PMS-FLUTICASONE HFA METERED-DOSE AEROSOL

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

FLUTICASONE PROPIONATE

มีจำหน่ายจาก:

PHARMASCIENCE INC

รหัส ATC:

R03BA05

INN (ชื่อสากล):

FLUTICASONE

ปริมาณ:

125MCG

แบบฟอร์มเภสัชกรรม:

METERED-DOSE AEROSOL

องค์ประกอบ:

FLUTICASONE PROPIONATE 125MCG

เส้นทางการบริหาร:

INHALATION

หน่วยในแพ็คเกจ:

15G/50G

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

ADRENALS

สรุปสินค้า:

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

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2020-08-06

สรุปลักษณะสินค้า

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