TARO-TEMOZOLOMIDE CAPSULE

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

TEMOZOLOMIDE

Fáanlegur frá:

TARO PHARMACEUTICALS INC

ATC númer:

L01AX03

INN (Alþjóðlegt nafn):

TEMOZOLOMIDE

Skammtar:

140MG

Lyfjaform:

CAPSULE

Samsetning:

TEMOZOLOMIDE 140MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

5/20

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTINEOPLASTIC AGENTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2015-07-08

Vara einkenni

_TARO-TEMOZOLOMIDE (temozolomide) _
_ _
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) _
_ _
Page 2 of 57
_ _
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
.......................................................................................