MYLAN-AZELASTINE/FLUTICASONE SPRAY, METERED DOSE

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

FLUTICASONE PROPIONATE; AZELASTINE HYDROCHLORIDE

Dostupno od:

MYLAN PHARMACEUTICALS ULC

ATC koda:

R01AD58

INN (International ime):

FLUTICASONE, COMBINATIONS

Doziranje:

50MCG; 137MCG

Farmaceutski oblik:

SPRAY, METERED DOSE

Sastav:

FLUTICASONE PROPIONATE 50MCG; AZELASTINE HYDROCHLORIDE 137MCG

Administracija rute:

NASAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2022-09-01

Svojstava lijeka

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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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
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4
4.2
Recommended Dose and Dosage Adjustment
......................................................... 4
4.4
Administration
..........................................................................................................
5
4.5
Missed Dose
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