LAMISIL TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

זמין מ:

NOVARTIS PHARMACEUTICALS CANADA 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:

14/28

סוג מרשם:

Prescription

איזור תרפויטי:

ALLYLAMINES

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

1997-08-13

מאפייני מוצר

_LAMISIL_
_®_
_ (Terbinafine Hydrochloride) Product Monograph Page 1 of 58_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LAMISIL
®
Terbinafine Hydrochloride
Tablets, 250 mg, oral
Cream, 1% w/w (10 mg/g), topical
Spray solution, 1% w/w (10 mg/g), topical
Antifungal
ATC code: D01AE15
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Initial Authorization:
December 31, 1993
Date of Revision:
August 15, 2022
Control No. 261997
LAMISIL is a registered trademark.
_LAMISIL_
_®_
_ (Terbinafine Hydrochloride) Product Monograph _
_Page 2 of 58_
_ _
RECENT MAJOR LABEL CHANGES
None at the time of authorization
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................5
2
CONTRAINDICATIONS
...................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................5
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.4
Administration.............................................................