TEVA-CLOBAZAM TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
22-12-2021
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:
CLOBAZAM
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
N05BA09
INN (Alþjóðlegt nafn):
CLOBAZAM
Skammtar:
10MG
Lyfjaform:
TABLET
Samsetning:
CLOBAZAM 10MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100/300
Gerð lyfseðils:
Targeted (CDSA IV)
Lækningarsvæði:
BENZODIAZEPINES
Vörulýsing:
Active ingredient group (AIG) number: 0114637001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2014-06-05
Vara einkenni
_Teva-Clobazam Product Monograph _
_ _
_ 1 of 46 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
TEVA-CLOBAZAM
Clobazam Tablets
10
m
g
Teva Standard
P
re
sc
ribe
d Antiepileptic
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
December 22, 2021
SUBMISSION CONTROL NO: 253637
_Teva-Clobazam Product Monograph _
_ _
_ 2 of 46 _ TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
SUMMARY PRODUCT
INFORMATION.........................................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................................
3
CONTRAINDICATIONS
....................................................................................................................
3
WARNINGS AND PRECAUTIONS
..................................................................................................
4
ADVERSE REACTIONS
..................................................................................................................
11
DRUG INTERACTIONS
..................................................................................................................
15
DOSAGE AND ADMINISTRATION
..............................................................................................
17
OVERDOSAGE
.................................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.............................................................................
20
STORAGE AND STABILITY
..........................................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................................. 23
PAR
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