Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
CHLOROPROCAINE HYDROCHLORIDE
Mercury Pharmaceuticals Ltd
N01BA04
CHLOROPROCAINE HYDROCHLORIDE
10 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Esters of aminobenzoic acid
Authorised
2012-07-13
PACKAGE LEAFLET: INFORMATION FOR THE USER AMPRES 10 MG/ML SOLUTION FOR INJECTION chloroprocaine hydrochloride 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 or pharmacist. - If you get any side effects, talk to your doctor, or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Ampres is and what it is used for 2. What you need to know before you are given Ampres 3. How Ampres is used 4. Possible side effects 5. How to store Ampres 6. Contents of the pack and other information 1. WHAT AMPRES IS AND WHAT IT IS USED FOR Ampres is a type of medicine called local anaesthetic, belonging to the category of the esters, and is a solution for injection. Ampres is used to anaesthetise (numb) specific parts of the body and prevent pain during surgery. Ampres is indicated in adults only. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AMPRES DO NOT USE AMPRES: - if you are allergic to chloroprocaine hydrochloride, other ester-type local anaesthetics or any of the other ingredients of this medicine (listed in section 6), - if you have serious problems with cardiac conduction, - if you suffer from severe anaemia, It is also necessary to take into consideration general and specific contraindications for the technique of spinal anaesthesia = intrathecal anaesthesia (decompensated cardiac insufficiency, hypovolemic shock). WARNINGS AND PRECAUTIONS If you suffer of any of these, you should discuss it with your doctor BEFORE being given this medicine. - if you have ever had a bad Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ampres 10mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains 10 mg of chloroprocaine hydrochloride 1 ampoule with 5 ml solution, contains 50 mg of chloroprocaine hydrochloride Excipients with known effect: 1 ml of solution contains 2.8 mg sodium For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. The pH of the solution is comprised between 3.0 and 4.0. The osmolality of the solution is comprised between 270 – 300 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Posology must be established on an individual basis in accordance with the characteristics of the specific case. When determining the dose, take into consideration the patient’s physical condition and the concomitant administration of other medicinal products. The duration of action is dose-dependent. The indications relating to recommended doses are valid in adults of average height and weight (approximately 70 kg) for obtaining an effective block with one single administration. There are wide individual variations with regard to extent and duration of action. The experience of the anaesthetist and knowledge of the patient’s general condition are essential for establishing the dose. With regard to posology the following guidelines are applied: _Posology Adults_ The maximum recommended dose is 50mg (=5ml) of chloroprocaine hydrochloride. _Extension of sensory_ _blockade required_ _T10_ _ml_ _mg_ _Average duration of_ _action (minutes)_ 4 5 40 50 80 100 HEALTH PRODUCTS REGULATORY AUTH Aqra d-dokument sħiħ