DOM-LAMOTRIGINE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
16-06-2016
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Aktiva substanser:
LAMOTRIGINE
Tillgänglig från:
DOMINION PHARMACAL
ATC-kod:
N03AX09
INN (International namn):
LAMOTRIGINE
Dos:
25MG
Läkemedelsform:
TABLET
Sammansättning:
LAMOTRIGINE 25MG
Administreringssätt:
ORAL
Enheter i paketet:
100/500
Receptbelagda typ:
Prescription
Terapiområde:
MISCELLANEOUS ANTICONVULSANTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0127134003; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2011-11-22
Produktens egenskaper
PRODUCT MONOGRAPH
PR
DOM-LAMOTRIGINE
Lamotrigine Tablets, USP
25 mg, 100 mg and 150 mg
ANTIEPILEPTIC
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Québec, Canada
H4P 2T4
Date of Revision:
June 15, 2016
Submission Control No.: 194947
_Dom-LAMOTRIGINE Product Monograph _
_Page 2 of 48_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT
INFORMATION........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
24
OVERDOSAGE
................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 29
STORAGE AND STABILITY
.........................................................................................
33
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 33
PART II: SCIENTIFIC INFORMATION
..............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.........................................................................................................
35
DETAILED PHARMACOLOGY
....................................................
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