SANDOZ-TERBINAFINE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Disponible depuis:

SANDOZ CANADA INCORPORATED

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:

28/100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ALLYLAMINES

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2017-05-19

Résumé des caractéristiques du produit

_Sandoz-Terbinafine _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
SANDOZ-TERBINAFINE
TERBINAFINE TABLETS 250 MG (AS TERBINAFINE HYDROCHLORIDE)
ANTIFUNGAL AGENT
Sandoz Canada Inc.
Date of Revision: July 25, 2016
145 Jules Leger St
Boucherville PQ
J4B 7K8
Control No. 196424
_Sandoz-Terbinafine _
_Page 2 of 38_
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
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
12
DOSING CONSIDERATIONS
........................................................................................
12
OVERDOSAGE
................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
......................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................