TEVA-TERBINAFINE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
21-10-2014
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Aktiv bestanddel:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Tilgængelig fra:
TEVA CANADA LIMITED
ATC-kode:
D01BA02
INN (International Name):
TERBINAFINE
Dosering:
125MG
Lægemiddelform:
TABLET
Sammensætning:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 125MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
ALLYLAMINES
Produkt oversigt:
Active ingredient group (AIG) number: 0132855001; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2015-10-16
Produktets egenskaber
_TEVA-TERBINAFINE _
_ Page 1 of 44_
PRODUCT MONOGRAPH
PR
TEVA-TERBINAFINE
(terbinafine hydrochloride)
125 mg and 250 mg tablet
(expressed as base)
Teva Standard
ANTIFUNGAL AGENT
Teva Canada Limited
Date of Revision:
30 Novopharm Court
October 7, 2014
Toronto, Canada
M1B 2K9
www.tevacanada.com
Control No.: 177227
_TEVA-TERBINAFINE _
_ Page 2 of 44_
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
...................................................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................................16
STORAGE AND STABILITY
............................................................................................................................17
SPECIAL HANDLING INSTRUCTION
.................................................................
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