AirFluSal Forspiro 50250 mcg

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Доступна з:

SANDOZ PRODUCTS MALAYSIA SDN. BHD.

ІПН (Міжнародна Ім'я):

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Одиниць в упаковці:

1units Units

Виробник:

AEROPHARM GMBH

інформаційний буклет

_Consumer Medication Information Leaflet (RiMUP) _
AIRFLUSAL FORSPIRO
®
Salmeterol xinafoate/Fluticasone propionate (50/250mcg & 50/500mcg
inhalation powder, pre-dispensed)
1
WHAT IS IN THIS LEAFLET
1.
What AIRFLUSAL is used for
2.
How AIRFLUSAL works
3.
Before you use AIRFLUSAL
4.
How to use AIRFLUSAL
5.
While you are using
AIRFLUSAL
6.
Side effects
7.
Storage and disposal of
AIRFLUSAL
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT AIRFLUSAL IS USED FOR
AIRFLUSAL is available as a dry
powder device called an
FORSPIRO.
AIRFLUSAL is used to help with
asthma and chronic obstructive
pulmonary disease (COPD) in
people who need regular treatment.
Asthma is a condition affecting the
lungs. Symptoms of asthma
include shortness of breath,
wheezing, chest tightness and
cough. Two main causes of asthma
symptoms are bronchoconstriction
(tightening of the muscle
surrounding the airways) and
inflammation (swelling and
irritation of the airways).
Chronic obstructive pulmonary
disease (COPD) is a long-term
condition affecting the lungs,
resulting from chronic bronchitis or
emphysema. Symptoms of COPD
include shortness of breath, cough,
chest discomfort and coughing up
phlegm. The COPD symptoms are
mainly due to bronchoconstriction
(tightening of the muscle surrounding
the airways) and inflammation
(swelling and irritation of the
airways).
HOW AIRFLUSAL WORKS
AIRFLUSAL contains two
medicines, fluticasone propionate
and salmeterol xinafoate.
Fluticasone propionate belongs to a
group of medicines known as
corticosteroids, frequently called
'steroids'. They are not 'anabolic
steroids' which are the steroids
sometimes misused by athletes.
Corticosteroids have an anti-
inflammatory action. They reduce
the swelling and irritation in the
walls of the small air passages in
the lungs and so help you to
breathe more easily.
Corticosteroids are used to treat
asthma and COPD.
Salmeterol xinafoate is a
bronchodilator. A bronchodilator
keeps the breathing tubes in your
lungs open and relieves

Характеристики продукта

1.
NAME OF THE MEDICINAL PRODUCT
AirFluSal
®
Forspiro
®
50/250 mcg
AirFluSal
®
Forspiro
®
50/500 mcg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AirFluSal
®
Forspiro
®
50/250 mcg: Each metered dose contains 50 mcg salmeterol (as
salmeterol
xinafoate) and 250 mcg fluticasone propionate.
Corresponding with a delivered dose of:
45 micrograms of Salmeterol (as salmeterol xinafoate) and 233
micrograms of fluticasone propionate
Excipient with known effect: lactose monohydrate 12.18 mg per metered
dose.
AirFluSal
®
Forspiro
®
50/500 mcg: Each metered dose contains 50 mcg salmeterol (as
salmeterol
xinafoate) and 500 mcg fluticasone propionate.
Corresponding with a delivered dose of:
45 micrograms of Salmeterol (as salmeterol xinafoate) and 465
micrograms of fluticasone propionate
Excipient with known effect: lactose monohydrate: 11.93 mg per metered
dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
The medicinal product is salmeterol (as salmeterol xinafoate) and
fluticasone propionate combined
with lactose as white, homogenous inhalation powder, pre-metered into
blisters for administration via a
purple colour plastic dry powder inhaler (Fospiro) device.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE (ROAD): Regular treatment of
ROAD, including asthma in
children and adults, where use of a combination (bronchodilator and
inhaled corticosteroid) is
appropriate.
This may include: Patients on effective maintenance doses of
long-acting β-agonists and inhaled
corticosteroids.
Patients who are symptomatic on current inhaled corticosteroid
therapy.
Patients on regular bronchodilator therapy who require inhaled
corticosteroids.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD): Regular treatment of
COPD including chronic
bronchitis and emphysema.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration:
Salmeterol + Fluticasone propionate (AirFluSal
®
Fospiro
®
) is for inhalation only.
Patients should be ma