Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37, ACETATE ION - UNII:569DQM74SC), 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, DIBASIC (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152, PHOSPHATE ION - UNII:NK08V
B. Braun Medical Inc.
DEXTROSE MONOHYDRATE
DEXTROSE MONOHYDRATE 5 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
This solution is indicated for use in adults as a source of electrolytes, calories and water for hydration, and as an alkalinizing agent. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
Isolyte® P (Multi-Electrolyte Injection) in 5% Dextrose is supplied sterile and nonpyrogenic in EXCEL® containers. The 500 mL containers are packaged 24 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25° C).
New Drug Application
ISOLYTE P IN DEXTROSE- DEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASIC INJECTION, SOLUTION B. BRAUN MEDICAL INC. ---------- ISOLYTE P IN 5% DEXTROSE (MULTI-ELECTROLYTE INJECTION) DESCRIPTION Each 100 mL of Isolyte® P (Multi-Electrolyte Injection) in 5% Dextrose contains: Hydrous Dextrose USP 5 g; Sodium Acetate Trihydrate USP 0.32 g Potassium Chloride USP 0.13 g; Magnesium Chloride Hexahydrate USP 0.031 g Dibasic Potassium Phosphate USP 0.026 g; Water for Injection USP qs pH adjusted with Hydrochloric Acid NF pH: 5.0 (4.0–6.0) Calories per liter: 170 Calculated Osmolarity: 340 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 23; Chloride 29 Acetate (CH COO ) 23; Potassium 20; Magnesium 3; Phosphate (HPO ) 3 Isolyte® P in 5% Dextrose is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents or added buffers. This product is intended for intravenous administration. The formulas of the active ingredients are: INGREDIENTS MOLECULAR FORMULA MOLECULAR WEIGHT Sodium Acetate Trihydrate USP CH COONa•3H O 136.08 Potassium Chloride USP KCl 74.55 Magnesium Chloride Hexahydrate USP MgCl •6H O 203.30 Dibasic Potassium Phosphate USP K HPO 174.18 Hydrous Dextrose USP 198.17 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a rubberized copolymer of ethylene and propylene. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, ® 3 - 1 3 2 2 2 2 4 biological testing was supportive of the safety of the plastic container materials. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Exposure to Baca dokumen lengkap