FLUDEOXYGLUCOSE [F-18] FDG INJECTION SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

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Download Ciri produk (SPC)
08-11-2017

Bahan aktif:

FLUDEOXYGLUCOSE 18F

Boleh didapati daripada:

THUNDER BAY REGIONAL HEALTH SCIENCES CENTRE

Kod ATC:

V09IX04

INN (Nama Antarabangsa):

FLUDEOXYGLUCOSE (18F)

Dos:

0.5GBQ

Borang farmaseutikal:

SOLUTION

Komposisi:

FLUDEOXYGLUCOSE 18F 0.5GBQ

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

100

Jenis preskripsi:

Schedule C

Kawasan terapeutik:

ROENTGENOGRAPHY

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2018-06-13

Ciri produk

                                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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