KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI INJECTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TETRAKIS [CU(MIBI)4]BF4

Available from:

CURIUM CANADA INC

ATC code:

V09GA01

INN (International Name):

TECHNETIUM (99m Tc) SESTAMIBI

Dosage:

1MG

Pharmaceutical form:

KIT

Composition:

TETRAKIS [CU(MIBI)4]BF4 1MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Schedule C

Therapeutic area:

ROENTGENOGRAPHY

Product summary:

Active ingredient group (AIG) number: 0152590001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-12-07

Summary of Product characteristics

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_Kit for the preparation of Technetium Tc 99m Sestamibi Injection _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI INJECTION
Freeze-dried Powder for Solution, 1 mg/vial and Intravenous
Professed Standard
Radiodiagnostic Agent (Myocardial Imaging), V09GA0
Curium Canada Inc.
2572 Boul. Daniel-Johnson, Suite 217 & 220
Laval, QC, H7T-2R3
CANADA
www.curiumpharma.com
Date of Initial Authorization:
JAN 21,2016
Date of Revision:
NOV 9. 2022
Submission Control Number: 265394
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_Kit for the preparation of Technetium Tc 99m Sestamibi Injection _
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RECENT MAJOR LABEL CHANGES
Section 4: Dosage and Administration, 4.1: Dosing Considerations
06/2022
Section 9: Drug Interactions, 9.2: Drug Interactions Overview
06/2022
Section 9: Drug Interactions, 9.4: Drug-Drug Interactions
06/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
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5
1.1
Pediatrics
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5
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION................................................................