CYCLODX SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUDEOXYGLUCOSE 18F

Available from:

CIUSS DE L'ESTRIE - CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE

ATC code:

V09IX04

INN (International Name):

FLUDEOXYGLUCOSE (18F)

Dosage:

7.4GBQ

Pharmaceutical form:

SOLUTION

Composition:

FLUDEOXYGLUCOSE 18F 7.4GBQ

Administration route:

INTRAVENOUS

Units in package:

20ML

Prescription type:

Schedule C

Therapeutic area:

ROENTGENOGRAPHY

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2017-04-06

Summary of Product characteristics

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