GLUCOVISION (CITRATE) SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

FLUDEOXYGLUCOSE 18F

Boleh didapati daripada:

CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION

Kod ATC:

V09IX04

INN (Nama Antarabangsa):

FLUDEOXYGLUCOSE (18F)

Dos:

453GBQ

Borang farmaseutikal:

SOLUTION

Komposisi:

FLUDEOXYGLUCOSE 18F 453GBQ

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

100

Jenis preskripsi:

Schedule C

Kawasan terapeutik:

ROENTGENOGRAPHY

Ringkasan produk:

Active ingredient group (AIG) number: 0152591020; AHFS: 36:68.00

Status kebenaran:

APPROVED

Tarikh kebenaran:

2010-07-02

Ciri produk

_ _
_GLUCOVISION_
_®_
_ ([F-18]-Fludeoxyglucose (FDG) Injection) _
_Page 1 of 25_
PRODUCT MONOGRAPH
GLUCOVISION
®
[F-18]-Fludeoxyglucose (FDG) Injection
[F-18]-FDG Phosphate, 1 - 540 GBq per batch at EOS
[F-18]-FDG Citrate, 1 - 453 GBq per batch at EOS
Diagnostic Radiopharmaceutical
Centre for Probe Development and Commercialization (CPDC)
1280 Main Street West
NRB A316
Hamilton ON L8S 4K1
www.imagingprobes.ca
_ _
Submission Control No: 195237
Date of Approval:
August 16, 2016
Date of Revision:
August 10, 2016
_ _
_GLUCOVISION_
_®_
_ ([F-18]-Fludeoxyglucose (FDG) Injection) _
_Page 2 of 25_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT
INFORMATION.........................................................................
3
DESCRIPTION
....................................................................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
4
CONTRAINDICATIONS
....................................................................................................
5
WARNINGS AND PRECAUTIONS
..................................................................................
5
ADVERSE REACTIONS
....................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
8
DOSAGE AND ADMINISTRATION
................................................................................
9
RADIATION DOSIMETRY
.............................................................................................
10
OVERDOSAGE
.................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 12
STORAGE AND STABILITY
.....................................