Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
CICLESONIDE
TAKEDA CANADA INC
R01AD13
CICLESONIDE
50MCG
AEROSOL, METERED DOSE
CICLESONIDE 50MCG
NASAL
30/60 ACTUATIONS
Prescription
CORTICOSTEROIDS
Active ingredient group (AIG) number: 0151669001; AHFS:
CANCELLED POST MARKET
2017-02-10
_OMNARIS_ _®_ _ HFA_ _(ciclesonide nasal aerosol) _ _ _ _ _ _Page 1 of 30 _ PRODUCT MONOGRAPH OMNARIS ® HFA ciclesonide nasal aerosol 50 mcg/metered aerosol (ex-valve) Corticosteroid for nasal use Takeda Canada Inc. Oakville, Ontario L6M 4X8 www.takedacanada.com Date of Revision: 10 February 2014 Submission Control No: 170760 _OMNARIS_ _®_ _ HFA_ _(ciclesonide nasal aerosol) _ _ _ _ _ _Page 2 of 30 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 3 SUMMARY PRODUCT INFORMATION .......................................................................... 3 INDICATIONS AND CLINICAL USE ................................................................................. 3 CONTRAINDICATIONS ...................................................................................................... 3 WARNINGS AND PRECAUTIONS ................................................................................... 3 ADVERSE REACTIONS ..................................................................................................... 5 DRUG INTERACTIONS ...................................................................................................... 9 DOSAGE AND ADMINISTRATION ................................................................................. 10 OVERDOSE ........................................................................................................................ 11 ACTION AND CLINICAL PHARMACOLOGY ................................................................ 11 STORAGE AND STABILITY ............................................................................................ 13 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 13 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 14 PART II: SCIENTIFIC INFORMATION ............................................................................. 15 PHARMACEUTICAL INFORMATION .............................. Կարդացեք ամբողջական փաստաթուղթը