MERCAPTOPURINE TABLETS USP

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

MERCAPTOPURINE

Disponible depuis:

STERIMAX INC

Code ATC:

L01BB02

DCI (Dénomination commune internationale):

MERCAPTOPURINE

Dosage:

50MG

forme pharmaceutique:

TABLET

Composition:

MERCAPTOPURINE 50MG

Mode d'administration:

ORAL

Unités en paquet:

25

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2013-10-25

Résumé des caractéristiques du produit

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