FLUDEOXYGLUCOSE (F-18) SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-03-2017
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Active ingredient:
FLUDEOXYGLUCOSE 18F
Available from:
LAWSON HEALTH RESEARCH INSTITUTE
ATC code:
V09IX04
INN (International Name):
FLUDEOXYGLUCOSE (18F)
Dosage:
232GBQ
Pharmaceutical form:
SOLUTION
Composition:
FLUDEOXYGLUCOSE 18F 232GBQ
Administration route:
INTRAVENOUS
Units in package:
20ML
Prescription type:
Schedule C
Therapeutic area:
ROENTGENOGRAPHY
Product summary:
Active ingredient group (AIG) number: 0152591014; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-10-02
Summary of Product characteristics
Fludeoxyglucose (
18
F)
1
PRODUCT MONOGRAPH
TRADE NAME
Fludeoxyglucose (
18
F) Injection
0.5 to 232 GBq/vial
Diagnostic Radiopharmaceutical
Lawson Health Research Institute
268 Grosvenor Street
London ON N6A 4V2
Date of Approval:
March 9, 2017
Control #:
197018
Fludeoxyglucose (
18
F)
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
.............................................................................................
5
ADVERSE REACTIONS
...............................................................................................................
6
DRUG INTERACTIONS
...............................................................................................................
6
DOSAGE AND ADMINISTRATION
...........................................................................................
7
RADIATION DOSIMETRY
..........................................................................................................
9
OVERDOSAGE............................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
11
STORAGE AND STABILITY
.....................................................................................................
12
SPECIAL HANDLING INSTRUCTIONS
..................................................................................
12
DOSAGE FORM
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