Land: Israël
Taal: Engels
Bron: Ministry of Health
FLUTICASONE PROPIONATE; SALMETEROL AS XINAFOATE
GLAXO SMITH KLINE (ISRAEL) LTD
R03AK06
POWDER FOR INHALATION
FLUTICASONE PROPIONATE 100 MCG; SALMETEROL AS XINAFOATE 50 MCG
INHALATION
Required
GLAXO WELLCOME PRODUCTION, FRANCE
SALMETEROL AND OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Seretide is indicated in the regular treatment of asthma in children and adults, where use of a combination (bronchodilator and inhaled corticosteroid) has been found to be appropriate.
2015-01-26
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a physician’s prescription only SERETIDE DISKUS 50/100 MCG, POWDER FOR INHALATION Each dose contains 50 micrograms salmeterol (as Xinafoate)/ 100 micrograms fluticasone propionate inhalation powder. SERETIDE DISKUS 50/250 MCG, POWDER FOR INHALATION Each dose contains 50 micrograms salmeterol (as Xinafoate)/ 250 micrograms fluticasone propionate inhalation powder. SERETIDE DISKUS 50/500 MCG, POWDER FOR INHALATION Each dose contains 50 micrograms salmeterol (as Xinafoate)/ 500 micrograms fluticasone propionate inhalation powder. For the list of the inactive and allergenic ingredients see section 2 – “Important information about some of the ingredients of the medicine” and section 6 – “Additional information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or the pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Seretide Diskus contains two active ingredients: salmeterol and fluticasone propionate: • Salmeterol is a long-acting bronchodilator. Bronchodilators help the airways in the lungs to stay open. This makes it easier for air to get in and out. The effect last for at least 12 hours. • Fluticasone propionate is a corticosteroid which reduces swelling and irritation in the lungs. The physician has prescribed this medicine to help prevent breathing problems such as: • Asthma • COPD – Seretide Diskus, at a dose of 50/250 and 50/500 micrograms, is also indicated to treat chronic obstructive pulmonary disease (COPD). The medicine reduces the number of flare-ups of COPD symptoms. You must use Seretide Diskus every day as directed by your physician. This will make sure that it works proper Lees het volledige document
Page 1 of 19 _ _ SERETIDE DISKUS 50/100 MCG SERETIDE DISKUS 50/250 MCG SERETIDE DISKUS 50/500 MCG 1. NAME OF THE MEDICINAL PRODUCT Seretide Diskus 50/100 mcg. Seretide Diskus 50/250 mcg. Seretide Diskus 50 /500 mcg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 47 micrograms of salmeterol (as salmeterol xinafoate) and 92, 231 or 460 micrograms of fluticasone propionate. This corresponds to a pre-dispensed dose of 50 micrograms of salmeterol (as salmeterol xinafoate) and 100, 250 or 500 micrograms fluticasone propionate. Excipients with known effect: Each delivered dose contains up to 12.5 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed. _ _ Moulded plastic device containing a foil strip with 60 regularly placed blisters. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ASTHMA _ _ _ Seretide is indicated in the regular treatment of asthma in children and adults, where use of a combination (bronchodilator _ _ and inhaled corticosteroid) has been found to be _ _ appropriate. _CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) _ _ _ Seretide (50/250 & 50/500mcg) is indicated for the symptomatic treatment of patients with COPD, with a FEV 1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology _ Route of administration: Inhalation use. Page 2 of 19 Patients should be made aware that Seretide Diskus must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Seretide they are receiving remains optimal _ _ and is only changed on medical advice. Patients should be given the strength of Seretide containing the appropriate fluticasone propionate dosage for the severity of their disease. If an individual patient should require Lees het volledige document