MERCAPTOPURINE TABLETS USP

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

MERCAPTOPURINE

から入手可能:

STERIMAX INC

ATCコード:

L01BB02

INN（国際名）:

MERCAPTOPURINE

投薬量:

50MG

医薬品形態:

TABLET

構図:

MERCAPTOPURINE 50MG

投与経路:

ORAL

パッケージ内のユニット:

25

処方タイプ:

Prescription

治療領域:

ANTINEOPLASTIC AGENTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2013-10-25

製品の特徴

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