EPREX STERILE SOLUTION 2000IU/ML

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

EPOETIN ALFA

Disponível em:

JANSSEN INC

Código ATC:

B03XA01

DCI (Denominação Comum Internacional):

ERYTHROPOIETIN

Dosagem:

2000UNIT

Forma farmacêutica:

SOLUTION

Composição:

EPOETIN ALFA 2000UNIT

Via de administração:

INTRAVENOUS

Unidades em pacote:

1ML

Tipo de prescrição:

Prescription

Área terapêutica:

HEMATOPOIETIC AGENTS

Resumo do produto:

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

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2014-09-25

Características técnicas

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_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
.........