TERBINAFINE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

제공처:

SIVEM PHARMACEUTICALS ULC

ATC 코드:

D01BA02

INN (국제 이름):

TERBINAFINE

복용량:

250MG

약제 형태:

TABLET

구성:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

관리 경로:

ORAL

패키지 단위:

30/100

처방전 유형:

Prescription

치료 영역:

ALLYLAMINES

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2016-06-01

제품 특성 요약

_ _
_Product Monograph _TERBINAFINE_ _
_Page 1 of 44_
PRODUCT MONOGRAPH
PR TERBINAFINE
(Terbinafine Hydrochloride Tablets)
250 mg Terbinafine as Terbinafine hydrochloride
Antifungal Agent
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Date of Revision:
December 10, 2019
SUBMISSION CONTROL NO.: 233709
_ _
_Product Monograph _TERBINAFINE_ _
_Page 2 of 44_
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
DOSING CONSIDERATIONS
........................................................................................
14
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 14
STORAGE AND STABILITY
.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
17
PHARMACEUTICAL INFORMATION
...........................................................