FIRDAPSE TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE)

Доступно од:

KYE PHARMACEUTICALS INC.

АТЦ код:

N07XX05

INN (Међународно име):

AMIFAMPRIDINE

Дозирање:

10MG

Фармацеутски облик:

TABLET

Састав:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE) 10MG

Пут администрације:

ORAL

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Терапеутска област:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2020-09-24

Карактеристике производа

_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,