GLUCOVISION (CITRATE) SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

FLUDEOXYGLUCOSE 18F

Tilgjengelig fra:

CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION

ATC-kode:

V09IX04

INN (International Name):

FLUDEOXYGLUCOSE (18F)

Dosering :

453GBQ

Legemiddelform:

SOLUTION

Sammensetning:

FLUDEOXYGLUCOSE 18F 453GBQ

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

100

Resept typen:

Schedule C

Terapeutisk område:

ROENTGENOGRAPHY

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2010-07-02

Preparatomtale

_ _
_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
.....................................