PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI POWDER

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FLUTICASONE PROPIONATE; SALMETEROL (SALMETEROL XINAFOATE)

Pieejams no:

PHARMASCIENCE INC

ATĶ kods:

R03AK06

SNN (starptautisko nepatentēto nosaukumu):

SALMETEROL AND FLUTICASONE

Deva:

100MCG; 50MCG

Zāļu forma:

POWDER

Kompozīcija:

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

Ievadīšanas:

INHALATION

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

ADRENALS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2019-12-10

Produkta apraksts

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
..