FLUGLUCOSCAN INJECTION SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

FLUDEOXYGLUCOSE 18F

から入手可能:

ALBERTA HEALTH SERVICES

ATCコード:

V09IX04

INN（国際名）:

FLUDEOXYGLUCOSE (18F)

投薬量:

0.5GBQ

医薬品形態:

SOLUTION

構図:

FLUDEOXYGLUCOSE 18F 0.5GBQ

投与経路:

INTRAVENOUS

パッケージ内のユニット:

20ML

処方タイプ:

Schedule C

治療領域:

ROENTGENOGRAPHY

製品概要:

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

認証ステータス:

APPROVED

承認日:

2018-10-09

製品の特徴

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