Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
mannitol
Pharmaxis Europe Limited
R05CB16
mannitol
Cough and cold preparations
Cystic Fibrosis
Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
Revision: 19
Authorised
2012-04-13
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER BRONCHITOL 40 MG INHALATION POWDER, HARD CAPSULES Mannitol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Bronchitol is and what it is used for 2. What you need to know before you use Bronchitol 3. How to use Bronchitol 4. Possible side effects 5. How to store Bronchitol 6. Contents of the pack and other information 1. WHAT BRONCHITOL IS AND WHAT IT IS USED FOR WHAT BRONCHITOL IS Bronchitol contains a medicine called mannitol which is a mucolytic agent. WHAT BRONCHITOL IS USED FOR Bronchitol is for use in adults 18 years of age and over. As well as using Bronchitol you will normally keep using the other medicines you take for cystic fibrosis. HOW BRONCHITOL WORKS Bronchitol is inhaled into the lungs to help with cystic fibrosis, an inherited disease that affects the glands in the lungs, gut and pancreas that secrete fluids such as mucus and digestive juices. Bronchitol helps by increasing the amount of water on the surface of your airways and in your mucus. This helps your lungs to clear mucus more easily. It also helps improve the condition of your lungs and your breathing. As a result you may get a ‘productive cough’, which also helps to remove mucus from your lungs. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRONCHITOL DO NOT USE BRONCHITOL - if you are allergic to mannitol - if you are sensitive to mannitol. Before you are started on Bronchitol, your doctor will check whether your airways are too sensitive to mannitol Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Bronchitol 40 mg inhalation powder, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 40 mg mannitol. Mean delivered dose per capsule is 32.2 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, hard capsule. Clear colourless hard capsules marked with ‘PXS 40 mg’ and containing white or almost white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Initiation dose assessment _ Before commencing treatment with Bronchitol all patients should be assessed for bronchial hyperresponsiveness to inhaled mannitol during administration of their initiation dose (see sections 4.4 and 5.1). The patient’s initiation dose of Bronchitol must be used under the supervision and monitoring of an experienced physician or another health care professional appropriately trained and equipped to perform spirometry, monitor oxygen saturation (SpO 2 ), and manage acute bronchospasm (see sections 4.4 and 4.8) including appropriate use of resuscitation equipment. The patient should be pre-medicated with a bronchodilator 5-15 minutes prior to the initiation dose but after the baseline FEV 1 and SpO 2 (Oxygen saturation in the blood) measurement. All FEV 1 measurements and SpO 2 monitoring should be performed 60 seconds after dose inhalation. Training the patient to practice correct inhaler technique during the initiation dose assessment is important. The initiation dose assessment must be performed according to the following steps: Step 1: Patients baseline FEV 1 and SpO 2 is measured prior to the initiation dose Step 2: Patient inhales 40 mg (1x40 mg capsules) and SpO 2 is monitored Step 3: Patient inhales 80 mg (2x40 mg capsules) and SpO 2 is monitored Step 4: Patient inhales Lesen Sie das vollständige Dokument