PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI POWDER

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

FLUTICASONE PROPIONATE; SALMETEROL (SALMETEROL XINAFOATE)

Dostupno od:

PHARMASCIENCE INC

ATC koda:

R03AK06

INN (International ime):

SALMETEROL AND FLUTICASONE

Doziranje:

500MCG; 50MCG

Farmaceutski oblik:

POWDER

Sastav:

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

Administracija rute:

INHALATION

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

ADRENALS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2019-12-10

Svojstava lijeka

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
..