FLUOROHMET (CITRATE) SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

FLUDEOXYGLUCOSE 18F

Tilgjengelig fra:

CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION

ATC-kode:

V09IX04

INN (International Name):

FLUDEOXYGLUCOSE (18F)

Dosering :

157GBQ

Legemiddelform:

SOLUTION

Sammensetning:

FLUDEOXYGLUCOSE 18F 157GBQ

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

100

Resept typen:

Schedule C

Terapeutisk område:

ROENTGENOGRAPHY

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2016-06-06

Preparatomtale

_ _
_[_
_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