BANZEL SUSPENSION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

RUFINAMIDE

Disponible depuis:

EISAI LIMITED

Code ATC:

N03AF03

DCI (Dénomination commune internationale):

RUFINAMIDE

Dosage:

40MG

forme pharmaceutique:

SUSPENSION

Composition:

RUFINAMIDE 40MG

Mode d'administration:

ORAL

Unités en paquet:

460ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS ANTICONVULSANTS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2020-04-27

Résumé des caractéristiques du produit

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