ARQUIST

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

FLUTICASONE PROPIONATE

제공처:

Cipla (EU) Limited

ATC 코드:

R03BA05

INN (국제 이름):

FLUTICASONE PROPIONATE

복용량:

250 Mcg/Acutuation

약제 형태:

Pressurised Inhalation Suspension

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

fluticasone

승인 상태:

Authorised

승인 날짜:

2015-10-02

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ARQUIST 125 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION
ARQUIST 250 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION
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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Arquist is and what it is used for
2.
What you need to know before you use Arquist
3.
How to use Arquist
4.
Possible side effects
5.
How to store Arquist
6.
Contents of the pack and other information
1.
WHAT ARQUIST IS AND WHAT IT IS USED FOR
This medicine contains the active substance_ _fluticasone propionate
which_ _belongs to a group of
medicines called corticosteroids. Arquist works by reducing swelling
and irritation in the lungs
inflammation in the lungs. Only a very small dose is needed as it is
inhaled straight to the lungs.
This has been prescribed by your doctor to treat either:

Asthma in adults and adolescents over 16 years of age or

Chronic Obstructive Pulmonary Disease (COPD) in adults only, when
given with other
medicines (long-acting beta agonist (such as salmeterol)) to open the
airways.
You must use Arquist every day as directed by your doctor, even if
there are no complaints.
This makes sure that it works properly in controlling your asthma or
COPD.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ARQUIST
DO NOT USE ARQUIST

if you are allergic to fluticasone propionate or any of the other
ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nu

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arquist 250 microgram per actuation pressurised inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One metered dose (ex-valve) contains 250 micrograms of fluticasone
propionate. This is equivalent to a delivered dose
(ex-actuator) of 227 micrograms fluticasone propionate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation suspension (pressurised inhalation).
Arquist is a white homogeneous suspension, filled in an aluminum
container fitted with a suitable metering valve and a
plastic actuator. Grey coloured body with yellow cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Arquist is indicated for the treatment of asthma in adults and
adolescents over 16 years of age. Arquist is also indicated
for the treatment of severe COPD in conjunction with a long-acting
beta agonist (such as salmeterol) for use in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Arquist is for inhalation by oral inhalation only.
Patients should be made aware of the prophylactic nature of therapy
with inhaled fluticasone propionate and that it
should be taken regularly even when they are asymptomatic. The onset
of therapeutic effect is 4 to 7 days, although
some benefit may be apparent as soon as 24 hours for patients who have
not previously received inhaled steroids.
If patients find that relief with short-acting bronchodilator
treatment becomes less effective or they need more
inhalations than usual, medical attention must be sought.
It is intended that each prescribed dose is given by a minimum of 2
inhalations.
In patients who find co-ordination of a pressurised metered-dose
inhaler difficult a volumatic spacer may be used with
Arquist inhaler.
The dosage of fluticasone propionate should be adjusted according to
the individual response.
_Adults and adolescents over 16 years of age_
100 to 1000 micrograms twice daily.
Patients should be given a starting dose of inhaled fluticasone
propionate which is appropri