देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
fusafungine
Les Laboratoires Servier
R02AB03
fusafungine
nasal/oromucosal spray solution
Authorised
2005-07-29
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LOCABIOTAL 1 %, 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 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. 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 take LOCABIOTAL 4. Possible side effects 5. How to store LOCABIOTAL 6. Contents of the pack and other information 1. WHAT LOCABIOTAL IS AND WHAT IT IS USED FOR LOCABIOTAL is recommended as adjuvant treatment for certain conditions affecting the upper respiratory tract. LOCABIOTAL is indicated in adults and adolescents aged 12 years and over. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOCABIOTAL DO NOT TAKE LOCABIOTAL - if you are allergic (hypersensitive) to fusafungine or any of the other ingredients of LOCABIOTAL. - for use in children under 12 years. - if you have allergic tendencies or if you have already had a feeling of breathlessness following a contraction of the airways (bronchospasm). WARNING AND PRECAUTIONS LOCABIOTAL is not suitable for prolonged treatment as it could produce an imbalance in your normal microbial flora with a risk of bacterial growth. Therefore, the duration of the treatment shoul पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT LOCABIOTAL 1 %, nasal/oromucosal spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Fusafungine ........................................................................................................ 50 mg for 5 ml of solution. Each metered dose contains 50 µg of solution which is equivalent to 500 µg of fusafungine. Excipients with known effect: ethanol and propylene glycol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Nasal/oromucosal spray, solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Local antibacterial adjuvant treatment of diseases of the upper respiratory tract. It is advisable to follow the official recommendations concerning the appropriate use of antibacterials. LOCABIOTAL is indicated in adults and adolescents aged 12 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One spray actuation through the mouth or in each nostril every 4 hours. Usual treatment should not exceed 7 days; beyond this, treatment management should be reassessed. Method of administration Prime the pump before using for the very first time (see section 6.5). 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Children under 12 years (see section 4.8). - Patients with allergic tendencies and bronchospasm (see section 4.8). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In case of allergic reaction, LOCABIOTAL should be stopped and not be readministered (see section 4.8). Due to risk of anaphylactic shock, in case of respiratory, laryngeal or cutaneous (pruritus, generalised erythema) signs, an intramuscular injection of पूरा दस्तावेज़ पढ़ें