Get your patient on Sodium Chloride - Sodium Chloride injection, Solution (Sodium Chloride)

Sodium Chloride Injection, USP is indicated as a source of water and electrolytes.

0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.

Important Preparation and Administration Instructions

• Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment.
  
  
• Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear, and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged.
  
  
• To reduce the risk of air embolism, adhere to the following preparation instructions for Sodium Chloride Injection, USP:
  
  
  • Use a non-vented infusion set or close the vent on a vented set.
  • Use a dedicated line without any connections (do not connect flexible containers in series).
    
  • The use of pressure infusion is not recommended as a method to increase flow rates. However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion.
    
  • If using a pumping device to administer Sodium Chloride Injection, turn off the pump before the container is empty.
    
  
  

Dosing Information

The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy.

Introduction of Additives

Additives may be incompatible.

Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available.

If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.

None known.

Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition, osmolarity, and ionic concentration are shown below:

0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride.

The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated from latex-free polyolefins or polypropylene plastic materials. The solution contact materials do not contain PVC, DEHP, or other plasticizers. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. The suitability of the container materials has been established through biological evaluations, which have shown the containers pass Class VI U.S. Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container systems.

Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

The available sizes of 0.9% Sodium Chloride Injection, USP are shown below:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at 20° to 25°C (68° to 77°F); excursions are permitted between 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature.]Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product.

For Information on Risk of Air Embolism – see Dosage and Administration.

To Open
Peel off the overwrap and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below.

Preparation for Administration
1.Suspend container from eyelet support.
2. Fleboflex bags: Remove plastic protector from outlet port at bottom of container.
Fleboflex Luer bags: Break the twist-off administration port by means of torsion.
3. Attach administration set. Refer to complete directions accompanying set.

To Add Medication
Additives may be incompatible.

To add medication before solution administration
1. Prepare medication site.
2. Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject.
3. Mix solution and medication thoroughly.

To add medication during solution administration
1. Close clamp on the set.
2. Prepare medication site.
3. Fleboflex bags: Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject.
Fleboflex Luer bags: Using syringe or vial, connect to the needle-free medication port and inject.
4. Remove container from intravenous pole and/or turn to an upright position.
5. Mix solution and medication thoroughly.
6. Return container to in-use position and continue administration.

Distributed by:
Nextgen Pharmaceuticals LLC
Brooklyn, NY 11207

Manufactured by:
Laboratorios Grifols, S.A.
30565 Murcia - SPAIN

Printed in SPAIN
Rev. 04/2025
GRIFOLS and FLEBOFLEX are trademarks of Grifols, S.A.

NEXTGEN
PHARMACEUTICALS

(Internal reference)