APO-LEVETIRACETAM TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

LEVETIRACETAM

Sẵn có từ:

APOTEX INC

Mã ATC:

N03AX14

INN (Tên quốc tế):

LEVETIRACETAM

Liều dùng:

500MG

Dạng dược phẩm:

TABLET

Thành phần:

LEVETIRACETAM 500MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS ANTICONVULSANTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0148843002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2006-09-21

Đặc tính sản phẩm

_APO-LEVETIRACETAM (levetiracetam tablets) _
_ _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LEVETIRACETAM
Levetiracetam Tablets
Tablets, 250 mg, 500 mg and 750 mg, Oral
USP
Antiepileptic
ATC Code: N03AX14
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
SEP 21, 2006
Date of Revision:
MAY 1, 2023
Submission Control Number: 270431
_APO-LEVETIRACETAM (levetiracetam tablets) _
_ _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
05/2023
7 WARNINGS AND PRECAUTIONS, Cardiovascular
05/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric
05/2023
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
..................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
....................................................................................
4
4.1
Dosing Considerations
................................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................... 4
4.4
Administration
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