DIVALPROEX-500 TABLET (ENTERIC-COATED)
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
23-08-2016
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Aktiv ingrediens:
VALPROIC ACID (DIVALPROEX SODIUM)
Tilgjengelig fra:
PRO DOC LIMITEE
ATC-kode:
N03AG01
INN (International Name):
VALPROIC ACID
Dosering :
500MG
Legemiddelform:
TABLET (ENTERIC-COATED)
Sammensetning:
VALPROIC ACID (DIVALPROEX SODIUM) 500MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
MISCELLANEOUS ANTICONVULSANTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0112996003; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2015-11-30
Preparatomtale
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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