Sterile Water

INDICATIONS AND USAGE Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION ).

2 DOSAGE AND ADMINISTRATION • 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 …

3 DOSAGE FORMS AND STRENGTHS Irrigation: • 250, 500, 1000, and 1500 mL sterile water for irrigation in a single-dose plastic pour bottle • 1000, 2000 and 3000 mL sterile water for irrigation in a single-dose flexible plastic container • 250, 500, 1000, and 1500 mL sterile water for irrigation in a single-dose plastic pour bottle. ( 3 ) • 1000, 2000 and 3000 mL sterile water for irrigation in a single-dose flexible plastic container. ( 3 )

CONTRAINDICATIONS NOT FOR INJECTION BY USUAL PARENTERAL ROUTES.

6 ADVERSE REACTIONS 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.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Appropriate administration of Sterile Water for Irrigation is not expected to cause adverse developmental outcomes. There are no available data on Sterile Water for Irrigation use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with Sterile Water for Irrigation. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. 8.2 Lactation Risk Summary Appropriate administration of Sterile Water for Irrigation is not expected to cause harm to a breastfed infant. There are no data on the presence of Sterile Water for Irrigation in either human or animal milk, the effects on the breastfed infant or the effects on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of Sterile Water for Irrigation to a breastfed infant; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Sterile Water for Irrigation and any potential adverse effects on the breastfed infant from Sterile Water for Irrigation or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. Pediatric patients are at higher risk compared to adults for developing encephalopathy as a complication of hyponatremia, if there is excessive absorption of Sterile Water for Irrigation [see Warnings and Precautions (5.2) ]. 8.5 Geriatric Use Sterile Water for Irrigation should be used cautiously in older patients. Geriatric patients are more likely to have decreased cardiac, renal, or hepatic function, and other diseases or concomitant drug therapy.

DESCRIPTION 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.

10 OVERDOSAGE Excessive rate, volume, pressure or duration of irrigation with hypotonic fluid can result in excessive fluid absorption and permanent morbidity or death as a result of hyponatremia, hypoosmolality and/or fluid overload. In the event of clinically relevant absorption of Sterile Water for Irrigation, immediate intervention may be required [see Warnings and Precautions (5.2) ].

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