Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
FUSAFUNGINE
Servier Laboratories (Ireland) Ltd
FUSAFUNGINE
125 Microgram
Nasal Spray Solution
Product subject to prescription which may not be renewed (A)
Withdrawn
2014-09-24
_LOCABIOTAL_ _®_ _ _ _ _ _PA 68/15/1 _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LOCABIOTAL PRESSURISED 125 MICROGRAMS Nasal/Oromucosal spray solution Fusafungine 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 further questions, please ask your doctor, or pharmacist or nurse - This medicine has been prescribed for you. 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What LOCABIOTAL is and what it is used for 2. What you need to know before you take LOCABIOTAL 3. How to use LOCABIOTAL 4. Possible side effects 5. How to store LOCABIOTAL 6. Contents of the pack and further information 1. WHAT LOCABIOTAL IS AND WHAT IT IS USED FOR LOCABIOTAL is a local antibiotic with anti-inflammatory properties for treatment of local infections and inflammatory conditions of the nose and throat. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LOCABIOTAL DO NOT USE LOCABIOTAL: - If you are allergic (sensitive) to the active substance fusafungine or any of the other ingredients of LOCABIOTAL. (listed in section 6) - the treatment is not recommended in children under 30 months (risk of laryngospasm). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist or nurse before using LOCABIOTAL. This medicine should be used with caution: - If you use LOCABIOTAL for a long period of time, it may cause superinfection. If your condition does n read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Locabiotal Pressurised 125 micrograms, Nasal/Oromucosal spray solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each puff (delivered dose, ex actuator) contains 125micrograms of fusafungine. The concentration of the solution is 500mg of fusafungine for 100ml. For full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Nasal/Oromucosal spray solution . Yellow solution with a characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of local infections of the nasal passages and oropharynx due to micro-organisms sensitive to this anti- infective. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults 4 puffs in the mouth and 2 puffs in each nostril 4 times daily. Special populations _Elderly population_ There is no dose adjustment necessary for elderly patients _Renal impairment_ There is no dose adjustment necessary for patients suffering from renal impairment _Hepatic impairment_ There is no dose adjustment necessary for patients suffering from hepatic impairment _Paediatric population_ Locabiotal should not be used in children aged 0 to 30 months because of safety concerns (see section 4.3). Children over 30 months : 2 puffs in the mouth and (or) 1 puff in each nostril 4 times daily. Method of administration Via the mouth and the nose using the appropriate attachment. Before the very first use, press 4 times on the main actuator so as to prime the valve. The bottle must be held upright between the thumb and index finger with the actuator uppermost. To administer the drug, place the mouth adaptor (white) in the mouth, closing the lips around it. Then press firmly and at length on the adaptor while breathing normally. Use the same procedure for nasal administration, after f read_full_document