APO-LEVETIRACETAM TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

LEVETIRACETAM

제공처:

APOTEX INC

ATC 코드:

N03AX14

INN (국제 이름):

LEVETIRACETAM

복용량:

500MG

약제 형태:

TABLET

구성:

LEVETIRACETAM 500MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

MISCELLANEOUS ANTICONVULSANTS

제품 요약:

Active ingredient group (AIG) number: 0148843002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2006-09-21

제품 특성 요약

_APO-LEVETIRACETAM (levetiracetam tablets) _
_ _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LEVETIRACETAM
Levetiracetam Tablets
Tablets, 250 mg, 500 mg and 750 mg, Oral
USP
Antiepileptic
ATC Code: N03AX14
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
SEP 21, 2006
Date of Revision:
MAY 1, 2023
Submission Control Number: 270431
_APO-LEVETIRACETAM (levetiracetam tablets) _
_ _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
05/2023
7 WARNINGS AND PRECAUTIONS, Cardiovascular
05/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric
05/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
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4
4.2
Recommended Dose and Dosage Adjustment
........................................................... 4
4.4
Administration
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