RATIO-VALPROIC 50MG/ML SYRUP

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

VALPROIC ACID (SODIUM VALPROATE)

Tersedia dari:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

Kode ATC:

N03AG01

INN (Nama Internasional):

VALPROIC ACID

Dosis:

50MG

Bentuk farmasi:

SYRUP

Komposisi:

VALPROIC ACID (SODIUM VALPROATE) 50MG

Rute administrasi :

ORAL

Unit dalam paket:

450 ML

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS ANTICONVULSANTS

Ringkasan produk:

Active ingredient group (AIG) number: 0112996002; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2015-10-26

Karakteristik produk

PRODUCT MONOGRAPH
PR
RATIO-VALPROIC
Capsules and Oral Solution
Capsules (250 mg)
Oral solution (250 mg / 5 mL)
USP
Antiepileptic
Ratiopharm Inc.
Date of Revision:
17 800 Lapointe
February 2, 2012
Mirabel, Quebec
Canada J7J 1P3
Control No.: 152606
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
DETAILED
PHARMACOLOGY.................................................................................
34
TOXICOLOGY
.............................................................................................................
34
REFERENCES
........................................................