Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sterile Water for Irrigation, USP is supplied sterile and nonpyrogenic in single dose flexible plastic containers. Product Code Unit of Sale Each 495010 NDC 65219-495-10 Package of 6 bags NDC 65219-495-01 1000 mL fill in a 1500 mL bag 497020 NDC 65219-497-20 Package of 5 bags NDC 65219-497-02 2000 mL fill in a 2000 mL bag 499030 NDC 65219-499-30 Package of 4 bags NDC 65219-499-03 3000 mL fill in a 3000 mL bag Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]; however, brief exposure up to 40°C (104°F) does not adversely affect the product.; PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 1000 mL Bag Label solu flex ® NDC 65219- 495 -01 1000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION ste0a-0002-01.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water for Irrigation, USP 1000 mL Case Label NDC 65219-495-10 495010 Sterile Water for Irrigation, USP 1,000 mL x 6 STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. ste0a-0002-02.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 2000 mL Bag Label solu flex ® NDC 65219- 497 -02 2000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION ste0a-0002-03.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water for Irrigation, USP 2000 mL Case Label NDC 65219-497-20 497020 Sterile Water for Irrigation, USP 2,000 mL x 5 STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. ste0a-0002-04.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 3000 mL Bag Label solu flex ® NDC 65219- 499 -03 3000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION ste0a-0002-05.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water for Irrigation, USP 3000 mL Case Label NDC 65219-499-30 499030 Sterile Water for Irrigation, USP 3,000 mL x 4 STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. ste0a-0002-06.jpg
- HOW SUPPLIED Sterile Water for Irrigation, USP is supplied sterile and nonpyrogenic in single dose flexible plastic containers. Product Code Unit of Sale Each 495010 NDC 65219-495-10 Package of 6 bags NDC 65219-495-01 1000 mL fill in a 1500 mL bag 497020 NDC 65219-497-20 Package of 5 bags NDC 65219-497-02 2000 mL fill in a 2000 mL bag 499030 NDC 65219-499-30 Package of 4 bags NDC 65219-499-03 3000 mL fill in a 3000 mL bag Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]; however, brief exposure up to 40°C (104°F) does not adversely affect the product.
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 1000 mL Bag Label solu flex ® NDC 65219- 495 -01 1000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION ste0a-0002-01.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water for Irrigation, USP 1000 mL Case Label NDC 65219-495-10 495010 Sterile Water for Irrigation, USP 1,000 mL x 6 STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. ste0a-0002-02.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 2000 mL Bag Label solu flex ® NDC 65219- 497 -02 2000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION ste0a-0002-03.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water for Irrigation, USP 2000 mL Case Label NDC 65219-497-20 497020 Sterile Water for Irrigation, USP 2,000 mL x 5 STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. ste0a-0002-04.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Irrigation, USP 3000 mL Bag Label solu flex ® NDC 65219- 499 -03 3000 mL STERILE WATER FOR IRRIGATION, USP INDICATIONS: FOR IRRIGATION CONTRAINDICATIONS: NOT FOR INJECTION ste0a-0002-05.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY - Sterile Water for Irrigation, USP 3000 mL Case Label NDC 65219-499-30 499030 Sterile Water for Irrigation, USP 3,000 mL x 4 STORE AT: 20 ° to 25 °C ( 68 ° to 77 °F) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. ste0a-0002-06.jpg
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 flexible plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a 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. Not made with natural rubber latex, PVC or DEHP.
Indications & Usage
Sterile Water for Irrigation 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 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. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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