PHL-TERBINAFINE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Dostupno od:

PHARMEL INC

ATC koda:

D01BA02

INN (International ime):

TERBINAFINE

Doziranje:

250MG

Farmaceutski oblik:

TABLET

Sastav:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

ALLYLAMINES

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2016-10-25

Svojstava lijeka

PRODUCT MONOGRAPH
PR
PHL-TERBINAFINE
Terbinafine Tablets, USP
250 mg Terbinafine, as Terbinafine Hydrochloride
ANTIFUNGAL AGENT
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
October 03, 2016
SUBMISSION CONTROL NO.: 197968
_ _
_phl-TERBINAFINE Product Monograph _
_Page 2 of 42_
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
OVERDOSAGE
.....................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 14
STORAGE AND STABILITY
................................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 15
PART II: SCIENTIFIC INFORMATION
...........................................................................
16
PHARMACEUTICAL INFORMATION
................................................................................
16
CLINICAL TRIALS
..........................................................................................