TEVA-LAMOTRIGINE TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
06-11-2020
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有効成分:
LAMOTRIGINE
から入手可能:
TEVA CANADA LIMITED
ATCコード:
N03AX09
INN（国際名）:
LAMOTRIGINE
投薬量:
100MG
医薬品形態:
TABLET
構図:
LAMOTRIGINE 100MG
投与経路:
ORAL
パッケージ内のユニット:
100
処方タイプ:
Prescription
治療領域:
MISCELLANEOUS ANTICONVULSANTS
製品概要:
Active ingredient group (AIG) number: 0127134001; AHFS:
認証ステータス:
APPROVED
承認日:
2010-11-12
製品の特徴
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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