DIVALPROEX TABLET (ENTERIC-COATED)

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

VALPROIC ACID (DIVALPROEX SODIUM)

Commercializzato da:

SANIS HEALTH INC

Codice ATC:

N03AG01

INN (Nome Internazionale):

VALPROIC ACID

Dosaggio:

125MG

Forma farmaceutica:

TABLET (ENTERIC-COATED)

Composizione:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

MISCELLANEOUS ANTICONVULSANTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2013-02-11

Scheda tecnica

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