Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
MERCAPTOPURINE
STERIMAX INC
L01BB02
MERCAPTOPURINE
50MG
TABLET
MERCAPTOPURINE 50MG
ORAL
25
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0134920001; AHFS:
APPROVED
2013-10-25
_ _ _Mercaptopurine Tablets USP Product Monograph _ _Page 1 of 34_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr MERCAPTOPURINE TABLETS USP Mercaptopurine Tablets Tablet, 50 mg, Oral USP Antineoplastic Agent SteriMax Inc. 2770 Portland Drive, Oakville, ON L6H 6R4 Date of Initial Authorization: October 25, 2013 Date of Revision: November 16, 2023 Submission Control No: 275938_ _ _ _ _Mercaptopurine Tablets USP Product Monograph _ _Page 2 of 34_ RECENT MAJOR LABEL CHANGES 3 Serious Warnings and Precautions Box 11/2023 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 11/2023 7 Warnings and Precautions, Immune 11/2023 7 Warnings and Precautions, Carcinogenesis and Mutagenesis 11/2023 7 Warnings and Precautions, Hematologic 11/2023 7 Warnings and Precautions, Monitoring and Laboratory Tests 11/2023 7.1 Special Populations, 7.1.3 Pediatrics 11/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ........................................................................................... 2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics ................................................................................................................... 4 1.2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ...................................... Perskaitykite visą dokumentą