STERILE WATER- water injection, solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Fresenius Kabi USA, LLC

INN（国际名称）:

WATER

组成:

WATER 1000 mL in 1000 mL

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Sterile Water for Injection is indicated for use only as a solvent or diluent vehicle for parenterally administered drugs or solutions and as a source of water for parenteral fluid replenishment after suitable additives are introduced. For intravenous administration, an osmolar concentration not less than two-fifths (0.4) of the normal osmolarity of the extracellular fluid (280 mOsmol/liter) is essential to avoid intravascular hemolysis. Do not administer without the addition of a solute. Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open - Turn solution container over so that the text is face down.  Using the pre-cut corner tabs, peel open the overwrap and remove solution container. - Check the solution container for leaks by squeezing firmly.  If leaks are found, or if the seal is not intact, discard the solution. - Do not use if the solution is cloud

產品總結:

Sterile Water for Injection, USP is supplied in a single dose flexible plastic container as follows: The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.

授权状态:

Abbreviated New Drug Application

产品特点

STERILE WATER- WATER INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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STERILE WATER FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY
Rx only
DESCRIPTION:
Sterile Water for Injection, USP is a sterile, nonpyrogenic,
solute-free preparation of
distilled water for injection. It is for use only as a sterile solvent
or diluent vehicle for
drugs or solutions suitable for parenteral administration. The pH is
5.5 (5.0 to 7.0).
Sterile Water for Injection contains no bacteriostat, antimicrobial
agent or added buffer
and is intended only for single dose injection after admixture with an
appropriate solute
or solution. When smaller amounts are required, the unused portion
should be
discarded.
Sterile Water for Injection is a pharmaceutic aid (vehicle) and
parenteral fluid replenisher
after addition of an appropriate solute.
Water for Injection, USP is chemically designated H
O.
The flexible container is fabricated from a specially formulated
non-plasticized, film
containing polypropylene and thermoplastic elastomers ( FREE_flex_
bag). The amount
of water that can permeate from the container into the overwrap is
insufficient to affect
the solution significantly. Solutions in contact with the flexible
container can leach out
certain of the container’s chemical components in very small amounts
within the
expiration period. The suitability of the container material has been
confirmed by tests in
animals according to USP biological tests for plastic containers.
CLINICAL PHARMACOLOGY:
When administered intravenously as a vehicle for drugs, sterile water
for injection
provides a source of water for parenteral fluid replenishment after
sufficient solute is
introduced to achieve an osmolarity of 112 mOsmol or more per liter.
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