البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
salmeterol xinafoate, Quantity: 36.32 microgram/actuation (Equivalent: salmeterol, Qty 25 microgram/actuation); fluticasone propionate, Quantity: 250 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 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
Registered
2016-12-15
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 اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة