Injection USP 0.9% in pediatric patients is supported by reported clinical experience with intravenous infusion and flush of sodium chloride injection in pediatric patients.
To minimize the risk of fluid overload, use the smallest dose of Sodium Chloride Injection USP 0.9% necessary for manually flushing contrast agent through the vascular access line.
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.
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
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
Made in USA
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)|