LEMTRADA SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

ALEMTUZUMAB

Disponibbli minn:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

Kodiċi ATC:

L04AG06

INN (Isem Internazzjonali):

ALEMTUZUMAB

Dożaġġ:

12MG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

ALEMTUZUMAB 12MG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

1.2ML/VIAL

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0151562001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2013-12-12

Karatteristiċi tal-prodott

_LEMTRADA_
_®_
_ (alemtuzumab for injection) _
_ Page 1 of 54 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LEMTRADA®
alemtuzumab for injection
12 mg/1.2 mL
Concentrate for solution for intravenous infusion
Therapeutic Classification: Selective Immunomodulator
TREATMENT WITH LEMTRADA SHOULD BE INITIATED AND SUPERVISED BY
NEUROLOGISTS EXPERIENCED
IN THE TREATMENT OF PATIENTS WITH MS AND WHO HAVE FULLY FAMILIARISED
THEMSELVES WITH THE
EFFICACY AND SAFETY PROFILE OF
PR
LEMTRADA®
LEMTRADA is a trademark of Genzyme Corporation
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
1755 Steeles Avenue West
Toronto ON
M2R 3T4
Date of Initial Authorization:
December 12, 2013
Date of Revision:
May 17, 2023
SUBMISSION CONTROL NUMBER: 269797
_ _
_LEMTRADA_
_®_
_ (alemtuzumab for injection) _
_Page 2 of 54 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
02/2020
2 CONTRAINDICATIONS
03/2021
7 WARNINGS AND PRECAUTIONS
05/2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
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
............................................................. 6
4
DOSAGE