DOM-LAMOTRIGINE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
16-06-2016
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Aktiv ingrediens:
LAMOTRIGINE
Tilgjengelig fra:
DOMINION PHARMACAL
ATC-kode:
N03AX09
INN (International Name):
LAMOTRIGINE
Dosering :
100MG
Legemiddelform:
TABLET
Sammensetning:
LAMOTRIGINE 100MG
Administreringsrute:
ORAL
Enheter i pakken:
100/500
Resept typen:
Prescription
Terapeutisk område:
MISCELLANEOUS ANTICONVULSANTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0127134001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2011-11-22
Preparatomtale
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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