BANZEL SUSPENSION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

RUFINAMIDE

Dostupné z:

EISAI LIMITED

ATC kód:

N03AF03

INN (Medzinárodný Name):

RUFINAMIDE

Dávkovanie:

40MG

Forma lieku:

SUSPENSION

Zloženie:

RUFINAMIDE 40MG

Spôsob podávania:

ORAL

Počet v balení:

460ML

Typ predpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS ANTICONVULSANTS

Prehľad produktov:

Active ingredient group (AIG) number: 0152938004; AHFS:

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2020-04-27

Súhrn charakteristických

PRODUCT MONOGRAPH
PR
BANZEL
®
Rufinamide Tablets
100 mg, 200 mg and 400 mg Tablets
PR
BANZEL
®
Rufinamide Oral Suspension
40 mg/mL Suspension
Professed Standard
ANTIEPILEPTIC
Eisai Limited
6925 Century Ave, Suite 701
Mississauga, Ontario
L5N 7K2
DATE OF REVISION:
APRIL 19, 2017
CONTROL NO: 194343
_BANZEL_
_®_
_(rufinamide) Product Monograph _
_Page 2 of 48 _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................24
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
...............................................................................32
PHARMACEUTICAL INFORMATION
..........................................................................32
CLINICAL TRIALS
..........................................................................................................32
DETAILED P