TERBINAFINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Διαθέσιμο από:

SIVEM PHARMACEUTICALS ULC

Φαρμακολογική κατηγορία (ATC):

D01BA02

INN (Διεθνής Όνομα):

TERBINAFINE

Δοσολογία:

250MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ALLYLAMINES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2016-06-01

Αρχείο Π.Χ.Π.

_ _
_Product Monograph _TERBINAFINE_ _
_Page 1 of 44_
PRODUCT MONOGRAPH
PR TERBINAFINE
(Terbinafine Hydrochloride Tablets)
250 mg Terbinafine as Terbinafine hydrochloride
Antifungal Agent
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Date of Revision:
December 10, 2019
SUBMISSION CONTROL NO.: 233709
_ _
_Product Monograph _TERBINAFINE_ _
_Page 2 of 44_
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
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
13
DOSING CONSIDERATIONS
........................................................................................
14
OVERDOSAGE
...............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 14
STORAGE AND STABILITY
.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
17
PHARMACEUTICAL INFORMATION
...........................................................