APO-CARBAMAZEPINE CR TABLET (EXTENDED-RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CARBAMAZEPINE

זמין מ:

APOTEX INC

קוד ATC:

N03AF01

INN (שם בינלאומי):

CARBAMAZEPINE

כמות:

200MG

טופס פרצבטיות:

TABLET (EXTENDED-RELEASE)

הרכב:

CARBAMAZEPINE 200MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30/60/100/500

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

Active ingredient group (AIG) number: 0108674001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2013-11-18

מאפייני מוצר

_APO-CARBAMAZEPINE and APO-CARBAMAZEPINE CR _
_Page 1 of 52 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-CARBAMAZEPINE
Carbamazepine Tablets
Tablets, 200 mg, oral
USP
PR
APO-CARBAMAZEPINE CR
Carbamazepine Controlled Release Tablets
Controlled-Release Tablets, 200 mg and 400 mg, oral
Apotex Standard
Anticonvulsant
For Symptomatic Relief of Trigeminal Neuralgia
Antimanic
ATC code: N03AF01
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
June 10, 1980
Date of Revision:
May 31, 2022
Submission Control Number: 262869
_APO-CARBAMAZEPINE and APO-CARBAMAZEPINE CR _
_Page 2 of 52 _
_ _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
05/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................................4
1
INDICATIONS
.......................................................................................................................4
1.1
Pediatrics
.....................................................................................................................
5
1.2
Geriatrics......................................................................................................................
5
2
CONTRAINDICATIONS
..........................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX......................................................................6
4
DOSAGE AND ADMINISTRATION
..........................................................................................7
4.1
Dosing Considerations
..................................................................................................
7
4.2
Recommended Dose and Dosage
Adjustment...........................................