ARANESP SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

DARBEPOETIN ALFA

Dostupné z:

AMGEN CANADA INC

ATC kód:

B03XA02

INN (Medzinárodný Name):

DARBEPOETIN ALFA

Dávkovanie:

60MCG

Forma lieku:

SOLUTION

Zloženie:

DARBEPOETIN ALFA 60MCG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

HEMATOPOIETIC AGENTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2002-08-02

Súhrn charakteristických

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