DEXTROSE- dextrose monohydrate injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Cardinal Health

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to insure proper utilization of dextrose and avoid production of hyperglycemia. A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present, nor in the presence of delirium tremens if the patient is already dehydrated. Dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

Περίληψη προϊόντος:

50% Dextrose Injection, USP is supplied in single-dose containers as follows: NDC No. Container Size 0409-4902-34 Lifeshield Abboject® Unit of Use Syringe with male luer lock adapter and protected needle 25 g in 50 mL 0409-6648-02 Fliptop Vial 25 g in 50 mL 0409-7517-15 Ansyr™ Plastic Syringe 25 g in 50 mL 0409-7517-16 Ansyr™ II Plastic Syringe with syringe and barrel detached 25 g in 50 mL Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: October, 2009 Printed in USA EN-2278 Hospira, Inc., Lake Forest, IL 60045 USA Abboject® is a trademark of the Abbott group of companies. Cardinal Health Zanesville, OH 43701 IA61530711

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

DEXTROSE- DEXTROSE MONOHYDRATE INJECTION, SOLUTION
CARDINAL HEALTH
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50% DEXTROSE INJECTION, USP
Concentrated Dextrose for
Intravenous Administration
NOTE: THIS SOLUTION IS HYPERTONIC — See _WARNINGS_ and
_PRECAUTIONS_.
LifeShield™ Abboject® Syringe
Fliptop Container
Ansyr™ Plastic Syringe
Ansyr™ II Plastic Syringe
Rx only
DESCRIPTION
50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic
solution of dextrose in water for
injection for intravenous injection as a fluid and nutrient
replenisher.
Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4
kcal/gram. The solution has an
osmolarity of 2.53 mOsmol/mL (calc.), a pH of 4.2 (3.2 to 6.5) and may
contain sodium hydroxide and/or
hydrochloric acid 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.
Dextrose, USP is chemically designated C H O • H O (D-glucose
monohydrate), a hexose sugar
freely soluble in water. Dextrose, hydrous has the following
structural formula:
Water for Injection, USP is chemically designated H O.
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.
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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. Dextrose injection undergoes oxidation to
carbon dioxide and w