Sterile Water
Generic: STERILE WATER
Basic Information
Manufacturer
Hikma Pharmaceuticals USA Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
b20a28b0-7dfa-42eb-9177-ec256d5a5ef7
Indications & Usage
INDICATIONS AND USAGE Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions.
Warnings
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.
Hemolysis may occur following infusion of Sterile Water for Injection, USP.
Hemoglobin induced renal failure has been reported following hemolysis.
Adverse Reactions
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.
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.