18F-FLUDEOXYGLUCOSE (18F-FDG) SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

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Ficha técnica Ficha técnica (SPC)
26-11-2019

Ingredientes activos:

FLUDEOXYGLUCOSE 18F

Disponible desde:

ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.

Código ATC:

V09IX04

Designación común internacional (DCI):

FLUDEOXYGLUCOSE (18F)

Dosis:

7400MBq

formulario farmacéutico:

SOLUTION

Composición:

FLUDEOXYGLUCOSE 18F 7400MBq

Vía de administración:

INTRAVENOUS

Unidades en paquete:

30ML

tipo de receta:

Schedule C

Área terapéutica:

ROENTGENOGRAPHY

Resumen del producto:

Active ingredient group (AIG) number: 0152591002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2017-05-10

Ficha técnica

                                PRODUCT MONOGRAPH
18
F-Fluorodeoxyglucose (
18
F-FDG)
Parenteral Solution, > 0.5 GBq /mL
Diagnostic Radiopharmaceutical
Isologic Innovative Radiopharmaceuticals Ltd.
Date of Initial Approval:
11215 Chemin de la Côte-De-Liesse
December 12th, 2016
Dorval, QC H9P 1B1
Submission control #: 231896
Date of Revision: November 26, 2019
Fludeoxyglucose
18
F Injection
Isologic Innovative Radiopharmaceuticals
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT
INFORMATION....................................................................................
3
DESCRIPTION
...............................................................................................................................
3
Physical Characteristics
.........................................................................................................................
3
External Radiation
.................................................................................................................................
4
INDICATIONS AND CLINICAL USE
.........................................................................................
4
CONTRAINDICATIONS
...............................................................................................................
4
WARNINGS AND PRECAUTIONS
.............................................................................................
4
ADVERSE REACTIONS
...............................................................................................................
6
DRUG INTERACTIONS
...............................................................................................................
7
DOSAGE AND ADMINISTRATION
...........................................................................................
7
Dosing considerations
...........................................................................................................................
7
Dosage
.........................................................
                                
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