RUZURGI TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

AMIFAMPRIDINE

זמין מ:

MEDUNIK CANADA

קוד ATC:

N07XX05

INN (שם בינלאומי):

AMIFAMPRIDINE

כמות:

10MG

טופס פרצבטיות:

TABLET

הרכב:

AMIFAMPRIDINE 10MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2020-08-10

מאפייני מוצר

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