DOM-LAMOTRIGINE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

LAMOTRIGINE

זמין מ:

DOMINION PHARMACAL

קוד ATC:

N03AX09

INN (שם בינלאומי):

LAMOTRIGINE

כמות:

100MG

טופס פרצבטיות:

TABLET

הרכב:

LAMOTRIGINE 100MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100/500

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

Active ingredient group (AIG) number: 0127134001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2011-11-22

מאפייני מוצר

PRODUCT MONOGRAPH
PR
DOM-LAMOTRIGINE
Lamotrigine Tablets, USP
25 mg, 100 mg and 150 mg
ANTIEPILEPTIC
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Québec, Canada
H4P 2T4
Date of Revision:
June 15, 2016
Submission Control No.: 194947
_Dom-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
....................................................