PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI POWDER

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

FLUTICASONE PROPIONATE; SALMETEROL (SALMETEROL XINAFOATE)

Disponible desde:

PHARMASCIENCE INC

Código ATC:

R03AK06

Designación común internacional (DCI):

SALMETEROL AND FLUTICASONE

Dosis:

500MCG; 50MCG

formulario farmacéutico:

POWDER

Composición:

FLUTICASONE PROPIONATE 500MCG; SALMETEROL (SALMETEROL XINAFOATE) 50MCG

Vía de administración:

INHALATION

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

ADRENALS

Resumen del producto:

Active ingredient group (AIG) number: 0238341003; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2019-12-10

Ficha técnica

PR
PMS-FLUTICASONE PROPIONATE / SALMETEROL DPI
Fluticasone Propionate and Salmeterol Inhalation Powder USP
Pr
pms-FLUTICASONE PROPIONATE / SALMETEROL DPI _ _
100 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate
salt)
Dry Powder Inhaler
Pr
pms-FLUTICASONE PROPIONATE / SALMETEROL DPI
250 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate
salt)
Dry Powder Inhaler
Pr
pms-FLUTICASONE PROPIONATE / SALMETEROL DPI
500 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate
salt)
Dry Powder Inhaler
CORTICOSTEROID AND BRONCHODILATOR FOR ORAL INHALATION
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF PREPARATION:
November 9, 2020
Submission Control No: 242762
_pms-FLUTICASONE PROPIONATE-SALMETEROL DPI Product Monograph _
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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
......................................................................................................
14
DRUG INTERACTIONS
.......................................................................................................
21
DOSAGE AND ADMINISTRATION
...................................................................................
23
OVERDOSAGE
.....................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 25
STORAGE AND STABILITY
..