SalplusF Inhaler 250/25 fluticasone propionate/salmeterol (as xinafoate) 250 microgram/25 microgram inhalation pressurised aerosol can metered dose

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:

Licence status A

Autorisasjon dato:

2016-12-15

Informasjon til brukeren

SALPLUSF INHALER 125/25
SALPLUSF INHALER 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 SalplusF Inhaler.
This leaflet answers some common questions
about SalplusF Inhaler. 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
SalplusF Inhaler 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 SALPLUSF INHALER IS USED FOR
SalplusF Inhaler is available as a Metered Dose
Inhaler (MDI).
•
SalplusF Inhaler 125/25 (125
microgram fluticasone propionate
and 25 microgram salmeterol), or
•
SalplusF Inhaler 250/25 (250
microgram fluticasone propionate
and 25 microgram salmeterol).
SalplusF Inhaler 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).
SalplusF Inhaler contains two medicines,
fluticasone propionate and salmeterol (as
xinafoate).
Fluticasone propionate belongs to a group of
medicines known

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION -
SALPLUSF 125/25 (FLUTICASONE PROPIONATE/ SALMETEROL (AS XINAFOATE)
SALPLUSF 250/25 (FLUTICASONE PROPIONATE/ SALMETEROL (AS XINAFOATE)
1
NAME OF THE MEDICINE
Fluticasone propionate/ Salmeterol (as xinafoate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single actuation of Fluticasone propionate/ Salmeterol
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).
Fluticasone propionate is a white or almost white powder. It is
practically insoluble in water,
sparingly soluble in methylene chloride, slightly soluble in ethanol
(96 per cent).
Salmeterol (as xinafoate) is a white or almost white powder.
Practically insoluble in water,
soluble in methanol, slightly soluble in anhydrous ethanol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SalplusF 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.
SalplusF250/25 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
Fluticasone propionate 125 microgram/actuation + salmeterol 25
microgram/actuation
pressurised inhalation, 120 actuations
NOTE:
−
This product is not indicated for initiation of treatment in asthma
−
This product is not PBS-subsidised for the treatment of chronic
obstruc