Sterile Water WATER CARDINAL HEALTH 107, LLC FDA Approved 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 H 2 O.
FunFoxMeds bottle
Substance Water
Route
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Applications
ANDA088400
Package NDC

Drug Facts

Composition & Profile

Strengths
10 ml
Quantities
10 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
UPC
0055154958851
UNII
059QF0KO0R
Packaging

How Supplied Unit of Sale Volume Overbagged with 5 x 10 mL in a 10 mL Single Dose Vial in each bag, NDC 55154-9588-5 10 mL in a 10 mL Single Dose Vial WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. 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.; Package/Label Display Panel NDC 55154-9588-5 STERILE WATER FOR INJECTION, USP 5 x 10 mL SINGLE-DOSE VIALS 10mL bag label

Package Descriptions
  • How Supplied Unit of Sale Volume Overbagged with 5 x 10 mL in a 10 mL Single Dose Vial in each bag, NDC 55154-9588-5 10 mL in a 10 mL Single Dose Vial WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. 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.
  • Package/Label Display Panel NDC 55154-9588-5 STERILE WATER FOR INJECTION, USP 5 x 10 mL SINGLE-DOSE VIALS 10mL bag label

Overview

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 H 2 O.

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 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.

Drug Interactions

Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available. Use aseptic technique for single or multiple entry and withdrawal from all containers. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers. Discard unused portion.


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