DOM-DIVALPROEX TABLET (ENTERIC-COATED)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

VALPROIC ACID (DIVALPROEX SODIUM)

Tersedia dari:

DOMINION PHARMACAL

Kode ATC:

N03AG01

INN (Nama Internasional):

VALPROIC ACID

Dosis:

250MG

Bentuk farmasi:

TABLET (ENTERIC-COATED)

Komposisi:

VALPROIC ACID (DIVALPROEX SODIUM) 250MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS ANTICONVULSANTS

Ringkasan produk:

Active ingredient group (AIG) number: 0112996001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2002-04-10

Karakteristik produk

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