PMS-TERBINAFINE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
22-07-2016
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Aktívna zložka:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Dostupné z:
PHARMASCIENCE 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:
2019-10-24
Súhrn charakteristických
PRODUCT MONOGRAPH
PR
PMS-TERBINAFINE
Terbinafine Tablets, USP
250 mg Terbinafine, as Terbinafine Hydrochloride
ANTIFUNGAL AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
July 15, 2016
www.pharmascience.com
SUBMISSION CONTROL NO.: 196239
_ _
_pms-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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