TEVA-TERBINAFINE TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
04-11-2016
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Aktivní složka:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Dostupné s:
TEVA CANADA LIMITED
ATC kód:
D01BA02
INN (Mezinárodní Name):
TERBINAFINE
Dávkování:
250MG
Léková forma:
TABLET
Složení:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
Podání:
ORAL
Jednotky v balení:
14/28/100
Druh předpisu:
Prescription
Terapeutické oblasti:
ALLYLAMINES
Přehled produktů:
Active ingredient group (AIG) number: 0132855002; AHFS:
Stav Autorizace:
CANCELLED POST MARKET
Datum autorizace:
2019-08-14
Charakteristika produktu
_TEVA-TERBINAFINE_
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PRODUCT MONOGRAPH
PR
TEVA-TERBINAFINE
(terbinafine hydrochloride)
250 mg tablet (expressed as base)
USP
ANTIFUNGAL AGENT
Teva Canada Limited
Date of Revision:
30 Novopharm Court
OCTOBER 26, 2016
Toronto, Canada
M1B 2K9
www.tevacanada.com
Control No.: 198039
_TEVA-TERBINAFINE_
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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
.....................................................................................................................................
8
DRUG INTERACTIONS
....................................................................................................................................
11
DOSING CONSIDERATIONS
..........................................................................................................................
15
OVERDOSAGE
..................................................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
..............................................................................................
16
STORAGE AND STABILITY
............................................................................................................................
17
SPECIAL HANDLING INSTRUCTION
......................................................................................
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