FLUDEOXYGLUCOSE [F-18] FDG INJECTION SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FLUDEOXYGLUCOSE 18F

Disponible depuis:

THUNDER BAY REGIONAL HEALTH SCIENCES CENTRE

Code ATC:

V09IX04

DCI (Dénomination commune internationale):

FLUDEOXYGLUCOSE (18F)

Dosage:

0.5GBQ

forme pharmaceutique:

SOLUTION

Composition:

FLUDEOXYGLUCOSE 18F 0.5GBQ

Mode d'administration:

INTRAVENOUS

Unités en paquet:

100

Type d'ordonnance:

Schedule C

Domaine thérapeutique:

ROENTGENOGRAPHY

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2018-06-13

Résumé des caractéristiques du produit

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
..................................................