Sterile Water

Product Type: HUMAN PRESCRIPTION DRUG

Route: INTRAVENOUS

Dosage Form:

NDC: 0143-9339

Application: ANDA212735

Effective: 20230508

INDICATIONS AND USAGE Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions.

DOSAGE AND ADMINISTRATION Following suitable admixture of prescribed additives, the dosage is usually dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations. See directions accompanying additive drug. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Injections in flexible plastic containers are intended for intravenous administration using sterile equipment. Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Do not store an unused portion of Sterile Water for Injection, USP. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

CONTRAINDICATIONS Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is contraindicated for intravenous administration without additives.

WARNINGS Do not use for intravenous injection unless adjusted to approximate isotonicity with a suitable solute. Hemolysis may occur following infusion of Sterile Water for Injection, USP. Hemoglobin induced renal failure has been reported following hemolysis.

ADVERSE REACTIONS The administration of a suitable admixture of prescribed additives may be associated with adverse reactions because of the solution or the technique of administration including febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary. 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.