APO-TERBINAFINE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
20-10-2016
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Aktiva substanser:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Tillgänglig från:
APOTEX INC
ATC-kod:
D01BA02
INN (International namn):
TERBINAFINE
Dos:
250MG
Läkemedelsform:
TABLET
Sammansättning:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
ALLYLAMINES
Produktsammanfattning:
Active ingredient group (AIG) number: 0132855002; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2000-05-16
Produktens egenskaper
Page 1 of 36
PRODUCT
MONOGRAPH
APO-TERBINAFINE
TERBINAFINE HYDROCHLORIDE TABLETS
250 MG TERBINAFINE (AS TERBINAFINE HYDROCHLORIDE)
ANTIFUNGAL AGENT
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
OCTOBER 14, 2016
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 198843
Page 2 of 36
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
.......................................................................................................8
DRUG INTERACTIONS
......................................................................................................
11
DOSAGE AND ADMINISTRATION
..................................................................................
14
OVERDOSAGE....................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 15
STORAGE AND STABILITY
..............................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 16
PART II: SCIENTIFIC
INFORMATION.....................................................................................
17
PHARMACEUTICAL INFORMATION
..............................................................................
17
CLINICAL TRIALS
.............................................................................................................
18
DETAILED PHARMACOLOGY
...........
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