EPREX STERILE SOLUTION 2000IU/ML

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

EPOETIN ALFA

Fáanlegur frá:

JANSSEN INC

ATC númer:

B03XA01

INN (Alþjóðlegt nafn):

ERYTHROPOIETIN

Skammtar:

2000UNIT

Lyfjaform:

SOLUTION

Samsetning:

EPOETIN ALFA 2000UNIT

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

1ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

HEMATOPOIETIC AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0126696004; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2014-09-25

Vara einkenni

_/CurrentRegulatoryControlledLabellingDocuments/CPM/ENGLISH/eprex/EPR06222011CPM2.NC.doc
_
_Page 1 of 73 _
PRODUCT MONOGRAPH
PR
EPREX
®
*
epoetin alfa
Sterile Solution
Single-use vials
†
: 1,000 IU/0.5 mL, 2,000 IU/mL, 4,000 IU/mL, 10,000 IU/mL, 40,000
IU/mL
Single-use pre-filled syringes with PROTECS
®*
needle guard:
1,000 IU/0.5 mL, 2,000 IU/0.5 mL, 3,000 IU/0.3 mL,
4,000 IU/0.4 mL, 5,000 IU/0.5 mL, 6,000 IU/0.6 mL,
8,000 IU/0.8 mL, 10,000 IU/mL,
20,000 IU/0.5 mL,
30,000 IU/0.75 mL, 40,000 IU/mL
Erythropoiesis Regulating Hormone
This Product Monograph is the exclusive property of Janssen Inc.
It may not be copied in whole or in part without the written
permission of Janssen Inc.
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.ca
Date of Approval:
October 14, 2011
Submission Control No:
145519
* All trademark rights used under license
© 2011 JANSSEN Inc.
_/CurrentRegulatoryControlledLabellingDocuments/CPM/ENGLISH/eprex/EPR06222011CPM2.NC.doc
_
_Page 2 of 73 _
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.................................................................................
6
ADVERSE
REACTIONS.................................................................................................
15
DRUG INTERACTIONS
.................................................................................................
22
DOSAGE AND
ADMINISTRATION.............................................................................
22
OVERDOSAGE
.........