(20 MMOL/L) POTASSIUM CHLORIDE IN 5% DEXTROSE AND 0.9% SODIUM CHLORIDE INJECTION USP SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

DEXTROSE; SODIUM CHLORIDE; POTASSIUM CHLORIDE

Beszerezhető a:

BAXTER CORPORATION

ATC-kód:

B05BB02

INN (nemzetközi neve):

ELECTROLYTES WITH CARBOHYDRATES

Adagolás:

5G; 900MG; 150MG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

DEXTROSE 5G; SODIUM CHLORIDE 900MG; POTASSIUM CHLORIDE 150MG

Az alkalmazás módja:

INTRAVENOUS

db csomag:

1000ML

Recept típusa:

Ethical

Terápiás terület:

REPLACEMENT PREPARATIONS

Termék összefoglaló:

Active ingredient group (AIG) number: 0300097006; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2012-12-10

Termékjellemzők

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