APO-CARBAMAZEPINE CR TABLET (EXTENDED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CARBAMAZEPINE

제공처:

APOTEX INC

ATC 코드:

N03AF01

INN (국제 이름):

CARBAMAZEPINE

복용량:

200MG

약제 형태:

TABLET (EXTENDED-RELEASE)

구성:

CARBAMAZEPINE 200MG

관리 경로:

ORAL

패키지 단위:

30/60/100/500

처방전 유형:

Prescription

치료 영역:

MISCELLANEOUS ANTICONVULSANTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2013-11-18

제품 특성 요약

_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...........................................