APTIOM TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ESLICARBAZEPINE ACETATE

Sẵn có từ:

SUMITOMO PHARMA CANADA, INC.

Mã ATC:

N03AF04

INN (Tên quốc tế):

ESLICARBAZEPINE

Liều dùng:

400MG

Dạng dược phẩm:

TABLET

Thành phần:

ESLICARBAZEPINE ACETATE 400MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS ANTICONVULSANTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0155850002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2014-07-08

Đặc tính sản phẩm

1
PRODUCT MONOGRAPH
Pr
APTIOM
®
eslicarbazepine acetate tablets
200 mg, 400 mg, 600 mg and 800 mg
Antiepileptic
Sumitomo Pharma Canada, Inc.
7025 Langer Drive, Suite 301
Mississauga, Ontario
Canada
Date of Preparation:
JAN 25, 2024
Submission Control No: 282495
Under license from
2
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
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
.........................................................................................................
26
DETAILED PHARMACOLOGY
.........................................................................