Seretide 125 Evohaler Pressurised Inhalation Suspension 25mcg/125mcg

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

SALMETEROL, FLUTICASONE PROPIONATE

제공처:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC 코드:

R03AK06

INN (국제 이름):

SALMETEROL 25 µg FLUTICASONE PROPIONATE 125 µg

약제 형태:

PRESSURISED INHALATION, SUSPENSION

구성:

SALMETEROL 25 µg FLUTICASONE PROPIONATE 125 µg

처방전 유형:

POM

치료 영역:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

승인 상태:

Withdrawn

승인 날짜:

2016-12-27

환자 정보 전단

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Seretide Evohaler 25 microgram/50 microgram per metered dose
pressurised inhalation, suspension
Seretide Evohaler 25 microgram/125 microgram per metered dose
pressurised inhalation, suspension
Seretide Evohaler 25 microgram/250 microgram per metered 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

제품 특성 요약

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Seretide Evohaler 25 microgram/50 microgram per metered dose
pressurised inhalation, suspension.
Seretide Evohaler 25 microgram/125 microgram per metered dose
pressurised inhalation, suspension.
Seretide Evohaler 25 microgram/250 microgram per metered dose
pressurised inhalation, suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex valve) contains:
25 micrograms of salmeterol (as salmeterol xinafoate)
_ _
and 50, 125 or 250 micrograms of fluticasone
propionate. This is equivalent to a delivered dose (ex actuator) of 21
micrograms of salmeterol and
44, 110 or 220 micrograms of fluticasone propionate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
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
4.1
THERAPEUTIC INDICATIONS
Seretide is indicated in the regular treatment of asthma where use of
a combination product (long-
acting
β
2
agonist and inhaled corticosteroid) is appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
‘as needed’ inhaled
short-acting
β
2
agonist.
or
-
patients already adequately controlled on both inhaled corticosteroid
and long-acting
β
2
agonist.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Route of administration: Inhalation use.
Patients should be made aware that Seretide Evohaler must be used
daily for optimum benefit, even
when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Seretide they are receiving
remains optimal
_ _
and is only changed on medical advice
. THE DOSE SHOULD BE TITRATED TO THE LOWEST
DOSE AT WHICH EFFECTIVE CONTROL OF SYMPTOMS IS MAINTAINED. WHERE THE
CONTROL OF SYMPTOMS IS
2
MAINTAINED WITH THE LOWEST STRENGTH OF THE COMBINATION GIVEN TWICE
DAILY THEN THE NEXT STEP
COULD INCLUDE A TEST