TEVA-LACOSAMIDE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

LACOSAMIDE

Pieejams no:

TEVA CANADA LIMITED

ATĶ kods:

N03AX18

SNN (starptautisko nepatentēto nosaukumu):

LACOSAMIDE

Deva:

200MG

Zāļu forma:

TABLET

Kompozīcija:

LACOSAMIDE 200MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

60

Receptes veids:

Prescription

Ārstniecības joma:

MISCELLANEOUS ANTICONVULSANTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2018-10-01

Produkta apraksts

_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
................................