AURO-TERBINAFINE TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Disponibbli minn:

AURO PHARMA INC

Kodiċi ATC:

D01BA02

INN (Isem Internazzjonali):

TERBINAFINE

Dożaġġ:

125MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 125MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

28

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ALLYLAMINES

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0132855001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2009-02-04

Karatteristiċi tal-prodott

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PRODUCT MONOGRAPH
PR AURO-TERBINAFINE
(Terbinafine hydrochloride Tablets)
125 MG AND 250 MG TABLETS (AS TERBINAFINE BASE)
ANTIFUNGAL AGENT
Auro Pharma Inc.
1170 Sheppard Ave. West, Unit #16
Toronto, Ontario
M3K 2A3
CANADA
e-mail : [e-mail]
www.auropharma.ca
Submission control No.: 127233 Date of Preparation:
January 21, 2009
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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
………………………………………………….…………..
6
DRUG INTERACTIONS
…………………………………………….………………..
9
DOSAGE AND ADMINISTRATION
……………………………………….………..
10
OVERDOSAGE
………………………………………………………………….….....
11
ACTION AND CLINICAL PHARMACOLOGY
……………………….…………..... 11
STORAGE AND STABILITY
…………………………………………………….….. 12
SPECIAL HANDLING INSTRUCTIONS
…………………………….………...……. 12
DOSAGE FORMS, COMPOSITION AND PACKAGING
…………………………..
13
PART II: SCIENTIFIC INFORMATION
………………………………………….……
14
PHARMACEUTICAL INFORMATION
……………………………………………... 14
CLINICAL
TRIALS…………………………………………….………………..…….
14
DETAILED PHARMACOLOGY
………………………………………………….….
20
MICROBIOLOGY
…………………………………………….………………..……...
21
TOXICOLOGY
………………………�