BACTROBAN CREAM

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

MUPIROCIN (MUPIROCIN CALCIUM)

Disponible desde:

GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC

Código ATC:

D06AX09

Designación común internacional (DCI):

MUPIROCIN

Dosis:

2%

formulario farmacéutico:

CREAM

Composición:

MUPIROCIN (MUPIROCIN CALCIUM) 2%

Vía de administración:

TOPICAL

Unidades en paquete:

15G

tipo de receta:

OTC

Área terapéutica:

ANTIBIOTICS

Resumen del producto:

Active ingredient group (AIG) number: 0117081001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2020-07-24

Ficha técnica

_ _
_Product Monograph: _
_July 6, 2016_
_ _
_Page 1 of 28_
PRODUCT MONOGRAPH
BACTROBAN
® CREAM
Mupirocin Cream USP 2% (w/w) as mupirocin calcium
TOPICAL ANTIBIOTIC
GlaxoSmithKline Consumer Healthcare Inc
7333 Mississauga Road North
Mississauga, Ontario
L5N 6L4
Date of Preparation:
July 6, 2016
Submission Control No: 194464
® Bactroban is a registered trademark, used under license by
GlaxoSmithKline Consumer Healthcare Inc.
_ _
_Product Monograph: _
_July 6, 2016_
_ _
_Page 2 of 28_
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
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
..........................................................................................10
SPECIAL HANDLING INSTRUCTIONS
.......................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
...............................................................................11
PHARMACEU