DOM-VALPROIC ACID E.C. CAPSULE (ENTERIC-COATED)

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

VALPROIC ACID

Disponibbli minn:

DOMINION PHARMACAL

Kodiċi ATC:

N03AG01

INN (Isem Internazzjonali):

VALPROIC ACID

Dożaġġ:

500MG

Għamla farmaċewtika:

CAPSULE (ENTERIC-COATED)

Kompożizzjoni:

VALPROIC ACID 500MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

150

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS ANTICONVULSANTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0112996003; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

1997-04-24

Karatteristiċi tal-prodott

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