SANDOZ-TERBINAFINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

D01BA02

INN (Διεθνής Όνομα):

TERBINAFINE

Δοσολογία:

250MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

28/100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ALLYLAMINES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0132855002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2017-05-19

Αρχείο Π.Χ.Π.

_Sandoz-Terbinafine _
_Page 1 of 38_
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
.........................................................