18F-FLUDEOXYGLUCOSE (18F-FDG) SOLUTION
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
26-11-2019
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Aktívna zložka:
FLUDEOXYGLUCOSE 18F
Dostupné z:
ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.
ATC kód:
V09IX04
INN (Medzinárodný Name):
FLUDEOXYGLUCOSE (18F)
Dávkovanie:
7400MBq
Forma lieku:
SOLUTION
Zloženie:
FLUDEOXYGLUCOSE 18F 7400MBq
Spôsob podávania:
INTRAVENOUS
Počet v balení:
30ML
Typ predpisu:
Schedule C
Terapeutické oblasti:
ROENTGENOGRAPHY
Prehľad produktov:
Active ingredient group (AIG) number: 0152591002; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2017-05-10
Súhrn charakteristických
PRODUCT MONOGRAPH
18
F-Fluorodeoxyglucose (
18
F-FDG)
Parenteral Solution, > 0.5 GBq /mL
Diagnostic Radiopharmaceutical
Isologic Innovative Radiopharmaceuticals Ltd.
Date of Initial Approval:
11215 Chemin de la Côte-De-Liesse
December 12th, 2016
Dorval, QC H9P 1B1
Submission control #: 231896
Date of Revision: November 26, 2019
Fludeoxyglucose
18
F Injection
Isologic Innovative Radiopharmaceuticals
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT
INFORMATION....................................................................................
3
DESCRIPTION
...............................................................................................................................
3
Physical Characteristics
.........................................................................................................................
3
External Radiation
.................................................................................................................................
4
INDICATIONS AND CLINICAL USE
.........................................................................................
4
CONTRAINDICATIONS
...............................................................................................................
4
WARNINGS AND PRECAUTIONS
.............................................................................................
4
ADVERSE REACTIONS
...............................................................................................................
6
DRUG INTERACTIONS
...............................................................................................................
7
DOSAGE AND ADMINISTRATION
...........................................................................................
7
Dosing considerations
...........................................................................................................................
7
Dosage
.........................................................
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