AERMONY RESPICLICK POWDER (METERED DOSE)

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

FLUTICASONE PROPIONATE

可用日期:

TEVA CANADA LIMITED

ATC代码:

R03BA05

INN（国际名称）:

FLUTICASONE

剂量:

113MCG

药物剂型:

POWDER (METERED DOSE)

组成:

FLUTICASONE PROPIONATE 113MCG

给药途径:

INHALATION

每包单位数:

60 DOSES

处方类型:

Prescription

治疗领域:

ADRENALS

產品總結:

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

授权状态:

APPROVED

授权日期:

2017-08-22

产品特点

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