LEVETIRACETAM INJECTION USP SOLUTION

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

LEVETIRACETAM

Доступна с:

STERIMAX INC

код АТС:

N03AX14

ИНН (Международная Имя):

LEVETIRACETAM

дозировка:

100MG

Фармацевтическая форма:

SOLUTION

состав:

LEVETIRACETAM 100MG

Администрация маршрут:

INTRAVENOUS

Штук в упаковке:

15G/50G

Тип рецепта:

Prescription

Обзор продуктов:

Active ingredient group (AIG) number: 0148843005; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2022-05-16

Характеристики продукта

_Product Monograph - Levetiracetam Injection USP _
_Page 1 of 47 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
L
EVETIRACETAM INJECTION USP
Levetiracetam for Injection
Solution, 100 mg/mL, Intravenous
Concentrate – must be diluted before use
Antiepileptic Agent
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario
L6H 6R4
Date of Initial Authorization:
May 13, 2022
Submission Control No: 255674
_Product Monograph - Levetiracetam Injection USP _
_Page 2 of 47 _
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 INFORM ATION
........................................................4
1.
INDICATIONS
............................................................................................................4
1.1
Pediatrics
...........................................................................................................4
1.2
Geriatrics
...........................................................................................................4
2.
CONTRAINDICATIONS
............................................................................................4
4.
DOSAGE AND ADMINISTRATION
..........................................................................5
4.1
Dosing Considerations
......................................................................................5
4.2
Recommended Dose and Dosage Adjustment
................................................5
4.3
Reconstitution
....................................................................................................9
4.4
Administration
....................................................................................................9
5.
OVERDOSAGE
....