FIRDAPSE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE)

Saatavilla:

KYE PHARMACEUTICALS INC.

ATC-koodi:

N07XX05

INN (Kansainvälinen yleisnimi):

AMIFAMPRIDINE

Annos:

10MG

Lääkemuoto:

TABLET

Koostumus:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE) 10MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2020-09-24

Valmisteyhteenveto

_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,