[F-18]-FLUDEOXYGLUCOSE (FDG) INJECTION SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

FLUDEOXYGLUCOSE 18F

可用日期:

SYLVIA FEDORUK CANADIAN CENTRE FOR NUCLEAR INNOVATION

ATC代码:

V09IX04

INN（国际名称）:

FLUDEOXYGLUCOSE (18F)

剂量:

441GBQ

药物剂型:

SOLUTION

组成:

FLUDEOXYGLUCOSE 18F 441GBQ

给药途径:

INTRAVENOUS

每包单位数:

10ML/30ML

处方类型:

Schedule C

治疗领域:

RADIOACTIVE AGENTS

產品總結:

Active ingredient group (AIG) number: 0152591022; AHFS:

授权状态:

APPROVED

授权日期:

2019-10-08

产品特点

_ _
_[F-18]-Fludeoxyglucose (FDG) Injection _
_Page 1 of 20_
PRODUCT MONOGRAPH
[F-18] Fludeoxyglucose Injection ([F-18]-FDG Injection)
1 - 441 GBq per batch at EOS
DIAGNOSTIC RADIOPHARMACEUTICAL
Sylvia Fedoruk Canadian Centre for Nuclear Innovation
303-111 Research Drive
Saskatoon SK S7N 3R2
www.fedorukcentre.ca
_ _
Submission Control No: 194866
Date of Approval:
TBD
Date of Revision:
January 17, 2019
_ _
_[F-18]-Fludeoxyglucose (FDG) Injection _
_Page 2 of 20_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
...................................................................................................
8
DOSAGE AND ADMINISTRATION
...............................................................................
8
RADIATION DOSIMETRY
............................................................................................
10
OVERDOSAGE
...............................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
STORAGE AND STABILITY
.........................................................................................
12
SPECIAL HANDLING INSTRUCTIONS
.................................................................