Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lidocaine
Aspen Pharma Trading Ltd
R02AD02
Lidocaine
10mg/1actuation
Spray
Oromucosal; Nasal; Gingival; Cutaneous; Endotracheopulmonary; Endosinusial
No Controlled Drug Status
Valid as a prescribable product
BNF: 15020100; GTIN: 5014162001695
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE USER XYLOCAINE ® 10 MG SPRAY lidocaine READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS GIVEN TO YOU 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, nurse, dentist 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 your doctor, nurse, dentist or pharmacist. This includes any possible side effects not listed in this leaflet . See section 4. WHAT IS IN THIS LEAFLET : 1. What Xylocaine Spray is and what it is used for 2. What you need to know before Xylocaine Spray is given to you 3. How Xylocaine Spray is given to you 4. Possible side effects 5. How to store Xylocaine Spray 6. Contents of the pack and other information 1. WHAT XYLOCAINE SPRAY IS AND WHAT IT IS USED FOR The name of your medicine is ‘Xylocaine 10 mg Spray’. It is referred to as ‘Xylocaine Spray’ in the rest of this leaflet. Xylocaine Spray contains a medicine called lidocaine. This belongs to a group of medicines called local anaesthetics. Xylocaine Spray is used to numb (anaesthetise) parts of the body. It stops pain happening during: • Medical examinations and operations of the nose and throat. • Childbirth, and after the birth if stitches are needed. • Treatment at the dentist. 2. WHAT YOU NEED TO KNOW BEFORE XYLOCAINE SPRAY IS GIVEN TO YOU YOU MUST NOT BE GIVEN XYLOCAINE SPRAY: • if you are allergic to lidocaine or any of the other ingredients of this medicine (listed in section 6). • if you are allergic to any other local anaesthetics of the same class (such as prilocaine or bupivacaine). You must not be given Xylocaine Spray if any of the above apply to you. If you are not sure, talk to your doctor, nurse, dentist or pharmacist before you are given Xylocaine Spray. WARNINGS AND PRECAUTIONS Talk to your do Olvassa el a teljes dokumentumot
OBJECT 1 XYLOCAINE 10MG SPRAY Summary of Product Characteristics Updated 07-Feb-2017 | Aspen 1. Name of the medicinal product Xylocaine 10 mg Spray 2. Qualitative and quantitative composition Lidocaine 10 mg/dose. Excipient(s) with known effect: Each depression also delivers 1 mg of propylene glycol (an excipient of the banana essence). Also contains ethanol. For the full list of excipients see section 6.1. 3. Pharmaceutical form Topical anaesthetic pump spray. 4. Clinical particulars 4.1 Therapeutic indications For the prevention of pain associated with the following procedures: Otorhinolaryngology Puncture of the maxillary sinus and minor surgical procedures in the nasal cavity, pharynx and epipharynx. Paracentesis. Obstetrics During the final stages of delivery and before episiotomy and perineal suturing as supplementary pain control. Introduction of instruments and catheters into the respiratory and digestive tract Provides surface anaesthesia for the oropharyngeal and tracheal areas to reduce reflex activity, attenuate haemodynamic response and to facilitate insertion of the tube or the passage of instruments during endotracheal intubation, laryngoscopy, bronchoscopy and oesophagoscopy. Dental practice Before injections, dental impressions, X-ray photography, removal of calculus. 4.2 Posology and method of administration As with any local anaesthetic, reactions and complications are best averted by employing the minimal effective dosage. Debilitated or elderly patients and children should be given doses commensurate with their age and physical condition. Xylocaine Spray should not be used on cuffs of endotracheal tubes (ETT) made of plastic (see also section 4.4). Each activation of the metered dose valve delivers 10 mg lidocaine base. It is unnecessary to dry the site prior to application. No more than 20 spray applications should be used in any adult to produce the desired anaesthetic effect. The number of sprays depend on the extent of the area to be anaesthetised. Dental practice 15 applicatio Olvassa el a teljes dokumentumot