AURO-TERBINAFINE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Dostupné z:

AURO PHARMA INC

ATC kód:

D01BA02

INN (Medzinárodný Name):

TERBINAFINE

Dávkovanie:

125MG

Forma lieku:

TABLET

Zloženie:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 125MG

Spôsob podávania:

ORAL

Počet v balení:

28

Typ predpisu:

Prescription

Terapeutické oblasti:

ALLYLAMINES

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2009-02-04

Súhrn charakteristických

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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
………………………�