HIGHLIGHTS OF PRESCRIBING INFORMATION• Supplied in 50 mL and 125 mL prefilled syringes (3)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%.

----------------------------------------- CONTRAINDICATIONS------------------------------------------

Sodium Chloride Injection USP 0.9% Prefilled Syringes, For Intravascular Use Only
Initial U.S. Approval: 2006-----------------------------------WARNINGS AND PRECAUTIONS------------------------------------------------------------------------- INDICATIONS AND USAGE---------------------------------------• May cause fluid overload in patients with congestive heart failure, severe
renal insufficiency, and in clinical states with edema, sodium retention, or
hypernatremia. (5.3)---------------------------------- DOSAGE AND ADMINISTRATION-----------------------------------• Establish intravascular catheter patency prior to administration. (5.4)• Determine the volume of flush based on the imaging procedure, location of thevascular access device, length of tubing between power injector and vascularaccess device, and the contrast agent package insert. (2)• Individualize the volume of flush based on body weight, fluid status andconcomitant medical conditions. (2)• Typical flush volumes for adults are 10 to 25 mL per injection at rates not to exceed
10 mL/sec. (2)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.

• 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 thepatient’s vascular access. (2)---------------------------------DOSAGE FORMS AND STRENGTHS---------------------------------

Rx only

FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Drug Handling
2.2 50 mL Syringe Assembly and Inspection
2.3 125 mL Syringe Assembly and Inspection
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Air Embolism
5.2 Infectious Complications
5.3 Fluid Overload
5.4 Extravasation

1• Pregnancy: It is not known whether Sodium Chloride Injection USP 0.9% cancause fetal harm. (8.1)• Pediatrics: Safety and effectiveness have not been established in pediatric patients.
(8.4)• Geriatrics: Dosing for an elderly patient should be cautious, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of concomitantdisease or other drug therapy. (8.5)•	50 mL Syringe: Sodium Chloride Injection USP 0.9% is indicated for use in flushingcompatible contrast agents through Liebel-Flarsheim intravenous administration
sets into indwelling intravascular access devices when delivered manually or by
the following Liebel-Flarsheim power injectors: Optistar® LE and Optistar® Elite®.
•

Revised: 12/2018

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8

10
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ADVERSE REACTIONSUSE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
OVERDOSAGEDESCRIPTION
CLINICAL PHARMACOLOGYHOW SUPPLIED/STORAGE AND HANDLING

125 mL Syringe: Sodium Chloride Injection USP 0.9% is indicated for use in flushingcompatible contrast agents through Liebel-Flarsheim intravenous administration
sets into indwelling intravascular access devices only when delivered by thefollowing Liebel-Flarsheim power injectors: Angiomat® Illumena®, Illumena® Néo,
CT9000®, CT9000® ADV, Optistat®, Optivantage® and Optistar Elite.

2

DOSAGE AND ADMINISTRATION•

The 50 mL syringe and the 125 mL syringe are for single patient use only.

•

Determine the volume of the saline flush for each patient individually based, inpart, on the imaging procedure, the location of the vascular access device, thelength of tubing between the Liebel-Flarsheim contrast agent power injector
and the vascular access device and the recommendations made on the package
insert for the contrast agent. Typical Sodium Chloride Injection USP 0.9% flush
volumes following contrast agent administration in adults are 10 to 25 mL per
injection at rates not to exceed 10 mL/sec.

•

Use of some Liebel-Flarsheim contrast agent power injectors allows for additional
infusion of Sodium Chloride Injection USP 0.9% to maintain the patency ofvascular access. Typical infusion rates used for this purpose are in the range of
0.5 to 1 mL per minute.

•Individualize infusion rates and flush volumes for each patient based on theirbody weight, fluid status and concomitant medical conditions.

•

Consult the Liebel-Flarsheim contrast agent power injector manual for proper use.

•

Inspect the syringe for signs of break in sterility.

•

Do not use if the syringe or its tip cap shows signs of damage, leakage ordisplacement.

•

Do not use if the solution is hazy, cloudy, discolored or contains particulatematter.

•Use aseptic technique.

•

Expel residual air in both the syringe and tubing prior to connection with thepatient’s vascular access.

•Instructions for assembly and inspection of the Sodium Chloride Injection USP
0.9% syringes prior to use are printed on this sheet.

2.2 50 mL Syringe Assembly and Inspection

1

Prior to using the syringe, twist off tip cap and discard. The area under
the tip cap is sterile, caution should now be used when handling. Syringe is
now ready for needle or infusion tubing attachment.

2.3 125 mL Syringe Assembly and Inspection
NOTE: Exterior of syringe is not sterile.
Contents of syringe and area under tip cap and piston ribs are sterile andshould be treated accordingly.

*Sections or subsections omitted from the full prescribing information are not listed.
2.1 Drug Handling

INDICATIONS AND USAGE

After screwing the push rod into the syringe piston, it is important to turnthe push rod an additional ½ turn so that the piston rotates freely.

----------------------------------- USE IN SPECIFIC POPULATIONS-----------------------------------• Supplied as a clear, colorless, odorless, sterile solution of Sodium Chloride
0.9% for intravenous administration (3)FULL PRESCRIBING INFORMATION

1188xx-in0000-us1218.indd 1----------------------------------------- ADVERSE REACTIONS-----------------------------------------• Adverse reactions due to solution or administration technique may include:
air embolism with stroke, chest pain, and dyspnea, arrhythmia, hypotension,
myocardial infarction, sepsis, febrile response, local tenderness, infection at
the site of injection, venous thrombosis or phlebitis extending from injection
site, extravasation, fluid overload and hypervolemia. (6)• May be used for additional infusion to maintain the patency of vascular access ata typical infusion rate of 0.5 to 1 mL per minute. (2)

PRESCRIBING INFORMATION• Remove all air from the syringe and associated tubing prior to injection. (5.1)• For use in flushing compatible contrast agents through Liebel-Flarsheim
intravenous administration sets into indwelling intravascular access devices (1)• For single patient use only. (2)Sodium Chloride
Injection USP 0.9%

• None (4)NOTE: Exterior of syringe is not sterile.
Contents of syringe and area under tip cap and piston ribs are sterile andshould be treated accordingly.

Remove syringe from carton and inspect the area around the tip cap andoutside 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.
The area under the cap is sterile. Caution should now be used
when handling.

Luer Locknut Detail:

Remove syringe from carton and inspect the area around the tip cap andoutside of piston for signs of leakage. Do not use if leakage is observed.

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8• extravasation• fluid overload• hypervolemia

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 anddistribution as a device under 510K 862653. The syringes are contained in shipping
cartons with the following configurations:

USE IN SPECIFIC POPULATIONS

Volume50 mL
in plastic syringes
125 mL
in plastic syringes
125 mL
in plastic RFID-Tagged
Syringes*

8.1 Pregnancy

Next remove cap from luer locknut dust cover by twisting to break tamper
evident seal. Discard cap.

Risk Summary
Administration of Sodium Chloride Injection USP 0.9% is not known to cause majorbirth 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 majorbirth defects and miscarriage in clinically recognized pregnancies is 2-4% and15-20%, respectively.
8.2 Lactation
Risk Summary
Appropriate administration of Sodium Chloride Injection USP 0.9% is not known tocause harm to a breastfed infant.

Attach luer locknut to syringe by holding dust cover and screwing to the stop.
Remove and discard dust cover when ready to attach sterile connector tubing.

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DOSAGE FORMS AND STRENGTHS

Sodium Chloride Injection USP (0.9%)• a clear, colorless, odorless solution• supplied in 50 mL and 125 mL prefilled syringes• contents are sterile

4

8.4 Pediatric Use
Safety and effectiveness of Sodium Chloride Injection USP 0.9% administered bypower injection in pediatric patients have not been established. Administration of
Sodium Chloride Injection USP 0.9% to pediatric patients by power injection is notrecommended. 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 pediatricpatients is supported by reported clinical experience with intravenous infusion andflush 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 thevascular access line.

CONTRAINDICATIONS

None

8.5 Geriatric Use
5

WARNINGS AND PRECAUTIONS

5.1 Air Embolism
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, anddeath.
5.2 Infectious Complications
Use of a damaged syringe or failure to maintain aseptic technique may result in
infection, sepsis and death [see Dosage and Administration (2)].
5.3 Fluid Overload
Sodium Chloride Injection USP 0.9% may cause fluid overload in patients withcongestive 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.
5.4 Extravasation
Extravasation of the Sodium Chloride Injection USP 0.9% may cause mechanicalcompression of neurovascular structures. Extravasation of contrast agent may resultin tissue injury by osmolar and direct cytotoxicity (see package inserts of specificcontrast agents). Establish intravascular catheter patency prior to the administrationof Sodium Chloride Injection USP 0.9%.

6ADVERSE REACTIONS

Reported adverse reactions include:• air embolization with stroke, chest pain, and dyspnea• arrhythmia• hypotension• myocardial infarction• sepsis• febrile response• local tenderness• infection at the site of injection• venous thrombosis or phlebitis extending from injection site

41188xx-in0000-us1218.indd 2

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 endof 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 byelectrolyte disturbance and/or fluid overload, particularly in pediatric patients andpatients 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

Packaging
10 syringes per carton

NDC
0019-1188-75

20 syringes per carton

0019-1188-81

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 theexchange 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 impactedwith 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 areprovided on the injector interface screens and operator’s manual.
If the RFID tag is damaged or otherwise non-functional, the injector will notify theuser. Should this occur, the Sodium Chloride Injection USP 0.9% syringe with thenon-functional RFID tag may still be used but no data will be transferred to theinjector.
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 apacemaker 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 11881218

Issued: 12/18

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 50 mL syringe with a 50 mL fill
and a 125 mL syringe with a 125 mL fill. The syringes are for single patient use andare 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
50 and 125 mL prefilled syringes containing 50 and 125 mL of solution respectively.

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