국가: 미국
언어: 영어
출처: 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, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)
ICU Medical Inc.
INTRAVENOUS
PRESCRIPTION DRUG
Normosol-R is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R 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. None known.
Normosol-R (Multiple Electrolytes Injection Type 1, USP) is supplied in single-dose flexible plastic containers. ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: October, 2018 EN-4693 ICU Medical, Inc., Lake Forest, IL Illinois, 60045, USA
New Drug Application
NORMOSOL-R- SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION ICU MEDICAL INC. ---------- NORMOSOL -R _MULTIPLE ELECTROLYTES INJECTION TYPE 1, USP_ FOR REPLACING ACUTE LOSSES OF EXTRACELLULAR FLUID FLEXIBLE PLASTIC CONTAINER R only DESCRIPTION Normosol-R 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 contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg. May contain HCl and/or NaOH for pH adjustment. pH 6.6 (4.0 to 8.0); 294 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 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: ® x 2 2 2 3 2 Sodium gluconate is chemically designated C H NaO , the normal sodium salt of gluconic acid soluble in water. It has the following structural formula: Water for Injection, USP is chemically designated H O. The flexible plastic container is fabricated from a s 전체 문서 읽기