Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
LIDOCAINE ; TETRACAINE
Galderma (UK) Ltd
N01BB52
LIDOCAINE ; TETRACAINE
70+70 mg/g
Cream
Product subject to prescription which may not be renewed (A)
lidocaine, combinations
Not Marketed
2012-07-20
70 mg/g + 70 mg/g, cream (lidocaine & tetracaine) PACKAGE LEAFLET: INFORMATION FOR THE USER PLIAGLIS 70 MG/G + 70 MG/G CREAM Lidocaine and Tetracaine 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 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. WHAT IS IN THIS LEAFLET: 1. What Pliaglis is and what it is used for 2. What you need to know before you use Pliaglis 3. How to use Pliaglis 4. Possible side effects 5. How to store Pliaglis 6. Contents of the pack and other information 1. WHAT PLIAGLIS IS AND WHAT IT IS USED FOR Pliaglis is a cream containing local anaesthetics, lidocaine and tetracaine which are used to numb an area of skin before a painful procedure such as needle insertion or laser treatments. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE PLIAGLIS DO NOT USE PLIAGLIS - if you are allergic to lidocaine or tetracaine, any similar local anaesthetics or any of the other ingredients of this medicine (listed in section 6). - if you know that you are allergic to para-aminobenzoic acid (sometimes called PABA), a substance that is made when your body breaks down tetracaine, methyl parahydroxy- benzoate (E218) or propyl parahydroxybenzoate (E216) - on broken or irritated skin - on mucous surfaces such as your mouth WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Pliaglis - if you have problems with your liver, kidney or heart - if you are very ill or physically weak as you may be more sensitive to Pliaglis Take care to avoid contact with the eyes. If Pliaglis comes into contact with your eye, immediately rinse your eye with water or salt solution and prot Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pliaglis 70mg/g + 70mg/g cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 gram of cream contains 70 mg lidocaine and 70 mg tetracaine. Excipients with known effect: methyl parahydroxybenzoate (E218) 0.5 mg/g propyl parahydroxybenzoate (E216) 0.1 mg/g For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream White to off-white viscous cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pliaglis is indicated in adults to produce local dermal anaesthesia on intact skin prior to dermatological procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For use in adults and elderly: For dermatological procedures such as pulsed-dye laser therapy, laser-assisted hair removal, non-ablative laser facial resurfacing, dermal filler injections and vascular access, Pliaglis should be applied onto intact skin at a thickness of approximately 1mm for 30 minutes (approximately 1.3 g of cream per 10 cm 2 ). After the required time, the peel must then be removed from the skin prior to the procedure. For dermatological procedures such as laser-assisted tattoo removal, and laser leg vein ablation, Pliaglis should be applied onto intact skin at a thickness of approximately 1mm for 60 minutes (approximately 1.3 g of cream per 10 cm 2 ). After the required time, the peel must then be removed from the skin prior to the procedure. The maximum application area should not exceed 400 cm 2 . Surface Area of Treatment Site (cm2) Approximate weight of Pliaglis Dispensed (g) 10 1.3 2 fingertip units 50 6.5 Half content of a 15g tube 100 13 Full content of a 15g tube 200 26 Full content of a 30g tube 400 52 Full content of two 30g tubes H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Đọc toàn bộ tài liệu