Water for Injection
Name: Water for Injection
Water for Injection Description
This preparation is designed solely for parenteral use only after addition to drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.
Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of Water for Injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single dose containers to dilute or dissolve drugs for injection. For IV injection, add sufficient amount to a solute to make an approximately isotonic solution. pH 5.0 to 7.0.
Water for Injection, USP is chemically designated H2O.
Contraindications
Sterile Water for Injection must be made approximately isotonic prior to use.
Warnings
Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.
Where Water for Injection is required for preparing or diluting medications for use in newborns, only preservative-free Sterile Water for Injection should be used.
Adverse Reactions
Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
How is Water for Injection Supplied
Product No. | NDC No. | Volume |
918501 | 63323-185-01 | 1 mL in a 3 mL vial |
918510 | 63323-185-10 | 10 mL in a 10 mL vial |
918520 | 63323-185-20 | 20 mL in a 20 mL vial |
918550 | 63323-185-50 | 50 mL in a 50 mL vial |
Packaged in a plastic vial. Vials are packaged 25 vials per tray.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Single dose use. No preservative added.
Unused portion of vial should be discarded.
Use only if solution is clear and seal intact.
45768F
Revised: July 2008
PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 10 mL Single Dose Vial Label
NDC 63323-185-10
918510
Sterile Water for Injection, USP
FOR DRUG DILUENT USE ONLY
Rx only
10 mL Single Dose Vial
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Labeler - Fresenius Kabi USA, LLC (608775388) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Fresenius Kabi USA, LLC | 840771732 | MANUFACTURE(63323-185) |