PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI POWDER
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
09-11-2020
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Active ingredient:
FLUTICASONE PROPIONATE; SALMETEROL (SALMETEROL XINAFOATE)
Available from:
PHARMASCIENCE INC
ATC code:
R03AK06
INN (International Name):
SALMETEROL AND FLUTICASONE
Dosage:
250MCG; 50MCG
Pharmaceutical form:
POWDER
Composition:
FLUTICASONE PROPIONATE 250MCG; SALMETEROL (SALMETEROL XINAFOATE) 50MCG
Administration route:
INHALATION
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
ADRENALS
Product summary:
Active ingredient group (AIG) number: 0238341002; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-12-10
Summary of Product characteristics
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
..
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