TEVA-TERBINAFINE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Pieejams no:

TEVA CANADA LIMITED

ATĶ kods:

D01BA02

SNN (starptautisko nepatentēto nosaukumu):

TERBINAFINE

Deva:

125MG

Zāļu forma:

TABLET

Kompozīcija:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 125MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

ALLYLAMINES

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED PRE MARKET

Autorizācija datums:

2015-10-16

Produkta apraksts

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