RATIO-VALPROIC-CAP 250MG CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

VALPROIC ACID

זמין מ:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

קוד ATC:

N03AG01

INN (שם בינלאומי):

VALPROIC ACID

כמות:

250MG

טופס פרצבטיות:

CAPSULE

הרכב:

VALPROIC ACID 250MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100/500

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2014-09-19

מאפייני מוצר

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