Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED NDC No. Product Container Size (mL) Container Type 0409-6139-22 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0990-6139-22 Sterile Water for Irrigation USP 250 Semi-Rigid Irrigation 0409-6139-03 0990-6139-03 Sterile Water for Irrigation USP 500 Semi-Rigid Irrigation 0409-7139-09 0990-7139-09 Sterile Water for Irrigation USP 1000 Semi-Rigid Irrigation 0409-7139-36 0990-7139-36 Sterile Water for Irrigation USP 1500 Semi-Rigid Irrigation 0409-7973-05 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0990-7973-05 Sterile Water for Irrigation USP 1000 Flexible Irrigation 0409-7973-07 0990-7973-07 Sterile Water for Irrigation USP 2000 Flexible Irrigation 0409-7973-08 0990-7973-08 Sterile Water for Irrigation USP 3000 Flexible Irrigation ICU Medical is transitioning NDC codes from the "0409" to a "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 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA EN-4662; PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label 500 mL NDC 0990-6139-03 Sterile Water for Irrigation, USP Sterile, distilled, nonpyrogenic, pH 5.5 (5.0 to 7.0). Warning: Not isotonic. Hemolytic. Indications: For irrigation only. Contraindications: Not for injection. Use only if clear and seal intact. Warnings: 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-7290 LOT EXP PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label; PRINCIPAL DISPLAY PANEL - 1500 mL Bottle Label 1500 mL NDC 0990-7139-36 Sterile Water for Irrigation, USP Sterile, distilled, nonpyrogenic, pH 5.5 (5.0 – 7.0) Warnings: Not isotonic. Hemolytic. Indications: For irrigation only. 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 icu medical AQUALITE™ SYSTEM Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA RL-7294 LOT EXP PRINCIPAL DISPLAY PANEL - 1500 mL Bottle Label; PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label 3000 mL NDC 0990-7973-08 Sterile Water for IRRIGATION, USP STERILE, DISTILLED, NONPYROGENIC. INDICATIONS: FOR IRRIGATION. CONTRAINDICATIONS: NOT FOR INJECTION. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. WARNINGS: NOT ISOTONIC. HEMOLYTIC. DO NOT HEAT OVER 66°C (150°F). OR STORE ABOVE 40°C (104°F). SINGLE-DOSE CONTAINER. CONTAINS NO BACTERIOSTAT. DISCARD UNUSED PORTION. USE ASEPTIC TECHNIQUE. DOSAGE AND ADMINISTRATION: AS DIRECTED BY PHYSICIAN. pH 5.5 (5.0 TO 7.0) RX ONLY 3 V CONTAINS DEHP IM-4379 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label; PRINCIPAL DISPLAY PANEL - 3000 mL Bag Overwrap 2 HDPE TO OPEN TEAR AT NOTCH 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 - 3000 mL Bag Overwrap
- HOW SUPPLIED NDC No. Product Container Size (mL) Container Type 0409-6139-22 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0990-6139-22 Sterile Water for Irrigation USP 250 Semi-Rigid Irrigation 0409-6139-03 0990-6139-03 Sterile Water for Irrigation USP 500 Semi-Rigid Irrigation 0409-7139-09 0990-7139-09 Sterile Water for Irrigation USP 1000 Semi-Rigid Irrigation 0409-7139-36 0990-7139-36 Sterile Water for Irrigation USP 1500 Semi-Rigid Irrigation 0409-7973-05 Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA 0990-7973-05 Sterile Water for Irrigation USP 1000 Flexible Irrigation 0409-7973-07 0990-7973-07 Sterile Water for Irrigation USP 2000 Flexible Irrigation 0409-7973-08 0990-7973-08 Sterile Water for Irrigation USP 3000 Flexible Irrigation ICU Medical is transitioning NDC codes from the "0409" to a "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 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA EN-4662
- PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label 500 mL NDC 0990-6139-03 Sterile Water for Irrigation, USP Sterile, distilled, nonpyrogenic, pH 5.5 (5.0 to 7.0). Warning: Not isotonic. Hemolytic. Indications: For irrigation only. Contraindications: Not for injection. Use only if clear and seal intact. Warnings: 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-7290 LOT EXP PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 1500 mL Bottle Label 1500 mL NDC 0990-7139-36 Sterile Water for Irrigation, USP Sterile, distilled, nonpyrogenic, pH 5.5 (5.0 – 7.0) Warnings: Not isotonic. Hemolytic. Indications: For irrigation only. 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 icu medical AQUALITE™ SYSTEM Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA RL-7294 LOT EXP PRINCIPAL DISPLAY PANEL - 1500 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label 3000 mL NDC 0990-7973-08 Sterile Water for IRRIGATION, USP STERILE, DISTILLED, NONPYROGENIC. INDICATIONS: FOR IRRIGATION. CONTRAINDICATIONS: NOT FOR INJECTION. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. WARNINGS: NOT ISOTONIC. HEMOLYTIC. DO NOT HEAT OVER 66°C (150°F). OR STORE ABOVE 40°C (104°F). SINGLE-DOSE CONTAINER. CONTAINS NO BACTERIOSTAT. DISCARD UNUSED PORTION. USE ASEPTIC TECHNIQUE. DOSAGE AND ADMINISTRATION: AS DIRECTED BY PHYSICIAN. pH 5.5 (5.0 TO 7.0) RX ONLY 3 V CONTAINS DEHP IM-4379 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA icu medical PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label
- PRINCIPAL DISPLAY PANEL - 3000 mL Bag Overwrap 2 HDPE TO OPEN TEAR AT NOTCH 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 - 3000 mL Bag Overwrap
Overview
Sterile Water for Irrigation, USP is a sterile, distilled, nonpyrogenic water for injection intended only for sterile irrigation, washing, rinsing and dilution purposes. pH 5.5 (5.0 to 7.0). Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded. Sterile Water for Irrigation, USP may be classified as a sterile irrigant, wash, rinse, diluent and pharmaceutical vehicle. Water for Irrigation, 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. 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 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
Sterile Water for Irrigation, USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of sterile, nonpyrogenic, solute-free water.
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 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. This preparation is solute-free and its entry into the circulation will cause hemolysis. Solutions for urologic irrigation must be used with caution in patients with severe cardiopulmonary or renal dysfunction. Irrigating fluids used during transurethral prostatectomy have been demonstrated to enter the systemic circulation in relatively large volumes, thus, Sterile Water for Irrigation, USP must be regarded as a systemic drug. Absorption of large amounts of Sterile Water for Irrigation, USP with or without additives 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 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.
Adverse Reactions
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes are completely 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 distention 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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