APO-FLUTICASONE HFA METERED-DOSE AEROSOL

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

FLUTICASONE PROPIONATE

Boleh didapati daripada:

APOTEX 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

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2022-04-11

Ciri produk

_APO-FLUTICASONE HFA (Fluticasone Propionate Inhalation Aerosol)_
Page 1 of 45
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-FLUTICASONE HFA
Fluticasone Propionate Inhalation Aerosol
50, 125 and 250 mcg / metered dose
Apotex Standard
Corticosteroid for Oral Inhalation
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L1T9
Date of Initial Authorization:
January 15, 2021
Date of Revision:
June 24, 2022
Submission Control Number: 249688
_ _
_APO-FLUTICASONE HFA (Fluticasone Propionate Inhalation Aerosol)_
Page 2 of 45
RECENT MAJOR LABEL CHANGES
Indications,1.1 Pediatrics
06/2022
Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
06/2022
Warnings and Precautions, 7.1.3 Pediatrics
06/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.......................................................................................
2
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
...............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
...........................................................