PMS-FLUTICASONE HFA METERED-DOSE AEROSOL

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

FLUTICASONE PROPIONATE

Dostupné z:

PHARMASCIENCE INC

ATC kód:

R03BA05

INN (Medzinárodný Name):

FLUTICASONE

Dávkovanie:

125MCG

Forma lieku:

METERED-DOSE AEROSOL

Zloženie:

FLUTICASONE PROPIONATE 125MCG

Spôsob podávania:

INHALATION

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

ADRENALS

Prehľad produktov:

Active ingredient group (AIG) number: 0124685004; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2020-08-06

Súhrn charakteristických

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_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-FLUTICASONE HFA
fluticasone propionate inhalation aerosol
50, 125, and 250 mcg/metered dose
PR
PMS-FLUTICASONE
fluticasone propionate dry powder for inhalation
100, 250, and 500 mcg/blister
Corticosteroid for Oral Inhalation
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Initial Approval:
August 5, 2020
Date of Revision:
May 25, 2021
Submission Control No: 251505
_pms-FLUTICASONE_
_ HFA and pms-FLUTICASONE- Product Monograph _
_Page 2 of 57_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE
NOT LISTED.
TABLE OF CONTENTS ..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................4
1
INDICATIONS
....................................................................................................................4
1.1 Pediatrics
........................................................................................................................4
1.2 Geriatrics
........................................................................................................................4
2
CONTRAINDICATIONS ..................................................................................................4
4 DOSAGE AND ADMINISTRATION .......................................................................................4
4.1 Dosing Considerations
...................................................................................................5
4.2 Recommended Dose and Dosage Adjustment
...............................................................5
4.4 Administration
...............................................................................................................7
4.5 Missed Dose
........................................................................................