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:

ICU Medical Inc.

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Sterile Water for Injection, USP in the Pharmacy Bulk Package is indicated for use with automated compounding devices for preparing intravenous admixtures in the pharmacy. NOT FOR DIRECT INFUSION. DO NOT USE FOR NON-AUTOMATED ADMIXTURE PREPARATIONS.

Ապրանքի ամփոփագիր:

Sterile Water for Injection, USP is supplied in 2000 mL flexible Pharmacy Bulk Packages. ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Patent 4,368,765 Revised: July, 2018 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA EN-4665

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

STERILE WATER- WATER INJECTION, SOLUTION
ICU MEDICAL INC.
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STERILE WATER FOR INJECTION, USP
PHARMACY BULK PACKAGE — NOT FOR DIRECT INFUSION.
FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES.
FLEXIBLE CONTAINER R only
DESCRIPTION
Sterile Water for Injection, USP is a sterile, nonpyrogenic water for
injection intended only for dilution
purposes. The pH is 5.4 (5.0 to 7.0). The Pharmacy Bulk Package is a
sterile dosage form which
contains multiple single doses for use only in a pharmacy bulk
admixture program.
Sterile Water for Injection, USP contains no bacteriostat,
antimicrobial agent or added buffer.
Sterile Water for Injection, USP may be classified as a sterile
diluent and pharmaceutical vehicle.
Sterile Water for Injection, USP is chemically designated H O.
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride. Water can
permeate from inside the container into the overwrap but not in
amounts sufficient to affect the solution
significantly. Solutions inside the plastic container also can leach
out certain of its chemical
components in very small amounts before the expiration period is
attained. However, the safety of the
plastic has been confirmed by tests in animals according to USP
biological standards for plastic
containers.
CLINICAL PHARMACOLOGY
Water is an essential constituent of all body tissues and accounts for
approximately 70% of total body
weight. Average normal adult daily requirement ranges from two to
three liters (1.0 to 1.5 liters each
for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water
distribution depends primarily on
the concentration of electrolytes in the body compartments and sodium
(Na ) plays a major role in
maintaining physiologic equilibrium.
INDICATIONS AND USAGE
Sterile Water for Injection, USP in the Pharmacy Bulk Package is
indicated for use with automated
compounding devices for preparing intravenous admixtures in the
pharmacy.
CONTRAINDICATIONS
NOT FOR