Riik: Kanada
keel: inglise
Allikas: Health Canada
FLUTICASONE PROPIONATE
APOTEX INC
R03BA05
FLUTICASONE
125MCG
METERED-DOSE AEROSOL
FLUTICASONE PROPIONATE 125MCG
INHALATION
15G/50G
Prescription
Active ingredient group (AIG) number: 0124685004; AHFS:
APPROVED
2022-04-11
_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 ........................................................... Lugege kogu dokumenti