Sodium Chloride Injection .9 mg/mL Package Insert

1 INDICATIONS AND USAGE

• 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.

2 DOSAGE AND ADMINISTRATION

• The 125 mL syringe are for single patient use only.
• Determine the volume of the saline flush for each patient individually based, in part, on the imaging procedure, the location of the vascular access device, the length 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 of vascular 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 their body weight, fluid status and concomitant medical conditions.
• Consult the Liebel-Flarsheim contrast agent power injector manual for proper use.

2.1 Drug Handling

• Inspect the syringe for signs of break in sterility.
• Do not use if the syringe or its tip cap shows signs of damage, leakage or displacement.
• Do not use if the solution is hazy, cloudy, discolored or contains particulate matter.
• Use aseptic technique.
• Expel residual air in both the syringe and tubing prior to connection with the patient’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.

2.2 125 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 and should be treated accordingly. 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. The area under the cap is sterile. Caution should now be used when handling. Next remove cap from luer locknut dust cover by twisting to break tamper evident seal. Discard cap. 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.

3 DOSAGE FORMS AND STRENGTHS

Sodium Chloride Injection USP (0.9%)

• a clear, colorless, odorless solution
• supplied in 125 mL prefilled syringes
• contents are sterile

4 CONTRAINDICATIONS

None

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, and death.

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 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.

5.4 Extravasation

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%.

6 ADVERSE 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
• extravasation
• fluid overload
• hypervolemia

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

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.

8.2 Lactation

Risk Summary

Appropriate administration of Sodium Chloride Injection USP 0.9% is not known to cause harm to a breastfed infant.

8.4 Pediatric Use

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.

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:

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