APO-CICLESONIDE SPRAY, METERED DOSE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
01-09-2017
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Active ingredient:
CICLESONIDE
Available from:
APOTEX INC
ATC code:
R01AD13
INN (International Name):
CICLESONIDE
Dosage:
50MCG
Pharmaceutical form:
SPRAY, METERED DOSE
Composition:
CICLESONIDE 50MCG
Administration route:
NASAL
Units in package:
120 METERED SPRAYS
Prescription type:
Prescription
Therapeutic area:
CORTICOSTEROIDS
Product summary:
Active ingredient group (AIG) number: 0151669004; AHFS:
Authorization status:
APPROVED
Authorization date:
2015-05-01
Summary of Product characteristics
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...........
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