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| Product NDC Code | 0338-0003 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sterile water |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | IRRIGATION | ||||||||
| Dosage Form | IRRIGANT | ||||||||
| RxCUI drug identifier | 150985 | ||||||||
| Application Number | NDA017866 | ||||||||
| Labeler Name | Baxter Healthcare Corporation | ||||||||
| Packages |
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Overdosage of Sterile Water
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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) ].
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 CONTRAINDICATIONS None. • None. ( 4 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.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.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 heating of irrigation fluids is not recommended.
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.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 )
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND USAGE Sterile Water for Irrigation is indicated for use as an irrigant. Sterile Water for Irrigation is indicated for use as an irrigant. ( 1 )
Spl product data elements
Usually a list of ingredients in a drug product.Sterile Water Water WATER WATER Sterile Water Water WATER WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE/LABEL PRINCIPAL DISPLAY PANEL 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 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 H 2 0 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 bottle label 0338-0004-04 Representative Container Label 0338-0003-46
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA 07-19-77-916 Baxter is a registered trademark of Baxter International Inc.
Sterile Water: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.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) ]
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.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.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.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) ].
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)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.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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.
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Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API