USA

Sodium Chloride Injection USP 0.9% in Ultraject® Prefilled Syringes

For more information about Sodium Chloride Injection USP 0.9%, please see the Full Prescribing Information.

Ultraject prefilled sodium chloride syringes, used in the OptiVantage®, OptiStar® Elite and Illumena® Neo Injectors, provide convenience and efficiency in flushing compatible contrast imaging agents.

Clinical Usage:

    • Ensures proper needle placement and reduces risk of CM extravasation during Patency Testing2
    • Provides a tighter bolus of contrast, creating prolonged and increased enhancement during CTA and MRA scans3

Process simplified. Efficiency amplified.

Important Safety Information1

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® Neo, CT9000®, CT9000® ADV, Optistat®, Optivantage® and Optistar® Elite.

Contraindications
None.

Warnings and Precautions

  • 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.
  • Infectious Complications: Use of damaged syringe or failure to maintain aseptic technique may result in infection, sepsis and death.
  • 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 hypematremia. 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: 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. Establish intravascular catheter patency prior to the administration of Sodium Chloride Injection USP 0.9%.

Adverse Reactions

Reported adverse reactions include:

  • Air embolization with stroke, chest pain, and dyspnea
  • Arrhytmia
  • Hypotension
  • Myocardial infarction
  • Sepsis
  • Febril response
  • Local tenderness
  • Infection at the site of injection
  • Venous thrombosis or phlebitis extending from injection site
  • Extravasation
  • Fluid overload
  • Hypervolemia

Use in Specific Populations

  • 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.
  • Lactation: Risk Summary: Appropriate administration of Sodium Chloride Injection USP 0.9% is not known to cause harm to breastfed infant.
  • 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 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.
  • 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.

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.

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Ordering Information

(Please see Full Prescribing Information)

Description

Qty

Unit

Size

Order #

11 Digit NDC

Sodium Chloride 0.9%, Ultraject® prefilled syringe

20

each

125 mL

118881

00019118881

Sodium Chloride 0.9%, Ultraject® prefilled syringe, RFID Enabled

20

each

125 mL

118827

00019118827

Ultraject® Prefilled Syringes are a registered trademark of Guerbet LLC, and is available by prescription only.

Legal Copyright 2019 Guerbet

REFERENCES

  1. Sodium Chloride Injection USP 0.9% Prescribing Information. Princeton, NJ: Guerbet LLC; Dec 2018.
  2. ACR Manual on Contrast Media, version 10.2. American College of Radiology, Reston, VA, 2017, 17.
  3. Bae, K. T. Intravenous contrast, medium administration and scan timing at CT: considerations and approaches Radiology. 2010 Jul; 256 (1): 48.
  4. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007). Accessed Nov 28, 2018, from www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf
  5. Centers for Medicare & Medicaid Services (2012). Accessed Nov 28, 2018, from www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-12-35.pdf
  6. Comprehensive Accreditation Manual for Hospitals: The Official Handbook. Oakbrook Terrace, IL: The Joint Commission on Accreditation of Healthcare Organizations; 2012.
  7. Agency for Healthcare Research and Quality. Accessed Nov 28, 2018 from www.ahrq.gov/qual/hais.html

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