EPREX STERILE SOLUTION 2000IU/ML

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

EPOETIN ALFA

متاح من:

JANSSEN INC

ATC رمز:

B03XA01

INN (الاسم الدولي):

ERYTHROPOIETIN

جرعة:

2000UNIT

الشكل الصيدلاني:

SOLUTION

تركيب:

EPOETIN ALFA 2000UNIT

طريقة التعاطي:

INTRAVENOUS

الوحدات في الحزمة:

1ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

HEMATOPOIETIC AGENTS

ملخص المنتج:

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

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2014-09-25

خصائص المنتج

_/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
.........