Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Sterile Water for Injection, USP is supplied in the following: 10 mL single dose vials packaged in cartons of 10 vials (NDC 0641-6147-10) and 25 vials (NDC 0641-6147-25) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] DO NOT FREEZE. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised July 2020 462-682-02; PRINCIPAL DISPLAY PANEL WARNINGS: NOT ISOTONIC. HEMOLYTIC. NDC 0641- 6147 -01 Rx only Sterile Water for Injection, USP FOR DRUG DILUENT USE ONLY 10 mL Single Dose Vial NDC 0641- 6147 -25 Rx only Sterile Water for Injection, USP FOR DRUG DILUENT USE ONLY 25 x 10 mL Single Dose Vials 10 ml vial 25 x 10 ml vial; PRINCIPAL DISPLAY PANEL NDC 0641- 6147 -10 Rx only Sterile Water for Injection, USP FOR DRUG DILUENT USE ONLY 10 x 10 mL Single Dose Vials shelfpack
- HOW SUPPLIED Sterile Water for Injection, USP is supplied in the following: 10 mL single dose vials packaged in cartons of 10 vials (NDC 0641-6147-10) and 25 vials (NDC 0641-6147-25) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] DO NOT FREEZE. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised July 2020 462-682-02
- PRINCIPAL DISPLAY PANEL WARNINGS: NOT ISOTONIC. HEMOLYTIC. NDC 0641- 6147 -01 Rx only Sterile Water for Injection, USP FOR DRUG DILUENT USE ONLY 10 mL Single Dose Vial NDC 0641- 6147 -25 Rx only Sterile Water for Injection, USP FOR DRUG DILUENT USE ONLY 25 x 10 mL Single Dose Vials 10 ml vial 25 x 10 ml vial
- PRINCIPAL DISPLAY PANEL NDC 0641- 6147 -10 Rx only Sterile Water for Injection, USP FOR DRUG DILUENT USE ONLY 10 x 10 mL Single Dose Vials shelfpack
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 intravenous injection, add sufficient solute to make an approximately isotonic solution. Water for Injection, USP is chemically designated H 2 O. The glass vial is a Type I borosilicate glass and meets the requirements according to the USP standards.
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.
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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