APO-LEVETIRACETAM TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

LEVETIRACETAM

Dostępny od:

APOTEX INC

Kod ATC:

N03AX14

INN (International Nazwa):

LEVETIRACETAM

Dawkowanie:

500MG

Forma farmaceutyczna:

TABLET

Skład:

LEVETIRACETAM 500MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS ANTICONVULSANTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2006-09-21

Charakterystyka produktu

_APO-LEVETIRACETAM (levetiracetam tablets) _
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_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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