מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Cetrimide; Lidocaine
Septodont
D08AJ; D08AJ04; N01BB02
Cetrimide; Lidocaine
10 mg/0.1 milligram(s)/dose
Oromucosal spray, solution
Product subject to prescription which may not be renewed (A)
Quaternary ammonium compounds; cetrimide; lidocaine
Marketed
1999-09-17
WHAT IS IN THIS LEAFLET 1. What Xylonor is and what it is used for 2. What you need to know before you use Xylonor 3. How to use Xylonor 4. Possible side effects 5. How to store Xylonor 6. Contents of the pack and other information 1. WHAT XYLONOR IS AND WHAT IT IS USED FOR Local anaesthetic. Oromucosal spray, solution containing 36g of solution. Xylonor contains lidocaine, an anaesthetic agent which stabilises the neuronal membrane and prevents the initiation and conduction of nerve impulses, thereby effecting local anaesthesia. Cetrimide is an antiseptic of the quaternary ammonium group with both bactericidal and detergent properties. Xylonor allows a topical anaesthesia of the mucous membrane in the oral cavity. Xylonor is used for production of topical anaesthesia and disinfection of the mucous membrane in the buccal cavity. Xylonor is indicated in adults, adolescents and children from aged 6. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE XYLONOR DO NOT USE XYLONOR SPRAY - if you are hypersensitive (allergic) to lidocaine and/or cetrimide or to any of the other ingredients of this medicine (listed in section 6). - in children under 6 years of age. WARNINGS AND PRECAUTIONS Take special care with Xylonor : - in debilitated, elderly patients, acutely ill patients and children. In these cases, reduced doses should be given, commensurate with the age and the physical status of the patient. - if there is sepsis or extremely traumatised mucosa in the area of application. - in persons with known drug sensitivities. Do not spray back of throat or mouth. OTHER MEDICINES AND XYLONOR Tell your doctor, pharmacist or dentist if you are taking or have recently taken any other medicines, even those not prescribed. - soaps and anionic surfactants known to decrease the bactericidal activity of cetrimide - other local anaesthetics or antiarrhythmic drugs - beta-adrenergic blocking agents which may slow metabolism of lidocaine because of decreased hepatic blood flow - cimetidine (drugs against stomach ulcer) which may inhibit hepatic קרא את המסמך השלם
Health Products Regulatory Authority 27 March 2019 CRN008M2S Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xylonor 150 mg/g + 1.5 mg/g oromucosal spray, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 gram of solution contains 150 mg of lidocaine and 1.5 mg of cetrimide Each actuation delivers approximately a dose of 10 mg of lidocaine and 0.1 mg of cetrimide. Excipients with known effect: this medicinal product contains 45.45 g of ethanol 96% per 100g of solution. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oromucosal spray, solution. Colourless to slightly yellow liquid with an odour of spearmint. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xylonor is indicated for the production of 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 is indicated in adults, adolescents and children from aged 6. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Recommended doses: 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 patient קרא את המסמך השלם