STERILE WATER- water injection

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Hospira, Inc.

INN (International namn):

WATER

Sammansättning:

WATER 1 mL in 1 mL

Administreringssätt:

INTRAMUSCULAR

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. Sterile Water for Injection, USP must be made approximately isotonic prior to use.

Produktsammanfattning:

Sterile Water for Injection, USP is supplied in the following: NDC 0409-4887-05 Tray of 25 Single-dose Glass Fliptop Vials 1 mL NDC 0409-4887-10 Tray of 25 Single-dose Plastic Fliptop Vials 10 mL NDC 0409-4887-34 Tray of 30 Single-dose Plastic Fliptop Vials 10 mL NDC 0409-4887-20 Tray of 25 Single-dose Plastic Fliptop Vials 20 mL NDC 0409-4887-50 Tray of 25 Single-dose Plastic Fliptop Vials 50 mL NDC 0409-4887-99 Case of 25 Single-dose Glass Fliptop Vials 100 mL Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                    LAB-1292-2.0 Revised: 05/2021

Bemyndigande status:

New Drug Application

Produktens egenskaper

STERILE WATER- WATER INJECTION
HOSPIRA, INC.
----------
STERILE WATER RX
ONLY
FOR INJECTION,
USP
GLASS VIAL
PLASTIC VIAL
DESCRIPTION
This preparation is designed solely for parenteral use only after
addition of drugs that
require dilution or must be dissolved in an aqueous vehicle prior to
injection.
Sterile Water for Injection, USP is a sterile, nonpyrogenic
preparation of water for
injection which contains no bacteriostat, antimicrobial agent or added
buffer and is
supplied only in single-dose containers to dilute or dissolve drugs
for injection. For I.V.
injection, add sufficient solute to make an approximately isotonic
solution.
Water for Injection, USP is chemically designated H O.
The glass vial is Type I or II borosilicate glass and meets the
requirements of the
powdered glass test according to the USP standards.
The semi-rigid vial is fabricated from a specially formulated
polyolefin. It is a copolymer of
ethylene and propylene. The safety of the plastic has been confirmed
by tests in animals
according to USP biological standards for plastic containers. The
container requires no
vapor barrier to maintain the proper labeled volume.
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
for distribution
depends primarily on the concentration of electrolytes in the body
compartments and
sodium (Na ) plays a major role in maintaining physiologic
equilibrium.
The small volume of fluid provided by Sterile Water for Injection, USP
when used only as
a pharmaceutic aid for diluting or dissolving drugs for parenteral
injection, is unlikely to
exert a significant effect on fluid balance except possibly in
neonates or very small
infants.
INDICATIONS AND USAGE
This parenteral preparation is indicated only for diluting