Drug Facts
Composition & Profile
Identifiers & Packaging
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).; 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
- 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).
- 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
Overview
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.
Indications & 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 ).
Dosage & 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.
Warnings & Precautions
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.
Contraindications
Not for injection.
Adverse Reactions
None known.
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