DATSCAN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IOFLUPANE (123I)

Available from:

GE HEALTHCARE CANADA INC

ATC code:

V09AB03

INN (International Name):

IODINE IOFLUPANE 123 I

Dosage:

74MBq

Pharmaceutical form:

SOLUTION

Composition:

IOFLUPANE (123I) 74MBq

Administration route:

INTRAVENOUS

Units in package:

2.5ML/5ML

Prescription type:

Schedule C

Therapeutic area:

ROENTGENOGRAPHY

Product summary:

Active ingredient group (AIG) number: 0159810001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-12-11

Summary of Product characteristics

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
DATSCAN
Ioflupane (
123
I)
74 MBq/ml solution for injection
Diagnostic Radiopharmaceutical
GE Healthcare Canada Inc.
Date of Approval:
2300 Meadowvale Boulevard
December 7, 2017
Mississauga, ON
L5N 5P9
Submission Control No.: 201481
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
...............................................................................................................
7
DRUG INTERACTIONS
................................................................................................................
7
DOSAGE AND ADMINISTRATION
............................................................................................
8
RADIATION DOSIMETRY
.........................................................................................................
10
OVERDOSAGE
............................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
12
STORAGE AND STABILITY
.....................................................................................................
13
SPECIAL HANDLING INSTRUCTIONS
...........................................................................