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| Product NDC Code | 0264-7386 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Sterile water |
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| Type | Generic | ||||||
| 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 made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. 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 Sterile 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 STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION REF R8005 NDC 0264-7386-50 LOT EXP. 2000 mL No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) WARNINGS: HYPOTONIC AND HEMOLYTIC See Package Insert. Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single unit container. Discard unused portion. Dosage: Irrigation. Use as directed by physician. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-063 LD-255-6 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 S ET Sterile Water Irrigation 2L Container Label Recycle 7 Symbol set arrow illustration Sterile Water Irrigation 2L Container Label
PRINCIPAL DISPLAY PANEL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION REF R8006 NDC 0264-7386-60 LOT EXP. 3000 mL No antimicrobial agent or other substance has been added. pH: 5.7 (5.0-7.0) WARNINGS: HYPOTONIC AND HEMOLYTIC See Package Insert. Use only if solution is clear and container and seal are intact. Sterile, nonpyrogenic. Single unit container. Discard unused portion. Dosage: Irrigation. Use as directed by physician. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Not made with natural rubber latex, PVC or DEHP. Rx only Y38-000-064 LD-256-6 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 SET Sterile Water Irrigation 3L Container Label Recycle 7 Symbol set arrow illustration Sterile Water Irrigation 3L Container Label
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.Rx only B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 LD-401-5 Y36-002-984 Revised: August 2018
Instructions for use
Information about safe handling and use of the drug product.Directions for Use of Plastic Container Not for injection. Not for use with pressurized irrigation systems. Aseptic technique is required. Inspect irrigation bag: overwrap and primary bag. Do not use if overwrap has been damaged. Do not use unless solution is clear and closure is intact. To open: Tear overwrap starting from the tear notches. (Figure 1) Prepare medication port by removal of aluminum foil. (Figure 2a) Puncture resealable medication port by using 19 – 22 gauge needle and inject additive(s). (Figure 2b) Mix solution and medication thoroughly. (Figure 3a) Medication port must be swabbed with disinfection agent before re-puncturing. Check admixture visually for particulate matter. (Figure 3b) Remove aluminum foil from outlet/set port at the bottom of container (Figure 4a) and attach administration set (Figure 4b): use non-vented infusion set or close air vent on a vented set. Refer to directions for use accompanying the administration set. Hang bag on IV Pole. (Figure 5) Tear Notches. Overwrap Illustration. Tear Overwrap Illustration Illustration 2 Illustration 3 Illustration 4 Illustration 5
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 single-dose 2000 and 3000 mL flexible irrigation containers packaged 4 per case. NDC REF SIZE 0264-7386-50 R8005 2000 mL 0264-7386-60 R8006 3000 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.
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| 0264-7386-50 | R8005 | 2000 mL |
| 0264-7386-60 | R8006 | 3000 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