KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI INJECTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

TETRAKIS [CU(MIBI)4]BF4

可用日期:

CURIUM CANADA INC

ATC代码:

V09GA01

INN（国际名称）:

TECHNETIUM (99m Tc) SESTAMIBI

剂量:

1MG

药物剂型:

KIT

组成:

TETRAKIS [CU(MIBI)4]BF4 1MG

给药途径:

INTRAVENOUS

每包单位数:

15G/50G

处方类型:

Schedule C

治疗领域:

ROENTGENOGRAPHY

產品總結:

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

授权状态:

APPROVED

授权日期:

2018-12-07

产品特点

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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
_ _
_ _
_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................................................................