BACTERIOSTATIC WATER

Bacteriostatic VWater for Injection, USP, is sterile, nonpyrogenic, distilled water for
intravenous administration after addition of a suitable solute. It may also be used as a
dispensing container for diluent use. No antimicrobial or other substance has been added.
The pH is 5.5 (5.0 to 7.0). The osmolarity is 0.

  • 9.00

Description

Bacteriostatic Water

ATC code: V07AB
CAS number:7732-18-5
Dosage Form: Injectable
Market Status: Prescription
Company: Hilma Biocare

DESCRIPTION

Bacteriostatic VWater for Injection, USP, is sterile, nonpyrogenic, distilled water for
intravenous administration after addition of a suitable solute. It may also be used as a
dispensing container for diluent use. No antimicrobial or other substance has been added.
The pH is 5.5 (5.0 to 7.0). The osmolarity is 0.

CLINICAL PHARMACOLOGY

Sterile Water for Injection, USP is used for fluid replacement only after suitable additives are
introduced to approximate isotonicity and to serve as a vehicle for suitable medications.

INDICATIONS AND USAGE

Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions.

CONTRAINDICATIONS

Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is
contraindicated for intravenous administration without additives.

WARNINGS

Do not use intravenous injection unless adjusted to approximate isotonicity with a suitable
solute. Hemolysis may occur following infusion of Sterile Water for Injection, USP.
Hemoglobin induced renal failure has been reported following hemolysis.

PRECAUTIONS

Do not administer unless the solution is clear and the seal is intact.

ADVERSE REACTIONS

The administration of a suitable admixture of prescribed additives may be associated
reactions because of the solution or the technique of administration including febrile
response, infection at the site with adverse of injection, venous thrombosis or phlebitis
extending from the site of injection, extravasation, and hypervolemia. If an adverse reaction
does occur, discontinue the infusion. evaluate the patient, institute appropriate therapeutic
countermeasures, and save the remainder of the fluid for examination if deemed necessary.

DOSAGE AND ADMINISTRATION

Following suitable admixture of prescribed additives, the dosage is usually dependent upon
the age, weight and clinical condition of the patient as well as laboratory determinations. See
directions accompanying additive drugs. Do not store an unused portion of Sterile Water for
Injection, USP. Mix thoroughly when additives have been introduced. Do not store solutions
containing additives.

PRESENTATION

Sterile water, 10ml multiple dose vial.

STORAGE

Store between 20 – 25°C.

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