(20 MMOL/L) POTASSIUM CHLORIDE IN 3.3% DEXTROSE AND 0.3% 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:

3.3G; 300MG; 150MG

pharmaceutical_form:

SOLUTION

composition:

DEXTROSE 3.3G; SODIUM CHLORIDE 300MG; POTASSIUM CHLORIDE 150MG

administration_route:

INTRAVENOUS

units_in_package:

250/500/1000ML

prescription_type:

Ethical

therapeutic_area:

REPLACEMENT PREPARATIONS

leaflet_short:

Active ingredient group (AIG) number: 0300097026; AHFS:

authorization_status:

APPROVED

authorization_date:

2012-12-07

SPC

Page 1 of 10
PRESCRIBING INFORMATION
3.3% Dextrose and 0.3% Sodium Chloride Injection
5% Dextrose and 0.2% Sodium Chloride Injection
5% Dextrose and 0.45% Sodium Chloride Injection
5% Dextrose and 0.9% Sodium Chloride Injection
10% Dextrose and 0.9% Sodium Chloride Injection
DEXTROSE AND SODIUM CHLORIDE INJECTION, USP
Solution for infusion
Intravenous Fluid and Nutrient Replenisher
In VIAFLEX Plastic Container
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision:
December 14, 2018
Submission Control No: 221959
Baxter and VIAFLEX are Trademarks of Baxter International Inc.
Page 2 of 10
DEXTROSE AND SODIUM CHLORIDE INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
SUMMARY PRODUCT INFORMATION
Dextrose and Sodium Chloride Injection USP solutions are sterile,
nonpyrogenic and contain no bacteriostatic or antimicrobial
agents or added buffers. The composition, osmolarity and approximate
pH of the individual solutions are shown in TABLE 1.
TABLE 1.
Size (mL)
DIN
Composition
(g/L)
Osmolarity (mOsmol/L)
pH
Ionic Concentration
(mmol/L)
Caloric Content (cal/L)
*
Dextrose
Monohyd.
Sodium
Chloride
Sodium
Chloride
3.3% Dextrose & 0.3%
NaCl
500
00060712
33.0 g
3.0 g
271
3.5 to 6.5
51
51
112
1000
5% Dextrose & 0.2%
NaCl
500
00060704
50.0 g
2.0 g
321
3.5 to 6.5
34
34
170
5% Dextrose & 0.45%
NaCl
500
00060739
50.0 g
4.5 g
406
3.5 to 6.5
77
77
170
1000
5% Dextrose & 0.9%
NaCl
500
00060747
50.0 g
9.0 g
560
3.5 to 6.5
154
154
170
1000
10% Dextrose & 0.9%
NaCl
1000
00060755
100.0 g
9.0 g
813
3.5 to 6.5
154
154
340
*The dextrose is purified from corn and may contain fructose.
The VIAFLEX plastic container is fabricated from a specially
formulated polyvinyl chloride (PL 146 Plastic).
Water in a solution in the container can permeate through the plastic
wall, but in an insufficient amount to significantly affect the
solution. Before the product expires, very small amounts of chemical
components of the plastic can be leached into the solution
in the container, such as up to 5 parts per million for
di-2-ethylhexyl phthalate (D