HERZUMA POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

TRASTUZUMAB

Disponibbli minn:

CELLTRION HEALTHCARE CO LTD

Kodiċi ATC:

L01FD01

INN (Isem Internazzjonali):

TRASTUZUMAB

Dożaġġ:

150MG

Għamla farmaċewtika:

POWDER FOR SOLUTION

Kompożizzjoni:

TRASTUZUMAB 150MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0154252002; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2020-10-20

Karatteristiċi tal-prodott

page 1 / 117
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
Herzuma
®
Trastuzumab for Injection
Powder for concentrate for solution, 440 mg/vial, Intravenous Infusion
Powder for concentrate for solution, 150 mg/vial, Intravenous Infusion
Professed Standard
Antineoplastic
Manufactured by
Celltrion Healthcare Co., Ltd.
19, Academy-ro 51 beon-gil,
Yeonsu-gu, Incheon
Republic of Korea
22014
Distributed by:
Teva Canada Limited.
Toronto, Ontario M1B 2K9
Date of Initial Approval:
September 3, 2019
Date of Revision:

Submission Control Number: 237674 Date of Approval: April 16, 2021
Submission Control No: 237674
Pr
Herzuma
®
is a trademark of Celltrion Healthcare Co., Ltd.
page 2 / 117
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS................................................................................................................
4
1.1
Pediatrics
..............................................................................................................
5
1.2
Geriatrics...............................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX........................................................ 5
4
DOSAGE AND ADMINISTRATION
................................................................................
6
4.1
Dosing Considerations
...........................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4.3
Administration........................................................................................................
8
4.4
Reconstitution..................................................................................................