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| Product NDC Code | 0264-2101 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | NDA016734 | ||||||
| Labeler Name | B. Braun Medical Inc. | ||||||
| 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.OVERDOSAGE None known.
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.ADVERSE REACTIONS None known.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Sterile Water for Irrigation USP is utilized for a variety of clinical indications. Because of its low refractive index (1.3325), water provides excellent visibility during endoscopic urological procedures. It is also utilized as a pharmaceutic aid, as well as in the preparation of enteral nutrient products. Water is hypotonic and will cause hemolysis and will be readily absorbed by the tissues during surgical procedures; therefore, its use under such conditions is not recommended.
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.CONTRAINDICATIONS Not for injection.
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.DESCRIPTION Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) entirely composed of Sterile Water for Injection USP. It is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. The pH is 5.7 (5.0–7.0) The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert. Not made with natural rubber Latex, PVC or DEHP.
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.DOSAGE AND ADMINISTRATION Irrigation Use as directed by physician. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Nutrient Mixtures Sterile Water for Irrigation USP may be used to prepare non-intravenously administered nutrient mixtures. It contains no electrolytes or other added substances. Refer to preparation instructions of particular mixture to be used. The plastic container may be used for administration of non-intravenous nutrient mixture to the patient as appropriate.
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.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 ).
Spl product data elements
Usually a list of ingredients in a drug product.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.PRINCIPAL DISPLAY PANEL - 1000 mL Container Sterile Water for Irrigation USP Warnings: Hypotonic and Hemolytic REF R5000-01 NDC 0264-2101-00 DIN 01963961 HK 23675 1000 mL PIC™ Container Rx only Lot Exp. No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) Not for Injection. See Package Insert. Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single-dose container. Discard unused portion. Warning: Do not warm above 150°F (66°C). Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. Dosage: See Prescribing Information. Not made with natural rubber latex, PVC or DEHP. Y37-002-594 LD-775-1 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Imported by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Sterile Water for Irrigation USP 1000 mL Container Label R5000-01
PRINCIPAL DISPLAY PANEL - 500 mL Container Sterile Water for Irrigation USP Warnings: Hypotonic and Hemolytic REF R5001-01 NDC 0264-2101-10 DIN 01963961 HK 23675 500 mL PIC™ Container Rx only Lot Exp. No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) Not for Injection. See Package Insert. Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single-dose container. Discard unused portion. Warning: Do not warm above 150°F (66°C). Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. Dosage: See Prescribing Information. Not made with natural rubber latex, PVC or DEHP. Y37-002-595 LD-776-1 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Imported by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Sterile Water for Irrigation USP 500 mL Container Label R5001-01
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.Revised: May 2023 PIC is a trademark of B. Braun Medical Inc.
Directions for Use of PIC™ (Plastic Irrigation Container) Not for injection. Aseptic technique is required. Caution – Before use, perform the following checks: (a) Read the label. Ensure solution is the one ordered and is within the expiration date. (b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used. Use only if solution is clear and container and seal are intact. Single-dose container. Discard unused portion. Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off. (Figure 1) Connect the administration set through the sterile set port according to set instructions (Figure 2) or remove screw cap and pour. Do not warm above 150°F (66°C) to assure minimal bottle distortion. Keep bottles upright. Figure 1 Figure 2
B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Imported by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y36-003-075 LD-774-1
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.HOW SUPPLIED Sterile Water for Irrigation USP is supplied sterile and nonpyrogenic in plastic irrigating containers. The 1000 mL and 500 mL containers are packaged 16 per case. NDC Cat. No. Size Sterile Water for Irrigation USP (Canada DIN 01963961) 0264-2101-00 R5000-01 1000 mL 0264-2101-10 R5001-01 500 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).
| NDC | Cat. No. | Size |
|---|---|---|
| Sterile Water for Irrigation USP (Canada DIN 01963961) | ||
| 0264-2101-00 | R5000-01 | 1000 mL |
| 0264-2101-10 | R5001-01 | 500 mL |
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS Use only if solution is clear and container and seal are intact.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS Sterile Water for Irrigation USP is hypotonic and will cause hemolysis, and is not recommended for use during surgical procedures. After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard unused portion of irrigating solution since it contains no preservative.
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