TEVA-TEMOZOLOMIDE CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

TEMOZOLOMIDE

Tilgængelig fra:

TEVA CANADA LIMITED

ATC-kode:

L01AX03

INN (International Name):

TEMOZOLOMIDE

Dosering:

5MG

Lægemiddelform:

CAPSULE

Sammensætning:

TEMOZOLOMIDE 5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

5/20

Recept type:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0138781001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2015-06-04

Produktets egenskaber

_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
................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1 INDICATIONS
.........................................................................................................................
4
1.1 Pediatrics
.......................................................................................................................
4
1.2 Geriatrics
.......................................................................................................................
4
2 CONTRAINDICATIONS
...........................................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................................
4
4 DOSAGE AND ADMINISTRATION
...........................................................................................
5
4.1 Dosing Considerations
...................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
............................................................