Maa: Kanada
Kieli: englanti
Lähde: Health Canada
LACOSAMIDE
TEVA CANADA LIMITED
N03AX18
LACOSAMIDE
50MG
TABLET
LACOSAMIDE 50MG
ORAL
60
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0152810001; AHFS:
APPROVED
2018-10-01
_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 ................................ Lue koko asiakirja