FLUOROHMET (CITRATE) SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

FLUDEOXYGLUCOSE 18F

Commercializzato da:

CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION

Codice ATC:

V09IX04

INN (Nome Internazionale):

FLUDEOXYGLUCOSE (18F)

Dosaggio:

157GBQ

Forma farmaceutica:

SOLUTION

Composizione:

FLUDEOXYGLUCOSE 18F 157GBQ

Via di somministrazione:

INTRAVENOUS

Confezione:

100

Tipo di ricetta:

Schedule C

Area terapeutica:

ROENTGENOGRAPHY

Dettagli prodotto:

Active ingredient group (AIG) number: 0152591019; AHFS: 36:68.00

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2016-06-06

Scheda tecnica

_ _
_[_
_18_
_F]Fluorodeoxyglucose, _
_18_
_F -FDG _
_Page 1 of 24_
PRODUCT MONOGRAPH
FLUOROHMET
([
18
F]Fluorodeoxyglucose,
18
F-FDG)
Solution for Injection, 45 - 4240 mCi per multi-dose vial
Diagnostic Radiopharmaceutical
University of Ottawa Heart Institute
National Cardiac PET Centre
40 Ruskin Street
Ottawa, ON K1Y 4W7
Date of Authorization:
December 29, 2010
NDS Control # 136101
_ _
_[_
_18_
_F]Fluorodeoxyglucose, _
_18_
_F -FDG _
_Page 2 of 24_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................4
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND
PRECAUTIONS..................................................................................5
ADVERSE
REACTIONS....................................................................................................7
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND
ADMINISTRATION................................................................................8
RADIATION
DOSIMETRY.............................................................................................10
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND
STABILITY..........................................................................................13
SPECIAL HANDLING INSTRUCTIONS
.......................................................................13
DOSAGE FOR