国家: 加拿大
语言: 英文
来源: Health Canada
DARBEPOETIN ALFA
AMGEN CANADA INC
B03XA02
DARBEPOETIN ALFA
15MCG
SOLUTION
DARBEPOETIN ALFA 15MCG
SUBCUTANEOUS
100
Prescription
HEMATOPOIETIC AGENTS
Active ingredient group (AIG) number: 0148081001; AHFS:
APPROVED
2002-08-02
_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 ........................................... 阅读完整的文件