20% SODIUM CHLORIDE INJECTION, BP SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

SODIUM CHLORIDE

Boleh didapati daripada:

BAXTER CORPORATION

Kod ATC:

B05XA03

INN (Nama Antarabangsa):

SODIUM CHLORIDE

Dos:

20%

Borang farmaseutikal:

SOLUTION

Komposisi:

SODIUM CHLORIDE 20%

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Ethical

Kawasan terapeutik:

REPLACEMENT PREPARATIONS

Ringkasan produk:

Active ingredient group (AIG) number: 0100053046; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2021-03-22

Ciri produk

Page 1 of 6
PRESCRIBING INFORMATION
20% SODIUM CHLORIDE INJECTION, BP
20% W / V
For Intravenous Infusion after Dilution
Intravenous Fluid and Electrolyte Replenisher
BAXTER CORPORATION
7125 Mississauga Road,
Mississauga, Ontario, Canada
L5N 0C2
Date of Preparation:
March 20, 2021
Submission Control No.: 235122
Baxter and Clearflex are trademarks of Baxter International Inc.
Page 2 of 6
20% SODIUM CHLORIDE INJECTION, BP
Not for multiple-dose use. Do not inject without dilution. Use only if
solution is clear. No
preservative added; the contents of the clearflex plastic bag should
be promptly used.
CONCENTRATED SOLUTIONS SUITABLE FOR USE ONLY AFTER DILUTION
WITH COMPATIBLE I.V. FLUIDS TO CORRECT HYPONATREMIA WHEN
ORAL REPLACEMENT IS NOT FEASIBLE.
DESCRIPTION
20% Sodium Chloride Injection, BP is a sterile, nonpyrogenic,
concentrated solution for
intravenous administration ONLY AFTER DILUTION to replenish
electrolytes. The
preparation contains 3.422 mEq/mL (20%) sodium chloride, in water for
injection, EP. The
solution contains no bacteriostat, antimicrobial agent or added
buffer; the pH of the solution
ranges from 5 to 7.5. Each mL contains: sodium chloride 200 mg; water
for injection q.s. May
contain hydrochloric acid to adjust the pH. The osmolar concentration
of the 3.422 mEq/mL
solution is 6.844 mOsmol/mL (calculated). Sodium chloride is
chemically designated NaCl
and is a white crystalline compound freely soluble in water.
A pharmacy bulk package is a sterile dosage form containing many
single doses. The contents
are intended for use in a pharmacy admixture program and are
restricted to the preparation of
admixtures for I.V. infusion.
CLINICAL PHARMACOLOGY
Sodium chloride dissociates in water to provide sodium (Na
+
) and chloride (Cl
-
) ions. These
ions are normal constituents of body fluids (mainly extracellular) and
are essential for
maintaining electrolyte balance.
Sodium is the principal cation of extracellular fluid. It stands for
more than 90% of total
cations at its normal plasma concentration (approxim