FIRDAPSE TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE)

Доступна с:

KYE PHARMACEUTICALS INC.

код АТС:

N07XX05

ИНН (Международная Имя):

AMIFAMPRIDINE

дозировка:

10MG

Фармацевтическая форма:

TABLET

состав:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE) 10MG

Администрация маршрут:

ORAL

Штук в упаковке:

15G/50G

Тип рецепта:

Prescription

Терапевтические области:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Обзор продуктов:

Active ingredient group (AIG) number: 0162417001; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2020-09-24

Характеристики продукта

_FIRDAPSE Product Monograph _
_September 21, 2020 _
_Page 1 of 27 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
FIRDAPSE
TM
Amifampridine tablets
Tablets, 10 mg amifampridine (as 18.98 mg amifampridine phosphate),
oral
Potassium Channel Blocker
Kye Pharmaceuticals Inc.
2233 Argentia Rd., East Tower,
Suites 302 & 302A,
Mississauga, Ontario
L5N 2X7
Date of Initial Approval:
July 31, 2020
Date of Revision:
September 23, 2020
Submission Control No.: 243044
_ _
_FIRDAPSE Product Monograph _
_September 21, 2020 _
_Page 2 of 27 _
TABLE OF CONTENTS
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
DOSAGE AND ADMINISTRATION
................................................................................
4
3.1
Dosing Considerations
...........................................................................................
4
3.2
Recommended Dose and Dosage Adjustment
....................................................... 5
3.3
Administration
........................................................................................................
6
3.4
Missed Dose
..........................................................................................................
6
4
OVERDOSAGE
...............................................................................................................
6
5
DOSAGE FORMS, STRENGTHS,