BEXXAR THERAPY SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

TOSITUMOMAB

MAH:

GLAXOSMITHKLINE INC

ATC_code:

V10XA53

INN:

TOSITUMOMAB/IODINE (131 I) TOSITUMOMAB

dosage:

14MG

pharmaceutical_form:

SOLUTION

composition:

TOSITUMOMAB 14MG

administration_route:

INTRAVENOUS

units_in_package:

35/225 MG VIAL

prescription_type:

Schedule D

therapeutic_area:

ANTINEOPLASTIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0151303001; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2014-07-31

SPC

_Webtop/1147/517/131-pm-non-Bexxar.doc _
_April 10, 2013 _
_ _
_Page 1 of 52_
PRODUCT MONOGRAPH
BEXXAR
® THERAPY
(tositumomab and iodine I 131 tositumomab)
Intravenous 35 mg and 225 mg tositumomab
444-666 MBq (12 -18 mCi) and 4144-6216 MBq (112 - 168 mCi) iodine I
131
tositumomab
Anti-Neoplastic Radioimmunotherapeutic
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Approval:
April 19, 2013
Submission Control No: 161826
_©_
_ 2013 GlaxoSmithKline Inc. All Rights Reserved _
_®_
_BEXXAR used under license by GlaxoSmithKline Inc._
_Webtop/1147/517/131-pm-non-Bexxar.doc _
_April 10, 2013 _
_ _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................ 3
SUMMARY PRODUCT INFORMATION
........................................................... 3
DESCRIPTION.......................................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................. 4
CONTRAINDICATIONS
......................................................................................
5
WARNINGS AND PRECAUTIONS
.....................................................................
5
ADVERSE REACTIONS
.......................................................................................
9
DRUG INTERACTIONS
.....................................................................................
16
DOSAGE AND ADMINISTRATION
................................................................. 16
OVERDOSAGE
...................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
............................................... 34
RADIATION DOSIMETRY
..............................................................................
36
STORAGE AND STABILITY
.............................................................................
36
SPECIAL HANDLING INSTRUCTIONS
..............................................