FLUGLUCOSCAN INJECTION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FLUDEOXYGLUCOSE 18F

Διαθέσιμο από:

ALBERTA HEALTH SERVICES

Φαρμακολογική κατηγορία (ATC):

V09IX04

INN (Διεθνής Όνομα):

FLUDEOXYGLUCOSE (18F)

Δοσολογία:

0.5GBQ

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

FLUDEOXYGLUCOSE 18F 0.5GBQ

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

20ML

Τρόπος διάθεσης:

Schedule C

Θεραπευτική περιοχή:

ROENTGENOGRAPHY

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-10-09

Αρχείο Π.Χ.Π.

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