FLUDEOXYGLUCOSE [F-18] FDG INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FLUDEOXYGLUCOSE 18F

Διαθέσιμο από:

THUNDER BAY REGIONAL HEALTH SCIENCES CENTRE

Φαρμακολογική κατηγορία (ATC):

V09IX04

INN (Διεθνής Όνομα):

FLUDEOXYGLUCOSE (18F)

Δοσολογία:

0.5GBQ

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

FLUDEOXYGLUCOSE 18F 0.5GBQ

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Schedule C

Θεραπευτική περιοχή:

ROENTGENOGRAPHY

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0152591001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-06-13

Αρχείο Π.Χ.Π.

Fludeoxyglucose (
18
F)
1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
FDG(
18
F)
Fludeoxyglucose (
18
F)
Intravenous solution, >0.5 GBq/vial or syringe
Diagnostic Radiopharmaceutical
Thunder Bay Regional Health Sciences Centre
980 Oliver Rd
Thunder Bay ON P7B 6V4
Date of Preparation:
June 22
nd
, 2017
Submission Control #: 201447
Date of Approval: November 08, 2017
Fludeoxyglucose (
18
F)
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 4
1
INDICATIONS
.........................................................................................................
4
1.1
Pediatrics
........................................................................................................
4
1.2
Geriatrics
........................................................................................................
4
2
CONTRAINDICATIONS
.........................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
....................................................... 4
4
DOSAGE AND ADMINISTRATION
........................................................................
5
4.1
Dosing considerations
....................................................................................
5
4.2
Dosage
...........................................................................................................
5
4.3
Administration
.................................................................................................
5
4.4
Image Acquisition and Interpretation
.............................................................. 5
4.5
Instructions for Preparation and Use
.............................................................. 6
4.6
Directions for Quality Control
..........................................................................
6
5
RADIATION DOSIMETRY
......................................................................................
7
6
OVERDOSAGE
..................................................