FIRDAPSE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE)

Disponible desde:

KYE PHARMACEUTICALS INC.

Código ATC:

N07XX05

Designación común internacional (DCI):

AMIFAMPRIDINE

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE) 10MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2020-09-24

Ficha técnica

_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,