APO-OXCARBAZEPINE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

OXCARBAZEPINE

제공처:

APOTEX INC

ATC 코드:

N03AF02

INN (국제 이름):

OXCARBAZEPINE

복용량:

300MG

약제 형태:

TABLET

구성:

OXCARBAZEPINE 300MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

MISCELLANEOUS ANTICONVULSANTS

제품 요약:

Active ingredient group (AIG) number: 0140461002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2015-05-01

제품 특성 요약

_APO-OXCARBAZEPINE (Oxcarbazepine tablets) _
_ _
_Page 1 of 70_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-OXCARBAZEPINE
Oxcarbazepine Tablets
Tablets, 150 mg, 300 mg and 600 mg, oral
Apotex Standard
Antiepileptic
ATC code: N03AF02
APOTEX INC
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
July 31, 2006
Date of Revision:
May 1, 2023
Submission Control Number: 270099
_APO-OXCARBAZEPINE (Oxcarbazepine tablets) _
_ _
_Page 2 of 70_
RECENT MAJOR LABEL CHANGES
None at the time of authorization
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 4
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
.................................................