PMS-FLUTICASONE HFA METERED-DOSE AEROSOL

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

FLUTICASONE PROPIONATE

Boleh didapati daripada:

PHARMASCIENCE INC

Kod ATC:

R03BA05

INN (Nama Antarabangsa):

FLUTICASONE

Dos:

125MCG

Borang farmaseutikal:

METERED-DOSE AEROSOL

Komposisi:

FLUTICASONE PROPIONATE 125MCG

Laluan pentadbiran:

INHALATION

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ADRENALS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2020-08-06

Ciri produk

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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
........................................................................................