TEVA-LAMOTRIGINE TABLET
Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
Karatteristiċi tal-prodott
(SPC)
06-11-2020
Xi dokumenti għal dan il-prodott mhumiex disponibbli bħalissa, tista 'tibgħat talba lis-servizz tal-konsumatur tagħna u aħna ninnotifikawkom malli nkunu nistgħu niksbuhom.
Ibgħat talba.
Ibgħat talba.
Ingredjent attiv:
LAMOTRIGINE
Disponibbli minn:
TEVA CANADA LIMITED
Kodiċi ATC:
N03AX09
INN (Isem Internazzjonali):
LAMOTRIGINE
Dożaġġ:
100MG
Għamla farmaċewtika:
TABLET
Kompożizzjoni:
LAMOTRIGINE 100MG
Rotta amministrattiva:
ORAL
Unitajiet fil-pakkett:
100
Tip ta 'preskrizzjoni:
Prescription
Żona terapewtika:
MISCELLANEOUS ANTICONVULSANTS
Sommarju tal-prodott:
Active ingredient group (AIG) number: 0127134001; AHFS:
L-istatus ta 'awtorizzazzjoni:
APPROVED
Data ta 'l-awtorizzazzjoni:
2010-11-12
Karatteristiċi tal-prodott
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
.....................................................................................................
Aqra d-dokument sħiħ
