מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
Dextrose monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)
International Medication Systems, Limited
INTRAVENOUS
PRESCRIPTION DRUG
50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to ensure proper utilization of dextrose and avoid production of hyperglycemia. A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present, nor in the presence of delirium tremens if the patient is already dehydrated. Dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.
50% Dextrose Injection, USP 25 g/50 mL (0.5 g/mL) is supplied in single-dose prefilled syringes as follows: NDC No. Stock No. Container Size Needle 76329-3302-1 3302 50 mL None One shrink wrapped package containing 10 unit cartons, each containing a Luer-Jet™ Luer-Lock Prefilled Syringe. Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Revised 01/21 6933010E © International Medication Systems, Ltd., 2021 International Medication Systems, Ltd. South El Monte, CA 91733, USA An Amphastar Pharmaceuticals Company Printed in USA
Abbreviated New Drug Application
DEXTROSE MONOHYDRATE - DEXTROSE MONOHYDRATE INJECTION, SOLUTION INTERNATIONAL MEDICATION SYSTEMS, LIMITED ---------- 50% Dextrose Injection, USP Concentrated Dextrose for Intravenous Administration NOTE: THIS SOLUTION IS HYPERTONIC − SEE WARNINGS AND PRECAUTIONS. DESCRIPTION 50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher. Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4 kcal/gram. The solution has an osmolarity of 2.5 mOsmol/mL (calc.) and a pH of 3.2-6.5. May contain Hydrochloric acid and/or Sodium hydroxide for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Dextrose, USP is chemically designated C H O • H O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following formula: Water for Injection, USP is chemically designated H O. The delivery device is composed of a 50 mL glass syringe barrel with rubber stopper, and custom molded IMS injector with Luer Connector. CLINICAL PHARMACOLOGY When administered intravenously this solution restores blood glucose levels in hypoglycemia and provides a source of carbohydrate calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injection undergoes oxidation to carbon dioxide and water. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodi קרא את המסמך השלם