SODIUM CHLORIDE injection, solution, concentrate

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Dostupné s:

Fresenius Kabi USA, LLC

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

14.6% Sodium Chloride Injection, USP Additive Solution is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. 14.6% Sodium Chloride Additive Solution may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes. 14.6% Sodium Chloride Injection, USP Additive Solution is contraindicated in patients with hypernatremia or fluid retention.

Přehled produktů:

14.6% Sodium Chloride Injection, USP Additive Solution is supplied as the following: 　 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Preservative Free The container closure is not made with natural rubber latex.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

SODIUM CHLORIDE - SODIUM CHLORIDE INJECTION, SOLUTION, CONCENTRATE
FRESENIUS KABI USA, LLC
----------
14.6%
SODIUM CHLORIDE INJECTION, USP
Rx only
ADDITIVE SOLUTION
CONCENTRATED SOLUTION
CONCENTRATE
_CAUTION: MUST BE DILUTED FOR I.V. USE_
For use only after dilution with compatible I.V. fluids to correct
sodium deficiency when
oral replacement is not feasible.
PLASTIC VIAL
DESCRIPTION
14.6% Sodium Chloride Injection, USP Additive Solution is a sterile,
nonpyrogenic,
concentrated solution for intravenous administration ONLY AFTER
DILUTION to replenish
electrolytes. The preparations contain either 2.92 or 5.84 g of sodium
chloride (50 or
100 mEq each of Na and Cl ) in Water for Injection, USP. The solution
contains no
bacteriostat, antimicrobial agent or added buffer; pH 4.8 (4.5 to
7.0). May contain
hydrochloric acid for pH adjustment. The osmolar concentration is 5
mOsmol/mL (calc.);
specific gravity is 1.10.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline compound freely
soluble in water.
The semi-rigid material used for the plastic vials is fabricated from
a specially formulated
polyolefin. It is a copolymer of 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 drug
concentration.
CLINICAL PHARMACOLOGY
Sodium chloride in water dissociates to provide sodium (Na ) and
chloride (Cl ) ions.
These ions are normal constituents of the body fluids (principally
extracellular) and are
essential for maintaining electrolyte balance.
Sodium is the principal cation of extracellular fluid. It comprises
more than 90% of the
total cations at its normal plasma concentration of approximately 142
mEq/liter. While
the sodium ion can diffuse across cell membranes, intracellular sodium
is maintained at a
much lower concentration than extracellular sodium through the
expenditure of energy
by the cell (so called "sodium cation pump"). Loss of intracellular
potassiu