Nazione: Canada
Lingua: inglese
Fonte: Health Canada
CATUMAXOMAB
FRESENIUS BIOTECH GMBH
L01FX03
CATUMAXOMAB
0.1MG
SOLUTION
CATUMAXOMAB 0.1MG
INTRAPERITONEAL
500 µL
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0153159001; AHFS:
CANCELLED PRE MARKET
2018-02-22
_ _ _REMOVAB_ _®_ _ (catumaxomab) _ _Page 1 of 30_ PRODUCT MONOGRAPH Pr REMOVAB ® catumaxomab Concentrate for solution for infusion 0.1 mg/mL 10 microgram and 50 microgram pre-filled syringes Other antineoplastic agents, monoclonal antibodies. ATC Code: L01XC09 Fresenius Biotech GmbH Am Haag 6-7 82166 Graefelfing Germany www.fresenius-biotech.de Date of Revision: Feb 24, 2012 Date of Approval : May 11, 2012 Canadian Distributor: Submission Control No: 142629 Removab ® is a registered trademark of Fresenius Biotech GmbH _ _ _REMOVAB_ _®_ _ (catumaxomab) _ _Page 2 of 30_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 DESCRIPTION................................................................................................................... 3 INDICATIONS AND CLINICAL USE............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS................................................................................. 4 ADVERSE REACTIONS................................................................................................... 6 DRUG INTERACTIONS ................................................................................................. 12 DOSAGE AND ADMINISTRATION............................................................................. 12 OVERDOSAGE ............................................................................................................... 16 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 16 STORAGE AND STABILITY......................................................................................... 19 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 20 DO Leggi il documento completo