Seroflo 250/25 fluticasone propionate/salmeterol (as xinafoate) 250 microgram/25 microgram inhalation pressurised aerosol can me

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

salmeterol xinafoate, Quantity: 36.32 microgram/actuation (Equivalent: salmeterol, Qty 25 microgram/actuation); fluticasone propionate, Quantity: 250 microgram/actuation

Tilgjengelig fra:

Cipla Australia Pty Ltd

INN (International Name):

fluticasone propionate,Salmeterol xinafoate

Legemiddelform:

Inhalation, pressurised

Sammensetning:

Excipient Ingredients: norflurane

Administreringsrute:

Inhalation

Enheter i pakken:

120 metered doses

Resept typen:

(S4) Prescription Only Medicine

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 less than 50 precent predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. Fluticasone propionate/salmeterol (125 microgram/25 microgram and 250 microgram/25 microgram) is not indicated for the initiation of bronchodilator therapy in COPD.

Produkt oppsummering:

Visual Identification: A rigid, aluminium container fitted with a metered dose valve, containing a white homogeneous suspension, fitted to a plastic actuator with a white coloured body and rubin red coloured cap, with a dose indicator.; Container Type: Aerosol Can - Metered Dose; Container Material: 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:

2016-12-15

Informasjon til brukeren

SEROFLO 125/25
SEROFLO 250/25
_125/25 MICROGRAM AND 250/25 MICROGRAM MDI _
_ Fluticasone propionate/Salmeterol (as xinafoate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start
using SEROFLO.
This leaflet answers some common questions
about
SEROFLO. 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
SEROFLO 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 SEROFLO IS USED FOR
SEROFLO is available as a Metered Dose Inhaler
(MDI).

SEROFLO 125/25 (125 microgram
fluticasone
propionate
and
25
microgram salmeterol), or

SEROFLO 250/25 (250 microgram
fluticasone
propionate
and
25
microgram salmeterol).
SEROFLO 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).
SEROFLO
contains
two
medicines,
fluticasone
propionate
and
salmeterol
(as
xinafoate).
Fluticasone propionate belongs to a group of
medicines known as corticosteroids, frequently
called 'steroids'. They are not 'anabolic steroids'
which are the s

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION -
SEROFLO 125/25 (FLUTICASONE PROPIONATE/ SALMETEROL (AS XINAFOATE))
SEROFLO 250/25 (FLUTICASONE PROPIONATE/ SALMETEROL (AS XINAFOATE))
1
NAME OF THE MEDICINE
Fluticasone propionate/ Salmeterol xinafoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single actuation of Seroflo pressurised metered dose inhalation
contains, 125 micrograms or
250 micrograms of fluticasone propionate (delivered from the valve)
and 25 micrograms of
salmeterol (as salmeterol xinafoate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pressurised Inhalation
Seroflo 125/25 are a rigid, aluminium, container fitted with a metered
dose valve, containing a
white homogeneous suspension, fitted to a plastic actuator with a
white coloured body and pink
coloured cap, with a dose indicator.
Seroflo 250/25 are a rigid, aluminium, container fitted with a metered
dose valve, containing a
white homogeneous suspension, fitted to a plastic actuator with a
white coloured body and rubin
red coloured cap, with a dose indicator.
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 the following:

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 propionate/salmeterol (125/25
microgram and 250 /25
microgram) is not indicated for the initiation of bronchodilator
therapy in COPD.
4.2
DOSE AND METHOD OF ADMINISTRATION
NOTE:
Seroflo is not for use in patients aged under 12 years. A lower
strength fluticasone and
salmeterol (50/25 microgram) inhalation can be available from other
brand/s.
Seroflo is for inhalation only.
Seroflo must be