SANDOZ-TERBINAFINE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Dostupno od:

SANDOZ CANADA INCORPORATED

ATC koda:

D01BA02

INN (International ime):

TERBINAFINE

Doziranje:

250MG

Farmaceutski oblik:

TABLET

Sastav:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Administracija rute:

ORAL

Jedinice u paketu:

28/100

Tip recepta:

Prescription

Područje terapije:

ALLYLAMINES

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2017-05-19

Svojstava lijeka

_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
.........................................................