देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
FLUDARABINE PHOSPHATE
ACCORD HEALTHCARE INC
L01BB05
FLUDARABINE
25MG
SOLUTION
FLUDARABINE PHOSPHATE 25MG
INTRAVENOUS
2ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0123842003; AHFS:
APPROVED
2015-03-11
Page 1 of 55 PRODUCT MONOGRAPH PR FLUDARABINE PHOSPHATE INJECTION, USP Fludarabine Phosphate Sterile Solution for Injection 25 mg/mL (2 mL per vial) USP Antineoplastic Accord Healthcare Inc. 3535 Boulevard St. Charles, Suite 704, Kirkland, QC, Canada, H9H 5B9 Date of Revision: September 29, 2021 Submission Control No: 253592 Page 2 of 55 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 ................................................................................................. 13 DOSAGE AND ADMINISTRATION.............................................................................. 13 OVERDOSAGE ............................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY............................................................ 14 STORAGE AND STABILITY.......................................................................................... 16 SPECIAL HANDLING INSTRUCTIONS ...................................................................... 17 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................. 17 PART II: SCIENTIFIC INFORMATION ........................................................................... 18 PHARMACEUTICAL INFORMATION ........................................................................ 18 CLINICAL TRIALS............................................................ पूरा दस्तावेज़ पढ़ें