DOM-DIVALPROEX TABLET (ENTERIC-COATED)

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

VALPROIC ACID (DIVALPROEX SODIUM)

から入手可能:

DOMINION PHARMACAL

ATCコード:

N03AG01

INN（国際名）:

VALPROIC ACID

投薬量:

500MG

医薬品形態:

TABLET (ENTERIC-COATED)

構図:

VALPROIC ACID (DIVALPROEX SODIUM) 500MG

投与経路:

ORAL

パッケージ内のユニット:

100/500

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS ANTICONVULSANTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2002-04-10

製品の特徴

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
................................................