TEVA-LAMOTRIGINE TABLET
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
06-11-2020
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Aktivna sestavina:
LAMOTRIGINE
Dostopno od:
TEVA CANADA LIMITED
Koda artikla:
N03AX09
INN (mednarodno ime):
LAMOTRIGINE
Odmerek:
150MG
Farmacevtska oblika:
TABLET
Sestava:
LAMOTRIGINE 150MG
Pot uporabe:
ORAL
Enote v paketu:
100
Tip zastaranja:
Prescription
Terapevtsko območje:
MISCELLANEOUS ANTICONVULSANTS
Povzetek izdelek:
Active ingredient group (AIG) number: 0127134006; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2010-11-12
Lastnosti izdelka
PRODUCT MONOGRAPH
PR
TEVA-LAMOTRIGINE
(lamotri
g
ine)
25 mg, 100 mg and 150 mg
Tablets
Antiepileptic
USP
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
Nov 6, 2020
Submission Control No:
245553
TEVA-LAMOTRIGINE Product Monograph Page 2 of 49
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
........................................................................................................
20
DOSAGE
AND
ADMINISTRATION
....................................................................................
26
OVERDOSAGE
......................................................................................................................
30
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................... 30
STORAGE
AND
STABILITY
................................................................................................
34
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING .................................................... 34
PART II: SCIENTIFIC INFORMATION
............................................................................
36
PHARMACEUTICAL
INFORMATION
................................................................................
36
CLINICAL
TRIALS
.....................................................................................................
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