FIRDAPSE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE)

Tilgængelig fra:

KYE PHARMACEUTICALS INC.

ATC-kode:

N07XX05

INN (International Name):

AMIFAMPRIDINE

Dosering:

10MG

Lægemiddelform:

TABLET

Sammensætning:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE) 10MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2020-09-24

Produktets egenskaber

_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,