Q-TERBINAFINE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
08-10-2013
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Aktívna zložka:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Dostupné z:
QD PHARMACEUTICALS ULC
ATC kód:
D01BA02
INN (Medzinárodný Name):
TERBINAFINE
Dávkovanie:
250MG
Forma lieku:
TABLET
Zloženie:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
Spôsob podávania:
ORAL
Počet v balení:
28/100
Typ predpisu:
Prescription
Terapeutické oblasti:
ALLYLAMINES
Prehľad produktov:
Active ingredient group (AIG) number: 0132855002; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2015-08-21
Súhrn charakteristických
Page 1 of 43
PRODUCT MONOGRAPH
PR
Q-TERBINAFINE
(terbinafine hydrochloride)
250 MG TABLETS (EXPRESSED AS BASE)
ANTIFUNGAL AGENT
QD PHARMACEUTICALS ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Control No.: 168232
Date of Revision: October 8, 2013
Page 2 of 43
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS
AND
PRECAUTIONS
.........................................................................................
3
ADVERSE
REACTIONS
...........................................................................................................
7
DRUG
INTERACTIONS
.........................................................................................................
10
DOSAGE
AND
ADMINISTRATION
.....................................................................................
13
OVERDOSAGE
.......................................................................................................................
14
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
14
STORAGE
AND
STABILITY
.................................................................................................
16
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
17
PHARMACEUTICAL
INFORMATION
.................................................................................
17
CLINICAL
TRIALS
.................................................................................................................
18
DETAILED
PHAR
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