RATIO-FLUTICASONE METERED-DOSE PUMP
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
07-12-2016
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Active ingredient:
FLUTICASONE PROPIONATE
Available from:
TEVA CANADA LIMITED
ATC code:
R01AD08
INN (International Name):
FLUTICASONE
Dosage:
50MCG
Pharmaceutical form:
METERED-DOSE PUMP
Composition:
FLUTICASONE PROPIONATE 50MCG
Administration route:
NASAL
Units in package:
120 DOSES
Prescription type:
Prescription
Therapeutic area:
CORTICOSTEROIDS
Product summary:
Active ingredient group (AIG) number: 0124685001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2021-07-30
Summary of Product characteristics
Page 1 of 35
PRODUCT MONOGRAPH
PR
RATIO-FLUTICASONE
fluticasone propionate nasal spray USP
50 mcg/metered spray
Corticosteroid for nasal use
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
December 05, 2016
CONTROL NUMBER: 199651
Page 2 of 35
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
...................................................................................................
10
DOSAGE AND ADMINISTRATION
...............................................................................
11
OVERDOSAGE
.................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 13
STORAGE AND STABILITY
...........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 15
PART II: SCIENTIFIC INFORMATION
.............................................................................
16
PHARMACEUTICAL INFORMATION
...........................................................................
16
CLINICAL TRIALS
...........................................................................................................
17
DETAILED PHARMACOLOGY
.............................
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