AERMONY RESPICLICK POWDER (METERED DOSE)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

FLUTICASONE PROPIONATE

Disponibbli minn:

TEVA CANADA LIMITED

Kodiċi ATC:

R03BA05

INN (Isem Internazzjonali):

FLUTICASONE

Dożaġġ:

113MCG

Għamla farmaċewtika:

POWDER (METERED DOSE)

Kompożizzjoni:

FLUTICASONE PROPIONATE 113MCG

Rotta amministrattiva:

INHALATION

Unitajiet fil-pakkett:

60 DOSES

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ADRENALS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2017-08-22

Karatteristiċi tal-prodott

_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
.................................