STERILE WATER- water injection, solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Baxter Healthcare Company

INN (Alþjóðlegt nafn):

WATER

Samsetning:

WATER 100 mL in 100 mL

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Sterile Water for Injection, USP is indicated in the aseptic preparation of parenteral solutions. Sterile Water for Injection, USP is a hemolytic agent due to its hypotonicity. Therefore, it is contraindicated for intravenous administration without additives.

Vörulýsing:

Sterile Water for Injection, USP is supplied in VIAFLEX plastic containers as follows: 1000 mL 2B0304 NDC 0338-0013-04 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.

Leyfisstaða:

New Drug Application

Vara einkenni

STERILE WATER- WATER INJECTION, SOLUTION
BAXTER HEALTHCARE COMPANY
----------
STERILE WATER FOR INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
FOR DRUG DILUENT USE ONLY
DESCRIPTION
Sterile Water for Injection, USP, is sterile, nonpyrogenic, distilled
water in a single dose container 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.
The VIAFLEX plastic container is fabricated from a specially
formulated polyvinyl chloride (PL 146
Plastic). The amount of water that can permeate from inside the
container into the overwrap is
insufficient to affect the solution significantly. Solutions in
contact with the plastic container may leach
out certain chemical components from the plastic in very small
amounts; however, biological testing
was supportive of the safety of the plastic container materials.
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 for 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 solution is clear and seal is intact.
ADVERSE REACTIONS
The administration of a suitable admixture of prescribed additives may
be associated with adverse
reactions because of the solution or the technique of administration
including febrile response,
infection