Dymista 137 micrograms/50 micrograms per actuation nasal spray, suspension

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Azelastine hydrochloride; Fluticasone propionate

제공처:

IMED Healthcare Ltd.

ATC 코드:

R01AD; R01AD58

INN (국제 이름):

Azelastine hydrochloride; Fluticasone propionate

복용량:

137/50 µg/actuation

약제 형태:

Nasal spray, suspension

치료 영역:

Corticosteroids; fluticasone, combinations

승인 날짜:

2017-10-27

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DYMISTA 137 MICROGRAMS / 50 MICROGRAMS PER ACTUATION, NASAL SPRAY,
SUSPENSION
Azelastine hydrochloride/fluticasone propionate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Dymista is and what it is used for
2. What you need to know before you use Dymista
3. How to use Dymista
4. Possible side effects
5. How to store Dymista
6. Contents of the pack and other information
1. WHAT DYMISTA IS AND WHAT IT IS USED FOR
Dymista contains two active substances: azelastine hydrochloride and
fluticasone propionate.
•
Azelastine hydrochloride belongs to a group of medicines called
antihistamines. Antihistamines
work by preventing the effects of substances such as histamine that
the body produces as part of
an allergic reaction – thus reducing symptoms of allergic rhinitis.
•
Fluticasone propionate belongs to a group of medicines called
corticosteroids which reduces
inflammation.
Dymista is used to relieve the symptoms of moderate to severe seasonal
and perennial allergic
rhinitis if the use of either intranasal antihistamine or
corticosteroid alone is not considered sufficient.
Seasonal and perennial allergic rhinitis are allergic reactions to
substances such as pollen (hayfever),
house mites, moulds, dust or pets.
Dymista relieves the symptoms of allergies, for example: runny nose,
post nasal drip, sneezing and
itchy or blocked nose.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DYMISTA
DO NOT USE DYMISTA:
•
If you are allergic to azelastine hydrochlor

제품 특성 요약

Health Products Regulatory Authority
25 September 2023
CRN00DV97
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dymista 137 micrograms/50 micrograms per actuation nasal spray,
suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g of suspension contains 1000 micrograms azelastine hydrochloride
and 365 micrograms fluticasone propionate.
Each actuation (0.14 g) delivers 137 micrograms azelastine
hydrochloride (equivalent to 125 micrograms azelastine) and 50
micrograms fluticasone propionate.
Excipient with known effect: Benzalkonium chloride
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray Suspension
_Product imported from France _
White, homogenous suspension.
4 CLINICAL PARTICULARS
As per PA23355/010/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23355/010/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Disodium edetate
Glycerol
Microcrystalline cellulose
Carmellose sodium
Polysorbate 80
Benzalkonium chloride
Phenylethyl alcohol
Purified water
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
bottle and outer carton of the product as marketed in the
country of origin.
In-use shelf life (after first use): 6 months
Health Products Regulatory Authority
25 September 2023
CRN00DV97
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not refrigerate or freeze.
6.5 NATURE AND CONTENTS OF CONTAINER
Cardboard outer carton containing an amber coloured glass bottle
fitted with a spray pump, applicator and a protective cap.
Pack size: 1 bottle with 23 g suspension in 25 ml bottles (at least
120 actuations)
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements for disposal.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/151/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 27
th