PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI POWDER

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Nusipirk tai dabar

Parsisiųsti Prekės savybės (SPC)
09-11-2020

Veiklioji medžiaga:

FLUTICASONE PROPIONATE; SALMETEROL (SALMETEROL XINAFOATE)

Prieinama:

PHARMASCIENCE INC

ATC kodas:

R03AK06

INN (Tarptautinis Pavadinimas):

SALMETEROL AND FLUTICASONE

Dozė:

250MCG; 50MCG

Vaisto forma:

POWDER

Sudėtis:

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

Vartojimo būdas:

INHALATION

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Gydymo sritis:

ADRENALS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2019-12-10

Prekės savybės

                                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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_ Page 2 of 53_
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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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