KIMMTRAK SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

TEBENTAFUSP

可用日期:

IMMUNOCORE IRELAND LIMITED

ATC代码:

L01XX75

INN（国际名称）:

TEBENTAFUSP

剂量:

100MCG

药物剂型:

SOLUTION

组成:

TEBENTAFUSP 100MCG

给药途径:

INTRAVENOUS

每包单位数:

15G/50G

处方类型:

Prescription

產品總結:

Active ingredient group (AIG) number: 0163721001; AHFS:

授权状态:

APPROVED

授权日期:

2022-06-07

产品特点

_KIMMTRAK (tebentafusp) _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
KIMMTRAK
®
Tebentafusp
100 μg (mcg)/ 0.5 mL solution for intravenous infusion
Professed Standard
Antineoplastic agent
Immunocore Ireland Limited
Unit 1, Sky Business Centres,
Unit 21 Block Port Tunnel Business Park,
Clonshaugh
Dublin 17
Ireland
Date of Initial Authorization:
June 7, 2022
Imported and Distributed by:
Medison Pharma Canada Inc.
One Dundas Street West, Suite 2500
Toronto, Ontario
Canada, M5G 1Z3
Submission Control Number: 258717
_ _
_KIMMTRAK (tebentafusp) _
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1 Pediatrics
..............................................................................................................
4
1.2
Geriatrics...............................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1 Dosing Considerations
...........................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
........................................................ 5
4.3 Reconstitution
.....................................................................