FLUDEOXYGLUCOSE [F-18] FDG INJECTION SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

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Hent Produktets egenskaber (SPC)
08-11-2017

Aktiv bestanddel:

FLUDEOXYGLUCOSE 18F

Tilgængelig fra:

THUNDER BAY REGIONAL HEALTH SCIENCES CENTRE

ATC-kode:

V09IX04

INN (International Name):

FLUDEOXYGLUCOSE (18F)

Dosering:

0.5GBQ

Lægemiddelform:

SOLUTION

Sammensætning:

FLUDEOXYGLUCOSE 18F 0.5GBQ

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

100

Recept type:

Schedule C

Terapeutisk område:

ROENTGENOGRAPHY

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2018-06-13

Produktets egenskaber

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