DEXTROSE injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

Compra'l ara

Descargar Fitxa tècnica (SPC)
21-07-2014

ingredients actius:

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

Disponible des:

B. Braun Medical Inc.

Designació comuna internacional (DCI):

DEXTROSE MONOHYDRATE

Composición:

DEXTROSE MONOHYDRATE 70 g in 100 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

This intravenous solution is indicated for use in adults and pediatric patients as a source of calories and water for hydration. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products. Administration of solutions containing hypertonic dextrose is contraindicated in patients with intracranial or intraspinal hemorrhage, diabetic coma or delirium tremens, especially if such patients are already dehydrated. There is no specific pediatric dose. The dose is dependent on weight, clinical condition, and laboratory results. Follow recommendations of appropriate pediatric reference text. (See WARNINGS and PRECAUTIONS .)

Resumen del producto:

70% Dextrose Injection, USP is supplied sterile and nonpyrogenic in 1000 mL glass containers, packaged 6 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C/77°F); however, brief exposure up to 40°C/104°F does not adversely affect the product. Rx only Revised: January 2014

Estat d'Autorització:

unapproved drug other

Fitxa tècnica

                                DEXTROSE- DEXTROSE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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70% DEXTROSE INJECTION, USP
Package Insert
ADMINISTER ONLY AFTER DILUTION VIA CENTRAL VENOUS CATHETER.
DESCRIPTION
Each 100 mL of 70% DEXTROSE INJECTION, USP contains:
Hydrous Dextrose USP 70 g; Water for Injection USP qs
pH: 4.6 (3.2-6.5); Calculated Osmolarity: 3530 mOsmol/liter
Calories per liter: 2380; Calculated Specific Gravity 1.23
70% Dextrose Injection, USP is sterile, nonpyrogenic and contains no
bacteriostatic or antimicrobial
agents.
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULA MOLECULAR WEIGHT
Hydrous Dextrose USP
198.17
CLINICAL PHARMACOLOGY
70% Dextrose Injection, USP provides calories and is a source of water
for hydration. This solution is
capable of inducing diuresis depending on the clinical condition of
the patient.
Dextrose is readily metabolized, may decrease losses of body protein
and nitrogen, promotes glycogen
deposition and decreases or prevents ketosis if sufficient doses are
provided.
70% dextrose solution provides a maximum source of calories in a
minimal fluid volume.
INDICATIONS AND USAGE
This intravenous solution is indicated for use in adults and pediatric
patients as a source of calories and
water for hydration.
CONTRAINDICATIONS
Solutions containing dextrose may be contraindicated in patients with
hypersensitivity to corn products.
Administration of solutions containing hypertonic dextrose is
contraindicated in patients with
intracranial or intraspinal hemorrhage, diabetic coma or delirium
tremens, especially if such patients are
already dehydrated.
WARNINGS
The administration of intravenous solutions can cause fluid and/or
solute overload resulting in dilution
of serum electrolyte concentrations, overhydration, congested states
or pulmonary edema. The risk of
dilutional states is inversely proportion
                                
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