TEVA-TERBINAFINE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

D01BA02

INN (Kansainvälinen yleisnimi):

TERBINAFINE

Annos:

125MG

Lääkemuoto:

TABLET

Koostumus:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 125MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ALLYLAMINES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0132855001; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2015-10-16

Valmisteyhteenveto

_TEVA-TERBINAFINE _
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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 _
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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
...................................................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................................16
STORAGE AND STABILITY
............................................................................................................................17
SPECIAL HANDLING INSTRUCTION
.................................................................