Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
FUSAFUNGINE
Servier Laboratories (Ireland) Ltd
FUSAFUNGINE
500 Microgram
Unknown
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
_LOCABIOTAL_ _®_ _ _ _ _ _PA68/4/1 _ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LOCABIOTAL 500 MICROGRAMS PER METERED DOSE 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 b efore 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 read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Locabiotal 500 micrograms per metered dose, Nasal/Oromucosal spray solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Fusafungine 1% w/v Each metered dose delivers approximately 500 micrograms of fusafungine. Excipients: trace amounts of ethanol (alcohol) and propylene glycol (E1520). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal/Oromucosal spray solution. The solution is oily, colourless to pale yellow, clear, 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: 1 spray actuation by mouth and (or) 1 spray actuation in each nostril every 4 hours. 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: 1 spray actuation by mouth and (or) 1 spray actuation in each nostril every 6 hours. Method of administration Via the mouth and the nose using the appropriate attachment. Before the very first use, press 5 times on the main adapter so as to prime the pump. The bottle must be held upright between the thumb and index finger with the adapter uppermost. To administer the drug, place the mouth adapter (white) in the mouth, closing the lips around it. Then press firmly and IRISH M read_full_document