国: カナダ
言語: 英語
ソース: Health Canada
CICLESONIDE
APOTEX INC
R01AD13
CICLESONIDE
50MCG
SPRAY, METERED DOSE
CICLESONIDE 50MCG
NASAL
120 METERED SPRAYS
Prescription
CORTICOSTEROIDS
Active ingredient group (AIG) number: 0151669004; AHFS:
APPROVED
2015-05-01
PRODUCT MONOGRAPH APO-CICLESONIDE CICLESONIDE NASAL SPRAY 50 MCG/METERED SPRAY CORTICOSTEROID FOR NASAL USE ANTIALLERGIC APOTEX INC. DATE OF REVISION: 150 SIGNET DRIVE JULY 27, 2017 TORONTO ONTARIO M9L 1T9 CONTROL NO.: 206051 Page 2 of 26 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 ......................................................................................................... 6 DRUG INTERACTIONS .......................................................................................................... 8 DOSAGE AND ADMINISTRATION ......................................................................................... 9 OVERDOSAGE ....................................................................................................................... 9 ACTION AND CLINICAL PHARMACOLOGY ....................................................................... 10 STORAGE AND STABILITY ................................................................................................. 11 SPECIAL HANDLING INSTRUCTIONS ................................................................................ 11 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................... 11 PART II: SCIENTIFIC INFORMATION ...................................................................................... 12 PHARMACEUTICAL INFORMATION ................................................................................... 12 CLINICAL TRIALS........... 完全なドキュメントを読む