PHL-TERBINAFINE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
12-10-2016
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Aktívna zložka:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Dostupné z:
PHARMEL INC
ATC kód:
D01BA02
INN (Medzinárodný Name):
TERBINAFINE
Dávkovanie:
250MG
Forma lieku:
TABLET
Zloženie:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
ALLYLAMINES
Prehľad produktov:
Active ingredient group (AIG) number: 0132855002; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2016-10-25
Súhrn charakteristických
PRODUCT MONOGRAPH
PR
PHL-TERBINAFINE
Terbinafine Tablets, USP
250 mg Terbinafine, as Terbinafine Hydrochloride
ANTIFUNGAL AGENT
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
October 03, 2016
SUBMISSION CONTROL NO.: 197968
_ _
_phl-TERBINAFINE Product Monograph _
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................3
INDICATIONS AND CLINICAL USE
....................................................................................3
CONTRAINDICATIONS
.........................................................................................................3
WARNINGS AND PRECAUTIONS
........................................................................................4
ADVERSE REACTIONS
.........................................................................................................7
DRUG INTERACTIONS
........................................................................................................
10
DOSAGE AND ADMINISTRATION
....................................................................................
13
OVERDOSAGE
.....................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 14
STORAGE AND STABILITY
................................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 15
PART II: SCIENTIFIC INFORMATION
...........................................................................
16
PHARMACEUTICAL INFORMATION
................................................................................
16
CLINICAL TRIALS
..........................................................................................
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