POTASSIUM CHLORIDE IN SODIUM CHLORIDE- potassium chloride and sodium chloride injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)

Доступна с:

Baxter Healthcare Corporation

ИНН (Международная Имя):

SODIUM CHLORIDE

состав:

SODIUM CHLORIDE 900 mg in 100 mL

Администрация маршрут:

INTRAVENOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Potassium Chloride in Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. Potassium Chloride in Sodium Chloride Injection, USP is contraindicated in patients with:

Обзор продуктов:

Potassium Chloride in Sodium Chloride Injection, USP in VIAFLEX Plus Plastic Container is available as follows: Code Size (mL) NDC Product Name 2B1357 1000 0338-0704-34 20 mEq/L Potassium Chloride in 0.45% Sodium Chloride Injection, USP 2B1764 1000 0338-0691-04 20 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP 2B1984 1000 0338-0695-04 40 mEq/L Potassium Chloride in 0.9% Sodium Chloride Injection, USP Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored between 20ºC to 25°C (68º F to 77°F). [See USP controlled room temperature.]; brief exposure up to 40° C (104° F) does not adversely affect the product.

Статус Авторизация:

New Drug Application

Характеристики продукта

POTASSIUM CHLORIDE IN SODIUM CHLORIDE- POTASSIUM CHLORIDE AND SODIUM
CHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
POTASSIUM CHLORIDE IN SODIUM CHLORIDE INJECTION, USP
IN PLASTIC CONTAINER
VIAFLEX PLUS CONTAINER
DESCRIPTION
Potassium Chloride in Sodium Chloride Injection, USP is a sterile,
nonpyrogenic, solution for fluid and
electrolyte replenishment in a single dose container for intravenous
administration. It contains no
antimicrobial agents. Composition, osmolarity, pH and ionic
concentration are shown in Table 1.
*
TABLE 1
Size
(mL)
Composition (g/L)
Osmolarity
(mOsmol/L)
(Calc.)
pH
Ionic Concentration (mEq/L)
Sodium
Chloride,
USP
(NaCl)
Potassium
Chloride,
USP
(KCl)
SodiumPOTAS S IUM Chloride
20 mEq/L
Potassium
Chloride
in
0.45%
Sodium
Chloride
Injection,
USP
1000
4.5
1.5
194
5.5
(3.5
to
6.5)
77
20
97
20 mEq/L
Potassium
Chloride
in
0.9%
Sodium
Chloride
Injection,
USP
1000
9
1.5
348
5.5
(3.5
to
6.5)
154
20
174
40 mEq/L
Potassium
Chloride
in
0.9%
Sodium
Chloride
Injection,
USP
1000
9
3
388
5.5
(3.5
to
6.5)
154
40
194
Normal physiologic osmolarity range is approximately 280 to 310
mOsmol/L.
Administration of substantially hypertonic solutions (≥ 600
mOsmol/L) may cause vein
damage.
*
The VIAFLEX Plus plastic container is fabricated from a specially
formulated polyvinyl chloride (PL
146 Plastic). VIAFLEX Plus on the container indicates the presence of
a drug additive in a drug
vehicle. The VIAFLEX Plus plastic container system utilizes the same
container as the VIAFLEX
plastic container system. The amount of water that can permeate from
inside the container into the
overwrap is insufficient to affect the solution significantly.
Solutions in contact with the plastic
container can leach out certain of its chemical components in very
small amounts within the expiration
period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per
million. However, the safety of the
plastic has been confirmed in tests in animals according to USP
biological tests for plastic containers as
well as by tis