KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI INJECTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

TETRAKIS [CU(MIBI)4]BF4

Предлага се от:

CURIUM CANADA INC

АТС код:

V09GA01

INN (Международно Name):

TECHNETIUM (99m Tc) SESTAMIBI

дозиране:

1MG

Лекарствена форма:

KIT

Композиция:

TETRAKIS [CU(MIBI)4]BF4 1MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

15G/50G

Вид предписание :

Schedule C

Терапевтична област:

ROENTGENOGRAPHY

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2018-12-07

Данни за продукта

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_Kit for the preparation of Technetium Tc 99m Sestamibi Injection _
_Page 1 of 28_
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
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
5
1
INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
..........................................................................................................
5
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION................................................................