NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.
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).
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.
Do not use for irrigation that may result in absorption into the blood. Caution should be observed when solute-free water is used for continuous irrigation or allowed to “dwell” inside body cavities because of possible absorption into the blood stream and the production of intravascular hemolysis and circulatory overload. Aseptic technique is essential with the use of sterile preparations for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues.
When used as a “pour” irrigation, no part of the contents should be allowed to contact the surface below the outer protected thread area of the semi-rigid wide mouth container. The flexible container is designed for use with nonvented irrigation sets. When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size 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.
Do not administer unless water is clear, seal is intact and container is undamaged. Discard unused portion.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Studies with Sterile Water for Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Caution should be exercised when Sterile Water for Irrigation, USP is administered to a nursing woman.
Pregnancy: Teratogenic Effects.
Pregnancy Category C. Animal reproduction studies have not been conducted with Sterile Water for Irrigation, USP. It is also not known whether Sterile Water for Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sterile Water for Irrigation, USP should be given to a pregnant woman only if clearly needed.
Safety and effectiveness in pediatric patients have not been established.
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.
In the event of overhydration or solute overload (if solutes have been added to the irrigation), re-evaluate the patient and institute appropriate corrective measures.