RATIO-FLUTICASONE METERED-DOSE PUMP

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

FLUTICASONE PROPIONATE

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

R01AD08

INN (Tên quốc tế):

FLUTICASONE

Liều dùng:

50MCG

Dạng dược phẩm:

METERED-DOSE PUMP

Thành phần:

FLUTICASONE PROPIONATE 50MCG

Tuyến hành chính:

NASAL

Các đơn vị trong gói:

120 DOSES

Loại thuốc theo toa:

Prescription

Khu trị liệu:

CORTICOSTEROIDS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2021-07-30

Đặc tính sản phẩm

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
.............................