FLUGLUCOSCAN INJECTION SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FLUDEOXYGLUCOSE 18F

Pieejams no:

ALBERTA HEALTH SERVICES

ATĶ kods:

V09IX04

SNN (starptautisko nepatentēto nosaukumu):

FLUDEOXYGLUCOSE (18F)

Deva:

0.5GBQ

Zāļu forma:

SOLUTION

Kompozīcija:

FLUDEOXYGLUCOSE 18F 0.5GBQ

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

20ML

Receptes veids:

Schedule C

Ārstniecības joma:

ROENTGENOGRAPHY

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2018-10-09

Produkta apraksts

_ _
_ _
_FLUGLUCOSCAN_
_®_
_, fluorine (_
_18_
_F) fluorodeoxyglucose injection _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
FLUGLUCOSCAN
®
Fluorine (
18
F) fluorodeoxyglucose injection
Sterile solution for intravenous injection
> 0.5 GBq/vial at calibration
Diagnostic Radiopharmaceutical
Alberta Health Services
8
th
Floor Seventh Street Plaza (North Tower)
10030 107 Street
Edmonton, AB T5J 3E4, Canada
Date of Initial Authorization:
OCT 2, 2007
Date of Revision:
FEB 12, 2024
Submission Control Number: 275036
FLUGLUCOSCAN
®
is a registered trademark owned by Alberta Health Services
_ _
_FLUGLUCOSCAN_
_®_
_, (fluorine (_
_18_
_F) fluorodeoxyglucose injection) _
_Page 2 of 26_
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
................................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
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 BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1 Dosing Considerations
......................