TEMODAL POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

TEMOZOLOMIDE

Sẵn có từ:

MERCK CANADA INC

Mã ATC:

L01AX03

INN (Tên quốc tế):

TEMOZOLOMIDE

Liều dùng:

100MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

TEMOZOLOMIDE 100MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

100MG

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTINEOPLASTIC AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0138781003; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2016-02-01

Đặc tính sản phẩm

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_TEMODAL_
®
_ (temozolomide) _
_Page 1 of 51_
PRODUCT MONOGRAPH
TEMODAL
®
temozolomide
5 mg, 20 mg, 100 mg, 140 mg and 250 mg Capsules
and
100 mg/vial Powder for Solution for Injection
Antineoplastic Agent
Merck Canada Inc.
16750, route Transcanadienne
Kirkland, QC H9H 4M7
Canada
www.merck.ca
Date of Revision:
February 26, 2015
Submission Control No: 180516
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_TEMODAL_
®
_ (temozolomide) _
_Page 2 of 51_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
.......................................................