MABCAMPATH SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ALEMTUZUMAB

Tilgængelig fra:

GENZYME CORPORATION

ATC-kode:

L04AG06

INN (International Name):

ALEMTUZUMAB

Dosering:

10MG

Lægemiddelform:

SOLUTION

Sammensætning:

ALEMTUZUMAB 10MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

3ML

Recept type:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

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

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2008-08-07

Produktets egenskaber

_Product Monograph Master Template _
_Template Date: September 2020 _
_MabCampath (alemtuzumab) _
_Page 1 of 59_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MABCAMPATH
®
Alemtuzumab
30 mg/1 mL (30 mg/mL) vial for Intravenous Use
Antineoplastic
ATC Code: L04AA34
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
2700 Matheson Blvd East
Mississauga, ON L4W 4V9
www.sanofi.ca
Date of Initial Authorization:
JAN 19, 2007
Date of Revision:
MAY 25, 2023
Submission Control Number: 271300
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_MabCampath (alemtuzumab) _
_Page 2 of 59_
RECENT MAJOR LABEL CHANGES
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
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4.3
Reconstitution
................................................