AURO-TERBINAFINE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Dostępny od:

AURO PHARMA INC

Kod ATC:

D01BA02

INN (International Nazwa):

TERBINAFINE

Dawkowanie:

125MG

Forma farmaceutyczna:

TABLET

Skład:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 125MG

Droga podania:

ORAL

Sztuk w opakowaniu:

28

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ALLYLAMINES

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2009-02-04

Charakterystyka produktu

_ _
_ _
_ _
_ Page 1 of 36_
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
_ _
_ _
_ _
_ Page 2 of 36_
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
………………………�