TEVA-LACOSAMIDE TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
01-08-2018
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
LACOSAMIDE
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
N03AX18
INN (Alþjóðlegt nafn):
LACOSAMIDE
Skammtar:
200MG
Lyfjaform:
TABLET
Samsetning:
LACOSAMIDE 200MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
60
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS ANTICONVULSANTS
Vörulýsing:
Active ingredient group (AIG) number: 0152810004; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2018-10-01
Vara einkenni
_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
................................
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