TERBINAFINE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Disponible depuis:

SANIS HEALTH INC

Code ATC:

D01BA02

DCI (Dénomination commune internationale):

TERBINAFINE

Dosage:

250MG

forme pharmaceutique:

TABLET

Composition:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Mode d'administration:

ORAL

Unités en paquet:

30/100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ALLYLAMINES

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2010-06-18

Résumé des caractéristiques du produit

_ _
_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
..