DOM-VALPROIC ACID SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

VALPROIC ACID (SODIUM VALPROATE)

Tersedia dari:

DOMINION PHARMACAL

Kode ATC:

N03AG01

INN (Nama Internasional):

VALPROIC ACID

Dosis:

250MG

Bentuk farmasi:

SOLUTION

Komposisi:

VALPROIC ACID (SODIUM VALPROATE) 250MG

Rute administrasi :

ORAL

Unit dalam paket:

450ML

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS ANTICONVULSANTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

1998-10-06

Karakteristik produk

PRODUCT MONOGRAPH
PR
DOM-VALPROIC ACID
Valproic Acid Capsules, USP
250 mg
PR
DOM-VALPROIC ACID E.C.
Valproic Acid Enteric Coated Capsules
500 mg
PR
DOM-VALPROIC ACID
Valproic Acid Oral Solution, USP
250 mg /5 mL
ANTIEPILEPTIC
DOMINION PHARMACAL DATE OF REVISION:
6111 Royalmount Avenue, suite 100 May 12, 2017
Montréal, Quebec
H4P 2T4
SUBMISSION CONTROL NO.: 204664
_ _
_Monographie de produit Dom-VALPROIC ACID & Dom-VALPROIC ACID E.C. _
_Page 2 de 61 _
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
.................................................................................................
21
DRUG INTERACTIONS
.................................................................................................
26
DOSAGE AND ADMINISTRATION
.............................................................................
34
OVERDOSAGE
................................................................................................................
36
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 37
STORAGE AND STABILITY
.........................................................................................
39
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 40
PART II: SCIENTIFIC INFORMATION
.............................................................................
41
PHARMACEUTICAL INFORMATION
.........................................................................
41
CLINICAL TRIALS
............................