DEXTROSE- dextrose monohydrate injection, solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Доступно од:

Medical Purchasing Solutions, LLC

Пут администрације:

INTRAVENOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

25% Dextrose Injection is indicated in the treatment of acute symptomatic episodes of hypoglycemia in the neonate or older infant to restore depressed blood glucose levels and control symptoms. Other drugs, such as epinephrine and glucagon, should be considered in patients unresponsive or intolerant to dextrose (glucose). Oral feeding of dextrose may be necessary in infants with frequently recurring hypoglycemic episodes or to prevent recurrences due to hyperinsulinemia. 25% Dextrose Injection also provides a minimal source of carbohydrate calories. A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present.

Резиме производа:

25% Dextrose Injection, USP is supplied in single-dose containers as follows: NDC No. Container Size 0409-1775-10 Ansyr™ Plastic Syringe 10 mL Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1057-3.0 Revised: June 2020

Статус ауторизације:

New Drug Application

Карактеристике производа

DEXTROSE- DEXTROSE MONOHYDRATE INJECTION, SOLUTION
MEDICAL PURCHASING SOLUTIONS, LLC
----------
INFANT
25% DEXTROSE INJECTION, USP
CONCENTRATED DEXTROSE FOR INTRAVENOUS ADMINISTRATION TO INFANTS
_._
NOTE: THIS SOLUTION IS HYPERTONIC—SEE WARNINGS AND PRECAUTIONS.
ANSYR™ PLASTIC SYRINGE
Rx only
DESCRIPTION
25% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic
solution of dextrose
in water for injection administered by intravenous injection to
restore blood glucose
levels in hypoglycemia and as a source of carbohydrate calories. Each
milliliter (mL) of
fluid contains dextrose, hydrous, 250 mg which delivers 3.4 kcal/gram
(0.85 kcal/mL).
The solution has an osmolarity of 1.39 mOsmol/mL (calc.). pH is 3.2 to
6.5. May contain
hydrochloric acid and sodium hydroxide for pH adjustment.
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 with the entire
unit.
25% Dextrose Injection, USP is a dextrose (glucose) and nutrient
(carbohydrate)
replenisher.
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:
6
12
6
2
The syringe is molded from a specially formulated polypropylene. Water
permeates from
inside the container at an extremely slow rate which will have an
insignificant effect on
solution concentration over the expected shelf life. Solutions in
contact with the plastic
container may leach out certain chemical components from the plastic
in very small
amounts; however, biological testing was supportive of the safety of
the syringe
material.
CLINICAL PHARMACOLOGY
When administered intravenously, this solution restores blood glucose
levels in
hypoglycemia and provides a source of carbohydrate calories.
Carbohydrate in the form
of dextrose may aid in minimizing liver glycogen depletion and exerts
a protein-sparing
action. Dext