Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
INDACATEROL (INDACATEROL ACETATE); MOMETASONE FUROATE
NOVARTIS PHARMACEUTICALS CANADA INC
R03AK14
INDACATEROL AND MOMETASONE
150MCG; 80MCG
CAPSULE
INDACATEROL (INDACATEROL ACETATE) 150MCG; MOMETASONE FUROATE 80MCG
INHALATION
15G/50G
Prescription
ADRENALS
Active ingredient group (AIG) number: 0262235001; AHFS:
APPROVED
2020-05-06
_ATECTURA_ _®_ _ BREEZHALER_ _®_ _ Product Monograph _ _Page 1 of 39_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr ATECTURA® BREEZHALER® Indacaterol (as acetate)/mometasone furoate inhalation powder hard capsules 150 mcg/80 mcg 150 mcg/160 mcg 150 mcg/320 mcg ATECTURA BREEZHALER capsules to be used only with the supplied ATECTURA BREEZHALER inhalation device Bronchodilator (Long-Acting Beta 2 -Adrenergic Agonist (LABA)) and Inhaled Corticosteroid (ICS) Combination for Oral Inhalation Novartis Pharmaceuticals Canada Inc. 385 Bouchard Blvd. Dorval, Quebec H9S 1A9 Date of Initial Authorization: May 5, 2020 Date of Revision: Nov 12, 2021 Submission Control Number: 246914 ATECTURA and BREEZHALER are registered trademarks. _ _ _ATECTURA_ _®_ _ BREEZHALER_ _®_ _ Product Monograph _ _Page 2 of 39_ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Endocrine and Metabolism 11/2021 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 .......... Přečtěte si celý dokument