(20MMOL/L) POTASSIUM CHLORIDE IN 5% DEXTROSE AND 0.2% SODIUM CHLORIDE INJECTION USP SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

DEXTROSE; SODIUM CHLORIDE; POTASSIUM CHLORIDE

MAH:

BAXTER CORPORATION

ATC_code:

B05BB02

INN:

ELECTROLYTES WITH CARBOHYDRATES

dosage:

5G; 200MG; 150MG

pharmaceutical_form:

SOLUTION

composition:

DEXTROSE 5G; SODIUM CHLORIDE 200MG; POTASSIUM CHLORIDE 150MG

administration_route:

INTRAVENOUS

units_in_package:

500ML/1000ML

prescription_type:

Ethical

therapeutic_area:

REPLACEMENT PREPARATIONS

leaflet_short:

Active ingredient group (AIG) number: 0300097004; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2016-07-15

SPC

Page 1 of 19
PRESCRIBING INFORMATION
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE
INJECTION, USP
SOLUTION FOR INFUSION
Solutions Affecting the Electrolyte Balance
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision: April 7, 2016
Submission Control No: 192811
Baxter, Viaflex, and PL 146 are trademarks of Baxter International
Inc.
Page 2 of 19
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
DESCRIPTION
Potassium Chloride in Dextrose and Sodium Chloride Injection, USP is a
sterile,
nonpyrogenic solution for fluid and electrolyte replenishment and
caloric supply in a single
dose container for intravenous administration. It contains no
antimicrobial agents.
Composition, osmolarity, pH, ionic concentration and caloric content
are shown in TABLE
1.
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 can leach out certain of its chemical
components in very small
amounts within the expiration period, e.g., di-2-ethylhexyl phthalate
(DEHP), up to 5 parts
per million. However, the safety of the plastic has been confirmed in
tests in animals
according to USP biological tests for plastic containers as well as by
tissue culture toxicity
studies.
CLINICAL PHARMACOLOGY
Potassium Chloride in Dextrose and Sodium Chloride Injection, USP has
value as a source
of water, electrolytes and calories. It is capable of inducing
diuresis depending on the
clinical condition of the patient.
INDICATIONS AND USAGE
Potassium Chloride in Dextrose and Sodium Chloride Injection, USP is
indicated as a
source of water, electrolytes and calories. Dextrose-containing
solutions may also be
indicated in clinical conditions where enteral nutritional supply is
or is expected to be
insufficient or impossible.
Page 3 of 19
CONTRAINDICATIONS
Potassiu