Maa: Malta
Kieli: englanti
Lähde: Medicines Authority
CETRIMIDE, LIDOCAINE
Septodont 58 Rue du Pont de Créteil, 94100 SAINT MAUR DES FOSSES, France
N01BB52
CETRIMIDE 0.1 µg/dose LIDOCAINE 10 µg/dose
OROMUCOSAL SPRAY
CETRIMIDE 0.1 µg/dose LIDOCAINE 10 µg/dose
POM
ANESTHETICS
Authorised
2006-02-01
Patient Information Leaflet Page 1 / 4 Malta – Xylonor Spray Proposed changes on Sept2014 PACKAGE LEAFLET: INFORMATION FOR THE USER XYLONOR SPRAY, 10 MG/0.1 MG PER METERED DOSE, OROMUCOSAL SPRAY LIDOCAINE – CETRIMIDE 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 dentist or pharmacist. - 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 dentist or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET: 1. What Xylonor Spray is and what it is used for 2. What you need to know before you use Xylonor Spray 3. How to use Xylonor Spray 4. Possible side effects 5. How to store Xylonor Spray 6. Contents of the pack and other information 1. WHAT XYLONOR SPRAY IS AND WHAT IT IS USED FOR Xylonor Spray contains an effective anaesthetic agent, lidocaine, and an antiseptic of the quaternary ammonium group, cetrimide. Xylonor Spray is used for topical anaesthesia and disinfection of the mucous membrane in the buccal cavity. Xylonor Spray is indicated in adults, and in children and adolescents aged 3 to 18 years of age. Only a dentist can administer this product. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE XYLONOR SPRAY DO NOT USE XYLONOR SPRAY - If you are allergic to lidocaine or cetrimide or any of the other ingredients of this medicine (listed in section 6). - In children under 3 years old. WARNINGS AND PRECAUTIONS Talk to your dentist before taking Xylonor Spray if: - You have a severe infection or an inflammation in the area where the application will be done. - Lue koko asiakirja
Page 1 of 6 1. NAME OF THE MEDICINAL PRODUCT Xylonor Spray, 10 mg/0.1 mg per metered dose, oromucosal spray 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose contains 10 mg Lidocaine and 0.10 mg Cetrimide For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal spray, solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Xylonor Spray is indicated in topical anaesthesia and disinfection of the mucous membrane in the buccal cavity, especially: - before the performance of a local or nerve block injection, - prior to the extraction of mobile, deciduous or permanent teeth, - prior to the adjustment and fitting of crowns and bridges or the adjustment of band in orthodontic treatments, - prior to scaling, - prior to the lancing of sub-mucosal abscesses. Xylonor Spray is indicated in adults, and in children and adolescents aged 3 to 18 years of age. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology 1 metered dose containing 10 mg of lidocaine is usually sufficient to achieve anaesthesia on a particular site. Two may be used. Dosage schedule: The application of one dose may be repeated in 4 or 5 (40-50 mg) different areas of the buccal mucosa during the same sitting; but no more than 3 doses should be applied to the same quadrant. Only one quadrant should be anaesthetized during the course of one sitting. A dose of 200 mg lidocaine should not be exceeded. Method of administration The tip of the nozzle should be placed at about two cm from the area to be anaesthetized. The actuation of the valve emits a dose of spray covering an area of about 1 cm in diameter. The product may be used on all categories of patients. Page 2 of 6 4.3. CONTRAINDICATIONS Hypersensitivity to lidocaine or cetrimide or to any of the excipients listed in section 6.1. Children below 3 years of Lue koko asiakirja