50% DEXTROSE injection, solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

HF Acquisition Co LLC, DBA HealthFirst

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

50% DEXTROSE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1216-1 50% DEXTROSE INJECTION, USP 25grams (0.5g/mL) 50mL SYR HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufactures dosage forms 50% Dextrose Injection, USP is supplied in single-dose containers as follows: 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.]

מצב אישור:

New Drug Application

מאפייני מוצר

50% DEXTROSE- 50% DEXTROSE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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50% DEXTROSE INJECTION, USP 25GRAMS (0.5G/ML) 50ML SYR
SPL UNCLASSIFIED
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 C6H12O6 ∙ H2O (D-glucose
monohydrate), a hexose sugar freely
soluble in water. Dextrose, hydrous has the following structural
formula:
Water for Injection, USP is chemically designated H2O.
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. Dextrose injection undergoes oxidation to carbon
dioxide and wate