ARANESP SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DARBEPOETIN ALFA

Commercializzato da:

AMGEN CANADA INC

Codice ATC:

B03XA02

INN (Nome Internazionale):

DARBEPOETIN ALFA

Dosaggio:

40MCG

Forma farmaceutica:

SOLUTION

Composizione:

DARBEPOETIN ALFA 40MCG

Via di somministrazione:

INTRAVENOUS

Confezione:

0.38ML

Tipo di ricetta:

Prescription

Area terapeutica:

HEMATOPOIETIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2012-09-24

Scheda tecnica

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