KIMMTRAK SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

TEBENTAFUSP

Prieinama:

IMMUNOCORE IRELAND LIMITED

ATC kodas:

L01XX75

INN (Tarptautinis Pavadinimas):

TEBENTAFUSP

Dozė:

100MCG

Vaisto forma:

SOLUTION

Sudėtis:

TEBENTAFUSP 100MCG

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2022-06-07

Prekės savybės

_KIMMTRAK (tebentafusp) _
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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) _
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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
.....................................................................