PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI POWDER

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

FLUTICASONE PROPIONATE; SALMETEROL (SALMETEROL XINAFOATE)

Tilgjengelig fra:

PHARMASCIENCE INC

ATC-kode:

R03AK06

INN (International Name):

SALMETEROL AND FLUTICASONE

Dosering :

250MCG; 50MCG

Legemiddelform:

POWDER

Sammensetning:

FLUTICASONE PROPIONATE 250MCG; SALMETEROL (SALMETEROL XINAFOATE) 50MCG

Administreringsrute:

INHALATION

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

ADRENALS

Produkt oppsummering:

Active ingredient group (AIG) number: 0238341002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2019-12-10

Preparatomtale

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
..