TEVA-LACOSAMIDE TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

LACOSAMIDE

Disponibbli minn:

TEVA CANADA LIMITED

Kodiċi ATC:

N03AX18

INN (Isem Internazzjonali):

LACOSAMIDE

Dożaġġ:

200MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

LACOSAMIDE 200MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

60

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS ANTICONVULSANTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0152810004; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2018-10-01

Karatteristiċi tal-prodott

_Teva-Lacosamide _
_Page 1 of 37_
PRODUCT MONOGRAPH
Pr
TEVA-LACOSAMIDE
lacosamide
50 mg, 100 mg, 150 mg, and 200 mg film-coated tablets
Antiepileptic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Revision:
August 01, 2018
Submission Control No: 217490
_ _
_Teva-Lacosamide _
_Page 2 of 37_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
................................................................................27
PHARMACEUTICAL INFORMATION
..........................................................................27
CLINICAL TRIALS
..........................................................................................................28
DETAILED PHARMACOLOGY
................................