FLUOROHMET (CITRATE) SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

FLUDEOXYGLUCOSE 18F

Saadav alates:

CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION

ATC kood:

V09IX04

INN (Rahvusvaheline Nimetus):

FLUDEOXYGLUCOSE (18F)

Annus:

157GBQ

Ravimvorm:

SOLUTION

Koostis:

FLUDEOXYGLUCOSE 18F 157GBQ

Manustamisviis:

INTRAVENOUS

Ühikuid pakis:

100

Retsepti tüüp:

Schedule C

Terapeutiline ala:

ROENTGENOGRAPHY

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2016-06-06

Toote omadused

_ _
_[_
_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