DIVALPROEX-250 TABLET (ENTERIC-COATED)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

VALPROIC ACID (DIVALPROEX SODIUM)

Mevcut itibaren:

PRO DOC LIMITEE

ATC kodu:

N03AG01

INN (International Adı):

VALPROIC ACID

Doz:

250MG

Farmasötik formu:

TABLET (ENTERIC-COATED)

Kompozisyon:

VALPROIC ACID (DIVALPROEX SODIUM) 250MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS ANTICONVULSANTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2015-10-31

Ürün özellikleri

Page 1 of 55
PRODUCT MONOGRAPH
Pr
DIVALPROEX – 125
Pr
DIVALPROEX – 250
Pr
DIVALPROEX – 500
DIVALPROEX SODIUM ENTERIC-COATED TABLETS
125 MG, 250 MG AND 500 MG VALPROIC ACID (AS DIVALPROEX SODIUM)
PRO DOC STANDARD
ANTIEPILEPTIC
DATE OF REVISION:
August 23, 2016
PRO DOC LTÉE
2925 boul. Industriel
Laval, Quebec
H7L 3W9
CONTROL NUMBER: 197080
Page 2 of 55
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
....................................................................................................................
20
DRUG INTERACTIONS
.....................................................................................................................
27
DOSAGE AND
ADMINISTRATION
..............................................................................................
34
OVERDOSAGE
...................................................................................................................................
36
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
37
STORAGE AND STABILITY
.............................................................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................ 40
PART II: SCIENTIFIC INFORMATION
............................................................................................
42
PHARMAC