APO-TERBINAFINE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
20-10-2016
Sommige documenten voor dit product zijn momenteel niet beschikbaar, u kunt een verzoek sturen naar onze klantenservice en we zullen u hiervan op de hoogte stellen zodra we ze kunnen verkrijgen.
Verzend verzoek.
Verzend verzoek.
Werkstoffen:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Beschikbaar vanaf:
APOTEX INC
ATC-code:
D01BA02
INN (Algemene Internationale Benaming):
TERBINAFINE
Dosering:
250MG
farmaceutische vorm:
TABLET
Samenstelling:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100
Prescription-type:
Prescription
Therapeutisch gebied:
ALLYLAMINES
Product samenvatting:
Active ingredient group (AIG) number: 0132855002; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2000-05-16
Productkenmerken
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
...........
Lees het volledige document
