Sodium Chloride Irrigation: Package Insert / Prescribing Info

Sodium Chloride Irrigation Description

Each 100 mL contains:

Sodium Chloride, USP 0.9 g; Water for Injection, USP qs pH adjusted with Hydrochloric Acid, NF

pH: 5.75 (4.50-7.00)

Calculated Osmolarity: 308 mOsmol/liter

Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154

0.9% Sodium Chloride Irrigation, USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.

The formula of the active ingredient is:

The flexible plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a copolymer of ethylene and propylene. The container is nontoxic and biologically inert.

The container-solution unit is a closed system and is not dependent upon entry of external air during administration.

Not made with natural rubber latex, PVC or DEHP.

Sodium Chloride Irrigation - Clinical Pharmacology

0.9% Sodium Chloride Irrigation is utilized for a variety of clinical indications such as sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.

0.9% Sodium Chloride Irrigation provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection (normal saline).

Physiological irrigation solutions are considered generally compatible with living tissues and organs.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Indications and Usage for Sodium Chloride Irrigation

0.9% Sodium Chloride Irrigation is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Contraindications

0.9% Sodium Chloride Irrigation is not for injection by usual parenteral routes.

An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Warnings

FOR IRRIGATION ONLY. NOT FOR INJECTION.

Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs.

Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Do not warm container above 140°F (60°C).

After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservatives.

Precautions

Adverse Reactions/Side Effects

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.

If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

In the event of overhydration or solute overload, reevaluate the patient's condition, and institute appropriate corrective treatment. Intravascular volume overload may respond to hemodialysis. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

Sodium Chloride Irrigation Dosage and Administration

As required for irrigation.

When used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

How is Sodium Chloride Irrigation supplied

0.9% Sodium Chloride Irrigation, USP is supplied sterile and nonpyrogenic in single-dose flexible plastic containers.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; however, brief exposure up to 40°C (104°F) does not adversely affect the product.

Do not warm container above 140°F (60°C).

INSTRUCTIONS FOR USE:

Not for Injection. Not for use with pressurized irrigation systems.

Check solution container composition, lot number, and expiry date.

Irrigation solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not use if the solution is cloudy or precipitate is present.

Check the solution container for leaks by squeezing firmly. If leaks are found, discard.

The intact port cap provides visual tamper evidence. Do not use if port cap is prematurely removed. Maintain strict aseptic technique during handling.

To Add Medication:

1.

Identify WHITE Additive Port with arrow pointing toward solution container.

2.

Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward solution container.

3.

Hold base of WHITE Additive Port.

4.

Insert needle (18 – 23 gauge) through the center of the WHITE Additive Port's resealable septum and inject additives.

5.

Mix solution container contents thoroughly.

6.

WHITE additive port must be swabbed with disinfection agent before repuncturing.

7.

Check admixture visually for particulate matter.

Preparation for Administration

1.

Immediately before inserting the irrigation set, break off BLUE Administration Port Cap with the arrow pointing away from the solution container.

2.

Use non-vented irrigation set or close the air-inlet on a vented set. Refer to directions for use accompanying the irrigation set.

3.

Hold the base of the BLUE Administration Port, twist and push spike until fully inserted.

4.

The BLUE Administration Port contains a self-sealing septum that helps prevent leakage after removing the spike. The Administration Port is not intended to be spiked more than once.

5.

Suspend solution container from hanger hole.

6.

For Single Use Only. Discard unused portion.

Manufactured for:

Lake Zurich, IL 60047

Made in Germany
www.fresenius-kabi.com/us

451818A
Revised: January 2025

PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 1000 mL Bag Label

soluflex® NDC 65219-502-01 1000 mL

0.9% SODIUM CHLORIDE
IRRIGATION, USP

ISOTONIC SOLUTION FOR IRRIGATION

PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 1000 mL Case Label

NDC 65219-502-10 502010

0.9% Sodium Chloride
Irrigation, USP

1,000 mL x 6

STORE AT: 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
Avoid excessive heat. Protect from freezing.

PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 2000 mL Bag Label

soluflex® NDC 65219-504-02 2000 mL

0.9% SODIUM CHLORIDE
IRRIGATION, USP

ISOTONIC SOLUTION FOR IRRIGATION

PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 2000 mL Case Label

NDC 65219-504-20 504020

0.9% Sodium Chloride
Irrigation, USP

2,000 mL x 5

STORE AT: 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
Avoid excessive heat. Protect from freezing.

PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 3000 mL Bag Label

soluflex® NDC 65219-506-03 3000 mL

0.9% SODIUM CHLORIDE
IRRIGATION, USP

ISOTONIC SOLUTION FOR IRRIGATION

PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 3000 mL Case Label

NDC 65219-506-30 506030

0.9% Sodium Chloride
Irrigation, USP

3,000 mL x 4

STORE AT: 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
Avoid excessive heat. Protect from freezing.