AG-TOPIRAMATE TABLETS

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TOPIRAMATE

זמין מ:

ANGITA PHARMA INC.

קוד ATC:

N03AX11

INN (שם בינלאומי):

TOPIRAMATE

כמות:

100MG

טופס פרצבטיות:

TABLET

הרכב:

TOPIRAMATE 100MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

leaflet_short:

Active ingredient group (AIG) number: 0132938002; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2023-03-30

מאפייני מוצר

_ _
_AG-Topiramate Tablets_
_Page 1 of 73_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-TOPIRAMATE TABLETS
Topiramate Tablets
Tablets, 25 mg, 100 mg and 200 mg, oral
USP
Antiepileptic/Migraine Prophylaxis
Angita Pharma Inc.
1310 Nobel Street
Boucherville, Québec
J4B 5H3
Date of Initial Authorization:
MAR 30, 2023
Submission Control Number: 272943
_ _
_AG-Topiramate Tablets_
_Page 2 of 73_
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
_Sections or subsections that are not applicable at the time of
authorization are not listed._
RECENT MAJOR LABEL CHANGES
...............................................................................................
2
TABLE OF CONTENTS
.....................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 4
1
INDICATIONS
....................................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
.............................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
...........................................................................................................
7
4.5
Missed Dose
.................................................................................................................
7
5
OVE