DIVALPROEX-250 TABLET (ENTERIC-COATED)
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
23-08-2016
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Werkstoffen:
VALPROIC ACID (DIVALPROEX SODIUM)
Beschikbaar vanaf:
PRO DOC LIMITEE
ATC-code:
N03AG01
INN (Algemene Internationale Benaming):
VALPROIC ACID
Dosering:
250MG
farmaceutische vorm:
TABLET (ENTERIC-COATED)
Samenstelling:
VALPROIC ACID (DIVALPROEX SODIUM) 250MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Therapeutisch gebied:
MISCELLANEOUS ANTICONVULSANTS
Product samenvatting:
Active ingredient group (AIG) number: 0112996001; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2015-10-31
Productkenmerken
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
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