Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
JAMP PHARMA CORPORATION
D01BA02
TERBINAFINE
250MG
TABLET
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
ORAL
30/100
Prescription
ALLYLAMINES
Active ingredient group (AIG) number: 0132855002; AHFS:
CANCELLED POST MARKET
2022-09-07
Page 1 of 33 PRODUCT MONOGRAPH PR JAMP-TERBINAFINE Terbinafine Tablets (250 mg Terbinafine as Terbinafine Hydrochloride) ANTIFUNGAL AGENT JAMP PHARMA CORPORATION DATE OF PREPARATION: 1380 – 203 Newton Street September 16, 2010 Boucherville, Quebec J4B 5H2 Control#: 141429 Page 2 of 33 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ...............................................................................3 INDICATIONS AND CLINICAL USE.....................................................................................3 CONTRAINDICATIONS ..........................................................................................................4 WARNINGS AND PRECAUTIONS.........................................................................................4 ADVERSE REACTIONS...........................................................................................................6 DRUG INTERACTIONS ...........................................................................................................8 DOSAGE AND ADMINISTRATION.......................................................................................9 OVERDOSAGE .......................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ...................................................................10 STORAGE AND STABILITY.................................................................................................12 DOSAGE FORMS, COMPOSITION AND PACKAGING ....................................................12 PART II: SCIENTIFIC INFORMATION ...............................................................................13 PHARMACEUTICAL INFORMATION.................................................................................13 CLINICAL TRIALS.................................................................................................................14 DETAI Baca dokumen lengkap