(20MMOL/L) POTASSIUM CHLORIDE IN 5% DEXTROSE AND 0.45% SODIUM CHLORIDE INJECTION USP SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Cumpara asta acum

Ingredient activ:

DEXTROSE; SODIUM CHLORIDE; POTASSIUM CHLORIDE

Disponibil de la:

BAXTER CORPORATION

Codul ATC:

B05BB02

INN (nume internaţional):

ELECTROLYTES WITH CARBOHYDRATES

Dozare:

5G; 450MG; 150MG

Forma farmaceutică:

SOLUTION

Compoziție:

DEXTROSE 5G; SODIUM CHLORIDE 450MG; POTASSIUM CHLORIDE 150MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

500/1000ML

Tip de prescriptie medicala:

Ethical

Zonă Terapeutică:

REPLACEMENT PREPARATIONS

Rezumat produs:

Active ingredient group (AIG) number: 0300097005; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2012-12-10

Caracteristicilor produsului

                                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
                                
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Caracteristicilor produsului Caracteristicilor produsului franceză 14-12-2018