5% DEXTROSE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DEXTROSE

Available from:

B. BRAUN MEDICAL INC

ATC code:

B05BA03

INN (International Name):

CARBOHYDRATES

Dosage:

50MG

Pharmaceutical form:

SOLUTION

Composition:

DEXTROSE 50MG

Administration route:

INTRAVENOUS

Units in package:

25/150/250/500/1000ML

Prescription type:

Ethical

Therapeutic area:

CALORIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0102181006; AHFS:

Authorization status:

APPROVED

Authorization date:

1998-04-29

Summary of Product characteristics

_5% and 10% Dextrose Injection USP Prescribing Information _
_Page 1 of 12 _
PRESCRIBING INFORMATION
5% DEXTROSE INJECTION USP
10% DEXTROSE INJECTION USP
IN EXCEL PLASTIC CONTAINERS
Solution for Infusion, Intravenous
Intravenous Fluid and Nutrient Replenisher
B. BRAUN MEDICAL INC.
824 Twelfth Avenue
Bethlehem, PA 18018-3524 USA
Date of Preparation:
July 24, 2020
Distributed by:
B. BRAUN OF CANADA, LTD.
2000 Ellesmere Road, Unit 16
Scarborough, Ontario M1H 2W4
Submission Control No: 238794
_5% and 10% Dextrose Injection USP Prescribing Information _
_Page 2 of 12 _
5% DEXTROSE INJECTION USP
10% DEXTROSE INJECTION USP
IN EXCEL PLASTIC CONTAINERS
SUMMARY PRODUCT INFORMATION
5% Dextrose Injection USP and 10% Dextrose Injection USP are sterile,
nonpyrogenic solutions
for fluid replenishment and caloric supply in single dose containers
for intravenous
administration. They contain no bacteriostatic or antimicrobial agents
or added buffers.
The composition, osmolarity, approximate pH, and caloric content of 5%
Dextrose Injection USP
and 10% Dextrose Injection USP are shown in TABLE 1.
TABLE 1: PRODUCT INFORMATION
PRODUCT
NAME
DIN
PACKAGE
SIZE
(ML)
COMPOSITION
(G/100 ML)*
OSMOLARITY
(MOSMOL/L)
PH
(RANGE)
CALORIC
CONTENT
(CAL/L)
HYDROUS
DEXTROSE USP**
5% Dextrose
Injection USP
01924281
250
5
250
4.4
(3.5 - 6.5)
170
500
1000
10% Dextrose
Injection USP
01924427
250
10
505
4.4
(3.5 - 6.5)
340
500
1000
* Non-medicinal ingredient = Water for Injection (qs)
** The dextrose is purified from corn and may contain fructose.
Excel Plastic Container not made with natural rubber latex, PVC or
DEHP.
The plastic container is made from a multilayered film specifically
developed for parenteral
drugs. It contains no plasticizers and exhibits virtually no
leachables. The solution contact layer
is a rubberized copolymer of ethylene and propylene. The container is
nontoxic and biologically
inert. The container-solution unit is a closed system and is not
dependent upon entry of external
air during administration.
The container is overwrapped to