RATIO-VALPROIC-CAP 250MG CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

VALPROIC ACID

Saatavilla:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

ATC-koodi:

N03AG01

INN (Kansainvälinen yleisnimi):

VALPROIC ACID

Annos:

250MG

Lääkemuoto:

CAPSULE

Koostumus:

VALPROIC ACID 250MG

Antoreitti:

ORAL

Kpl paketissa:

100/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTICONVULSANTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2014-09-19

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR
RATIO-VALPROIC
(VALPROIC ACID)
Capsules
Capsules (250 mg and 500 mg)
USP
Antiepileptic
Ratiopharm Inc.
Date of Revision:
17 800 Lapointe
March 8, 2012
Mirabel, Quebec
Canada J7J 1P3
Control No.: 152387
2
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
.........................................................................................................
19
DOSAGE AND
ADMINISTRATION.....................................................................................
26
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND
STABILITY.................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 32
PART II: SCIENTIFIC
INFORMATION....................................................................................
33
PHARMACEUTICAL
INFORMATION.................................................................................
33
CLINICAL
TRIALS.................................................................................................................
34
DETAILED
PHARMACOLOGY.........................