SODIUM CHLORIDE

SODIUM CHLORIDE- sodium chloride injection
Liebel-Flarsheim Company LLC

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.

Inspecting the 125 mL syringe
(click image for full-size original)

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.

Twisting off the 125 mL syringe cap
(click image for full-size original)

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
(click image for full-size original)

Removing cap from luer locknut
(click image for full-size original)
Attaching luer locknut to syringe
(click image for full-size original)

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

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.

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