FIRDAPSE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE)

から入手可能:

KYE PHARMACEUTICALS INC.

ATCコード:

N07XX05

INN（国際名）:

AMIFAMPRIDINE

投薬量:

10MG

医薬品形態:

TABLET

構図:

AMIFAMPRIDINE (AMIFAMPRIDINE PHOSPHATE) 10MG

投与経路:

ORAL

パッケージ内のユニット:

15G/50G

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2020-09-24

製品の特徴

_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,