MYLAN-AZELASTINE/FLUTICASONE SPRAY, METERED DOSE

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

FLUTICASONE PROPIONATE; AZELASTINE HYDROCHLORIDE

可用日期:

MYLAN PHARMACEUTICALS ULC

ATC代码:

R01AD58

INN（国际名称）:

FLUTICASONE, COMBINATIONS

剂量:

50MCG; 137MCG

药物剂型:

SPRAY, METERED DOSE

组成:

FLUTICASONE PROPIONATE 50MCG; AZELASTINE HYDROCHLORIDE 137MCG

给药途径:

NASAL

每包单位数:

15G/50G

处方类型:

Prescription

產品總結:

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

授权状态:

APPROVED

授权日期:

2022-09-01

产品特点

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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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
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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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