SANDOZ-TERBINAFINE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
25-07-2016
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Werkstoffen:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE)
Beschikbaar vanaf:
SANDOZ CANADA INCORPORATED
ATC-code:
D01BA02
INN (Algemene Internationale Benaming):
TERBINAFINE
Dosering:
250MG
farmaceutische vorm:
TABLET
Samenstelling:
TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG
Toedieningsweg:
ORAL
Eenheden in pakket:
28/100
Prescription-type:
Prescription
Therapeutisch gebied:
ALLYLAMINES
Product samenvatting:
Active ingredient group (AIG) number: 0132855002; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2017-05-19
Productkenmerken
_Sandoz-Terbinafine _
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PRODUCT MONOGRAPH
PR
SANDOZ-TERBINAFINE
TERBINAFINE TABLETS 250 MG (AS TERBINAFINE HYDROCHLORIDE)
ANTIFUNGAL AGENT
Sandoz Canada Inc.
Date of Revision: July 25, 2016
145 Jules Leger St
Boucherville PQ
J4B 7K8
Control No. 196424
_Sandoz-Terbinafine _
_Page 2 of 38_
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
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
12
DOSING CONSIDERATIONS
........................................................................................
12
OVERDOSAGE
................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
......................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................
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