Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
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
Hospira, Inc.
DEXTROSE MONOHYDRATE
DEXTROSE MONOHYDRATE 5 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
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.
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
New Drug Application
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 Прочетете целия документ