DIVALPROEX-250 TABLET (ENTERIC-COATED)
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
23-08-2016
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Aktivna sestavina:
VALPROIC ACID (DIVALPROEX SODIUM)
Dostopno od:
PRO DOC LIMITEE
Koda artikla:
N03AG01
INN (mednarodno ime):
VALPROIC ACID
Odmerek:
250MG
Farmacevtska oblika:
TABLET (ENTERIC-COATED)
Sestava:
VALPROIC ACID (DIVALPROEX SODIUM) 250MG
Pot uporabe:
ORAL
Enote v paketu:
100
Tip zastaranja:
Prescription
Terapevtsko območje:
MISCELLANEOUS ANTICONVULSANTS
Povzetek izdelek:
Active ingredient group (AIG) number: 0112996001; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2015-10-31
Lastnosti izdelka
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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