STERILE WATER

Sterile Water for Irrigation contains water that is sterilized and packaged for use as an irrigant. No antimicrobial agent or other substance has been added. The pH is 5.5 (5.0 to 7.0). Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L. The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the fluid significantly. Water 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. The plastic pour bottle is fabricated from specially formulated polyolefin. The polyolefin is a copolymer of ethylene and propylene. The container requires no vapor barrier.

Sterile Water for Irrigation is indicated for use as an irrigant. Sterile Water for Irrigation is indicated for use as an irrigant. ( 1 )

• For Irrigation only. Not for injection or infusion by usual parenteral routes. ( 2.1 , 5.1 ) • The volume and/or rate of irrigation depend on the type of the procedure and the capacity or the surface area of the structure to be irrigated. ( 2.2 ) • For preparation and administration instructions see the full prescribing information. ( 2.1 , 2.3 ) 2.1 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 (5.1) ]. • 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. 2.2 Recommended Dosage The volume and/or rate of irrigation depend on the type of the procedure and the capacity or the surface area of the structure to be irrigated. 2.3 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.

None. • None. ( 4 )

The following adverse reactions have been identified during post approval use of Sterile Water for Irrigation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Metabolism and Nutrition disorders : Hyponatremia, fluid overload, fluid absorption, electrolyte imbalance Nervous System Disorders : Cerebral edema General Disorders and Administration Site Conditions : Burning sensation (with irrigation of eyes and skin wounds) Musculoskeletal and Connective Tissue Disorders : Rhabdomyolysis (myoglobinuria) Renal and Urinary Disorders : Renal failure Other Adverse reactions which may occur in association with absorption of water for irrigation include: Blood and Lymphatic System Disorders : Hemolysis (hemoglobinemia, hemoglobinuria) Metabolism and Nutrition Disorders : Hypervolemia, hypoosmolality, hyperkalemia, acid/base balance disorder Nervous System Disorders : Encephalopathy (seizure, loss of vision, lethargy, disorientation, irritability, vomiting, nausea, headache) Cardiac Disorders : Cardiac arrest, cardiac failure, bradycardia, electrocardiogram abnormal Vascular Disorders : Hypertension, postoperative hypotension Respiratory, Thoracic and Mediastinal Disorders: Respiratory arrest, respiratory failure, pulmonary edema Most common adverse reactions are: hyponatremia, fluid overload, fluid absorption, electrolyte imbalance. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.