ARANESP -(HSA-FREE) SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DARBEPOETIN ALFA

Mevcut itibaren:

AMGEN CANADA INC

ATC kodu:

B03XA02

INN (International Adı):

DARBEPOETIN ALFA

Doz:

40MCG

Farmasötik formu:

SOLUTION

Kompozisyon:

DARBEPOETIN ALFA 40MCG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

0.5ML

Reçete türü:

Prescription

Terapötik alanı:

HEMATOPOIETIC AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0148081003; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2015-08-04

Ürün özellikleri

_ARANESP Product Monograph _
_Page 1 of 50 _
PRODUCT MONOGRAPH
PR
ARANESP

(darbepoetin alfa)
Single-use Vials
†
(15, 25, 40, 60, 100, 200, 325, 500 mcg/vial)
SingleJect

Prefilled Syringes
(10, 15
‡
, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 250
‡
, 300, 400
‡
, 500 mcg/syringe)
Subcutaneous Injection; Intravenous Injection
Erythropoiesis Regulating Hormone
Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, Ontario
L5N 0A4
Date of Approval:
September 4, 2013
Submission Control #: 164290
© 2013 Amgen Canada Inc
_ARANESP Product Monograph _
_Page 2 of 50 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
...............................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 25
STORAGE AND STABILITY
.........................................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 27