METROLOTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

METRONIDAZOLE

Beszerezhető a:

GALDERMA CANADA INC

ATC-kód:

D06BX01

INN (nemzetközi neve):

METRONIDAZOLE

Adagolás:

0.75%

Gyógyszerészeti forma:

LOTION

Összetétel:

METRONIDAZOLE 0.75%

Az alkalmazás módja:

TOPICAL

db csomag:

15/120ML

Recept típusa:

Prescription

Terápiás terület:

ANTIBIOTICS

Termék összefoglaló:

Active ingredient group (AIG) number: 0102572005; AHFS:

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2016-09-14

Termékjellemzők

_ _
_METROGEL 0.75% and 1%, METROCREAM, METROLOTION Page 1 of 24_
PRODUCT MONOGRAPH
PR
METROGEL

metronidazole topical gel USP, 0.75%
metronidazole topical gel
Galderma Std
, 1%
PR
METROCREAM

metronidazole topical cream, 0.75%
PR
METROLOTION™
metronidazole topical lotion, 0.75%
FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE)
Anti-Rosacea Agent
D06BX01
GALDERMA CANADA INC.
105 Commerce Valley Drive W., Suite 300
Thornhill, ON L3T 7W3
Date of Preparation:
July 17, 2007
Date of Revision:
January 7, 2014
Submission Control No: 169473
_ _
_METROGEL 0.75% and 1%, METROCREAM, METROLOTION Page 2 of 24_
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
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
..............................................................................