ACH-TEMOZOLOMIDE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

TEMOZOLOMIDE

Disponible depuis:

ACCORD HEALTHCARE INC

Code ATC:

L01AX03

DCI (Dénomination commune internationale):

TEMOZOLOMIDE

Dosage:

140MG

forme pharmaceutique:

CAPSULE

Composition:

TEMOZOLOMIDE 140MG

Mode d'administration:

ORAL

Unités en paquet:

5/20

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2014-07-23

Résumé des caractéristiques du produit

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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RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS, Reproductive Health: Females and
Males Potential
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
............................................................ 5
4.4
Administration
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