Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
BUPIVACAINE HYDROCHLORIDE
Amneal Pharma Europe Limited
BUPIVACAINE HYDROCHLORIDE
2.5 Mg/Ml
Solution for Injection
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER BUPIVACAINE-AMNEAL 2.5 MG/ML SOLUTION FOR INJECTION BUPIVACAINE-AMNEAL 5 MG/ML SOLUTION FOR INJECTION Bupivacaine hydrochloride monohydrate 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 of the 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 Bupivacaine-Amneal is and what it is used for 2. What you need to know before you are given Bupivacaine-Amneal 3. How to use Bupivacaine-Amneal 4. Possible side effects 5. How to store Bupivacaine-Amneal 6. Contents of the pack and other information _ _ _ _ 1. WHAT BUPIVACAINE-AMNEAL IS AND WHAT IT IS USED FOR Bupivacaine-Amneal contains a medicine called bupivacaine hydrochloride. It belongs to a group of medicines called amide-type local anaesthetics. It produces a loss of feeling or sensation that is confined to one part of the body. Bupivacaine-Amneal 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 ARE GIVEN BUPIVACAINE-AMNEAL _ _ DO NOT USE BUPIVACAINE-AMNEAL: If you are allergic (hypersensitive) to bupivacaine hydrochloride mo Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bupivacaine Amneal 2.5mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 2.5 mg of bupivacaine hydrochloride monohydrate Each vial with 10 ml solution contains 25 mg of bupivacaine hydrochloride monohydrate. Each vial with 20 ml solution contains 50 mg of bupivacaine hydrochloride monohydrate. Excipient with known effect: Each ml of the solution contains 3.15 mg of sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear, colourless, aqueous, sterile solution. pH of the solution is between 4.0 and 6.5 and osmolarity is 290 mOsmol/l. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the production of local anaesthesia by peripheral nerve block(s) and central neural block (caudal or epidural), that is, for specialist use in situations where prolonged anaesthesia is required. Bupivacaine-Amneal is also indicated for the relief of labour pain. - Surgical anaesthesia in adults and children above 12 years of age - Acute pain management in adults, infants and children above 1 year of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS AND CHILDREN ABOVE 12 YEARS OF AGE 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 abs Přečtěte si celý dokument