RIVA-TERBINAFINE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
14-10-2016
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Aktívna zložka:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Dostupné z:
LABORATOIRE RIVA INC.
ATC kód:
D01BA02
INN (Medzinárodný Name):
TERBINAFINE
Dávkovanie:
250MG
Forma lieku:
TABLET
Zloženie:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
Spôsob podávania:
ORAL
Počet v balení:
30/100
Typ predpisu:
Prescription
Terapeutické oblasti:
ALLYLAMINES
Prehľad produktov:
Active ingredient group (AIG) number: 0132855002; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2022-07-19
Súhrn charakteristických
PRODUCT MONOGRAPH
PR
RIVA-TERBINAFINE
(Terbinafine Hydrochloride Tablets)
250 mg Terbinafine as Terbinafine hydrochloride
Antifungal Agent
LABORATOIRE RIVA INC.
660 Industriel Blvd
Blainville, Québec
J7C 3V4
www.labriva.com
Date of Revision:
October 07, 2016
Control No.: 198433
112
_ _
_Product Monograph - RIVA-TERBINAFINE _
_Page 2 of 45_
_ _
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
DOSING CONSIDERATIONS
........................................................................................
14
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
..........................
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