GALLIUM (GA67) CITRATE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GALLIUM CITRATE GA 67

Available from:

CURIUM CANADA INC

ATC code:

V09HX01

INN (International Name):

GALLIUM 67 GA CITRATE

Dosage:

74MBq

Pharmaceutical form:

SOLUTION

Composition:

GALLIUM CITRATE GA 67 74MBq

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Schedule C

Therapeutic area:

ROENTGENOGRAPHY

Product summary:

Active ingredient group (AIG) number: 0152589005; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-12-07

Summary of Product characteristics

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_Page 1 of 15_
PRODUCT MONOGRAPH
GALLIUM (GA 67) CITRATE INJECTION
Gallium (Ga 67) Citrate
Solution, 74 MBq/mL
Radiodiagnostic agent
Curium Canada Inc.
2572 boul. Daniel-Johnson, Suite 245-249
Laval, QC, H7T-2R3
CANADA
Distributed by:
Curium Canada Inc.
Laval, QC, H7T-2R3
CANADA
Date of Revision: April 26
th
, 2019
CONTROL NO: 225104
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_Page 2 of 15_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
5
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
...................................................................................................
7
DOSAGE AND ADMINISTRATION
...............................................................................
7
RADIATION DOSIMETRY
..............................................................................................
8
OVERDOSAGE
.................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 9
STORAGE AND STABILITY
.........................................................................................
10
SPECIAL HANDLING INSTRUCTIONS
......................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 10