TEVA-TEMOZOLOMIDE CAPSULE

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

TEMOZOLOMIDE

Dostupno od:

TEVA CANADA LIMITED

ATC koda:

L01AX03

INN (International ime):

TEMOZOLOMIDE

Doziranje:

140MG

Farmaceutski oblik:

CAPSULE

Sastav:

TEMOZOLOMIDE 140MG

Administracija rute:

ORAL

Jedinice u paketu:

1/5/20

Tip recepta:

Prescription

Područje terapije:

ANTINEOPLASTIC AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2012-11-01

Svojstava lijeka

_TEVA TEMOZOLOMIDE _
_ _
_Page 1 of 60_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-TEMOZOLOMIDE
Temozolomide Capsules
Capsules, 5 mg, 20 mg, 100 mg, 140 mg and 250 mg, Oral
USP
Antineoplastic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B2K9
Date of Initial Authorization:
July 24, 2012
Date of Revision:
December 21, 2023
Submission Control Number: 277016
_TEVA TEMOZOLOMIDE _
_ _
_Page 2 of 60_
RECENT MAJOR LABEL CHANGES
7 WARNING AND PRECAUTIONS, Reproductive Health: Females and
Males Potential
12/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
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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
4 DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
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5
4.2 Recommended Dose and Dosage Adjustment
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