TERBINAFINE-250 TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
02-02-2018
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Aktívna zložka:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Dostupné z:
PRO DOC LIMITEE
ATC kód:
D01BA02
INN (Medzinárodný Name):
TERBINAFINE
Dávkovanie:
250MG
Forma lieku:
TABLET
Zloženie:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
ALLYLAMINES
Prehľad produktov:
Active ingredient group (AIG) number: 0132855002; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2000-11-16
Súhrn charakteristických
Page 1 of 36
PRODUCT
MONOGRAPH
TERBINAFINE-250
TERBINAFINE HYDROCHLORIDE TABLETS
250 MG TERBINAFINE (AS TERBINAFINE HYDROCHLORIDE)
ANTIFUNGAL AGENT
PRO DOC LTÉE DATE OF REVISION:
2925, BOUL. INDUSTRIEL FEBRUARY 2, 2018
LAVAL, QUEBEC
H7L 3W9
CONTROL NUMBER: 212862
Page 2 of 36
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
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
11
DOSAGE AND ADMINISTRATION
.....................................................................................
14
OVERDOSAGE
.......................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 15
STORAGE AND STABILITY
.................................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 16
PART II: SCIENTIFIC
INFORMATION.....................................................................................
17
PHARMACEUTICAL INFORMATION
.................................................................................
17
CLINICAL TRIALS
........................................................................................................
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