מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
MANNITOL
Pharmaxis Pharmaceuticals Ltd
V04CX
MANNITOL
0/5/10/20/ Milligram
Inhalation Powder, Capsule
Product subject to prescription which may not be renewed (A)
Other diagnostic agents
Marketed
2007-10-12
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER OSMOHALE INHALATION POWDER, HARD CAPSULE Mannitol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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. WHAT IS IN THIS LEAFLET: 1. What Osmohale is and what it is used for 2. What you need to know before you take Osmohale 3. How to take Osmohale 4. Possible side effects 5. How to store Osmohale 6. Contents of the pack and other information 1. WHAT OSMOHALE IS AND WHAT IT IS USED FOR Osmohale is a TEST to see if you have airways sensitivity or not. Osmohale contains the active substance mannitol. Airways sensitivity may be caused by inflammation of the airways, making it difficult to breathe sometimes. People with airways sensitivity are often very susceptible to factors in the environment such as exercise, dust, smoke and other irritants. Your doctor or another specifically trained healthcare professional will ask you to breathe in Osmohale, using a small inhaler. For people who DO have AIRWAYS SENSITIVITY, their airways will become narrower and so they may find it harder to breathe. People who DO NOT have AIRWAYS SENSITIVITY will not experience their airways becoming narrower when breathing in Osmohale. They will still be able to breathe normally. As part of the test, you will be asked to blow into a tube that will measure the effect of Osmohale on your lungs. This medicine is only used to see whether you have airways sensitivity. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OSMOHALE DO NOT TAKE OSMOHALE: if you are ALLERGIC (hypersensitive) to mannitol or any of the other ingredients קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Osmohale, inhalation powder, hard capsule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 capsule contains 0 mg, 5 mg, 10 mg, 20 mg or 40 mg mannitol The delivered dose from each of the 5, 10, 20 and 40 mg capsules is approximately 3.4, 7.7, 16.5 and 34.1 mg, respectively. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Inhalation powder, hard capsule. The powder is white or almost white. The empty capsule is clear, printed with two white bands. The capsule containing 5 mg is half white, half clear, marked 5 mg. The capsule containing 10 mg is half yellow, half clear, marked 10 mg. The capsule containing 20 mg is half pink, half clear, marked 20 mg. Capsules containing 40 mg are half red, half clear, marked 40 mg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Osmohale is indicated for identifying bronchial hyperresponsiveness in subjects with a baseline forced expiratory volume in one second (FEV 1 ) of 70% or more of the predicted value. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults The capsules are supplied in kit form containing sufficient number of capsules to complete one maximum dose challenge, and an inhaler. The airway response to Osmohale is measured using the forced expiratory volume in one second FEV 1. _Paediatric population_ The Osmohale test should not be used in children aged under 6 years because of their inability to provide reproducible spirometric measurements (see section 5.1). There is limited information on the use of Osmohale in patients 6-18 years of age therefore Osmohale is not recommended in this population. Method of administration Prior to the challenge, spirometry should be performed and the reproducibility of the baseline FEV 1 established. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ קרא את המסמך השלם