البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
FLUDARABINE PHOSPHATE
OMEGA LABORATORIES LIMITED
L01BB05
FLUDARABINE
25MG
LIQUID
FLUDARABINE PHOSPHATE 25MG
INTRAVENOUS
2ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0123842003; AHFS:
APPROVED
2013-11-13
PRODUCT MONOGRAPH PR FLUDARABINE PHOSPHATE INJECTION (25 mg/mL Fludarabine Phosphate) Omega Standard Antineoplastic Agent Concentrate – Must be diluted before use Omega Laboratories Ltd 11177 Hamon Montréal, Québec Canada H3M 3E4 Date of Preparation: November 6, 2013 Control Number: 147067 F LUDARABINE P HOSPHATE I NJECTION Product Monograph Page 2 of 48 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3 SUMMARY PRODUCT INFORMATION ..................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ................................................................................................ 3 WARNINGS AND PRECAUTIONS ............................................................................... 4 ADVERSE REACTIONS ................................................................................................. 8 DRUG INTERACTIONS ............................................................................................... 10 DOSAGE AND ADMINISTRATION ........................................................................... 10 OVERDOSAGE ............................................................................................................. 11 ACTION AND CLINICAL PHARMACOLOGY ......................................................... 11 STORAGE AND STABILITY ....................................................................................... 14 SPECIAL HANDLING INSTRUCTIONS .................................................................... 14 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 14 PART II: SCIENTIFIC INFORMATION .......................................................................... 15 PHARMACEUTICAL INFORMATION ....................................................................... 15 CLINICAL TRIALS ........................................................ اقرأ الوثيقة كاملة