KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI INJECTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

TETRAKIS [CU(MIBI)4]BF4

Sẵn có từ:

CURIUM CANADA INC

Mã ATC:

V09GA01

INN (Tên quốc tế):

TECHNETIUM (99m Tc) SESTAMIBI

Liều dùng:

1MG

Dạng dược phẩm:

KIT

Thành phần:

TETRAKIS [CU(MIBI)4]BF4 1MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Schedule C

Khu trị liệu:

ROENTGENOGRAPHY

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2018-12-07

Đặc tính sản phẩm

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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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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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................................................................