Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
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:5SL0G7R0OK), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN486
HF Acquisition Co LLC, DBA HealthFirst
INTRAVENOUS
PRESCRIPTION DRUG
These solutions are indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without 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. To Open: Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To Add Medication Prepare additive port. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication. The additive port may be protected by covering with an additive cap. Mix container contents thoroughly
LACTATED RINGER'S AND 5% DEXTROSE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1229-1 LACTATED RINGER'S AND 5% DEXTROSE INJECTION, USP 1000mL BAG NDC 51662-1300-1 LACTATED RINGER'S INJECTION, USP 500mL BAG HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms These solutions are supplied in single-dose flexible plastic containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: July, 2009 Printed in USA EN-2203 Hospira, Inc., Lake Forest, IL 60045 USA
New Drug Application
LACTATED RINGERS AND DEXTROSE- SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE, DEXTROSE INJECTION, SOLUTION LACTATED RINGERS- SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SOLUTION HF ACQUISITION CO LLC, DBA HEALTHFIRST ---------- LACTATED RINGER'S AND DEXTROSE SPL UNCLASSIFIED Flexible Plastic Container Rx only DESCRIPTION These products are sterile, nonpyrogenic solutions each containing isotonic concentrations of electrolytes (with or without dextrose) in water for injection. The solutions containing dextrose and electrolytes are hypertonic; those containing only electrolytes are isotonic. They are administered by intravenous infusion for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories. Each 100 mL of Lactated Ringer's Injection, USP contains sodium chloride 600 mg, sodium lactate, anhydrous 310 mg, potassium chloride 30 mg and calcium chloride, dihydrate 20 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. A liter provides 9 calories (from lactate), sodium (Na+), 130 mEq, potassium (K+) 4 mEq, calcium (Ca++) 3 mEq, chloride (Cl−) 109 mEq and lactate [CH3CH(OH) COO−] 28 mEq. The electrolyte content is isotonic (273 mOsmol/liter, calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 6.6 (6.0 − 7.5). Each 100 mL of Lactated Ringer's and 5% Dextrose Injection, USP contains dextrose, hydrous 5 g plus the same ingredients and mEq values as Lactated Ringer's Injection, USP (contains only hydrochloric acid for pH adjustment). A liter provides 179 calories (from dextrose and lactate) and has a hypertonic osmolar concentration of 525 mOsmol (calc.). The pH is 4.9 (4.0 − 6.5). The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. The Đọc toàn bộ tài liệu