FLUGLUCOSCAN INJECTION SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

FLUDEOXYGLUCOSE 18F

Dostopno od:

ALBERTA HEALTH SERVICES

Koda artikla:

V09IX04

INN (mednarodno ime):

FLUDEOXYGLUCOSE (18F)

Odmerek:

0.5GBQ

Farmacevtska oblika:

SOLUTION

Sestava:

FLUDEOXYGLUCOSE 18F 0.5GBQ

Pot uporabe:

INTRAVENOUS

Enote v paketu:

20ML

Tip zastaranja:

Schedule C

Terapevtsko območje:

ROENTGENOGRAPHY

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2018-10-09

Lastnosti izdelka

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