국가: 캐나다
언어: 영어
출처: Health Canada
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
COBALT PHARMACEUTICALS COMPANY
D01BA02
TERBINAFINE
250MG
TABLET
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
ORAL
14/28/30/100/500
Prescription
ALLYLAMINES
Active ingredient group (AIG) number: 0132855002; AHFS:
CANCELLED PRE MARKET
2017-09-01
_ _ _Product Monograph - _TERBINAFINE_ _ _Page 1 of 44_ PRODUCT MONOGRAPH PR TERBINAFINE (Terbinafine Hydrochloride Tablets) 250 mg Terbinafine as Terbinafine hydrochloride Antifungal Agent Cobalt Pharmaceuticals Company 6500 Kitimat Road Mississauga, Ontario L5N 2B8 Date of Revision: September 30, 2013 Control No.: 167631 _ _ _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 ........................................................................................ 13 OVERDOSAGE ............................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 14 STORAGE AND STABILITY ......................................................................................... 15 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 15 PART II: SCIENTIFIC INFORMATION .............................................................................. 16 PHARMACEUTICAL INFORMATION ......................................................................... 16 CLINICAL 전체 문서 읽기