Country: Sweden
Bahasa: Sweden
Sumber: Läkemedelsverket (Medical Products Agency)
lidokainhydrokloridmonohydrat
Ebb Medical AB
N01BB02
lidokainhydrokloridmonohydrat
20 mg/ml
Injektionsvätska, lösning
lidokainhydrokloridmonohydrat 21,33 mg Aktiv substans
Receptbelagt
Förpacknings: Ampull, 10 x 5 ml
Avregistrerad
2017-02-15
PACKAGE LEAFLET: INFORMATION FOR THE USER LIDOCAINE GRINDEKS 20 MG/ML SOLUTION FOR INJECTION lidocaine hydrochloride 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, pharmacist or nurse. - 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, 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 Grindeks is and what it is used for 2. What you need to know before you are given Lidocaine Grindeks 3. How Lidocaine Grindeks is given 4. Possible side effects 5. How to store Lidocaine Grindeks 6. Contents of the pack and other information 1. WHAT LIDOCAINE GRINDEKS IS AND WHAT IT IS USED FOR Lidocaine Grindeks is a local anaesthetic. It is used to numb parts of the body during small surgical procedures in adults. It stops the nerves from being able to pass pain messages to the brain and so stops you feeling pain. It starts to work a few minutes after being injected and slowly wears off when the surgical procedure is over. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LIDOCAINE GRINDEKS DO NOT USE LIDOCAINE GRINDEKS - if you are allergic to lidocaine hydrochloride, to local anaesthetics of the amide type or any of the other ingredients of this medicine (listed in section 6); - if you have very low blood pressure, or if you have lost too much blood or other body fluids or your heart is unable to pump enough blood for other reasons, you should not get Lidocaine Grindeks injected into your spine. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before having Lidocaine Grindeks injection if: you are elderly or in a generally debilitated condition, you have heart problems such as a slow or irregular h Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lidocaine Grindeks 20 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains 20 mg lidocaine hydrochloride. Each 5 ml ampoule contains 100 mg lidocaine hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection A clear, colourless or slightly yellowish liquid, free from visible particles. pH of solution 5.0-7.0 Osmolality of solution 0.310-0.340 Osmol/kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intravenous regional anaesthesia, infiltration anaesthesia, nerve blocks and epidural anaesthesia. Lidocaine Grindeks is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Lidocaine Grindeks should only be used by, or under the supervision of, doctors with experience of regional anaesthesia. The lowest possible dose producing the required effect should be given. Aspiration to control for accidental intravenous injection is recommended before injection of the full dose. Inject slow and keep contact with the patient during injection. For epidural injection, a small test dose of 3-5 ml is recommended. Injection of a cold solution below the body temperature should be avoided, as this could be painful. _Intravenous regional anaesthesia_ Arm: 5-10 ml of solution (100-200 mg of lidocaine hydrochloride). Leg: 10 ml of solution (200 mg of lidocaine hydrochloride). _Nerve blocks_ 1-2 ml of solution (20-40 mg of lidocaine hydrochloride). _Epidural anaesthesia_ Lumbar analgesia: 12.5-20 ml of solution (250-400 mg of lidocaine hydrochloride). Thoracic anaesthesia: 10-15 ml of solution (200-300 mg of lidocaine hydrochloride). Sacral surgery analgesia: 20 ml of solution (400 mg of lidocaine hydrochloride). Sacral obstetric analgesia:10-15 ml of solution (200-300 mg of lidocaine hydrochloride). The recommended maximum single dose of lidocaine hydrochloride should not exceed 400 mg. The dose should be reduced for patients in poor general condition Baca dokumen lengkap