País: Canadá
Língua: inglês
Origem: Health Canada
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
DOMINION PHARMACAL
D01BA02
TERBINAFINE
250MG
TABLET
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
ORAL
100
Prescription
ALLYLAMINES
Active ingredient group (AIG) number: 0132855002; AHFS:
APPROVED
2007-09-14
PRODUCT MONOGRAPH PR DOM-TERBINAFINE Terbinafine Tablets, USP 250 mg Terbinafine, as Terbinafine Hydrochloride ANTIFUNGAL AGENT DOMINION PHARMACAL 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 DATE OF REVISION: September 30, 2016 SUBMISSION CONTROL NO.: 197956 _ _ _Dom-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 ..................................... Leia o documento completo