Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
fluticasone propionate, Quantity: 250 microgram/actuation; salmeterol xinafoate, Quantity: 36.3 microgram/actuation (Equivalent: salmeterol, Qty 25 microgram/actuation)
Alphapharm Pty Ltd
fluticasone propionate,Salmeterol xinafoate
Inhalation, pressurised
Excipient Ingredients: norflurane
Inhalation
Sample Pack, 120 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 beta2-agonists and inhaled corticosteroids.,*Patients who are symptomatic on current inhaled corticosteroid therapy.,For the symptomatic treatment of patients with severe COPD (FEV1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. Evocair is not indicated for the initiation of bronchodilator therapy in COPD.
Visual Identification: Actuator & metal can with concave base fitted with a metering valve and a plastic doese counter. The canister contains a white to off-white suspension. The internal surfaces of the can & the valve are free from obvious defects.; Container Type: Aerosol Can - Metered Dose; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-05-07
EVOCAIR ® MDI _Fluticasone propionate/Salmeterol xinafoate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using EVOCAIR MDI. This leaflet answers some common questions about EVOCAIR MDI. 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 EVOCAIR MDI 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 EVOCAIR MDI IS USED FOR EVOCAIR MDI is available a Metered Dose Inhaler (MDI) also known as an "inhaler". • EVOCAIR MDI: 125/25, 250/25 EVOCAIR MDI 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). EVOCAIR MDI contains two medicines, fluticasone propionate and salmeterol xinafoate. Fluticasone propionate belongs to a group of medicines known as corticosteroids, frequently called 'steroids'. They are not 'anabolic steroids' which are the steroids sometimes misused by athletes. Corticosteroids have an anti-inflammatory action. They reduce the swelling and irritation in the walls of the small air passag Pročitajte cijeli dokument
AUSTRALIAN PRODUCT INFORMATION EVOCAIR ® MDI _Fluticasone propionate/ salmeterol xinafoate _ _ _ 1 NAME OF THE MEDICINE Fluticasone propionate/ salmeterol xinafoate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single actuation provides 125 or 250 micrograms of fluticasone propionate and 25 micrograms of salmeterol (as xinafoate) LIST OF EXCIPIENTS WITH KNOWN EFFECT : None. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Pressurised inhalation with counter 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 • Initiation of maintenance therapy in those patients with moderate persistent asthma not adequately controlled on ‘as needed’ reliever medication, and who have moderate/severe airway limitation and daily symptoms requiring reliever medication every day (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials). For the symptomatic treatment of patients with severe COPD (FEV1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. EVOCAIR is not indicated for the initiation of bronchodilator therapy in COPD. 4.2 DOSE AND METHOD OF ADMINISTRATION EVOCAIR MDI is for inhalation only. EVOCAIR MDI must be used regularly for optimum benefit, even when asymptomatic. Patients should be regularly assessed by a doctor, so the dose of EVOCAIR they are receiving remains optimal. Strength of dose should only be increased or decreased on medical advice. The use of one puff twice daily (bd) of the MDI has not been investigated in clinical trials. EVOCAIR MDI is supplied with a counter. The MDI comprises a suspension of fluticasone propionate and salmeterol in a CFC-free propellant. The suspension is Pročitajte cijeli dokument