PHL-LAMOTRIGINE TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
16-06-2016
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:
LAMOTRIGINE
Fáanlegur frá:
PHARMEL INC
ATC númer:
N03AX09
INN (Alþjóðlegt nafn):
LAMOTRIGINE
Skammtar:
25MG
Lyfjaform:
TABLET
Samsetning:
LAMOTRIGINE 25MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100/500
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS ANTICONVULSANTS
Vörulýsing:
Active ingredient group (AIG) number: 0127134003; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2017-09-13
Vara einkenni
PRODUCT MONOGRAPH
PR
PHL-LAMOTRIGINE
Lamotrigine Tablets, USP
25 mg, 100 mg and 150 mg
ANTIEPILEPTIC
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
June 15, 2016
Submission Control No.: 194956
_phl-LAMOTRIGINE Product Monograph _
_Page 2 of 48_
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
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
24
OVERDOSAGE
................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 29
STORAGE AND STABILITY
.........................................................................................
33
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 33
PART II: SCIENTIFIC INFORMATION
..............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.........................................................................................................
35
DETAILED PHARMACOLOGY
..................................................................
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