RATIO-VALPROIC CAPSULE
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
12-10-2016
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Aktívna zložka:
VALPROIC ACID
Dostupné z:
TEVA CANADA LIMITED
ATC kód:
N03AG01
INN (Medzinárodný Name):
VALPROIC ACID
Dávkovanie:
250MG
Forma lieku:
CAPSULE
Zloženie:
VALPROIC ACID 250MG
Spôsob podávania:
ORAL
Počet v balení:
100/500
Typ predpisu:
Prescription
Terapeutické oblasti:
MISCELLANEOUS ANTICONVULSANTS
Prehľad produktov:
Active ingredient group (AIG) number: 0112996001; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2018-05-18
Súhrn charakteristických
PRODUCT MONOGRAPH
PR
RATIO-VALPROIC
(VALPROIC ACID)
Capsules
Capsules (250 mg and 500 mg)
USP
Antiepileptic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Preparation :
July 24, 2013
Submission Control No: 166248
2
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
.........................................................................................................
16
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
26
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND STABILITY
.................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 32
PART II: SCIENTIFIC INFORMATION
....................................................................................
33
PHARMACEUTICAL INFORMATION
.................................................................................
33
CLINICAL TRIALS
.................................................................................................................
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