LYSODREN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MITOTANE

Available from:

HRA PHARMA RARE DISEASES

ATC code:

L01XX23

INN (International Name):

MITOTANE

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

MITOTANE 500MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0113395001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-04-03

Summary of Product characteristics

_LYSODREN Tablets, 500 mg _
_Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LYSODREN®
Mitotane tablets
Tablets, 500 mg, oral administration
Antineoplastic Agent
HRA Pharma Rare Diseases
200 Avenue de Paris
Châtillon, France 92320
Date of Initial Authorization:
DEC 31, 1979
Date of Revision:
SEPT 25, 2023
Submission Control Number: 275256
_ _
_LYSODREN 500 mg Tablets _
_Page 2 of 25_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.1 Dosing Considerations
09/2023
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
09/2023
4 Dosage and Administration, 4.4 Administration
09/2023
7 Warnings and Precautions, Endocrine and Metabolism
09/2023
7 Warnings and Precautions, General
09/2023
7 Warnings and Precautions, Hematologic
09/2023
7 Warnings and Precautions, Hepatic/Biliary/Pancreatic
09/2023
7 Warnings and Precautions, Monitoring and Laboratory Tests
09/2023
7 Warnings and Precautions, Peri-Operative Considerations
09/2023
7 Warnings and Precautions, Renal
09/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
09/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics (<18 years of age)
...................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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