STERILE WATER- water injection, solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)

Հասանելի է:

Baxter Healthcare Company

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral admixtures. Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is contraindicated for intravenous administration without admixing.

Ապրանքի ամփոփագիր:

Sterile Water for Injection, USP is supplied in a VIAFLEX plastic Pharmacy Bulk Package container as follows: 2000 mL 2B0306 NDC 0338-0013-06 3000 mL 2B0307 NDC 0338-0013-08 5000 mL 2B0309 NDC 0338-0013-29 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F). Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA Baxter, Viaflex, and PL 146 are trademarks of Baxter International Inc. 07 19 73 676 Rev. September 2014 Distributed in Canada by Baxter Corporation Mississauga, ON L5N 0C2

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

STERILE WATER- WATER INJECTION, SOLUTION
BAXTER HEALTHCARE COMPANY
----------
STERILE WATER FOR INJECTION, USP
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
VIAFLEX PLASTIC CONTAINER
DESCRIPTION
Sterile Water for Injection, USP 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.
WARNINGS
This solution is for compounding only, not for direct infusion.
Hemolysis may occur following
infusion of Sterile Water for Injection, USP. Hemoglobin induced renal
failure has been reported