PMS-FLUTICASONE HFA METERED-DOSE AEROSOL

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

FLUTICASONE PROPIONATE

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

R03BA05

INN (mednarodno ime):

FLUTICASONE

Odmerek:

125MCG

Farmacevtska oblika:

METERED-DOSE AEROSOL

Sestava:

FLUTICASONE PROPIONATE 125MCG

Pot uporabe:

INHALATION

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

ADRENALS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2020-08-06

Lastnosti izdelka

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