18F-FLUDEOXYGLUCOSE (18F-FDG) SOLUTION

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

FLUDEOXYGLUCOSE 18F

มีจำหน่ายจาก:

ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD.

รหัส ATC:

V09IX04

INN (ชื่อสากล):

FLUDEOXYGLUCOSE (18F)

ปริมาณ:

7400MBq

แบบฟอร์มเภสัชกรรม:

SOLUTION

องค์ประกอบ:

FLUDEOXYGLUCOSE 18F 7400MBq

เส้นทางการบริหาร:

INTRAVENOUS

หน่วยในแพ็คเกจ:

30ML

ประเภทใบสั่งยา:

Schedule C

พื้นที่บำบัด:

ROENTGENOGRAPHY

สรุปสินค้า:

Active ingredient group (AIG) number: 0152591002; AHFS:

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2017-05-10

สรุปลักษณะสินค้า

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
.........................................................