Label: STERILE WATER- water irrigant

  • NDC Code(s): 0338-0003-44, 0338-0003-46, 0338-0003-47, 0338-0004-02, view more
    0338-0004-03, 0338-0004-04, 0338-0004-05
  • Packager: Baxter Healthcare Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 17, 2017

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use STERILE WATER FOR IRRIGATION safely and effectively. See full prescribing information for STERILE WATER FOR IRRIGATION.

    STERILE WATER FOR IRRIGATION
    Initial U.S. Approval: 1974

    INDICATIONS AND USAGE

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

    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)

    DOSAGE FORMS AND STRENGTHS

    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

    None. (4)

    WARNINGS AND PRECAUTIONS

    Hypotonicity: Administration by parenteral routes can result in serious adverse reactions. For irrigation use only. (5.1)
    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). Avoid use in procedures that require longer irrigation times or an irrigation fluid pressure that promotes absorption. (5.2, 8.4)
    Use with Electrosurgery/Cautery: Ensure compatibility with equipment used with electrosurgery or cautery. (5.2)

    ADVERSE REACTIONS

    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.

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 10/2017

  • Table of Contents
  • 1 INDICATIONS AND USAGE

    Sterile Water for Irrigation is indicated for use as an irrigant.

  • 2 DOSAGE AND ADMINISTRATION

    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.

  • 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
  • 4 CONTRAINDICATIONS

    None.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Hypotonicity

    Sterile Water for Irrigation is hypotonic with an osmolarity of zero mOsmol/L. It is intended for use as irrigation fluid and not for intravenous administration or administration by other, usual parenteral routes, such as intravascular administration in general, subcutaneous administration, or intramuscular administration.

    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)].

    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 (6)]. 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). These complications can manifest after irrigation has ended and immediate intervention may be required.

    Monitor patients closely for absorption of clinically relevant amounts of fluid during and for an appropriate period after the procedure. If absorption occurs, discontinue Sterile Water for Irrigation.

    Additional close monitoring during and/or after the procedure is recommended for patients at increased risk for developing complications related to hypotonicity, such as:

    fluid overload syndrome, including patients with severe renal impairment, impaired cardiac function, or other clinical conditions associated with edematous states.
    hyponatremic encephalopathy, including pediatric patients; women, in particular premenopausal women; patients with hypoxemia; and patients with underlying central nervous system disease.

    Avoid use of Sterile Water for Irrigation in patients with wounds where significant absorption may occur, such as procedures that require irrigation over a longer period of time or an irrigation fluid pressure that promotes absorption (e.g., transurethral resection of prostate). Sterile Water for Irrigation should only be used by clinicians familiar with the treatment of possible complications.

    5.3 Use with Electrosurgery/Cautery

    In contrast to other irrigation fluids containing electrolytes, Sterile Water for Irrigation is non-conductive. Therefore, when choosing the distension solution/fluid used with electrosurgery or cautery, ensure compatibility with the equipment.

  • 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

  • 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.

  • 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)].

  • 11 DESCRIPTION

    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.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Sterile Water for Irrigation is supplied in single-dose plastic pour bottles and flexible plastic containers as follows:

     
    Container

    Product Codes

    Fill Volume (mL)

    NDC

    Plastic Pour Bottle

    2F7112

    250

    0338-0004-02

    2F7113

    500

    0338-0004-03

    2F7114

    1000

    0338-0004-04

    2F7115

    1500

    0338-0004-05

    Flexible Plastic Container

    2B7114

    1000

    0338-0003-44

    2B7116

    2000

    0338-0003-46

    2B7117

    3000

    0338-0003-47

    Storage

    Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

    Store at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product.

  • 17 PATIENT COUNSELING INFORMATION

    Inform patients, caregivers, or home healthcare providers of the following risks of Sterile Water for Irrigation:

    Hypotonicity [see Warnings and Precautions (5.1)]
    Excessive Water Absorption [see Warnings and Precautions (5.2)]
  • SPL UNCLASSIFIED SECTION

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Printed in USA
    07-19-77-916

    Baxter is a registered trademark of Baxter International Inc.

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Representative bottle label 0338-0004-04

    Container Label

    2F7114
    NDC 0338-0004-04

    1000 mL

    Baxter Logo

    Not for Injection

    For Irrigation Only

    Sterile Water for
    Irrigation USP

    Prepared by distillation. No antimicrobial agent
    or other substance has been added. pH 5.5 (5.0
    to 7.0). Osmolarity 0 mOsmol/L (calc.). Sterile,
    nonpyrogenic. Pour Bottle. Warning: This
    solution is not isotonic and is hemolytic. Dosage
    and Administration: As directed by a physician.
    Cautions: Warm in oven to not more than 50ºC for
    a maximum of 60 days. Discard after 60 days of
    warming. Do not use unless solution is clear and
    seal is intact. Discard unused portion.
    Rx only. Recommended storage: Room
    temperature (25ºC). Avoid excessive heat.

    PL 325 Plastic

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA
    Made in USA

    LOT
    EXP

    FPO
    (91)0709000246
    Bar Code

    07-09-00-0246

    Bar Code Position Only*
    303380004041

    Representative Container Label 0338-0004-04 2F7114

    Carton Label

    Sterile Water for
    Irrigation, USP
    Pour Bottle

    1000 ML

    Qty 12

    NDC 0338-0004-04 2F7114
    EXP JUN 08 LOT #G012345

    Bar Code
    (01)50303380004046(17)080630(10)G012345

    Representative Container Label 0338-0003-46

    LOT
    EXP
    2000 mL
    NOT FOR INJECTION
    2B7116
    NDC 0338-0003-46
    STERILE WATER
    For Irrigation USP

    For irrigation only Prepared by distillation
    No antimicrobial agent or other substance has been added
    pH 5.5 (5.0 TO 7.0). Osmolarity 0 mOsmol/L (calc) Sterile
    Nonpyrogenic Single dose container

    Do not use unless fluid is clear Discard unused portion

    Cautions This fluid is not isotonic and is hemolytic
    Squeeze and inspect inner bag which maintains product
    sterility Discard if leaks are found Rx Only Store unit in
    moisture barrier overwrap at room temperature (25ºC) until
    Ready to use Avoid excessive heat See insert

    Sterile Water
    H20
    For Irrigation USP

    UROMATIC container

    Baxter Logo
    Baxter Healthcare Corporation
    Deerfield IL 60015 USA

    Made in USA

    PL 146 Plastic

    Baxter UROMATIC and
    PL 146 are trademarks of
    Baxter International Inc

    For product information
    1-800-933-0303

    1800
    1600
    1400
    1200
    1000
    800
    600
    400
    200

    Representative Sample
  • INGREDIENTS AND APPEARANCE
    STERILE WATER 
    water irrigant
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0003
    Route of AdministrationIRRIGATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER100 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0003-4414 in 1 CARTON05/30/1980
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:0338-0003-466 in 1 CARTON05/30/1980
    22000 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:0338-0003-474 in 1 CARTON05/30/1980
    33000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01786605/30/1980
    STERILE WATER 
    water irrigant
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-0004
    Route of AdministrationIRRIGATION
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER100 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0338-0004-0224 in 1 CARTON12/31/1974
    1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0338-0004-0318 in 1 CARTON12/31/1974
    2500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0338-0004-0412 in 1 CARTON12/31/1974
    31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:0338-0004-059 in 1 CARTON12/31/197410/31/2022
    41500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01742812/31/1974
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation059140764ANALYSIS(0338-0003) , MANUFACTURE(0338-0003) , LABEL(0338-0003) , PACK(0338-0003) , STERILIZE(0338-0003) , API MANUFACTURE(0338-0003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation194684502ANALYSIS(0338-0003, 0338-0004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation001728059ANALYSIS(0338-0004) , MANUFACTURE(0338-0004) , LABEL(0338-0004) , PACK(0338-0004) , STERILIZE(0338-0004)