Țară: Canada
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Sursă: Health Canada
AZACITIDINE
DR REDDY'S LABORATORIES LTD
L01BC07
AZACITIDINE
100MG
POWDER FOR SUSPENSION
AZACITIDINE 100MG
SUBCUTANEOUS
30ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0152665001; AHFS:
CANCELLED POST MARKET
2023-06-27
1 PRODUCT MONOGRAPH PR REDDY-AZACITIDINE Azacitidine for I njecti on 100 mg azacitidine per vial Antineoplastic Agent Pyrimidine Analogue DIN OWNER: DR. REDDY’S LABORATORIES LIMITED Bachupally–500 090 INDIA IMPORTED BY: DR. REDDY’S LABORATORIES CANADA INC., DATE OF REVISION: 2425 Matheson Blvd East, #754 November 26, 2018 Mississauga, ON L4W 5K4 CANADA Submission Control No: 218731 2 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION................................................................3 SUMMARY PRODUCT INFORMATION ....................................................................................3 INDICATIONS AND CLINICAL US E ..........................................................................................3 CONTRAINDICATIONS...............................................................................................................3 WARNINGS AND PRECAUTIONS..............................................................................................4 ADVERSE REACTIONS................................................................................................................6 DRUG INTERACTIONS ..............................................................................................................14 DOSAGE AND ADMINISTRATION..........................................................................................15 OVERDOSAGE............................................................................................................................19 ACTION AND CLINICAL PHARMACOLOGY ........................................................................19 STORAGE AND STABILITY......................................................................................................21 SPECIAL HANDLING INSTRUCTIONS ...................................................................................22 DOSAGE FORMS, COMPOSITION AND PACKAGING.........................................................22 PART II: SCIENTIFIC INFORMATION ................................................ Citiți documentul complet