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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, Fo | SODIUM CHLORIDE [Liebel-Flarsheim Company LLC] | BioPortfolio

12:36 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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.

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

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.

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.

Sodium Chloride Injection USP (0.9%)

None

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.

Use of a damaged syringe or failure to maintain aseptic technique may result in infection, sepsis and death [see Dosage and Administration (2)].

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.

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%.

Reported adverse reactions include:

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 harm to a breastfed infant.

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.

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.

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.

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 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 and are disposable and not meant for reuse.

Sodium Chloride Injection USP 0.9% has an osmotic pressure similar to plasma.

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. 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 510K 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 LLCRaleigh, NC 27616

Made in USA

GBT 11880718 

Issued: 12/18

Guerbet Pharmaceuticals

Volume Packaging NDC
 50 mL
          in plastic syringes
 10 syringes per carton  0019-1188-75
 125 mL
          in plastic syringes
 20 syringes per carton  0019-1188-81
 125 mL
          in plastic RFID-Tagged Syringes*
 20 syringes per carton  0019-1188-27
        *Radio Frequency Identification (RFID) Technology

For Intravascular Use - Sterile Solution

NDC 0019-1188-75

Sodium Chloride Injection USP 0.9% 50 mL

Rx Only

MEDICATION AND FLUID PATHWAY ARE STERILE.OUTSIDE OF SYRINGE IS NOT STERILE.

SINGLE DOSE UNIT, DISCARD UNUSED PORTION.EXPEL AIR BEFORE USE.

PROTECT FROM FREEZING. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F)[see USP Controlled Room Temperature].

Each mL contains 9 mg sodium chloride.

Dosage: See package insert.

Discard if syringe seal is broken or leakage is observed.

Manufactured by:Liebel-Flarsheim Company LLCRaleigh, NC 27616Made in USA

Guerbet

12060916

For Intravascular Use

Sterile Solution

NDC 0019-1188-81

125 mL

Sodium Chloride Injection USP 0.9%

MEDICATION AND FLUID PATHWAY ARE STERILE.OUTSIDE OF SYRINGE IS NOT STERILE.

SINGLE DOSE UNIT, DISCARD UNUSED PORTION. EXPEL AIR BEFORE USE. PROTECT FROM FREEZING.

Rx only

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each mL contains 9 mg sodium chloride. Dosage: See package insert. Discard if syringe seal is broken or leakage is observed.

Manufactured by: Liebel-Flarsheim Company LLCRaleigh, NC 27616Made in USA

Guerbet

12070916

Manufacturer

Liebel-Flarsheim Company LLC

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