EPREX STERILE SOLUTION 4000IU/ML

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

EPOETIN ALFA

Доступно од:

JANSSEN INC

АТЦ код:

B03XA01

INN (Међународно име):

ERYTHROPOIETIN

Дозирање:

4000UNIT

Фармацеутски облик:

SOLUTION

Састав:

EPOETIN ALFA 4000UNIT

Пут администрације:

INTRAVENOUS

Јединице у пакету:

1ML

Тип рецептора:

Prescription

Терапеутска област:

HEMATOPOIETIC AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0126696005; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2014-10-09

Карактеристике производа

_/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
.........