Water

Excessive Water Absorption : May result in hyponatremia, hypoosmolality and fluid overload. Monitor patients for absorption of clinically relevant amounts of fluid during and after the procedure. Additional monitoring is recommended for patients at increased risk of developing complications of fluid overload syndrome (e.g., patients with renal or cardiac impairment) or hyponatremic encephalopathy (e.g., pediatric patients; women, in particular premenopausal women; patients with hypoxemia; and patients with central nervous system disease).

Serious adverse reactions, including cerebral or pulmonary edema, massive hemolysis, and acute renal failure can result from the hypotonicity of Sterile Water for Irrigation [see Warnings and Precautions ]. 5.2 Excessive Water Absorption Due to the hypotonicity, absorption of Sterile Water for Irrigation can result in serious adverse reactions of hyponatremia, hypoosmolality and fluid overload, resulting in fatality or permanent morbidity.

Complications include cerebral edema, encephalopathy, pulmonary edema, massive hemolysis, rhabdomyolysis, renal failure, and hyperkalemia [see Adverse Reactions ]. In addition, excessive volume or pressure of the irrigation fluid may also cause undue distension of body cavities and may cause tissue disruption (e.g., tears or perforation). fluid overload syndrome, including patients with severe renal impairment, impaired cardiac function, or other clinical conditions associated with edematous states.

Important Administration Instructions

For irrigation only. Not for intravenous injection.

Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L. It is intended for use as an irrigation fluid and not for intravenous administration or administration by other, parenteral routes (e.g., subcutaneous or intramuscular) [see Warnings and Precautions ].

Sterile Water for Irrigation is not potable water and is not intended for oral administration.

Sterile Water for Irrigation that has been warmed must not be returned to storage.

Preparation and Administration Instructions For single-dose only. Sterile Water for Irrigation is available in a flexible plastic container and a plastic pour bottle. Use the contents of the opened container immediately to minimize the potential for bacterial growth and pyrogen formation. Discard the unused contents of opened containers, as Sterile Water for Irrigation contains no antimicrobial preservative.

Adding Medications to Either the Flexible Plastic Container or the Plastic Pour Bottle

Use aseptic technique when making additions to Sterile Water for Irrigation.

Additives may be incompatible with Sterile Water for Irrigation.

The compatibility of additives with Sterile Water for Irrigation must be assessed. Before introducing additives, check for a possible color change and/or the appearance of precipitates, insoluble complexes, or crystals.

Before adding a substance or medication, verify that it is soluble and/or stable in water and that the pH range of Sterile Water for Irrigation is appropriate.

Additives known or determined to be incompatible should not be used.

Mix thoroughly after additives have been introduced.

Use immediately. Administration Instructions for Irrigation by Gravity Using the Flexible Plastic Container 1. Use aseptic technique. 2. Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.

Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired. 3.

Suspend container using hanger hole. 4. Remove plastic protector from outlet port at bottom of container. 5. Attach irrigation set. Refer to complete directions accompanying set. Warming If desired, warm the flexible plastic container in overwrap to near body temperature in a water bath or fluid warmer heated to not more than 45°C.

Microwave heating of irrigation fluids is not recommended. Administration Using the Plastic Pour Bottle 1. Inspect Sterile Water for Irrigation visually for particulate matter and discoloration prior to use. Discard if the fluid is not clear or the seal is broken. 2. Use aseptic technique 3. Remove the plastic shrink band by tearing along the perforation line and unscrew the bottle cap. 4.

Prevent contact of the fluid with the external surface of the container (including the thread for the bottle cap of the plastic pour bottle). Warming If desired, warm the plastic pour bottle in a fluid warmer to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Microwave heating of irrigation fluids is not recommended.