Sodium Chloride

Dosage Form: Irrigation

FOR ALL GENERAL IRRIGATION, RINSING, DILUTION AND CELL WASHING PURPOSES

Not For Injection By Usual Parenteral Routes

Flexible Irrigation Container

Rx only

Description

This product is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, rinsing, dilution and cell washing purposes.

Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium Chloride 900 mg. pH 5.6 (4.5 — 7.0). The solution is isotonic (308 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na+ 154; Cl¯ 154.

This irrigation solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose, short procedure irrigation, or cell washing fluid. When smaller volumes are required the unused portion should be discarded.

It may be classified as a sterile irrigant, rinse, diluent, cell wash and pharmaceutical vehicle.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Water for Injection, USP is chemically designated H2O.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

Sodium Chloride - Clinical Pharmacology

This irrigation solution exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and 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, USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection, USP (normal saline).

0.9% Sodium Chloride Irrigation, USP is considered generally compatible with living tissues and organs.

Sodium Chloride in water dissociates to provide sodium (Na+) and chloride (Cl¯) ions. Sodium (Na+) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl¯) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na+) and chloride (Cl¯) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

Indications and Usage for Sodium Chloride

This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment).

Contraindications

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, each of these irrigations must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading 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 administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

Do not heat over 66° C (150° F).

Precautions

Do not use for irrigation that may result in absorption into the blood.

Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues or for cell washing techniques.

The flexible container is designed for use with nonvented irrigation sets or nonvented sets for cell washing harvesting systems. When used for irrigation via irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient. When used for cell washing, the nonvented set should be attached promptly. The three liter container may be used to dispense new aliquots of washing solution for each wash cycle for the same patient. However, unused portions should be discarded and a separate container should be used for each patient and each start-up procedure.

Do not administer unless solution is clear and container is undamaged.

Pregnancy Category C.

Animal reproduction studies have not been conducted with this solution. It is also not known if it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution should be given to a pregnant woman only if clearly needed.

Adverse Reactions

Possible adverse effects arising from the irrigation of body cavities, tissues, cells or indwelling catheters and tubes are usually avoidable 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.

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

Overdosage

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.

Sodium Chloride Dosage and Administration

The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a diluent or vehicle for other drugs, the manufacturer’s recommendations should be followed. For use in cell washing, the manufacturer’s recommendations for blood salvaging and red cell processing should be followed.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

How is Sodium Chloride Supplied

0.9% Sodium Chloride Irrigation, USP is supplied in a single-dose 3000 mL flexible irrigation container (List No. 7972).

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25° C); however, brief exposure up to 40° C does not adversely affect the product.

Caution: Federal (USA) law prohibits dispensing without prescription.

September, 2004

©Hospira 2004	EN-0479	Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Sodium Chloride (Sodium Chloride)

PRODUCT INFO Product Code 0409-7972 Dosage Form IRRIGANT Route Of Administration IRRIGATION DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Sodium Chloride (Sodium Chloride) Active 900 MILLIGRAM  In 100 MILLILITER Water Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size

PACKAGING # NDC Package Description Multilevel Packaging 1 0409-7972-08 4 BAG In 1 CASE contains a BAG 1 3000 MILLILITER In 1 BAG This package is contained within the CASE (0409-7972-08)

Revised: 10/2006