Description

Hospira Sterile Water for Injection 10ml is a sterile, nonpyrogenic preparation of water for injection which does not contain bacteriostatic (added buffer) and is supplied in a single-dose vial used to dilute or dissolve medications.

Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled water in a single dose container for intravenous administration after addition of a suitable solute. It may also be used as a dispensing container for diluent use. No antimicrobial or other substance has been added. The pH is 5.5 (5.0 to 7.0). The osmolarity is 0. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

CLINICAL PHARMACOLOGY
Sterile Water for Injection, USP is used for fluid replacement only after suitable additives are introduced to approximate isotonicity and to serve as a vehicle for suitable medications.

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

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.