Land: Malta
Sprog: engelsk
Kilde: Malta Medicines Authority
BUPIVACAINE HYDROCHLORIDE
Mercury Pharmaceuticals (Ireland) Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland
N01BB01
BUPIVACAINE HYDROCHLORIDE 2.5 mg/ml
SOLUTION FOR INJECTION
BUPIVACAINE HYDROCHLORIDE 2.5 mg/ml
POM
ANESTHETICS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-09-17
PACKAGE LEAFLET: INFORMATION FOR THE USER BUPIVACAINE HYDROCHLORIDE 0.25% W/V SOLUTION FOR INJECTION AND BUPIVACAINE HYDROCHLORIDE 0.5% W/V SOLUTION FOR INJECTION 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. 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Bupivacaine Hydrochloride 0.25%w/v solution for Injection and 0.5% w/v solution for injection. It will be referred to as Bupivacaine Injection for ease hereafter. What is in this leaflet: 1. What Bupivacaine Injection is and what it is used for 2. What you need to know before you take Bupivacaine Injection 3. How to take Bupivacaine Injection 4. Possible side effects 5. How to store Bupivacaine Injection 6. Contents of the pack and other information 1. WHAT BUPIVACAINE INJECTION IS AND WHAT IT IS USED FOR Bupivacaine Hydrochloride is a local anaesthetic; it produces loss of feeling or sensation that is confined to one part of the body. Bupivacaine belongs to a group of medicines called amide type local anaesthetics. Bupivacaine Injection is used to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to: - numb parts of the body during surgery in adults and children above 12 years - relieve pain in adults, infants and children above 1 year of age 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUPIVACAINE INJECTION DO NOT TAKE BUPIVACAINE INJECTION IF: You are allergic (hypersensitive) to bupivacaine hydrochloride or any of the other ingredients of Bupivacaine Injection (see Section 6: Further information). • you are allergic to Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bupivacaine Hydrochloride 0.25% w/v Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10ml of sterile solution for injection contains Bupivacaine Hydrochloride Equivalent to 25mg of Anhydrous Bupivacaine Hydrochloride (2.5 mg in 1ml) For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection A colourless or almost colourless sterile aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Surgical anaesthesia in adults and children above 12 years of age • Acute pain management in adults, infants and children above 1 year of age The suggested dose and strength of solution appropriate for each indication are provided in Section 4.2. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Routes of administration: Infiltration by injection. Epidural. Caudal. _ _ Posology The dosage varies and depends upon the area to be anaesthetised, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tolerance and the technique of anaesthesia used. The lowest dosage needed to provide effective anaesthesia should be administered. For most indications, the duration of anaesthesia with bupivacaine solutions is such that a single dose is sufficient. The maximum dosage must be determined by evaluating the size and physical status of the patient and considering the usual rate of systemic absorption from a particular injection site. Experience to date indicates a single dose of up to 150 mg bupivacaine hydrochloride. Doses of up to 50 mg 2-hourly may subsequently be used. A maximum dose of 2 mg/kg should not be exceeded in any four-hour period. _ _ When prolonged blocks are used, either by continuous infusion or by repeated bolus administration, the risks of reaching a toxic plasma concentration must be considered. The dosages in the following table are recommended as a guide for use in the average adult. Individual variations in onset and duration occur. For young, elderly Læs hele dokumentet