Baxter Sterile Water for Injection USP 5000 mL VIAFLEX Plastic Container

Description

Baxter Sterile Water for Injection USP 5000 mL VIAFLEX Plastic Container

Baxter Sterile Water for Injection USP 5000 mL VIAFLEX Plastic Container is sterile, nonpyrogenic, distilled water in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. No antimicrobial or other substance has been added. pH 5.5 (5.0 to 7.0). Osmolarity O mOsmol/L (calc.).

The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. 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 admixing to approximate isotonicity.

INDICATIONS AND USAGE

Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral admixtures.

CONTRAINDICATIONS

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

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