देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
CICLESONIDE
COVIS PHARMA GMBH
R03BA08
CICLESONIDE
200MCG
AEROSOL, METERED DOSE
CICLESONIDE 200MCG
INHALATION
15G/50G
Prescription
ADRENALS
Active ingredient group (AIG) number: 0151669002; AHFS:
APPROVED
2020-10-02
COPYRIGHT 2021 COVIS PHARMA GmbH Page 1 of 37 PRODUCT MONOGRAPH ALVESCO ® ciclesonide inhalation aerosol 100 mcg and 200 mcg/ actuation (ex-valve) Corticosteroid for oral inhalation Covis Pharma GmbH Baarn, Zug Branch Grafenauweg 12 6300 Zug, Switzerland www.covispharma.com Importer: Innomar Strategies Inc. 3470 Superior Court, Oakville, ON L6L 0C4 Canada Date of Revision: March 30, 2021 Submission Control No.: 249470 ALVESCO ® is a registered trademark of Covis Pharma GmbH The Covis logo is a registered trademark of Covis Pharma GmbH COPYRIGHT 2021 COVIS PHARMA GmbH Page 2 of 37 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ...................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ................................................................................................. 3 WARNINGS AND PRECAUTIONS ............................................................................... 4 ADVERSE REACTIONS ................................................................................................. 8 DRUG INTERACTIONS ............................................................................................... 12 DOSAGE AND ADMINISTRATION ........................................................................... 13 OVERDOSAGE .............................................................................................................. 15 ACTION AND CLINICAL PHARMACOLOGY .......................................................... 15 STORAGE AND STABILITY ....................................................................................... 18 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 18 PART II: SCIENTIFIC INFORMATION .............................................................................. 19 PHARMACEUTICAL INFORMATION ........ पूरा दस्तावेज़ पढ़ें