HERCEPTIN SC SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

TRASTUZUMAB

Tilgjengelig fra:

HOFFMANN-LA ROCHE LIMITED

ATC-kode:

L01FD01

INN (International Name):

TRASTUZUMAB

Dosering :

600MG

Legemiddelform:

SOLUTION

Sammensetning:

TRASTUZUMAB 600MG

Administreringsrute:

SUBCUTANEOUS

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0154252003; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-09-11

Preparatomtale

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_Page 1 of 122_
PRODUCT MONOGRAPH
PR
HERCEPTIN
®
SC
trastuzumab injection
600 mg / 5 mL single-dose vial
Sterile solution for subcutaneous use only
Professed Standard
Antineoplastic
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
Date of Initial Approval:
September 11, 2018
Date of Revision:
May 7, 2020
www.rochecanada.com
SUBMISSION CONTROL NO: 235649
HERCEPTIN
®
is a registered trade-mark of Genentech Inc.
used under license
©
Copyright 1998-2020, Hoffmann-La Roche Limited
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_Page 2 of 122_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................21
DRUG INTERACTIONS
..................................................................................................72
DOSAGE AND ADMINISTRATION
..............................................................................73
ACTION AND CLINICAL PHARMACOLOGY
............................................................76
STORAGE AND STABILITY
..........................................................................................78
SPECIAL HANDLING INSTRUCTIONS
.......................................................................79
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................79
PART II: SCIENTIFIC INFORMATION
...............................................................................80
PHARMACEUTICAL INFORMATION
...........................................................