PHL-TERBINAFINE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

זמין מ:

PHARMEL INC

קוד ATC:

D01BA02

INN (שם בינלאומי):

TERBINAFINE

כמות:

250MG

טופס פרצבטיות:

TABLET

הרכב:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

ALLYLAMINES

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2016-10-25

מאפייני מוצר

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
..........................................................................................