RUZURGI TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

AMIFAMPRIDINE

Tersedia dari:

MEDUNIK CANADA

Kode ATC:

N07XX05

INN (Nama Internasional):

AMIFAMPRIDINE

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

AMIFAMPRIDINE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-08-10

Karakteristik produk

_RUZURGI (amifampridine tablets) Product Monograph _
_Page 1 of 29 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RUZURGI
®
Amifampridine Tablets
10 mg
Potassium Channel Blocker
Médunik Canada
950, boul. Michèle-Bohec
Blainville, Québec
Canada, J7C 5E2
Date of Initial Approval:
August 5, 2020
Submission Control No: 234655
_ _
_RUZURGI (amifampridine tablets) Product Monograph _
_Page 2 of 29_
TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................4
1
INDICATION ......................................................................................................................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
...............................................................................................................7
4
OVERDOSAGE .................................................................................................................7
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................7
6
WARNINGS AND PRECAUTIONS ...........................................