FLUTICASONE SALMETEROL MULTI HALER 250/50 fluticasone propionate/salmeterol 250/50 mcg/dose inhalation powder pre-dispensed BP plastic inhaler

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

salmeterol xinafoate, Quantity: 0.0725 mg; fluticasone propionate, Quantity: 0.25 mg

Tilgjengelig fra:

Cipla Australia Pty Ltd

Legemiddelform:

Inhalation, powder for

Sammensetning:

Excipient Ingredients: lactose monohydrate

Administreringsrute:

Inhalation

Indikasjoner:

For the regular treatment of asthma, where the use of a combination product is appropriate. This may include ? Patients on effective maintenance doses of long acting beta 2 agonists and inhaled corticosteroids ? Patients who are symptomatic on current inhaled corticosteroid therapy For the symptomatic treatment of patients with severe COPD (FEV1 not more than 50 per cent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta 2 agonist bronchodilator therapy. FLUTICASONE SALMETEROL MULTI HALER 250/50 is not indicated for the initiation of bronchodilator therapy in COPD

Produkt oppsummering:

Visual Identification: Salmeterol/fluticasone propionate inhalation powder pre-dispensed BP is a white to off white powder filled in a strip of 60 blisters; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

2021-08-12

Informasjon til brukeren

FLUTICASONE SALMETEROL CIPHALER 250/50
250 microgram/50 microgram dose inhalation powder, pre-dispensed
_Fluticasone propionate/Salmeterol xinafoate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start
using FLUTICASONE SALMETEROL
CIPHALER 250/50.
This leaflet answers some common questions
about FLUTICASONE SALMETEROL
CIPHALER 250/50. It does not contain all the
available information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your
doctor has weighed the risks of you taking
FLUTICASONE SALMETEROL CIPHALER
250/50 against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLUTICASONE SALMETEROL
CIPHALER 250/50 IS USED FOR
FLUTICASONE SALMETEROL CIPHALER
250/50 (250 microgram fluticasone propionate
and 50 microgram salmeterol) is available as a
dry powder device called an inhaler.
FLUTICASONE SALMETEROL CIPHALER
250/50 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 FLUTICASONE SALMETEROL _
_CIPHALER 250/50 WORKS_
FLUTICASONE SALMETEROL CIPHALER
250/50 contains two medicines, fluticasone
propiona

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION - FLUTICASONE SALMETEROL CIPHALER
250/50
(FLUTICASONE PROPIONATE/SALMETEROL XINAFOATE) DOSE INHALATION POWDER,
PRE-DISPENSED
1.
NAME OF THE MEDICINE
Fluticasone propionate/Salmeterol xinafoate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each a foil strip contains regularly placed blisters each containing
250 micrograms of fluticasone
propionate and 50 micrograms of salmeterol (as xinafoate).
Description
Fluticasone propionate is a white to almost white powder. It is
sparingly soluble in methylene
chloride, slightly soluble in alcohol, and practically insoluble in
water.
Salmeterol xinafoate is a white to almost white powder. It is soluble
in methanol, slightly soluble in
anhydrous ethanol, and practically insoluble in water.
Excipient with known effect
Each blister of 250 micrograms of fluticasone propionate and 50
micrograms of salmeterol (as
xinafoate) contains 12.17 mg of lactose monohydrate.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
FLUTICASONE SALMETEROL CIPHALER 250/50 is a white to off white powder
filled in a strip
of 60 blisters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the regular treatment of asthma, where the use of a combination
product is appropriate. This may
include:
•
Patients on effective maintenance doses of long-acting beta-2 agonists
and inhaled corticosteroids
•
Patients who are symptomatic on current inhaled corticosteroid therapy
For the symptomatic treatment of patients with severe COPD (FEV
1
<50% predicted normal) and a
history of repeated exacerbations who have significant symptoms
despite regular beta-2 agonist
bronchodilator therapy. FLUTICASONE SALMETEROL CIPHALER 250/50 is not
indicated for the
initiation of bronchodilator therapy in COPD.
4.2
DOSE AND METHOD OF ADMINISTRATION
FLUTICASONE SALMETEROL CIPHALER 250/50 must be used regularly for
optimum benefit,
even when asymptomatic.
Patients should be regularly assessed by a doctor, so the dose of
flu