Sterile Water WATER FRESENIUS KABI USA, 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.

Drug Facts

Composition & Profile

Strengths
10 unit 10 ml 20 unit 20 ml 50 unit 50 ml 100 ml 05 unit 5 ml 6 ml
Quantities
10 ml 20 ml 50 ml 100 ml 5 ml 6 ml 25 vial
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
UPC
0363323185084 0363323185077 0363323185046
UNII
059QF0KO0R
Packaging

HOW SUPPLIED Product Code Unit of Sale Volume Each 918510 NDC 63323-185-10 Unit of 25 10 mL in a 10 mL vial NDC 63323-185-07 10 mL Single Dose Vial 918520 NDC 63323-185-20 Unit of 25 20 mL in a 20 mL vial NDC 63323-185-08 20 mL Single Dose Vial 918550 NDC 63323-185-50 Unit of 25 50 mL in a 50 mL vial NDC 63323-185-09 50 mL Single Dose Vial 187100 NDC 65219-187-10 Unit of 25 100 mL in a 100 mL vial NDC 65219-187-01 100 mL Single Dose Vial 18505 NDC 63323-185-05 Unit of 25 5 mL in a 6 mL vial NDC 63323-185-04 5 mL Single Dose 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.; PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 10 mL Single Dose Vial Label NDC 63323-185-07 918510 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 10 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 10 mL Single Dose Vial Label; PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 10 mL Single Dose Vial Tray Label NDC 63323-185-10 918510 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 10 mL Single Dose Vial 25 Vials PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 10 mL Single Dose Vial Tray Label; PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Label NDC 63323-185-08 918520 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 20 mL Single Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Label; PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Tray Label NDC 63323-185-20 918520 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 20 mL Single Dose Vial 25 Vials PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Tray Label; PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Label NDC 63323-185-09 918550 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 50 mL Single Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Label; PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Tray Label NDC 63323-185-50 918550 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 50 mL Single Dose Vial 25 Vials PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Tray Label; PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Vial Label NDC 63323-185-04 18505 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 5 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Tray Label NDC 63323-185-05 18505 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 5 mL Single Dose Vial 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Tray Label

Package Descriptions
  • HOW SUPPLIED Product Code Unit of Sale Volume Each 918510 NDC 63323-185-10 Unit of 25 10 mL in a 10 mL vial NDC 63323-185-07 10 mL Single Dose Vial 918520 NDC 63323-185-20 Unit of 25 20 mL in a 20 mL vial NDC 63323-185-08 20 mL Single Dose Vial 918550 NDC 63323-185-50 Unit of 25 50 mL in a 50 mL vial NDC 63323-185-09 50 mL Single Dose Vial 187100 NDC 65219-187-10 Unit of 25 100 mL in a 100 mL vial NDC 65219-187-01 100 mL Single Dose Vial 18505 NDC 63323-185-05 Unit of 25 5 mL in a 6 mL vial NDC 63323-185-04 5 mL Single Dose 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.
  • PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 10 mL Single Dose Vial Label NDC 63323-185-07 918510 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 10 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 10 mL Single Dose Vial Label
  • PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 10 mL Single Dose Vial Tray Label NDC 63323-185-10 918510 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 10 mL Single Dose Vial 25 Vials PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 10 mL Single Dose Vial Tray Label
  • PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Label NDC 63323-185-08 918520 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 20 mL Single Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Label
  • PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Tray Label NDC 63323-185-20 918520 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 20 mL Single Dose Vial 25 Vials PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 20 mL Single Dose Vial Tray Label
  • PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Label NDC 63323-185-09 918550 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 50 mL Single Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Label
  • PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Tray Label NDC 63323-185-50 918550 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 50 mL Single Dose Vial 25 Vials PACKAGE LABEL – PRINCIPAL DISPLAY – STERILE WATER – 50 mL Single Dose Vial Tray Label
  • PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Vial Label NDC 63323-185-04 18505 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 5 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Vial Label
  • PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Tray Label NDC 63323-185-05 18505 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 5 mL Single Dose Vial 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY - STERILE WATER - 5 mL Single Dose Tray 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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