AERMONY RESPICLICK POWDER (METERED DOSE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUTICASONE PROPIONATE

Available from:

TEVA CANADA LIMITED

ATC code:

R03BA05

INN (International Name):

FLUTICASONE

Dosage:

113MCG

Pharmaceutical form:

POWDER (METERED DOSE)

Composition:

FLUTICASONE PROPIONATE 113MCG

Administration route:

INHALATION

Units in package:

60 DOSES

Prescription type:

Prescription

Therapeutic area:

ADRENALS

Product summary:

Active ingredient group (AIG) number: 0124685012; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-08-22

Summary of Product characteristics

_Aermony RESPICLICK Product Monograph _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
Aermony RESPICLICK
TM
fluticasone propionate inhalation powder, Mfr. Std.
55 mcg, 113 mcg and 232 mcg fluticasone propionate / actuation
Corticosteroid for Oral Inhalation
Distributed by:
Teva Canada Limited
Toronto, Ontario M1B 2K9
Manufactured for:
Teva Canada Innovation
Montréal, Quebec H2Z 1S8
Date of Preparation:
December 14, 2018
Submission Control No: 219965
Aermony RESPICLICK is a trademark of Ivax International B.V., a member
of the Teva Group; used under license.
_ _
_Aermony RESPICLICK Product Monograph _
_Page 2 of 45 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
.................................