DEXTROSE- dextrose monohydrate injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Baxter Healthcare Corporation

INN (Algemene Internationale Benaming):

DEXTROSE MONOHYDRATE

Samenstelling:

DEXTROSE MONOHYDRATE 70 g in 100 mL

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Dextrose Injection is indicated as source of calories and fluid replenishment when mixed with amino acids or other compatible intravenous fluids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated. The use of Dextrose Injection is contraindicated in patients: Appropriate administration of Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. However, maternal hyperglycemia secondary to infusion of glucose-containing products at the time of delivery has been associated with adverse neonatal outcomes such as neonatal hypoglycemia. Malnutrition in pregnant women is associated with adverse maternal and fetal outcomes (see Clinical Considerations). Animal reproduction studies have not been conducted with injectable dextrose solutions. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a bac

Product samenvatting:

Dextrose Injection 70%, USP (0.7 grams/mL) is a sterile hypertonic solutions of dextrose supplied in a single-dose, 500 mL partial-fill flexible container for intravenous administration after appropriate admixture or dilution [see Dosage and Administration (2.1)] . Product Description Code NDC Dextrose Injection 70%, USP (0.7 grams/mL) 2B0114 0338-0719-13 Do not remove container from the overwrap until intended for use. Use the product immediately after mixing and the introduction of additives. Store between 20ºC to 25°C (68º F to 77°F). [See USP controlled room temperature.] Do not freeze.

Autorisatie-status:

New Drug Application

Productkenmerken

DEXTROSE- DEXTROSE MONOHYDRATE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXTROSE INJECTION 70% SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXTROSE INJECTION
70%.
DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1940
INDICATIONS AND USAGE
Dextrose Injection is indicated as a source of calories when mixed
with amino acids or other compatible intravenous fluids
for patients requiring parenteral nutrition when oral or enteral
nutrition is not possible, insufficient or contraindicated. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 70% (0.7 grams/mL), 70 grams of dextrose hydrous per 100 mL
in a single-dose, partial-fill flexible container
with 500 mL fill volume in 1000 mL flexible container. (3)
CONTRAINDICATIONS
Severe dehydration. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions are, hyperglycemia, hypersensitivity
reactions, infection both systemic and at the
injection site, and vein thrombosis or phlebitis. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAXTER HEALTHCARE AT
1-866-888-2472 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Must be diluted with compatible intravenous fluids or used as
admixture, prior to administration. Not for direct
intravenous infusion. (2.1)
For slow intravenous infusion only into a: (2.2)
o
o
Central vein, if final dextrose concentration is greater than 5% or
osmolality is greater than 900 mOsm/L
approximate ly.
Peripheral vein, if final dextrose concentration 5% or less and
osmolality is less than 900 mOsm/L
approximate ly.
Individualize dosage based on the patient’s clinical condition, body
weight, nutritional/fluid requirements, as well as
additional energy given orally/enterally. (2.3)
Discontinue infusion of concentrated dextrose solutions slowly. (2.4)
Pulmonary Embolism due t