NASAL SPRAY ALLERGY 24HR SPRAY, METERED DOSE

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

TRIAMCINOLONE ACETONIDE

Sẵn có từ:

APOTEX INC

Mã ATC:

R01AD11

INN (Tên quốc tế):

TRIAMCINOLONE

Liều dùng:

55MCG

Dạng dược phẩm:

SPRAY, METERED DOSE

Thành phần:

TRIAMCINOLONE ACETONIDE 55MCG

Tuyến hành chính:

NASAL

Các đơn vị trong gói:

120 ACT.(9.075 MG)

Loại thuốc theo toa:

OTC

Khu trị liệu:

CORTICOSTEROIDS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0106310010; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2016-02-24

Đặc tính sản phẩm

Page 1 of 25
PRODUCT MONOGRAPH
NASAL SPRAY ALLERGY 24HR
ADULTS AND CHILDREN 12 YEARS AND OLDER
TRIAMCINOLONE ACETONIDE AQUEOUS NASAL SPRAY
55 MCG/METERED SPRAY
APOTEX STANDARD
CORTICOSTEROID FOR NASAL USE
APOTEX INC.
150 SIGNET DRIVE
TORONTO ONTARIO
M9L 1T9
DATE OF REVISION:
JANUARY 13, 2021
CONTROL NO: 243465
Page 2 of 25
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
.......................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................
3
ADVERSE REACTIONS
......................................................................................................
6
DOSAGE AND ADMINISTRATION
......................................................................................
9
OVERDOSAGE
...................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
......................................................................10
STORAGE AND
STABILITY................................................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................12
PART II: SCIENTIFIC INFORMATION
....................................................................................14
PHARMACEUTICAL INFORMATION
..................................................................................14
CLINICAL TRIALS
...............................................................................................................15
DETAILED PHARMACOLOGY
............................................................