CYCLODX SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

FLUDEOXYGLUCOSE 18F

Sẵn có từ:

CIUSS DE L'ESTRIE - CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE

Mã ATC:

V09IX04

INN (Tên quốc tế):

FLUDEOXYGLUCOSE (18F)

Liều dùng:

7.4GBQ

Dạng dược phẩm:

SOLUTION

Thành phần:

FLUDEOXYGLUCOSE 18F 7.4GBQ

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

20ML

Loại thuốc theo toa:

Schedule C

Khu trị liệu:

ROENTGENOGRAPHY

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0152591015; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2017-04-06

Đặc tính sản phẩm

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_Page 1 of 23_
PRODUCT MONOGRAPH
CYCLODX
TM
(Fludeoxyglucose F 18 Injection)
Solution for intravenous injection containing 0.5 to 232 GBq of
Fludeoxyglucose F 18 (multiple-dose
20 mL vials), at the date and time of calibration.
DIAGNOSTIC AGENT IN CONJUNCTION WITH POSITRON-EMISSION TOMOGRAPHY
(PET)
FOR INTRAVENOUS USE
Distributor:
Centre intégré universitaire de santé et de services sociaux de
l'Estrie - Centre hospitalier universitaire de Sherbrooke
3001, 12
ème
Avenue Nord
Sherbrooke (Québec)
J1H 5N4
Control number: 199175 Date of Approval: April 12, 2017
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_Page 2 of 23_
TABLE OF CONTENT
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
................................................................................................
9
RADIATION DOSIMETRY
.............................................................................................................
11
OVERDOSAGE
.....................................................................................................................