Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
LIDOCAINE HYDROCHLORIDE
Mercury Pharmaceuticals (Ireland) Ltd
N01BB02
LIDOCAINE HYDROCHLORIDE
1 %w/v
Solution for Injection
Product subject to prescription which may not be renewed (A)
Amides
Authorised
1994-07-22
PACKAGE LEAFLET: INFORMATION FOR THE USER LIDOCAINE HYDROCHLORIDE 1% W/V 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 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 LIDOCAINE INJECTION IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIDOCAINE INJECTION 3. HOW TO TAKE LIDOCAINE INJECTION 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE LIDOCAINE INJECTION 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT LIDOCAINE INJECTION IS AND WHAT IT IS USED FOR Lidocaine Hydrochloride is a local anaesthetic. It produces loss of feeling or sensation confined to one part of the body (local anaesthesia). Lidocaine belongs to a group of medicines called amide-type local anaesthetics. Lidocaine Injection may be used to produce local anaesthesia by injection of the solution into or around a peripheral nerve or network of nerves, in children and adults. It may also be used in adults to relieve pain by administering the solution into the epidural space, which is close to the spinal cord, or into a vein in a limb that has been isolated from the circulation by means of a tourniquet. The dosage should be adjusted according to the response of the patient and the site of administration and with precautions in children and elderly. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIDOCAINE INJECTION DO NOT USE LIDOCAINE INJECTION IF YOU: • Are allergic to lidocaine or to any other amide-type of local anaesthetic or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS T Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lidocaine Hydrochloride 1% w/v Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of solution contains 10mg of Lidocaine Hydrochloride (Lignocaine Hydrochloride). Each 2ml ampoule contains 20mg of Lidocaine Hydrochloride Each 5ml ampoule contains 50mg of Lidocaine Hydrochloride Each 10ml ampoule contains 100mg of Lidocaine Hydrochloride Each 20ml ampoule contains 200mg of Lidocaine Hydrochloride For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless sterile solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a local anaesthetic agent. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Adults: Infiltration by injection. Intravenous, Epidural. Children: Infiltration by injection The dosage should be adjusted according to the response of the patient and the site of administration. The lowest concentration and smallest dose producing the required effect should be given in healthy adults. A maximum dose of 3mg/kg or 200mg, whichever is the lower, should not be exceeded. Elderly or debilitated patients require smaller doses, commensurate with age and physical status. Paediatric population: For Infiltration anaesthesia only According to nature of procedure, up to 3 mg/kg (0.3 mL/kg of 1% solution) to a maximum of 200mg, repeated not more often than every 4 hours. 4.3 CONTRAINDICATIONS Known hypersensitivity to lidocaine or to other local anaesthetics of the amide type. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Přečtěte si celý dokument