FLUDEOXYGLUCOSE [F-18] FDG INJECTION SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

FLUDEOXYGLUCOSE 18F

Tersedia dari:

THUNDER BAY REGIONAL HEALTH SCIENCES CENTRE

Kode ATC:

V09IX04

INN (Nama Internasional):

FLUDEOXYGLUCOSE (18F)

Dosis:

0.5GBQ

Bentuk farmasi:

SOLUTION

Komposisi:

FLUDEOXYGLUCOSE 18F 0.5GBQ

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100

Jenis Resep:

Schedule C

Area terapi:

ROENTGENOGRAPHY

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-06-13

Karakteristik 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
..................................................