País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Bupivacaine hydrochloride
Aspen Pharma Trading Limited
N01BB; N01BB01
Bupivacaine hydrochloride
0.25 percent weight/volume
Solution for injection
Product subject to prescription which may not be renewed (A)
Amides; bupivacaine
Marketed
1988-09-19
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER MARCAIN POLYAMP STERIPACK 0.25% W/V AND 0.5% W/V SOLUTION FOR INJECTION bupivacaine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS GIVEN TO YOU 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 nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Marcain Polyam p Steripack is and what it is used for 2. What you need to know before Marcain Polyamp Steripack is given to you 3. How Marcain Polyamp Steripack is given to you 4. Possible side effects 5. How to store Marcain Polyamp Steripack 6. Contents of the pack and other information 1. WHAT MARCAIN POLYAMP STERIPACK IS AND WHAT IT IS USED FOR Marcain Polyamp Steripack contains a medicine called bupivacaine hydrochloride. It belongs to a group of medicines called local anaesthetics. Marcain Polyamp Steripack 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 MARCAIN POLYAMP STERIPACK IS GIVEN TO YOU YOU MUST NOT BE GIVEN MARCAIN POLYAMP STERIPACK: • If you are allergic to bupivacaine hydrochloride or any of the other ingredients of this medicine (listed in section 6). • If you are allergic to any other local anaesthetics of the same class (such as lidocaine or ropivacaine). • If you have a skin infection near to where the injection will be given. You must not be given this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine. WARNINGS AND PRECAUTIONS Talk to your doctor or nurse before having Marcain Polyamp Llegiu el document complet
Health Products Regulatory Authority 19 April 2023 CRN00DGML Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Marcain Polyamp Steripack 0.25% w/v Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bupivacaine hydrochloride equivalent to bupivacaine hydrochloride anhydrous 2.5 mg/ml. Excipient(s) with known effect: sodium (31.47 mg per 10 ml ampoule and 62.94 mg per 20 ml ampoule). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection A clear, colourless, aqueous, sterile 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 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 Marcain 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 yo Llegiu el document complet