MERCAPTOPURINE TABLETS USP

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

MERCAPTOPURINE

제공처:

STERIMAX INC

ATC 코드:

L01BB02

INN (International Name):

MERCAPTOPURINE

복용량:

50MG

약제 형태:

TABLET

구성:

MERCAPTOPURINE 50MG

관리 경로:

ORAL

패키지 단위:

25

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2013-10-25

제품 특성 요약

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