SODIUM CHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)

Available from:

Liebel-Flarsheim Company LLC

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE .9 mg in 1 mL

Administration route:

INTRAVASCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- 125 mL Syringe:  Sodium Chloride Injection USP 0.9% is indicated for use in flushing compatible contrast agents through Liebel-Flarsheim intravenous administration sets into indwelling intravascular access devices only when delivered by the following Liebel-Flarsheim power injectors: Angiomat® , Illumena® , Illumena® Néo, CT9000® , CT9000® ADV, Optistat® , Optivantage® and Optistar Elite. None Risk Summary 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. Risk Summary Appropriate administration of Sodium Chloride Injection USP 0.9% is not known to cause ha

Product summary:

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: 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

Authorization status:

New Drug Application

Summary of Product characteristics

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION
LIEBEL-FLARSHEIM COMPANY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SODIUM CHLORIDE INJECTION
USP 0.9% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SODIUM CHLORIDE
INJECTION USP 0.9%.
SODIUM CHLORIDE INJECTION USP 0.9% PREFILLED SYRINGES, FOR
INTRAVASCULAR USE ONLY
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
For use in flushing compatible contrast agents through
Liebel-Flarsheim intravenous administration
sets into indwelling intravascular access devices (1)
DOSAGE AND ADMINISTRATION
For single patient use only. (2)
Determine the volume of flush based on the imaging procedure, location
of the vascular access device,
length of tubing between power injector and vascular access device,
and the contrast agent package
insert. (2)
Individualize the volume of flush based on body weight, fluid status
and concomitant medical
conditions. (2)
Typical flush volumes for adults are 10 to 25 mL per injection at
rates not to exceed 10 mL/sec. (2)
May be used for additional infusion to maintain the patency of
vascular access at a typical infusion rate
of 0.5 to 1 mL per minute. (2)
Do not use if packaging is damaged, wet, or not intact, if syringe or
its tip cap shows signs of damage,
leakage or displacement. Do not use if solution is hazy, cloudy,
discolored, or contains particulate
matter. (2)
Use aseptic technique. (2)
Expel residual air from the syringe and tubing prior to connection
with the patient’s vascular access. (2)
DOSAGE FORMS AND STRENGTHS
Supplied as a clear, colorless, odorless, sterile solution of Sodium
Chloride 0.9% for intravenous
administration (3)
Supplied in 125 mL prefilled syringes (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Remove all air from the syringe and associated tubing prior to
injection. (5.1)
May cause fluid overload in patients with congestive heart failure,
severe renal insufficiency, and in
clinical states with edema, sodium retention, or