MYLAN-AZELASTINE/FLUTICASONE SPRAY, METERED DOSE

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

FLUTICASONE PROPIONATE; AZELASTINE HYDROCHLORIDE

Доступна з:

MYLAN PHARMACEUTICALS ULC

Код атс:

R01AD58

ІПН (Міжнародна Ім'я):

FLUTICASONE, COMBINATIONS

Дозування:

50MCG; 137MCG

Фармацевтична форма:

SPRAY, METERED DOSE

Склад:

FLUTICASONE PROPIONATE 50MCG; AZELASTINE HYDROCHLORIDE 137MCG

Адміністрація маршрут:

NASAL

Одиниць в упаковці:

15G/50G

Тип рецепту:

Prescription

Огляд продуктів:

Active ingredient group (AIG) number: 0256150002; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2022-09-01

Характеристики продукта

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_Mylan-Azelastine/Fluticasone, Azelastine Hydrochloride and
Fluticasone Propionate Product Monograph Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MYLAN-AZELASTINE/FLUTICASONE
Azelastine Hydrochloride and Fluticasone Propionate
Suspension Spray, 137 mcg/50 mcg per metered spray, Intranasal
Antihistamine and Corticosteroid Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Submission Control Number: 266159
Date of
Initial
Authorization:
AUG
30, 2022
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_Mylan-Azelastine/Fluticasone, Azelastine Hydrochloride and
Fluticasone Propionate Product Monograph Page 2 of 36_
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
..............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 4
4.4
Administration
..........................................................................................................
5
4.5
Missed Dose
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