Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL
Fresenius Kabi USA, LLC
INTRAVENOUS
PRESCRIPTION DRUG
These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with minimal carbohydrate calories, as required by the clinical condition of the patient. Solutions containing lactate are NOT FOR USE IN THE TREATMENT OF LACTIC ACIDOSIS. 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
Lactated Ringer's and 5% Dextrose Injection, USP is supplied in single-dose free flex ® plastic containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
Abbreviated New Drug Application
LACTATED RINGERS AND DEXTROSE - SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- LACTATED RINGER'S AND 5% DEXTROSE INJECTION, USP FLEXIBLE PLASTIC CONTAINER Rx only DESCRIPTION The product is sterile, nonpyrogenic solution containing isotonic concentration of electrolytes with dextrose in water for injection. The solutions containing dextrose and electrolytes are hypertonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with minimal carbohydrate calories. Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g, sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. Contains only hydrochloric acid for pH adjustment. A liter provides 179 calories (from dextrose and lactate), sodium (Na ), 130 mEq, potassium (K ) 4 mEq, calcium (Ca ) 3 mEq, chloride (Cl ) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5). 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. This solution is a 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: Calcium Chloride, USP is chemically designated calcium chloride dihydrate (CaCl • 2 H O), white fragments or granules freely soluble in water. 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 + + ++ − 6 12 6 2 2 2 soluble in water. Sodium Lacta Lire le document complet