RUZURGI TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

AMIFAMPRIDINE

Доступно од:

MEDUNIK CANADA

АТЦ код:

N07XX05

INN (Међународно име):

AMIFAMPRIDINE

Дозирање:

10MG

Фармацеутски облик:

TABLET

Састав:

AMIFAMPRIDINE 10MG

Пут администрације:

ORAL

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Терапеутска област:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2020-08-10

Карактеристике производа

_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 ...........................................