BACTERIOSTATIC 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:

US MedSource, LLC

INN (Միջազգային անվանումը):

WATER

Կազմը:

WATER 1 mL in 1 mL

Կառավարման երթուղին:

INTRAMUSCULAR

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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. Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population. Parenteral preparations with benzyl alcohol should not be used for fluid replacement. Parenteral preparations containing benzyl alcohol should not be used in epidural or spinal anesthesia procedures. Bacteriostatic Water for Injection, USP must be made approximately isotonic prior to use.

Ապրանքի ամփոփագիր:

Unit of Sale Benzyl Alcohol Preservative Concentration Each NDC 0409-3977-03 Tray of 25 9 mg/mL NDC 0409-3977-01 Multiple-dose 30 mL plastic fliptop vial Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: 10/2013                                                                                     EN-3371 Hospira, Inc., Lake Forest, IL 60045 USA

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

BACTERIOSTATIC WATER- WATER INJECTION, SOLUTION
US MEDSOURCE, LLC
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BACTERIOSTATIC WATER
FOR INJECTION, USP
Multiple-dose Plastic Vial
Rx only
WARNING:
NOT FOR USE IN NEONATES.
DESCRIPTION
The following 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.
Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic
preparation of water for injection
containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic
preservative. It is supplied in a
multiple-dose container from which repeated withdrawals may be made to
dilute or dissolve drugs for
injection. The pH is 5.7 (4.5 to 7.0).
Water for Injection, USP is chemically designated H O.
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
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 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 very small
infants.
INDICATIONS AND USAGE
This parenteral preparation is indicated only for diluting or
dissolving drugs for intravenous,
intramuscular or subcutaneo