ARANESP SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

DARBEPOETIN ALFA

Beschikbaar vanaf:

AMGEN CANADA INC

ATC-code:

B03XA02

INN (Algemene Internationale Benaming):

DARBEPOETIN ALFA

Dosering:

60MCG

farmaceutische vorm:

SOLUTION

Samenstelling:

DARBEPOETIN ALFA 60MCG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

HEMATOPOIETIC AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0148081004; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2002-08-02

Productkenmerken

_ARANESP Product Monograph _
_Page 1 of 50 _
PRODUCT MONOGRAPH
PR
ARANESP

(darbepoetin alfa)
Single-use Vials
†
(15, 60, 325 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
Submission Control #: 215710
© 2002-2018 Amgen Canada Inc., all rights reserved.
Date of Authorization: May 24, 2018
_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
...........................................