Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM GLUCONATE (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838)
Hospira, Inc.
SODIUM CHLORIDE
SODIUM CHLORIDE 526 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Normosol-R pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R pH 7.4 is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume. Normosol-R pH 7.4 is particularly valuable as a solution for use in starting blood, i.e., as a priming solution for the infusion set. No hemolysis of blood is seen at the interface or with mixed solution and blood. It may also be used as a diluent to aid in the transfusion of packed red blood cells (PRBC). Normosol-R pH 7.4 and physiologic saline solution (0.9% Sodium Chloride Injection, USP) are compatible with both young and old PRBC. None known.
Normosol-R pH 7.4 (Multiple Electrolytes Injection Type 1, USP) is supplied in 500 and 1000 mL single-dose flexible plastic containers (NDC 0409-7670-03 and 0409-7670-09). Exposure of pharmaceutical products to heat should be minimized. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: January, 2009 Printed in USA EN-2025 Hospira, Inc., Lake Forest, IL 60045 USA
New Drug Application
NORMOSOL-R- SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION HOSPIRA, INC. ---------- NORMOSOL -R PH 7.4 _MULTIPLE ELECTROLYTES INJECTION TYPE 1, USP_ FOR REPLACING ACUTE LOSSES OF EXTRACELLULAR FLUID FLEXIBLE PLASTIC CONTAINER R only DESCRIPTION Normosol -R pH 7.4 is a sterile, nonpyrogenic, isotonic solution of balanced electrolytes in water for injection. The solution is administered by intravenous infusion for parenteral replacement of acute losses of extracellular fluid. Each 100 mL of Normosol-R pH 7.4 contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride, hexahydrate 30 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH range 6.5 to 7.6; 295 mOsmol/liter (calc.). Electrolytes per 1000 mL (not including pH adjustment): Sodium 140 mEq; potassium 5 mEq; magnesium 3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23 mEq. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. Normosol-R pH 7.4 is a parenteral fluid and electrolyte replenisher. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl • 6H O) deliquescent crystals very soluble in water. Sodium Acetate, USP is chemically designated sodium acetate, anhydrous (C H NaO ), a hygroscopic powder soluble in water. It has the following structural formula: Sodium gluconate is chemically designated C H NaO , the normal sodium salt of gluconic acid soluble in water. It has the following structural formula: ® x ® 2 2 2 3 2 6 11 7 Water for Injection, USP is chemically desig Прочетете целия документ