Country: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
salmeterol xinafoate, Quantity: 36.32 microgram/actuation (Equivalent: salmeterol, Qty 25 microgram/actuation); fluticasone propionate, Quantity: 125 microgram/actuation
Cipla Australia Pty Ltd
fluticasone propionate,Salmeterol xinafoate
Inhalation, pressurised
Excipient Ingredients: norflurane
Inhalation
120 metered doses
(S4) Prescription Only Medicine
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.
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 pink 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
Licence status A
2016-12-15
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 Aqra d-dokument sħiħ
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 Aqra d-dokument sħiħ