MONISTAT DERM CREAM

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

MICONAZOLE NITRATE

Disponible desde:

INSIGHT PHARMACEUTICALS, LLC

Código ATC:

D01AC02

Designación común internacional (DCI):

MICONAZOLE

Dosis:

2%

formulario farmacéutico:

CREAM

Composición:

MICONAZOLE NITRATE 2%

Vía de administración:

TOPICAL

Unidades en paquete:

9/15/30G

tipo de receta:

OTC

Área terapéutica:

AZOLES

Resumen del producto:

Active ingredient group (AIG) number: 0110272001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2011-11-03

Ficha técnica

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_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MONISTAT* DERM CREAM
MICONAZOLE NITRATE
VAGINAL CREAM 2%
Antifungal Agent
Insight Pharmaceuticals LLC
660 White Plains Road, Suite 250
Tarrytown, NY 10591, USA
Date of Initial Approval:
December 31, 1980
Date of Revision:
January 18, 2021
Submission Control No: 242581
*Trademark
_ _
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_Page 2 of 24_
RECENT MAJOR LABEL CHANGES
None.
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.3
Administration
........................................................................................................
5
4.4
Reconstitution
........................................................................................................
5
4.5
Missed Dose
..........................................................................................................
6
5
OVERDOSAGE
...............................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
............