TEVA-DIVALPROEX TABLET (ENTERIC-COATED)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

VALPROIC ACID (DIVALPROEX SODIUM)

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

N03AG01

INN (Tên quốc tế):

VALPROIC ACID

Liều dùng:

500MG

Dạng dược phẩm:

TABLET (ENTERIC-COATED)

Thành phần:

VALPROIC ACID (DIVALPROEX SODIUM) 500MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS ANTICONVULSANTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0112996003; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2020-06-10

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
TEVA-DIVALPROEX
(Divalproex Sodium Enteric-Coated Tablets)
125, 250, 500 mg
USP
Antiepileptic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No.: 204247
Date of Revision:
May 1, 2017
_ TEVA-DIVALPROEX_
_ _
_Product Monograph_
_Page 2 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL
USE...........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
..............................................................................................
21
DRUG INTERACTIONS
...............................................................................................
27
DOSAGE AND ADMINISTRATION
...........................................................................
37
OVERDOSAGE
.............................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 41
STORAGE AND STABILITY
......................................................................................
44
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 44
PART II: SCIENTIFIC INFORMATION
............................................................................
45
PHARMACEUTICAL INFORMATION
......................................................................
45
CLINICAL
TRIALS.......................................................................................................
45
DETAILED PHARMACOLOGY
.................................................................................