Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sterile Water for Injection, USP is supplied in the following: Unit of Sale Total Content NDC 0409-4887-05 Tray of 25 Single-dose Glass Fliptop Vials 1 mL NDC 0409-4887-10 Tray of 25 Single-dose Plastic Fliptop Vials 10 mL NDC 0409-4887-34 Tray of 30 Single-dose Plastic Fliptop Vials 10 mL NDC 0409-4887-20 Tray of 25 Single-dose Plastic Fliptop Vials 20 mL NDC 0409-4887-50 Tray of 25 Single-dose Plastic Fliptop Vials 50 mL NDC 0409-4887-99 Case of 25 Single-dose Glass Fliptop Vials 100 mL Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1292-2.0 Revised: 05/2021 Hospira logo; PRINCIPAL DISPLAY PANEL - 20 mL Vial Label 20 mL Single-dose Sterile Water for Injection, USP FOR DRUG DILUENT USE wate.jpg; PRINCIPAL DISPLAY PANEL - OUTER PACKAGE NDC 71872-7290-1 1 x 20 mL Single-dose Vial Rx only Sterile Water for Injection, USP FOR DRUG DILUENT USE 7290.jpg
- HOW SUPPLIED Sterile Water for Injection, USP is supplied in the following: Unit of Sale Total Content NDC 0409-4887-05 Tray of 25 Single-dose Glass Fliptop Vials 1 mL NDC 0409-4887-10 Tray of 25 Single-dose Plastic Fliptop Vials 10 mL NDC 0409-4887-34 Tray of 30 Single-dose Plastic Fliptop Vials 10 mL NDC 0409-4887-20 Tray of 25 Single-dose Plastic Fliptop Vials 20 mL NDC 0409-4887-50 Tray of 25 Single-dose Plastic Fliptop Vials 50 mL NDC 0409-4887-99 Case of 25 Single-dose Glass Fliptop Vials 100 mL Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1292-2.0 Revised: 05/2021 Hospira logo
- PRINCIPAL DISPLAY PANEL - 20 mL Vial Label 20 mL Single-dose Sterile Water for Injection, USP FOR DRUG DILUENT USE wate.jpg
- PRINCIPAL DISPLAY PANEL - OUTER PACKAGE NDC 71872-7290-1 1 x 20 mL Single-dose Vial Rx only Sterile Water for Injection, USP FOR DRUG DILUENT USE 7290.jpg
Overview
This preparation is designed solely for parenteral use only after addition of 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 I.V. injection, add sufficient solute to make an approximately isotonic solution. Water for Injection, USP is chemically designated H 2 O. The glass vial is Type I or II borosilicate glass and meets the requirements of the powdered glass test according to the USP standards. The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper labeled volume.
Indications & Usage
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Dosage & Administration
The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
WARNINGS Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.
Contraindications
Sterile Water for Injection, USP must be made approximately isotonic prior to use.
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.
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