(40 MMOL/L) POTASSIUM CHLORIDE IN 5% DEXTROSE INJECTION USP SOLUTION

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

DEXTROSE; POTASSIUM CHLORIDE

Доступна с:

BAXTER CORPORATION

код АТС:

B05BB02

ИНН (Международная Имя):

ELECTROLYTES WITH CARBOHYDRATES

дозировка:

5G; 300MG

Фармацевтическая форма:

SOLUTION

состав:

DEXTROSE 5G; POTASSIUM CHLORIDE 300MG

Администрация маршрут:

INTRAVENOUS

Штук в упаковке:

1000ML

Тип рецепта:

Ethical

Терапевтические области:

REPLACEMENT PREPARATIONS

Обзор продуктов:

Active ingredient group (AIG) number: 0200305003; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2012-12-07

Характеристики продукта

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PRESCRIBING INFORMATION
POTASSIUM CHLORIDE IN 5% DEXTROSE INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
IV Fluid and Nutrient Replenisher
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Revision:
March 11, 2021
Submission
Control No: 249296
Baxter, Viaflex and PL 146 are registered trademarks of Baxter
International Inc.
2 of 14
POTASSIUM CHLORIDE IN 5% DEXTROSE INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
SUMMARY PRODUCT INFORMATION
Potassium Chloride in 5% Dextrose Injection, USP is a sterile,
nonpyrogenic solution for fluid
and electrolyte replenishment and caloric supply in a single dose
container for intravenous
administration. It contains no antimicrobial agents. Composition,
osmolarity,
pH, ionic
concentration and caloric content are shown in TABLE 1.
TABLE 1.
Size
Composition (g/l)
Osmolarity
Ionic Concentration
How
Supplied
Potassium
Chloride in
5%
Dextrose
Injection,
USP
mL
Dextrose
Hydrous,
USP*
Potassium
Chloride,
USP (KCl)
mOsmol/L
pH
Potassium
Chloride
Caloric
Conct.
(kcal/L)
20 mmol/L
1000
50
1.5
292
4.0
20
20
170
40 mmol/L
1000
50
3
332
4.0
40
40
170
*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, a 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 DEHP. No safety issues of the plastic material were identified in
USP
biological
tests in animals as well as by tissue culture toxicity studies.
ACTIONS
Potassium Chloride in 5% Dextrose Injection, USP has value as a source
of water, electrolytes
and calories. It is capable of inducing diuresis depending on the
clinical condition of the patient.
INDICATIONS AND CLINICAL USE
Potassium Chloride in 5% Dextrose Injection, USP is indicated as a
source of