Water Injection
FDA Drug Information • Also known as: Insulin Diluting Medium For Novolog, Sterile Water
- Brand Names
- Insulin Diluting Medium For Novolog, Sterile Water
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
Description 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.
What Is Water Injection Used For?
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.
Dosage and Administration
Dosage and 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.
Side Effects (Adverse Reactions)
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.
Warnings and Precautions
Warnings Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis.
Contraindications
Contraindications Sterile Water for Injection, USP must be made approximately isotonic prior to use.
Overdosage
Overdosage Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.
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) 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 0641-6147-10 Carton of 10 NDC 0404-9781-10 1 10 mL single dose vial in a bag (Vial bears NDC 0641-6147-01) 10 mL 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
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.