Country: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
salmeterol xinafoate, Quantity: 0.0725 mg; fluticasone propionate, Quantity: 0.25 mg
Cipla Australia Pty Ltd
Inhalation, powder for
Excipient Ingredients: lactose monohydrate
Inhalation
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 CIP HALER 250/50 is not indicated for the initiation of bronchodilator therapy in COPD.
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
Registered
2021-08-12
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 propionate a সম্পূর্ণ নথি পড়ুন
PI-0722 AUSTR 331741 Page 1 of 19 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. PI-0722 AUSTR 331741 Page 2 of 19 4.2 DOSE AND METHOD OF ADMINISTRATION FLUTICASONE SALMETEROL CIPHALER 250/50 must be used regularly for optimum benefit, even when asymptomatic. P সম্পূর্ণ নথি পড়ুন