5% DEXTROSE INJECTION, USP SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

DEXTROSE

Доступна з:

BAXTER CORPORATION

Код атс:

B05BA03

ІПН (Міжнародна Ім'я):

CARBOHYDRATES

Дозування:

5G

Фармацевтична форма:

SOLUTION

Склад:

DEXTROSE 5G

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

15G/50G

Тип рецепту:

Ethical

Терапевтична области:

CALORIC AGENTS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2019-03-25

Характеристики продукта

Page 1 of 9
PRESCRIBING INFORMATION
5% DEXTROSE INJECTION, USP
IN AVIVA PLASTIC CONTAINER
Solution for Infusion
Intravenous Fluid and Nutrient Replenisher
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision:
June 11, 2019
Submission Control No: 227512
Baxter and Aviva are Trademarks of Baxter International Inc.
Page 2 of 9
5% DEXTROSE INJECTION, USP
IN AVIVA PLASTIC CONTAINER
SUMMARY PRODUCT INFORMATION
5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for
fluid replenishment and caloric supply in single dose
containers for intravenous administration. It contains no
bacteriostatic or antimicrobial agents or added buffers.
The composition, osmolarity and approximate pH of 5% Dextrose
Injection, USP are shown in Table 1.
TABLE 1. PRODUCT INFORMATION
Product
Name
DIN
Package
Size
Composition
(g/L)
Osmolarity
(mOsmol/L)
pH
Caloric Content (cal/L)
Dextrose
Hydrous*, USP
5%
Dextrose
Injection,
USP
00060348
250mL
50
252
3.2 – 6.5
170
* The dextrose is purified from corn and may contain fructose.
The flexible AVIVA plastic container is made with non-latex plastic
materials specially designed for a wide range of parenteral
drugs including those requiring delivery in containers made of
polyolefins or polypropylene. For example, the AVIVA container
system is compatible with the admixture and administration of
paclitaxel. In addition, the AVIVA container system is compatible
with the admixture and administration of all drugs deemed compatible
with existing polyvinyl chloride container systems. The
solution contact materials do not contain PVC, DEHP or other
plasticizers.
No safety issues of the plastic material were identified in Class VI
U.S.Pharmacopeia (USP) testing for plastic containers.
The flexible container is a closed system and air is prefilled in the
container to facilitate drainage. The container does not require
entry of external air during administration.
The container has two ports: one is the administration outlet port for
attachment of an intravenous administration set and