[F-18]-FLUDEOXYGLUCOSE (FDG) INJECTION SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

FLUDEOXYGLUCOSE 18F

Tillgänglig från:

SYLVIA FEDORUK CANADIAN CENTRE FOR NUCLEAR INNOVATION

ATC-kod:

V09IX04

INN (International namn):

FLUDEOXYGLUCOSE (18F)

Dos:

441GBQ

Läkemedelsform:

SOLUTION

Sammansättning:

FLUDEOXYGLUCOSE 18F 441GBQ

Administreringssätt:

INTRAVENOUS

Enheter i paketet:

10ML/30ML

Receptbelagda typ:

Schedule C

Terapiområde:

RADIOACTIVE AGENTS

Produktsammanfattning:

Active ingredient group (AIG) number: 0152591022; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2019-10-08

Produktens egenskaper

_ _
_[F-18]-Fludeoxyglucose (FDG) Injection _
_Page 1 of 20_
PRODUCT MONOGRAPH
[F-18] Fludeoxyglucose Injection ([F-18]-FDG Injection)
1 - 441 GBq per batch at EOS
DIAGNOSTIC RADIOPHARMACEUTICAL
Sylvia Fedoruk Canadian Centre for Nuclear Innovation
303-111 Research Drive
Saskatoon SK S7N 3R2
www.fedorukcentre.ca
_ _
Submission Control No: 194866
Date of Approval:
TBD
Date of Revision:
January 17, 2019
_ _
_[F-18]-Fludeoxyglucose (FDG) Injection _
_Page 2 of 20_
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
...............................................................................
8
RADIATION DOSIMETRY
............................................................................................
10
OVERDOSAGE
...............................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
STORAGE AND STABILITY
.........................................................................................
12
SPECIAL HANDLING INSTRUCTIONS
.................................................................