Drug Facts
Composition & Profile
Identifiers & 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 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 for Injection, USP Vial Label WARNINGS: NOT ISOTONIC. HEMOLYTIC NDC 65219-187-01 187100 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 100 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Injection, USP Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Injection, USP Tray Label WARNINGS: NOT ISOTONIC. HEMOLYTIC NDC 65219-187-10 187100 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 100 mL Single Dose Vial 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Injection, USP Tray Label
- 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 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 for Injection, USP Vial Label WARNINGS: NOT ISOTONIC. HEMOLYTIC NDC 65219-187-01 187100 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 100 mL Single Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Injection, USP Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Injection, USP Tray Label WARNINGS: NOT ISOTONIC. HEMOLYTIC NDC 65219-187-10 187100 STERILE WATER FOR INJECTION, USP FOR DRUG DILUENT USE ONLY Rx only 100 mL Single Dose Vial 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY – Sterile Water for Injection, USP 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
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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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