BACTERIOSTATIC WATER- water injection, solution STERILE WATER- water injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

These parenteral preparations are 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 and Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use. Bacteriostatic Water for Injection should not be used in patients with a known sensitivity to the antimicrobial preservative employed.

Product summary:

Sterile Water for Injection, USP *Indicates vial with tear-off seal. Preservative Free.  Discard unused portion. Packaged in trays of twenty-five. Bacteriostatic Water for Injection, USP contains parabens (NOT FOR USE IN NEWBORNS): Packaged in trays of twenty-five. Use only if solution is clear and seal intact. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

unapproved drug other

Summary of Product characteristics

BACTERIOSTATIC WATER - WATER INJECTION, SOLUTION
STERILE WATER - WATER INJECTION
FRESENIUS KABI USA, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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STERILE WATER FOR INJECTION USP-BACTERIOSTATIC WATER FOR INJECTION USP
DESCRIPTION
These preparations are 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 IV
injection, add sufficient solute to make an
approximately isotonic solution. pH 5.0 to 7.0.
Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic
preparation of bacteriostatic water
for injection packaged in multiple dose vials. It contains 0.12%
methylparaben, 0.012% propylparaben.
pH 4.5 to 7.0. _(NOT FOR USE IN NEWBORNS)._
Water for Injection, USP is chemically designated H O.
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 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.
The small volume of fluid provided by Sterile Water for Injection, USP
or Bacteriostatic 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 newborns or very
sm