IONOSOL MB AND DEXTROSE- dextrose monohydrate, sodium lactate, potassium chloride, magnesium chloride, potassium phosphate, mono

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

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Ficha técnica Ficha técnica (SPC)
14-11-2019

Ingredientes activos:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) (POTASSIUM CATION - UNII:295O53K152, PHOSPH

Disponible desde:

Hospira, Inc.

Designación común internacional (DCI):

DEXTROSE MONOHYDRATE

Composición:

DEXTROSE MONOHYDRATE 5 g in 100 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Ionosol MB and 5% Dextrose Injection is indicated for intravenous administration to infants for treatment of dehydration, acidosis, diarrhea, and burns, but only after administration of an initial priming solution: 15 mL of 5% dextrose and 0.45% Sodium Chloride Injection/kg of body weight. In adults, Ionosol MB and 5% Dextrose Injection is indicated postoperatively for intravenous fluid and electrolyte maintenance therapy, with a small amount of carbohydrate calories for reducing catabolism of endogenous protein reserves. Solutions containing potassium are contraindicated in diseases where high potassium levels may be encountered.

Resumen del producto:

Ionosol MB and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is supplied in flexible plastic single-dose containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: October, 2009 Printed in USA            EN-2269 Hospira, Inc., Lake Forest, IL 60045 USA

Estado de Autorización:

New Drug Application

Ficha técnica

                                IONOSOL MB AND DEXTROSE- DEXTROSE MONOHYDRATE, SODIUM LACTATE,
POTASSIUM CHLORIDE,
MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM
PHOSPHATE, MONOBASIC,
MONOHYDRATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
IONOS OL MB AND 5% DEXTROSE INJECTION
_(MULTIPLE ELECTROLYTES AND 5% DEXTROSE INJECTION TYPE 1, USP)_
_A MAINTENANCE ELECTROLYTE SOLUTION_
FLEXIBLE PLASTIC CONTAINER
R only
DESCRIPTION
Ionosol MB and 5% Dextrose Injection (Multiple Electrolytes and 5%
Dextrose Injection Type 1, USP)
is a sterile, nonpyrogenic solution designed for intravenous
administration. The solution is formulated
to provide fluid and electrolytes for treatment of dehydration and
acidosis.
Each 100 mL contains dextrose, hydrous 5 g; sodium lactate, anhydrous
260 mg; potassium chloride
141 mg; magnesium chloride, hexahydrate 30 mg; monobasic potassium
phosphate, anhydrous 15 mg;
and monobasic sodium phosphate, monohydrate 25 mg.
Each liter contains 25 mEq sodium (Na ); 20 mEq potassium (K ); 3 mEq
magnesium (Mg
); 22 mEq
chloride (Cl¯); 3 mM of phosphate (PO ≡); and 23 mEq lactate (CH
CH(OH)COO¯).
The electrolyte content is hypotonic (100 mOsmol/L) in relation to the
extracellular fluid (approx. 280
mOsmol/L). The osmolarity for the total solution is 352 mOsmol/L
(calc.). May contain hydrochloric
acid for pH adjustment. pH is 5.0 (4.0 to 6.5).
Dextrose, USP, hydrous is chemically designated C H O • H O
(D-glucose, monohydrate), a hexose
sugar freely soluble in water. Dextrose, hydrous has the following
structural formula:
Magnesium Chloride, USP, hexahydrate is chemically designated MgCl
• 6H O, colorless flakes or
crystals very soluble in water.
Potassium Chloride, USP is chemically designated KCl, a white granular
powder freely soluble in
water.
Monobasic Potassium Phosphate, NF, anhydrous is chemically designated
KH PO , colorless crystals
®
x
+
+
++
4
3
6
12
6
2
2
2
2
4
or white granular powder freely soluble in water.
Sodium Lactate, USP is chemically designated CH CH(OH)COONa, a 60%
aqueous solution miscible
                                
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