AURO-TERBINAFINE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Dostupné s:

AURO PHARMA INC

ATC kód:

D01BA02

INN (Mezinárodní Name):

TERBINAFINE

Dávkování:

250MG

Léková forma:

TABLET

Složení:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Podání:

ORAL

Jednotky v balení:

28/100

Druh předpisu:

Prescription

Terapeutické oblasti:

ALLYLAMINES

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2008-12-03

Charakteristika produktu

PRODUCT MONOGRAPH
PR
AURO-TERBINAFINE
(Terbinafine Tablets)
250 mg terbinafine (as terbinafine hydrochloride)
ANTIFUNGAL AGENT
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402, July 27, 2016
Woodbridge, Ontario, L4L8K8
CANADA
Submission Control No.: 196718
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION …………………………
3
SUMMARY PRODUCT INFORMATION
………………………………………
3
INDICATIONS AND CLINICAL USE
……………………………………………
3
CONTRAINDICATIONS………………………….………………………….…..
4
WARNINGS AND PRECAUTIONS
……………………………...………………
4
ADVERSE REACTIONS
………………………………………………….………
8
DRUG INTERACTIONS
…………………………………………….……………
11
DOSAGE AND ADMINISTRATION……………………….…………
14
OVERDOSAGE
………………………………………………………………….…
14
ACTION AND CLINICAL PHARMACOLOGY
……………………….…………
15
STORAGE AND STABILITY
…………………………………………………….
16
DOSAGE FORMS, COMPOSITION AND PACKAGING ………………………
16
PART II: SCIENTIFIC INFORMATION
………………………………………….
17
PHARMACEUTICAL INFORMATION
…………………………………………
17
DETAILED PHARMACOLOGY
…………………………………………………
24
TOXICOLOGY
…………………………………………….………………….……
27
REFERENCES
…………………………………………….…………………..……
35
PART III: CONSUMER INFORMATION
……………………………………..…
40
PR
AURO-TERBINAFINE
(Terbinafine Tablets)
250 mg terbinafine (as terbinafine hydrochloride)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM / STRENGTH
ALL NON-MEDICINAL INGREDIENTS
Oral
Tablets 250