ACH-TEMOZOLOMIDE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TEMOZOLOMIDE

Available from:

ACCORD HEALTHCARE INC

ATC code:

L01AX03

INN (International Name):

TEMOZOLOMIDE

Dosage:

140MG

Pharmaceutical form:

CAPSULE

Composition:

TEMOZOLOMIDE 140MG

Administration route:

ORAL

Units in package:

5/20

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0138781006; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-07-23

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACH-TEMOZOLOMIDE
Temozolomide capsules
Capsules, 5 mg, 20 mg, 100 mg, 140 mg, and 250 mg, Oral
USP
Antineoplastic Agent
Accord Healthcare, Inc.,
3535 boul. St. Charles, suite 704,
Kirkland, QC, H9H 5B9,
Canada
Date of Initial Authorization:
July 24, 2012
Date of Revision:
February 17, 2023
Submission Control Number: 268934
_ACH-TEMOZOLOMIDE (temozolomide) _
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7 WARNING AND PRECAUTIONS, Reproductive Health: Females and
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02/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED .
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS...................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing
Considerations.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
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4.4
Administration
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