Ország: Kanada
Nyelv: angol
Forrás: Health Canada
TOSITUMOMAB
GLAXOSMITHKLINE INC
V10XA53
TOSITUMOMAB/IODINE (131 I) TOSITUMOMAB
14MG
SOLUTION
TOSITUMOMAB 14MG
INTRAVENOUS
35/225 MG VIAL
Schedule D
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0151303001; AHFS:
CANCELLED POST MARKET
2014-07-31
_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 .............................................. Olvassa el a teljes dokumentumot