KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI INJECTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

TETRAKIS [CU(MIBI)4]BF4

Disponibil de la:

CURIUM CANADA INC

Codul ATC:

V09GA01

INN (nume internaţional):

TECHNETIUM (99m Tc) SESTAMIBI

Dozare:

1MG

Forma farmaceutică:

KIT

Compoziție:

TETRAKIS [CU(MIBI)4]BF4 1MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Schedule C

Zonă Terapeutică:

ROENTGENOGRAPHY

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-12-07

Caracteristicilor produsului

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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 _
_Page 2 of 28_
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
.....................................................................
5
1
INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
..........................................................................................................
5
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION................................................................