TERBINAFINE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Dostupno od:

SANIS HEALTH INC

ATC koda:

D01BA02

INN (International ime):

TERBINAFINE

Doziranje:

250MG

Farmaceutski oblik:

TABLET

Sastav:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Administracija rute:

ORAL

Jedinice u paketu:

30/100

Tip recepta:

Prescription

Područje terapije:

ALLYLAMINES

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2010-06-18

Svojstava lijeka

_ _
_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
..