TERBINAFINE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Commercializzato da:

SANIS HEALTH INC

Codice ATC:

D01BA02

INN (Nome Internazionale):

TERBINAFINE

Dosaggio:

250MG

Forma farmaceutica:

TABLET

Composizione:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Via di somministrazione:

ORAL

Confezione:

30/100

Tipo di ricetta:

Prescription

Area terapeutica:

ALLYLAMINES

Dettagli prodotto:

Active ingredient group (AIG) number: 0132855002; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2010-06-18

Scheda tecnica

_ _
_Product Monograph - _TERBINAFINE_ _
_Page 1 of 44_
PRODUCT MONOGRAPH
PR TERBINAFINE
(Terbinafine Hydrochloride Tablets)
250 mg Terbinafine as Terbinafine hydrochloride
Antifungal Agent
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
April 28, 2017
Control No.: 203937
_ _
_Product Monograph - _TERBINAFINE_ _
_Page 2 of 44_
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
DOSING CONSIDERATIONS
........................................................................................
13
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 14
STORAGE AND STABILITY
.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 15
PART II: SCIENTIFIC INFORMATION
..............................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
..