LACTATED RINGERS AND DEXTROSE- sodium chloride, sodium lactate, potassium chloride, calcium chloride, and dextrose monohydrate i

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN486

Sẵn có từ:

HF Acquisition Co LLC, DBA HealthFirst

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

LACTATED RINGER'S AND 5% DEXTROSE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1521-1 LACTATED RINGER'S AND 5% DEXTROSE INJECTION, USP 1000mL 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: * Manufactured by ICU Medical, Inc., Lake Forest, Illinois, 60045, USA † Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA ICU Medical is transitioning NDC codes from "0409" to a"0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: April, 2018 EN-4688

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

LACTATED RINGERS AND DEXTROSE- SODIUM CHLORIDE, SODIUM LACTATE,
POTASSIUM
CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE INJECTION,
SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
LACTATED RINGER'S AND 5% DEXTROSE INJECTION, USP 1000ML BAG
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 solutions are parenteral fluid, nutrient and/or electrolyte
rep