EPREX STERILE SOLUTION 4000IU/ML

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

EPOETIN ALFA

Commercializzato da:

JANSSEN INC

Codice ATC:

B03XA01

INN (Nome Internazionale):

ERYTHROPOIETIN

Dosaggio:

4000UNIT

Forma farmaceutica:

SOLUTION

Composizione:

EPOETIN ALFA 4000UNIT

Via di somministrazione:

INTRAVENOUS

Confezione:

1ML

Tipo di ricetta:

Prescription

Area terapeutica:

HEMATOPOIETIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2014-10-09

Scheda tecnica

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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.
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_
_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
.........