PMS-TERBINAFINE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Sẵn có từ:

PHARMASCIENCE INC

Mã ATC:

D01BA02

INN (Tên quốc tế):

TERBINAFINE

Liều dùng:

250MG

Dạng dược phẩm:

TABLET

Thành phần:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ALLYLAMINES

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2019-10-24

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
PMS-TERBINAFINE
Terbinafine Tablets, USP
250 mg Terbinafine, as Terbinafine Hydrochloride
ANTIFUNGAL AGENT
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
July 15, 2016
www.pharmascience.com
SUBMISSION CONTROL NO.: 196239
_ _
_pms-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
......................