ONTRUZANT POWDER FOR SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

TRASTUZUMAB

Disponibbli minn:

SAMSUNG BIOEPIS 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

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2022-01-28

Karatteristiċi tal-prodott

_Ontruzant _
_Page 1 of 128 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ONTRUZANT
®
Trastuzumab for injection
440 mg/vial, 150 mg/vial lyophilized powder
For intravenous infusion only
Pharmaceutical standard professed
Antineoplastic
Manufactured by:
Samsung Bioepis Co., Ltd.
76, Songdogyoyuk-ro, Yeonsu-gu, Incheon
Republic of Korea
21987
Distributed by:
Organon Canada
16766 route Transcanadienne
Kirkland, QC H9H 4M7
Date of Initial Authorization:
January 28, 2022
Submission Control No: 235995
Pr
ONTRUZANT
®
is a trademark of Samsung Bioepis Co., Ltd.
_Ontruzant _
_Page 2 of 128 _
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
Reconstitution.....................................................................................................
8
4.4
Administration...................................................................................................
10
4.5
Missed
Dose.....................