MYLERAN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BUSULFAN

Available from:

ASPEN PHARMACARE CANADA INC.

ATC code:

L01AB01

INN (International Name):

BUSULFAN

Dosage:

2MG

Pharmaceutical form:

TABLET

Composition:

BUSULFAN 2MG

Administration route:

ORAL

Units in package:

25

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0103273001; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-12-08

Summary of Product characteristics

_Product Monograph Template _
_ _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYLERAN
®
Busulfan
Tablets 2 mg, Oral
Manufacturer’s Standard
Antileukemic
ATC code L01AB01_._
Aspen Pharmacare Canada Inc.
8-1155 North Service Road West
Oakville, Ontario, L6M 3E3
Submission Control No: 243043
Date of Initial Approval:
December 31, 1954
Date of Revision:
February 1, 2021
_ _
_Myleran_
®
_ Product Monograph _
_ _
_Page 2 of 33_
RECENT MAJOR LABEL CHANGES
Serious Warnings and Precautions Box (3.0)
12/2018
Dosage and Administration, Dosing Considerations (4.1.)
2/2021
Dosage and Administration, Recommended Dose and Dosage Adjustment
(4.2)
2/2021
Warnings and Precautions (7.0)
2/2021
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
3
1
INDICATIONS..............................................................................................................
3
1.1
Pediatrics
...............................................................................................................
3
1.2
Geriatrics
...............................................................................................................
3
2
CONTRAINDICATIONS
...............................................................................................
3
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX...................................................... 3
4
DOSAGE AND ADMINISTRATION
..............................................................................
4
4.1
Dosing Considerations
...........................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 4
5
OVERDOSAGE
...........................................................................................................
4
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
........................ 5
7
WARNINGS AND PRECAUTIONS
..............................................