BANZEL SUSPENSION
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
25-04-2017
Nekateri dokumenti za ta izdelek trenutno niso na voljo, pošljete lahko zahtevo v našo stranko in obvestili vas bomo takoj, ko jih bomo lahko pridobili.
Pošlji zahtevo.
Pošlji zahtevo.
Aktivna sestavina:
RUFINAMIDE
Dostopno od:
EISAI LIMITED
Koda artikla:
N03AF03
INN (mednarodno ime):
RUFINAMIDE
Odmerek:
40MG
Farmacevtska oblika:
SUSPENSION
Sestava:
RUFINAMIDE 40MG
Pot uporabe:
ORAL
Enote v paketu:
460ML
Tip zastaranja:
Prescription
Terapevtsko območje:
MISCELLANEOUS ANTICONVULSANTS
Povzetek izdelek:
Active ingredient group (AIG) number: 0152938004; AHFS:
Status dovoljenje:
CANCELLED PRE MARKET
Datum dovoljenje:
2020-04-27
Lastnosti izdelka
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
Preberite celoten dokument
