SANDOZ-TERBINAFINE TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
25-07-2016

Viambatanisho vya kazi:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Inapatikana kutoka:

SANDOZ CANADA INCORPORATED

ATC kanuni:

D01BA02

INN (Jina la Kimataifa):

TERBINAFINE

Kipimo:

250MG

Dawa fomu:

TABLET

Tungo:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

28/100

Dawa ya aina:

Prescription

Eneo la matibabu:

ALLYLAMINES

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2017-05-19

Tabia za bidhaa

                                _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
.........................................................
                                
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