STERILE WATER WATER HENRY SCHEIN, INC. FDA Approved 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.
Generic: WATER
Mfr: HENRY SCHEIN, INC. FDA Rx Only
FunFoxMeds bottle
Substance Water
Route
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Applications
NDA018801
Product NDC
Package NDC

Drug Facts

Composition & Profile

Strengths
100 ml
Quantities
100 ml
Treats Conditions
Indications And 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

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
059QF0KO0R
Packaging

How Supplied Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0409-4887-99 Case of 25 Single-dose Glass Fliptop Vials NDC 0404-9971-00 1 100 mL Single-dose Fliptop Vial in a bag (Vial bears NDC 0409-4887-25) 100 mL Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1292-2.0 Revised: 05/2021 Image1.jpg; SAMPLE PACKAGE LABEL Label1.jpg

Package Descriptions
  • How Supplied Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0409-4887-99 Case of 25 Single-dose Glass Fliptop Vials NDC 0404-9971-00 1 100 mL Single-dose Fliptop Vial in a bag (Vial bears NDC 0409-4887-25) 100 mL Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1292-2.0 Revised: 05/2021 Image1.jpg
  • SAMPLE PACKAGE LABEL Label1.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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