Country: United States
Language: English
Source: NLM (National Library of Medicine)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698)
Fresenius Kabi USA, LLC
INTRAVENOUS
PRESCRIPTION DRUG
These solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride. Solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. Flexible Plastic Container (free flex ® bag) To Open - Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. - Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. - Do not use if the solution is cloudy or a precipitate is present. To Add Medication - Identify WHITE Additive Port with arrow pointing toward container. - Immediately before injecting additives, break off WHIT
Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP is supplied in single-dose free flex ® plastic containers as follows: Avoid excessive heat. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
Abbreviated New Drug Application
POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE- DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- POTASSIUM CHLORIDE IN DEXTROSE AND SODIUM CHLORIDE R only POTASSIUM CHLORIDE IN 5% DEXTROSE AND 0.9% SODIUM CHLORIDE INJECTION, USP FLEXIBLE PLASTIC CONTAINER DESCRIPTION Intravenous solutions with potassium chloride (I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water for injection. They are for administration by intravenous infusion only. See table below for summary of content and characteristics of these solutions. Table 1 COMPOSITION (g/L) Approx. Ionic Concentrations (mEq/L) Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP mEq Potassium Size (mL) Dextrose, Hydrous Sodium Chloride Potassium Chloride Calculated Osmolarity (mOsmol/L) pH Sodium (Na ) Potassium (K ) Chloride (Cl ) Approximate Kcal/L 20 mEq 1000 50 9 1.49 600 4.2 (3.5 to 6.5) 154 20 174 170 40 mEq 1000 50 9 2.98 640 4.2 (3.5 to 6.5) 154 40 194 170 May contain HCl for pH adjustment. The solutions contain no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. These solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose, USP is chemically designated D-glucose, monohydrate (C H O • H O), a hexose sugar freely soluble in water. It has the following structural formula: x + + - 6 12 6 2 Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H O. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (FREE_flex_ bag) . Water can permeate from inside the container into the overwrap but not in amo Read the complete document