Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Lidocaine hydrochloride
Laboratoire AGUETTANT
N01BB; N01BB02
Lidocaine hydrochloride
20 milligram(s)/millilitre
Solution for injection in pre-filled syringe
Product subject to prescription which may not be renewed (A)
Amides; lidocaine
Not marketed
2018-07-20
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LIDOCAINE 20 MG/ML (2 % W/V) SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE Lidocaine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or nurse. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lidocaine is and what it is used for 2. What you need to know before you are given Lidocaine 3. How Lidocaine is given 4. Possible side effects 5. How to store Lidocaine 6. Contents of the pack and other information 1. WHAT LIDOCAINE IS AND WHAT IT IS USED FOR Lidocaine contains the active substance lidocaine hydrochloride. Lidocaine is a local anaesthetic. It is used to numb parts of the body during surgical procedures. It stops the nerves from being able to pass pain messages to the brain and so stops you feeling pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LIDOCAINE YOU MUST NOT BE GIVEN LIDOCAINE : - if you are allergic to lidocaine, local anaesthetics of the amide type or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before you are given Lidocaine : - if you suffer from epilepsy. Your doctor will monitor you closely for manifestation of symptoms. - if you have kidney or liver disease. - if you have a disease leading to muscle weakness (myasthenia gravis). - if you have heart disorders including conduction disorders, slow heartbeat. - if you have respiratory depression (breathing difficulties with slow and shallow breathing). - if you are elderly or have a poor general health condition. - if you have, or are treated for, bleeding disorders. Additionally your doctor knows that an injection of this medicine into inflamed tissue may lead to an incr Read the complete document
Health Products Regulatory Authority 25 October 2023 CRN00DQWC Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lidocaine 20 mg/ ml (2% w/v) solution for injection in pre-filled syringe 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution for injection contains 20 mg of lidocaine hydrochloride (as lidocaine hydrochloride monohydrate). Each 10 ml pre-filled syringe contains 200 mg of lidocaine hydrochloride (as lidocaine hydrochloride monohydrate). Excipient with known effect: Each ml of solution for injection contains 2.3 mg equivalent to 0.10 mmol of sodium. Each 10 ml pre-filled syringe contains 23 mg equivalent to 1.0 mmol of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection (injection). Clear and colorless solution pH: 5.0 to 6.5 Osmolality: 270-330 mOsm/Kg 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lidocaine is indicated in infiltration anaesthesia and peripheral nerve block anaesthesia. Lidocaine 20 mg/ml (2 % w/v) is indicated for adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Lidocaine should only be used by or under the supervision of, doctors with experience of regional anaesthesia and resuscitative skills. Facilities for resuscitation should be available when administering local anaesthetics. Posology The lowest concentration and smallest dose producing the required effect should be given. _Adults_ The dose should be adjusted according to the response of the patient, the site of administration, and the expected duration of the surgical procedure. It should be considered that usual total dose of lidocaine is 3–5 mg/kg; corresponding to volumes of 2 to 20 mL (at 10 mg/ml) and 1 to 10 mL (at 20 mg/ml). The generally maximum recommended total dose of lidocaine should not exceed 200 mg in adults for infiltration and peripheral nerve block, but depending on the procedure and patient factors, higher maximum doses may be required. The volume of the solution used plays a role in the size of the area of spr Read the complete document