EPREX STERILE SOLUTION 4000IU/ML

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

EPOETIN ALFA

Предлага се от:

JANSSEN INC

АТС код:

B03XA01

INN (Международно Name):

ERYTHROPOIETIN

дозиране:

4000UNIT

Лекарствена форма:

SOLUTION

Композиция:

EPOETIN ALFA 4000UNIT

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

1ML

Вид предписание :

Prescription

Терапевтична област:

HEMATOPOIETIC AGENTS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2014-10-09

Данни за продукта

_/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
.........