Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
CHLOROPROCAINE HYDROCHLORIDE
B. Braun Melsungen AG
N01BA; N01BA04
CHLOROPROCAINE HYDROCHLORIDE
10 milligram(s)/millilitre
Solution for injection
Esters of aminobenzoic acid; chloroprocaine
Marketed
2012-07-13
PACKAGE LEAFLET 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, pharmacist or nurse. - If you get any 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 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 contains the active substance chloroprocaine hydrochloride. It 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, medicinal products of the PABA (para- aminobenzoic acid) ester group, 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, - if you have general or specific contraindications to the method of administration. 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 reaction to an anaesthetic in the past - if you have signs of skin infection or inflammation at or near the proposed site of the injection - if you are suffering from any of the following: - diseases of the central nervous system such as meningitis, polio and problems with Leggi il documento completo
Health Products Regulatory Authority 14 January 2022 CRN00C6L3 Page 1 of 8 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 The equipment, medicinal products and personnel capable of dealing with an emergency, e.g. maintaining the patency of the airways and administering oxygen, must be immediately available, since in rare cases severe reactions, sometimes with a fatal outcome, have been reported after using local anaesthetics, even in the absence of individual hypersensitivity in the patient's case history. The doctor in charge is responsible for taking the measures needed to avoid an intravascular injection and should be fully trained in emergency medicine and resuscitation to be ready to prevent and treat the side effects and complication of the procedure. Posology Posology must be established on an individual basis in accordance with the characteristics of the specific case. When determining the dose, the patient’s physical condition and the concomitant administration of other medicinal products should be taken into consideration. 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 rega Leggi il documento completo