MERCAPTOPURINE TABLETS USP

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

MERCAPTOPURINE

Boleh didapati daripada:

STERIMAX INC

Kod ATC:

L01BB02

INN (Nama Antarabangsa):

MERCAPTOPURINE

Dos:

50MG

Borang farmaseutikal:

TABLET

Komposisi:

MERCAPTOPURINE 50MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

25

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0134920001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2013-10-25

Ciri produk

_ _
_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
......................................