BANZEL SUSPENSION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
25-04-2017
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Aktiv bestanddel:
RUFINAMIDE
Tilgængelig fra:
EISAI LIMITED
ATC-kode:
N03AF03
INN (International Name):
RUFINAMIDE
Dosering:
40MG
Lægemiddelform:
SUSPENSION
Sammensætning:
RUFINAMIDE 40MG
Indgivelsesvej:
ORAL
Enheder i pakken:
460ML
Recept type:
Prescription
Terapeutisk område:
MISCELLANEOUS ANTICONVULSANTS
Produkt oversigt:
Active ingredient group (AIG) number: 0152938004; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2020-04-27
Produktets egenskaber
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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