Sodium Chloride

INDICATIONS AND USAGE 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).

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. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS .

CONTRAINDICATIONS 0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes. An electrolyte solution should not be used for irrigation during electrosurgical procedures.

ADVERSE REACTIONS 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.

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

DESCRIPTION These products are sterile, nonpyrogenic solutions of electrolytes in water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg; pH 5.6 (4.5 to 7.0). May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution is isotonic (308 mOsmol/liter, CALC.) and has the following electrolyte content (mEq/liter): Na + 154; Cl − 154. These irrigations contain no bacteriostat, antimicrobial agent or added buffer and are intended only for use as single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Each of these irrigations may be classified as a sterile irrigant, wash, rinse, diluent 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 H 2 O. 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. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The container requires no vapor barrier to maintain the proper drug concentration. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

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 .

HOW SUPPLIED 0.9% Sodium Chloride Irrigation, USP: Container Size NDC Single-dose 500 mL semi-rigid irrigation container 0409-6138-03 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA Single-dose 500 mL semi-rigid irrigation container 0990-6138-03 Single-dose 250 mL semi-rigid irrigation container 0409-6138-22 Single-dose 250 mL semi-rigid irrigation container 0990-6138-22 Single-dose 1000 mL semi-rigid irrigation container 0409-7138-09 Single-dose 1000 mL semi-rigid irrigation container 0990-7138-09 Single-dose 1500 mL semi-rigid irrigation container 0409-7138-36 Single-dose 1500 mL semi-rigid irrigation container 0990-7138-36 Single-dose 1000 mL flexible irrigation container 0409-7972-05 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA Single-dose 1000 mL flexible irrigation container 0990-7972-05 Single-dose 2000 mL flexible irrigation container 0409-7972-07 Single-dose 2000 mL flexible irrigation container 0990-7972-07 ICU Medical is transitioning NDC codes from "0409" to "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: July, 2018 EN-4660 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA