MERCAPTOPURINE TABLETS USP

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

MERCAPTOPURINE

Dostupno od:

STERIMAX INC

ATC koda:

L01BB02

INN (International ime):

MERCAPTOPURINE

Doziranje:

50MG

Farmaceutski oblik:

TABLET

Sastav:

MERCAPTOPURINE 50MG

Administracija rute:

ORAL

Jedinice u paketu:

25

Tip recepta:

Prescription

Područje terapije:

ANTINEOPLASTIC AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2013-10-25

Svojstava lijeka

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