NAF PLUS SOLUTION
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
23-04-2014
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Aktívna zložka:
SODIUM FLUORIDE F 18
Dostupné z:
ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.
ATC kód:
V09IX04
INN (Medzinárodný Name):
FLUDEOXYGLUCOSE (18F)
Dávkovanie:
7400MBq
Forma lieku:
SOLUTION
Zloženie:
SODIUM FLUORIDE F 18 7400MBq
Spôsob podávania:
INTRAVENOUS
Počet v balení:
30ML
Typ predpisu:
Schedule C
Terapeutické oblasti:
ROENTGENOGRAPHY
Prehľad produktov:
Active ingredient group (AIG) number: 0153703002; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2017-05-10
Súhrn charakteristických
PRODUCT MONOGRAPH
NaF Plus
Sodium Fluoride [
18
F] Injection, U.S.P.
Parenteral Solution
Diagnostic Radiopharmaceutical
Isologic Innovative Radiopharmaceuticals Ltd.
Date of Approval:
1855 32e Avenue, Lachine, Quebec H8T 3J1
Control # 171576
April 23, 2014
NaF Plus
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
DESCRIPTION
...........................................................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
4
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
...........................................................................................................
5
DRUG
INTERACTIONS............................................................................................................
5
DOSAGE AND ADMINISTRATION
.......................................................................................
6
RADIATION DOSIMETRY
......................................................................................................
7
OVERDOSAGE
..........................................................................................................................
7
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
8
STORAGE AND STABILITY
...................................................................................................
8
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
8
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................
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