国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Lidocaine; Tetracaine
Eurocept International BV
N01BB; N01BB52
Lidocaine; Tetracaine
70 mg/70 milligram(s)
Medicated plaster
Product subject to prescription which may not be renewed (A)
Amides; lidocaine, combinations
Not marketed
2008-01-25
RAPY IE+UK en var016 PIL Mar2017 Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER RAPYDAN 70MG/70MG MEDICATED PLASTER Lidocaine/Tetracaine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Rapydan is and what it is used for 2. Before you use Rapydan 3. How to use Rapydan 4. Possible side effects 5 How to store Rapydan 6. Further information 1. WHAT RAPYDAN IS AND WHAT IT IS USED FOR Rapydan contains two local anaesthetics – lidocaine and tetracaine. These medicines are used to numb a small area of skin before a procedure that might be painful, such as an injection or a minor surgical procedure. 2. BEFORE YOU USE RAPYDAN DO NOT USE RAPYDAN - if you are allergic (hypersensitive) to lidocaine, tetracaine or sodium borate or any of the other ingredients of Rapydan (see section 6). - if you are allergic (hypersensitive) to other local anaesthetics. - if you are allergic (hypersensitive) to para-aminobenzoic acid, a compound that is formed when your body breaks down tetracaine. Do not use Rapydan on broken or damaged skin or on mucous membranes, e.g. inside the mouth or nose. TAKE SPECIAL CARE WITH RAPYDAN Tell your doctor or pharmacist - if you have problems with your liver, kidney or heart. - if you are very unwell or in poor physical condition, because you may be more sensitive to the effects of lidocaine and tetracaine. Rapydan should be used with caution close to the eyes. If Rapydan comes into contact with your eye, immediately rinse your eye with water or salt solution and protect it until feeling returns. Rapydan contains a heat-releasing component that may reac 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rapydan 70 mg/70 mg medicated plaster 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each medicated plaster contains 70 mg of lidocaine and 70 mg of tetracaine. Excipients: 0.35 mg methyl parahydroxybenzoate, 0.07 mg propyl parahydroxybenzoate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Medicated plaster. Oval, light brown plaster (approximate dimensions: 8.5 cm x 6.0 cm) with a removable opaque plastic tray. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Surface anaesthesia of the skin in connection with needle puncture and in cases of superficial surgical procedures (such as excision of various skin lesions and punch biopsies) on normal intact skin in adults. Surface anaesthesia of the skin in connection with needle puncture on normal intact skin in children from 3 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults (including elderly):_ 1 or at most 4 plasters simultaneously. Maximum 4 plasters per 24 hours. _Children from 3 years of age:_ 1 or at most 2 plasters simultaneously. Maximum 2 plasters per 24 hours. _Application time:_ 30 minutes. The plaster should be applied for the duration of 30 minutes before needle puncture or a superficial surgical procedure is conducted as a shorter duration may result in a decreased efficacy. Please note that the medicated patch contains a heat-releasing component that may reach a maximum temperature of 40°C, with a mean temperature of 26-34°C. If considered necessary, hairs in the affected area can be cut off (not shaved) before the plaster is applied to ensure that there is adequate contact between the skin and the plaster. Rapydan medicated plasters are for single use only, and should be used immediately once the sachet has been opened. Used plasters should be discarded carefully in accordance with instructions given in section 6.6. _Children under 3 years of age:_ Use of Rapydan is strongly discouraged for children under the age of 3 years due to insufficient clin 阅读完整的文件