(20MMOL/L) POTASSIUM CHLORIDE IN 5% DEXTROSE AND 0.2% SODIUM CHLORIDE INJECTION USP SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-04-2016
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Active ingredient:
DEXTROSE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
Available from:
BAXTER CORPORATION
ATC code:
B05BB02
INN (International Name):
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
Product summary:
Active ingredient group (AIG) number: 0300097004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2016-07-15
Summary of Product characteristics
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
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