Seretide 250 Evohaler 25 microgram/250 microgram/dose pressurised inhalation, suspension

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

थमां उपलब्ध:

IMED Healthcare Ltd.

ए.टी.सी कोड:

R03AK; R03AK06

INN (इंटरनेशनल नाम):

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

डोज़:

25/250 Mcg/Dose

फार्मास्यूटिकल फॉर्म:

Pressurised inhalation, suspension

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salmeterol and fluticasone

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2016-07-01

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
Seretide® 125 Evohaler® 25 microgram/125 microgram/ dose
pressurised inhalation, suspension
Seretide® 250 Evohaler® 25 microgram/250 microgram/ dose
pressurised inhalation, suspension
salmeterol/fluticasone propionate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 symptoms and 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 Seretide is and what it is used for
2. What you need to know before you use Seretide
3. How to use Seretide
4. Possible side effects
5. How to store Seretide
6. Contents of the pack and other information
1. WHAT SERETIDE IS AND WHAT IT IS USED FOR
Seretide contains two medicines, salmeterol and fluticasone
propionate:
• Salmeterol is a long-acting bronchodilator. Bronchodilators help
the airways in the lungs to stay open. This
makes it easier for air to get in and out. The effects last for at
least 12 hours.
• Fluticasone propionate is a corticosteroid which reduces swelling
and irritation in the lungs.
The doctor has prescribed this medicine to help prevent breathing
problems such as asthma.
You must use Seretide every day as directed by your doctor. This will
make sure that it works properly in
controlling your asthma.
SERETIDE HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON.
HOWEVER SERETIDE SHOULD NOT BE
USED TO RELIEVE A SUDDEN ATTACK OF BREATHLESSNESS OR WHEEZING. IF THIS
HAPPENS YOU NEED TO USE A
FAST-ACTING ‘RELIEVER’ (‘RESCUE’) INHALER, SUCH AS SALBUTAMOL.
YOU SHOULD ALWAYS HAVE YOUR FAST-ACTING
‘RESCUE’ INHALER WITH YOU.
2. WHAT YOU NEED TO KNOW

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seretide 250 Evohaler 25 microgram/250 microgram/dose pressurised
inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex valve) contains:
25 micrograms of salmeterol (as salmeterol xinafoate) and 250
micrograms of fluticasone propionate. This is equivalent
to a delivered dose (ex actuator) of 21 micrograms of salmeterol and
220 micrograms of fluticasone propionate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
_Product imported from Holland_
The canister contains a white to off white suspension.
The canisters are fitted into purple plastic actuators incorporating
an atomising orifice and fitted with dustcaps
4 CLINICAL PARTICULARS
As per PA1077/046/006
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/046/006
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Propellant: norflurane (HFA 134a)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
o
C.
The canister contains a pressurised liquid. Do not expose to
temperatures higher than 50°C, protect from direct
sunlight. Do not pierce or burn the canister even when empty.
As with most inhaled medicinal products in pressurised canisters, the
therapeutic effect of this medicinal product may
decrease when the canister is cold.
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