DIVALPROEX TABLET (ENTERIC-COATED)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

VALPROIC ACID (DIVALPROEX SODIUM)

MAH:

SANIS HEALTH INC

ATC_code:

N03AG01

INN:

VALPROIC ACID

dosage:

125MG

pharmaceutical_form:

TABLET (ENTERIC-COATED)

composition:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2013-02-11

SPC

Page 1 of 49
PRODUCT MONOGRAPH
Pr
DIVALPROEX
DIVALPROEX SODIUM ENTERIC-COATED TABLETS
125 MG, 250 MG AND 500 MG VALPROIC ACID (AS DIVALPROEX SODIUM)
HOUSE STANDARD
ANTIEPILEPTIC
SANIS HEALTH INC.
DATE OF REVISION:
333 CHAMPLAIN ST. SUITE 102
DIEPPE, NEW BRUNSWICK
JUNE 16, 2014
E1A 1P2
CONTROL NUMBER: 174536
Page 2 of 49
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
....................................................................................................................
16
DRUG INTERACTIONS
.....................................................................................................................
23
DOSAGE AND
ADMINISTRATION
..............................................................................................
29
OVERDOSAGE
...................................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
32
STORAGE AND STABILITY
.............................................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................ 35
PART II: SCIENTIFIC INFORMATION
...........................................................................................
36
PHARMACEUTICAL INFORMATION
....................