REMOVAB SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CATUMAXOMAB

Διαθέσιμο από:

FRESENIUS BIOTECH GMBH

Φαρμακολογική κατηγορία (ATC):

L01FX03

INN (Διεθνής Όνομα):

CATUMAXOMAB

Δοσολογία:

0.1MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

CATUMAXOMAB 0.1MG

Οδός χορήγησης:

INTRAPERITONEAL

Μονάδες σε πακέτο:

100 µL

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0153159001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2018-02-22

Αρχείο Π.Χ.Π.

_ _
_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