ISOLYTE S- sodium chloride, sodium gluconate, sodium acetate, potassium chloride, and magnesium chloride injection, solution

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM GLUCONATE (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37, GLUCONIC ACID - UNII:R4R8J0Q44B), SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNI

Доступна з:

B. Braun Medical Inc.

ІПН (Міжнародна Ім'я):

SODIUM CHLORIDE

Склад:

SODIUM CHLORIDE 0.53 g in 100 mL

Адміністрація маршрут:

INTRAVENOUS

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration, and as an alkalinizing agent. This solution is contraindicated where the administration of sodium, potassium, magnesium, chloride, acetate or gluconate could be clinically detrimental.

Огляд продуктів:

Isolyte® S (Multi-Electrolyte Injection) is supplied sterile and nonpyrogenic in 1000 mL EXCEL® Containers packaged 12 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Статус Авторизація:

New Drug Application

Характеристики продукта

ISOLYTE S- SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE,
POTASSIUM CHLORIDE, AND
MAGNESIUM CHLORIDE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
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IS OLYTE S
(MULTI-ELECTROLYTE INJECTION)
DESCRIPTION
Each 100 mL of Isolyte
S (Multi-Electrolyte Injection) contains:
Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g
Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 g
Magnesium Chloride Hexahydrate USP 0.03 g
Water for Injection USP qs
pH adjusted with Glacial Acetic Acid USP
pH: 6.7 (6.3–7.3)
Calculated Osmolarity: 295 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 140; Potassium 5
Magnesium 3; Chloride 98; Acetate (CH COO ) 27
Gluconate (HOCH (CHOH) COO ) 23
Isolyte
S is sterile, nonpyrogenic, and contains no bacteriostatic or
antimicrobial agents.
The formulas of the active ingredients are:
INGREDIENTS
MOLECULAR
FORMULA
MOLECULAR
WEIGHT
Sodium Chloride USP
NaCl
58.44
Sodium Acetate Trihydrate USP
CH COONa•3H O
136.08
Potassium Chloride USP
KCl
74.55
Magnesium Chloride Hexahydrate USP MgCl
•6H O
203.30
Sodium Gluconate USP
218.14
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 provide protection from the physical
environment and to provide an
additional moisture barrier when necessary.
Addition of medication should be accomplished using complete aseptic
technique.
The closure system has two ports; the one for the administration set
has a tamper evident plastic
protector and the other is a medication addition site. Refer to the
Directions for Use of the container.
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CLINICAL PHARMACOLOGY
Isolyt