NU-TOPIRAMATE TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
08-08-2011
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:
TOPIRAMATE
Fáanlegur frá:
NU-PHARM INC
ATC númer:
N03AX11
INN (Alþjóðlegt nafn):
TOPIRAMATE
Skammtar:
100MG
Lyfjaform:
TABLET
Samsetning:
TOPIRAMATE 100MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
MISCELLANEOUS ANTICONVULSANTS
Vörulýsing:
Active ingredient group (AIG) number: 0132938002; AHFS:
Leyfisstaða:
CANCELLED (UNRETURNED ANNUAL)
Leyfisdagur:
2018-03-28
Vara einkenni
Page 1 of 70
PRODUCT MONOGRAPH
Pr
NU-TOPIRAMATE
TOPIRAMATE TABLETS
25 MG, 50 MG, 100 MG AND 200 MG
ANTIEPILEPTIC/MIGRAINE PROPHYLAXIS
NU-PHARM INC.
DATE OF REVISION:
50 MURAL STREET, UNITS 1 & 2
AUGUST 8, 2011
RICHMOND HILL, ON
CANADA
L4B 1E4
CONTROL # 148177
Page 2 of 70
TABLE OF CONTENTS
PART I: HEALTH PROFFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND
PRECAUTIONS.......................................................................................
4
ADVERSE
REACTIONS.......................................................................................................
12
DRUG INTERACTIONS
.......................................................................................................
34
DOSAGE AND ADMINISTRATION
...................................................................................
41
OVERDOSAGE......................................................................................................................
45
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
45
STORAGE AND
STABILITY...............................................................................................
47
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 48
PART II: SCIENTIFIC INFORMATION
.............................................................................
49
PHARMACEUTICAL
INFORMATION...............................................................................
49
CLINICAL TRIALS
...............................................................................................................
49
DETAILED PHARMACOLOGY
..............
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