PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI POWDER

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

FLUTICASONE PROPIONATE; SALMETEROL (SALMETEROL XINAFOATE)

Dostupné z:

PHARMASCIENCE INC

ATC kód:

R03AK06

INN (Medzinárodný Name):

SALMETEROL AND FLUTICASONE

Dávkovanie:

100MCG; 50MCG

Forma lieku:

POWDER

Zloženie:

FLUTICASONE PROPIONATE 100MCG; SALMETEROL (SALMETEROL XINAFOATE) 50MCG

Spôsob podávania:

INHALATION

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

ADRENALS

Prehľad produktov:

Active ingredient group (AIG) number: 0238341001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2019-12-10

Súhrn charakteristických

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
..