KIMMTRAK SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TEBENTAFUSP

제공처:

IMMUNOCORE IRELAND LIMITED

ATC 코드:

L01XX75

INN (국제 이름):

TEBENTAFUSP

복용량:

100MCG

약제 형태:

SOLUTION

구성:

TEBENTAFUSP 100MCG

관리 경로:

INTRAVENOUS

패키지 단위:

15G/50G

처방전 유형:

Prescription

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2022-06-07

제품 특성 요약

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