Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lidocaine hydrochloride
1%) solution for injection vials (hameln pharma Ltd
N01BB02
Lidocaine hydrochloride
10mg/1ml
Solution for injection
Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 15020100; GTIN: 5016386003356
PATIENT INFORMATION LEAFLET LIDOCAINE INJECTION WITH PRESERVATIVE 1% LIDOCAINE HYDROCHLORIDE 1. What Lidocaine Injection with Preservative 1% is and what it is used for Lidocaine Injection with Preservative 1% is a local anaesthetic and is used to produce local anaesthesia (numb a specific area) and STOP PAIN BEING FELT in the area of the body where it is administered. 2. What you need to know before you use Lidocaine Injection with Preservative 1% DO NOT USE LIDOCAINE INJECTION WITH PRESERVATIVE 1%: • if you are SENSITIVE OR ALLERGIC to Lidocaine Hydrochloride or any of the PRESERVATIVES (methylhydroxybenzoate and propylhydroxybenzoate) or other ingredients in this injection. The preservatives are often known just as benzoates or hydroxyl-benzoates. (see also section 4. “Possible side effects” for further information). Tell your doctor if you ever had an ALLERGIC or BAD REACTION , for example, skin rash or breathlessness, to ANY LOCAL ANAESTHETIC medicines or to ANY PRESERVATIVES . • if you have certain HEART disorders. Tell your doctor if you have any heart problems particularly where your heart may pump blood less efficiently, may beat irregularly, or may beat more slowly. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE USING LIDOCAINE INJECTION WITH PRESERVATIVE 1%: • if you suffer from PORPHYRIA - a disorder of the blood. Tell your doctor if you have any blood disorders. • if you suffer from a HEART or a BREATHING disorder. • if you have KIDNEY or LIVER disease. • if you are feeling UNWELL or RUN DOWN for any reason. • if you suffer from EPILEPSY or have FITS . • if you have MYASTHENIA GRAVIS (a condition causing weakness of your muscles). • if you are in SHOCK . • if you have a BLOOD DISORDER or an IMBALANCE in the CONSTITUENTS of your BLOOD . Important information about your medicine ► Your doctor or nurse will give you the injection ► If this injection causes you any problems talk to your doctor, nurse or pharmacist ► Please tell your doctor or pharma Read the complete document
OBJECT 1 LIDOCAINE INJECTION BP WITH PRESERVATIVE 1% Summary of Product Characteristics Updated 05-Jun-2015 | hameln pharmaceuticals ltd 1. Name of the medicinal product Lidocaine Injection BP with Preservative 1 % 2. Qualitative and quantitative composition Each 1 ml contains 10.0 mg of lidocaine hydrochloride, corresponding to 8.1 mg lidocaine. Each 20 ml solution contains 200 mg Lidocaine Hydrochloride For the full list of excipients, see section 6.1 3. Pharmaceutical form Solution for injection. Clear and colourless solution. 4. Clinical particulars 4.1 Therapeutic indications Lidocaine Injection is used as a local anaesthetic. 4.2 Posology and method of administration Lidocaine Injection is used as a local anaesthetic when injected subcutaneously. This solution is not intended for use intravenously. Solutions of lidocaine which contain preservatives should not be used for spinal, epidural, caudal or intravenous regional anaesthesia. The dosage should be adjusted according to the response of the patient and the site of administration. The lowest concentration and the smallest dose producing the required effect should be given. The maximum single dose for healthy adults should not exceed 200 mg corresponding to 20 mls. Children and elderly or debilitated patients require smaller doses, commensurate with age and physical status. 4.3 Contraindications • Known hypersensitivity to lidocaine or other anaesthetics of the amide type • Known hypersensitivity to hydroxybenzoates • Complete heart block • Hypovolaemia 4.4 Special warnings and precautions for use As with other local anaesthetics, lidocaine should be used with caution in patients with epilepsy, cardiac conduction disturbances, (see also section 4.3 Contraindications) congestive cardiac failure, bradycardia, severe shock, impaired respiratory function or impaired renal function with a creatinine clearance of less than 10mL/minute. Lidocaine is metabolised in the liver and it should be used with caution in patients with impaired hepatic function. Lid Read the complete document