Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)
Henry Schein, Inc.
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 insure 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 is supplied in single-dose containers as follows: 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.]
New Drug Application
DEXTROSE- DEXTROSE MONOHYDRATE INJECTION, SOLUTION HENRY SCHEIN, INC. ---------- 50% DEXTROSE 0.5 GM/ML INJECTION, USP 50 ML PREFILLED SYRINGE NOTE: This solution is hypertonic - See WARNINGS and PRECAUTIONS. LifeShield® Abboject® Syringe Fliptop Container Ansyr™ II Plastic Syringe Rx only 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 2.53 mOsmol/mL (calc.), a pH of 4.2 (3.2 to 6.5) and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. 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 with the entire unit. Dextrose, USP is chemically designated C6H12O6• H2O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following structural formula: Water for Injection, USP is chemically designated H2O . The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the syringe material. CLINICAL PHARMACOLOGY Water for Injection, USP is chemically designated H2O . The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. Solutions in contact with the plastic container may leach out certain chemical components from Les hele dokumentet