FLUOROHMET (CITRATE) SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FLUDEOXYGLUCOSE 18F

Διαθέσιμο από:

CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION

Φαρμακολογική κατηγορία (ATC):

V09IX04

INN (Διεθνής Όνομα):

FLUDEOXYGLUCOSE (18F)

Δοσολογία:

157GBQ

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

FLUDEOXYGLUCOSE 18F 157GBQ

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Schedule C

Θεραπευτική περιοχή:

ROENTGENOGRAPHY

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2016-06-06

Αρχείο Π.Χ.Π.

_ _
_[_
_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