Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
DEXTROSE (UNII: IY9XDZ35W2) (DEXTROSE - UNII:IY9XDZ35W2), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152)
B. Braun Medical Inc.
DEXTROSE
DEXTROSE 5 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes, calories and water for hydration. These solutions are contraindicated where the administration of sodium, potassium or chloride could be clinically detrimental. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.
Potassium Chloride in Dextrose and Sodium Chloride Injections USP are supplied in EXCEL® Containers. The 1000 mL containers are packaged 12 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
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE- DEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE INJECTION B. BRAUN MEDICAL INC. ---------- POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE INJECTIONS USP DESCRIPTION (See chart below for quantitative information.) Potassium Chloride in Dextrose and Sodium Chloride Injections USP are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents. These products are intended for intravenous administration. The formulas of the active ingredients are: INGREDIENTS MOLECULAR FORMULA MOLECULAR WEIGHT Sodium Chloride USP Potassium Chloride USP NaCl KCl 58.44 74.55 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 and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. 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. COMPOSITION – EACH 100 ML CONTAINS: SOLUTION HYDROUS DEXTROSE USP SODIUM CHLORIDE USP POTASSIUM CHLORIDE USP CONCENTRATION OF ELECTROLYTES (MEQ/LITER) CALORIES PER LITER CALCULATED OSMOLARITY MOSMOL/LITER PH SODIUMPOTASSIUMCHLORIDE 0.15% Potassium Chloride in 5% Dextrose and 0.20% Sodium Chloride Injection USP 5 g 0.2 g 0.15 g 34 20 54 170 360 4.4 (3.5– 6.5) Water for Injection USP qs 0.075% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.075 g 77 10 87 170 425 4.4 (3.5– 6.5) 0.15% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.15 g 77 20 97 170 445 4.4 (3.5– 6.5) 0.22% Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection USP 5 g 0.45 g 0.22 g 77 30 107 170 465 4.4 (3. Lue koko asiakirja