Drug Facts
Composition & Profile
Identifiers & Packaging
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; PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label 1000 mL NDC 0990-7138-09 0.9% SODIUM CHLORIDE Irrigation, USP Each 100 mL contains sodium chloride, 900 mg. 308 mOsmol/liter (calc.). May contain NaOH and/or HCl for pH adjustment. pH 5.6 (4.5 – 7.0). Sterile, nonpyrogenic. Indications: Isotonic solution for irrigation. Contraindications: Not for injection. Use only if clear and seal intact. Warning: Do not heat bottle over 66°C (150°F). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. Single-dose container. Contains no bacteriostat. Discard unused portion. Usual dosage: See insert. Rx only icumedical AQUALITE™ SYSTEM Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA RL-7284 LOT EXP PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label; PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label 500 mL NDC 0990-6138-03 0.9% SODIUM CHLORIDE Irrigation, USP Each 100 mL contains sodium chloride, 900 mg. 308 mOsmol/liter (calc.). May contain NaOH and/or HCl for pH adjustment. pH 5.6 (4.5–7.0). Sterile, nonpyrogenic. Isotonic solution for irrigation. Contraindications: Not for injection. Use only if clear and seal intact. Warning: Do not heat bottle over 66°C (150°F). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. Single-dose container. Contains no bacteriostat. Discard unused portion. Usual dosage: See insert. Rx only AQUALITE™ SYSTEM Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA RL-7282 LOT EXP PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label; PRINCIPAL DISPLAY PANEL - 2000 mL Bag Label 2000 mL NDC 0990-7972-07 0.9% SODIUM CHLORIDE Irrigation , USP EACH 100 mL CONTAINS SODIUM CHLORIDE, 900 mg. pH 5.6 (4.5 to 7.0) 308 mOsmol/LITER (CALC.) STERILE, NONPYROGENIC. INDICATIONS: ISOTONIC SOLUTION FOR IRRIGATION. CONTRAINDICATIONS: NOT FOR INJECTION. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. WARNINGS: DO NOT HEAT OVER 66°C (150°F). STORE AT 20 TO 25°C (68 TO 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] PROTECT FROM FREEZING. SINGLE-DOSE CONTAINER. CONTAINS NO BACTERIOSTAT. DISCARD UNUSED PORTION. USE ASEPTIC TECHNIQUE. DOSAGE AND ADMINISTRATION: AS DIRECTED BY PHYSICIAN. RX ONLY 3 V CONTAINS DEHP icumedical IM-4375 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 2000 mL Bag Label; PRINCIPAL DISPLAY PANEL - 2000 mL Bag Overwrap TO OPEN TEAR AT NOTCH 2 HDPE DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 PRINCIPAL DISPLAY PANEL - 2000 mL Bag Overwrap
- 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
- PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label 1000 mL NDC 0990-7138-09 0.9% SODIUM CHLORIDE Irrigation, USP Each 100 mL contains sodium chloride, 900 mg. 308 mOsmol/liter (calc.). May contain NaOH and/or HCl for pH adjustment. pH 5.6 (4.5 – 7.0). Sterile, nonpyrogenic. Indications: Isotonic solution for irrigation. Contraindications: Not for injection. Use only if clear and seal intact. Warning: Do not heat bottle over 66°C (150°F). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. Single-dose container. Contains no bacteriostat. Discard unused portion. Usual dosage: See insert. Rx only icumedical AQUALITE™ SYSTEM Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA RL-7284 LOT EXP PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label 500 mL NDC 0990-6138-03 0.9% SODIUM CHLORIDE Irrigation, USP Each 100 mL contains sodium chloride, 900 mg. 308 mOsmol/liter (calc.). May contain NaOH and/or HCl for pH adjustment. pH 5.6 (4.5–7.0). Sterile, nonpyrogenic. Isotonic solution for irrigation. Contraindications: Not for injection. Use only if clear and seal intact. Warning: Do not heat bottle over 66°C (150°F). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. Single-dose container. Contains no bacteriostat. Discard unused portion. Usual dosage: See insert. Rx only AQUALITE™ SYSTEM Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA RL-7282 LOT EXP PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 2000 mL Bag Label 2000 mL NDC 0990-7972-07 0.9% SODIUM CHLORIDE Irrigation , USP EACH 100 mL CONTAINS SODIUM CHLORIDE, 900 mg. pH 5.6 (4.5 to 7.0) 308 mOsmol/LITER (CALC.) STERILE, NONPYROGENIC. INDICATIONS: ISOTONIC SOLUTION FOR IRRIGATION. CONTRAINDICATIONS: NOT FOR INJECTION. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. WARNINGS: DO NOT HEAT OVER 66°C (150°F). STORE AT 20 TO 25°C (68 TO 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] PROTECT FROM FREEZING. SINGLE-DOSE CONTAINER. CONTAINS NO BACTERIOSTAT. DISCARD UNUSED PORTION. USE ASEPTIC TECHNIQUE. DOSAGE AND ADMINISTRATION: AS DIRECTED BY PHYSICIAN. RX ONLY 3 V CONTAINS DEHP icumedical IM-4375 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 2000 mL Bag Label
- PRINCIPAL DISPLAY PANEL - 2000 mL Bag Overwrap TO OPEN TEAR AT NOTCH 2 HDPE DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 PRINCIPAL DISPLAY PANEL - 2000 mL Bag Overwrap
Overview
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.
Indications & Usage
Each of these solutions is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Dosage & 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. 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 .
Warnings & Precautions
WARNINGS FOR IRRIGATION ONLY. NOT FOR INJECTION. Entry of a hypotonic solution into the circulation may cause hemolysis. 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 container over 66°C (150°F).
Contraindications
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 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.
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