Nchi: Uswidi
Lugha: Kiswidi
Chanzo: Läkemedelsverket (Medical Products Agency)
flutikasonpropionat
Elpen Pharmaceutical Co. Inc
R03BA05
fluticasone propionate
250 mikrogram/dos
Inhalationspulver, avdelad dos
flutikasonpropionat 250 mikrog Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagt
Förpacknings: Inhalatorer, 120 (2 x 60) doser (2 st Elpenhaler); Inhalator, 30 doser (1 st Elpenhaler); Inhalator, 60 doser (1 st Elpenhaler)
Godkänd
2019-03-28
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUTICASONE ELPEN 250 MICROGRAM/DOSE INHALATION POWDER, PRE-DISPENSED FLUTICASONE ELPEN 500 MICROGRAM/DOSE INHALATION POWDER, PRE-DISPENSED fluticasone propionate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What is and what it is used for 2. What you need to know before you use3. How to use Soma hati kamili4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR is a cortisone preparation that counteracts inflammation and allergy directly in the lungs. Reducing inflammation can prevent asthma attacks. is used as a regular treatment for asthma and COPD (Chronic Obstructive Pulmonary Disease) together with a long-acting bronchodilator. The full effect is first observed after several days of regular treatment. does not provide rapid relief in the event of acute asthma attacks. If such event occur, a quick and short-acting bronchodilator medicine should be used. If the treatment does not give the desired effect, consult a doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DO NOT USE - if you are allergic to fluticasone propionate or any of the other ingredients in this medicine (specified in section 6). Lactose monohydrate may contain lactoprotein. WARNINGS AND PRECAUTIONS Talk to your doctor, nurse or pharmacist before using . is not intended
1. ΝΑΜΕ OF THE MEDICINAL PRODUCT Fluticasone Elpen 250 microgram per dose inhalation powder, pre-dispensed Fluticasone Elpen 500 microgram per dose inhalation powder, pre-dispensed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of250 microgram contains 250 microgram of fluticasone propionate. Each dose of Soma hati kamili500 microgram contains 500 microgram of fluticasone propionate Excipient with known effect: Each dose of 250 microgram & 500 microgram contains approximately 14 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed. White powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bronchial asthma _IN ADULTS_ . For the treatment of severe chronic obstructive pulmonary disease, COPD (FEV1 <50% the predicted normal value) in combination with long-acting bronchodilators in patients with a history of recurrent exacerbations 4.2 POSOLOGY AND METHOD OF ADMINISTRATION is intended for oral inhalation only. Patients should be made aware that treatment with is prophylactic and that it must be used daily for optimum therapeutic effect, even in the absence of symptoms. If the patient experiences that the treatment with a short-acting bronchodilator becomes less effective or that more inhalations than usual are needed, he should seek medical attention. The dose should be titrated until effective control of symptoms is achieved, or reduced to the lowest effective dose according to individual response. _Asthma_ Dosage is individual. _Adults 250 or 500 microgram twice daily._ Prescribers should be awareasthma that fluticasone propionate is as effective as other inhaled steroids at approximately half the daily dose expressed in micrograms, e.g. 100 micrograms fluticasone propionate corresponds to approximately 200 micrograms beclomethasone dipropionate (inhalation spray with freons) or budesonide. A temporary dose increase may become necessary (in adults, up to 2,000 micrograms