Riik: Kanada
keel: inglise
Allikas: Health Canada
EPIRUBICIN HYDROCHLORIDE
OMEGA LABORATORIES LIMITED
L01DB03
EPIRUBICIN
2MG
SOLUTION
EPIRUBICIN HYDROCHLORIDE 2MG
INTRAVENOUS
5/25/100ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0116901002; AHFS:
APPROVED
2013-07-23
PRODUCT MONOGRAPH PR E PIRUBICIN H YDROCHLORIDE I NJECTION 2 mg/mL Professed Standard ANTINEOPLASTIC AGENT Omega Laboratories Limited 11,177 Hamon Street Montreal, Quebec H3M 3E4 SUBMISSION CONTROL NO.: 141753 DATE OF PREPARATION: July 15, 2013 _ _ IMPORTANT: PLEASE READ E PIRUBICIN H YDROCHLORIDE I NJECTION Product Monograph Page 2 of 38 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 3 SUMMARY PRODUCT INFORMATION ....................................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................................ 3 CONTRAINDICATIONS .................................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................................ 4 ADVERSE REACTIONS .................................................................................................................. 9 DRUG INTERACTIONS ................................................................................................................ 14 DOSAGE AND ADMINISTRATION ............................................................................................ 14 OVERDOSAGE ............................................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY ........................................................................... 17 STORAGE AND STABILITY ........................................................................................................ 19 SPECIAL HANDLING INSTRUCTIONS ...................................................................................... 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................................ 20 PART II: SCIENTIFIC INFORMATION ................................................. Lugege kogu dokumenti