APO-FLUTICASONE HFA METERED-DOSE AEROSOL

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

FLUTICASONE PROPIONATE

Доступно од:

APOTEX INC

АТЦ код:

R03BA05

INN (Међународно име):

FLUTICASONE

Дозирање:

125MCG

Фармацеутски облик:

METERED-DOSE AEROSOL

Састав:

FLUTICASONE PROPIONATE 125MCG

Пут администрације:

INHALATION

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2022-04-11

Карактеристике производа

_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
...........................................................