EPREX STERILE SOLUTION 20000IU/ML

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

EPOETIN ALFA

Доступна з:

JANSSEN INC

Код атс:

B03XA01

ІПН (Міжнародна Ім'я):

ERYTHROPOIETIN

Дозування:

20000UNIT

Фармацевтична форма:

SOLUTION

Склад:

EPOETIN ALFA 20000UNIT

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

1ML/10X1ML

Тип рецепту:

Prescription

Терапевтична области:

HEMATOPOIETIC AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0126696006; AHFS:

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2010-04-29

Характеристики продукта

_C:\Windows\Temp\notesE10B67\Eprex July 23 2009.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
Multi-use vial: 20,000 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,
7,000 IU/0.7 mL, 8,000 IU/0.8 mL, 9,000 IU/0.9 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-Ortho Inc.
It may not be copied in whole or in part without the written
permission of Janssen-Ortho Inc.
Janssen-Ortho Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen-ortho.com
Date of Authorization:
July 23, 2009
Submission Control No:
129164
* All trademark rights used under license
© 2009 JANSSEN-ORTHO Inc.
_C:\Windows\Temp\notesE10B67\Eprex July 23 2009.doc _
_Page 2 of 73 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
4
INDICATIONS AND CLINICAL
USE.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND
PRECAUTIONS.................................................................................
7
ADVERSE
REACTIONS.................................................................................................
16
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND
ADMINISTRATION.............................................................................
23
OVERDOSA