AERMONY RESPICLICK POWDER (METERED DOSE)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

FLUTICASONE PROPIONATE

Dostupné z:

TEVA CANADA LIMITED

ATC kód:

R03BA05

INN (Medzinárodný Name):

FLUTICASONE

Dávkovanie:

55MCG

Forma lieku:

POWDER (METERED DOSE)

Zloženie:

FLUTICASONE PROPIONATE 55MCG

Spôsob podávania:

INHALATION

Počet v balení:

60 DOSES

Typ predpisu:

Prescription

Terapeutické oblasti:

ADRENALS

Prehľad produktov:

Active ingredient group (AIG) number: 0124685001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2017-08-22

Súhrn charakteristických

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