KIMMTRAK SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TEBENTAFUSP

Tersedia dari:

IMMUNOCORE IRELAND LIMITED

Kode ATC:

L01XX75

INN (Nama Internasional):

TEBENTAFUSP

Dosis:

100MCG

Bentuk farmasi:

SOLUTION

Komposisi:

TEBENTAFUSP 100MCG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2022-06-07

Karakteristik produk

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