FLUGLUCOSCAN INJECTION SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

FLUDEOXYGLUCOSE 18F

Доступно од:

ALBERTA HEALTH SERVICES

АТЦ код:

V09IX04

INN (Међународно име):

FLUDEOXYGLUCOSE (18F)

Дозирање:

0.5GBQ

Фармацеутски облик:

SOLUTION

Састав:

FLUDEOXYGLUCOSE 18F 0.5GBQ

Пут администрације:

INTRAVENOUS

Јединице у пакету:

20ML

Тип рецептора:

Schedule C

Терапеутска област:

ROENTGENOGRAPHY

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2018-10-09

Карактеристике производа

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