70% DEXTROSE INJECTION USP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DEXTROSE

Διαθέσιμο από:

BAXTER CORPORATION

Φαρμακολογική κατηγορία (ATC):

B05BA03

INN (Διεθνής Όνομα):

CARBOHYDRATES

Δοσολογία:

70G

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

DEXTROSE 70G

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

500/1000/2000/3000ML

Τρόπος διάθεσης:

Ethical

Θεραπευτική περιοχή:

CALORIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0102181015; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

1999-03-05

Αρχείο Π.Χ.Π.

Page 1 of 14
PRESCRIBING INFORMATION
50% DEXTROSE INJECTION, USP
70% DEXTROSE INJECTION, USP
IN PHARMACY BULK PACK
IV Fluid and Nutrient Replenisher
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision:
November 21, 2018
Submission Control No: 220929
Baxter and Viaflex are trademarks of Baxter International Inc
.
Page 2 of 14
50% DEXTROSE INJECTION, USP/
70% DEXTROSE INJECTION, USP
NOT FOR DIRECT INFUSION
IN PHARMACY BULK PACK
SUMMARY PRODUCT INFORMATION
50% Dextrose Injection, USP and 70% Dextrose Injection, USP are
sterile, nonpyrogenic,
hypertonic solutions for fluid replenishment and caloric supply in a
Pharmacy Bulk Package. A
Pharmacy Bulk Package is a container of sterile preparation for
parenteral use that contains many
single doses. The contents are intended for use in a pharmacy
admixture program and are
restricted to the preparation of admixtures for intravenous infusion.
They contain no
antimicrobial agents. Composition, osmolarity, pH, and caloric content
are shown in Table 1.
TABLE 1. PRODUCT INFORMATION.
***
DEX
USP
G/L
OSMOLARITY
(MOSMOL/L)
*KCAL
/L
**KJ/
L
PH
CODE
VOLUM
E
50%
DEXTROSE
INJ USP
500
2520
1710
7147.8
4.0
2B0256
2000 mL
70%
DEXTROSE
INJ USP
700
3530
2380
9948.4
4.0
2B0296
2000 mL
70%
DEXTROSE
INJ USP
700
3530
2380
9948.4
4.0
JB0297
3000 mL
* Dex = 3.4 kcal/g
** 1 kcal = 4.18 kJ
*** the dextrose is purified from corn and may contain fructose
.
The structural formula of Dextrose Hydrous, USP is:
Page 3 of 14
The VIAFLEX plastic container is fabricated from a specially
formulated polyvinyl chloride (PL
146 Plastic) with di-2-ethylhexyl phthalate (DEHP) as a plasticizer.
Exposure to temperatures
above 25˚C during transport and storage will lead to minor losses in
moisture content. Higher
temperatures lead to greater losses. It is unlikely that these minor
losses will lead to clinically
significant changes within the expiration period. The amount of water
that can permeate from
inside the container into the overwrap is insufficient to affect the
solution significantly.