BANZEL SUSPENSION
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
25-04-2017
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
RUFINAMIDE
Fáanlegur frá:
EISAI LIMITED
ATC númer:
N03AF03
INN (Alþjóðlegt nafn):
RUFINAMIDE
Skammtar:
40MG
Lyfjaform:
SUSPENSION
Samsetning:
RUFINAMIDE 40MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
460ML
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS ANTICONVULSANTS
Vörulýsing:
Active ingredient group (AIG) number: 0152938004; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2020-04-27
Vara einkenni
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
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