国家: 加拿大
语言: 英文
来源: Health Canada
EPIRUBICIN HYDROCHLORIDE
PFIZER CANADA ULC
L01DB03
EPIRUBICIN
2MG
SOLUTION
EPIRUBICIN HYDROCHLORIDE 2MG
INTRAVENOUS
100ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0116901002; AHFS:
MARKETED
2008-11-24
PRODUCT MONOGRAPH PR EPIRUBICIN HYDROCHLORIDE INJECTION 2 MG/ML PROFESSED STANDARD ANTINEOPLASTIC AGENT Pfizer Canada Inc. 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Control No.: 209065 Date of Revision: October 6, 2017 _Product Monograph - _ _Pr_ _ Epirubicin Hydrochloride Injection _ _Page 2 of 37_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................14 DOSAGE AND ADMINISTRATION ..............................................................................14 OVERDOSAGE ................................................................................................................17 ACTION AND CLINICAL PHARMACOLOGY ............................................................18 STORAGE AND STABILITY ..........................................................................................19 SPECIAL HANDLING INSTRUCTIONS .......................................................................20 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................22 PART II: SCIENTIFIC INFORMATION ...............................................................................23 PHARMACEUTICAL INFORMATION ..........................................................................23 CLINICAL TRIALS ........................................................................ 阅读完整的文件