TARO-TEMOZOLOMIDE CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

TEMOZOLOMIDE

Saatavilla:

TARO PHARMACEUTICALS INC

ATC-koodi:

L01AX03

INN (Kansainvälinen yleisnimi):

TEMOZOLOMIDE

Annos:

5MG

Lääkemuoto:

CAPSULE

Koostumus:

TEMOZOLOMIDE 5MG

Antoreitti:

ORAL

Kpl paketissa:

5/20

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2015-07-08

Valmisteyhteenveto

_TARO-TEMOZOLOMIDE (temozolomide) _
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Page 1 of 57
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PRODUCT
M
O
N
O
GRAP
H
INCLUDING PATIENT MEDICATION
IN
FO
RMA
T
I
O
N
TARO-TEMOZOLOMIDE
Temozolomide Capsu
l
es
Capsules, 5 mg, 20 mg, 100 mg, 140 mg, and 250 mg, ora
l
Taro Standard
Antineoplastic Agent
Taro Pharmaceuticals Inc.
130 East Drive, Brampton
Ontario, Canada
L6T 1C1
Date of Initial Author
i
zat
i
on:
July 08, 2015
Date of Rev
i
s
i
on:
September 15, 2023
Submission Control Number: 268736
_TARO-TEMOZOLOMIDE (temozolomide) _
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Page 2 of 57
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RECENT MAJOR LABEL
CHANGES
7 WARNINGS AND PRECAUTIONS: Reproductive Health: Female and Male
Potential
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................................
2
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED. ................... 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
.......................................................................................