TEVA-TERBINAFINE TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Prieinama:

TEVA CANADA LIMITED

ATC kodas:

D01BA02

INN (Tarptautinis Pavadinimas):

TERBINAFINE

Dozė:

125MG

Vaisto forma:

TABLET

Sudėtis:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 125MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100

Recepto tipas:

Prescription

Gydymo sritis:

ALLYLAMINES

Produkto santrauka:

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

Autorizacija statusas:

CANCELLED PRE MARKET

Leidimo data:

2015-10-16

Prekės savybės

_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
.................................................................