DOM-DIVALPROEX TABLET (ENTERIC-COATED)

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

VALPROIC ACID (DIVALPROEX SODIUM)

可用日期:

DOMINION PHARMACAL

ATC代码:

N03AG01

INN（国际名称）:

VALPROIC ACID

剂量:

125MG

药物剂型:

TABLET (ENTERIC-COATED)

组成:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

给药途径:

ORAL

每包单位数:

100/500

处方类型:

Prescription

治疗领域:

MISCELLANEOUS ANTICONVULSANTS

產品總結:

Active ingredient group (AIG) number: 0112996004; AHFS:

授权状态:

APPROVED

授权日期:

2002-04-10

产品特点

PRODUCT MONOGRAPH
PR
DOM-DIVALPROEX
Divalproex Sodium Delayed-Release Tablets, USP
125 mg, 250 mg, 500 mg
ANTIEPILEPTIC
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Revision:
June 20, 2017
Submission Control No: 206234
_Dom-DIVALPROEX Product Monograph _
_Page 2 of 60_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................22
DRUG INTERACTIONS
..................................................................................................29
DOSAGE AND ADMINISTRATION
..............................................................................36
OVERDOSAGE
................................................................................................................39
ACTION AND CLINICAL PHARMACOLOGY
............................................................40
STORAGE AND STABILITY
..........................................................................................43
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................43
PART II: SCIENTIFIC INFORMATION
...............................................................................45
PHARMACEUTICAL INFORMATION
..........................................................................45
CLINICAL TRIALS
..........................................................................................................46
DETAILED PHARMACOLOGY
................................................