Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
CHLOROPROCAINE HYDROCHLORIDE
B. Braun Melsungen AG
N01BA; N01BA04
CHLOROPROCAINE HYDROCHLORIDE
20 milligram(s)/millilitre
Solution for injection
Esters of aminobenzoic acid; chloroprocaine
Not marketed
2020-06-26
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER AMPRES 20 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 of aminobenzoic acid. Ampres is used to anaesthetise (numb) specific parts of the body and prevent pain during surgery by injecting the solution in proximity to the selected nerves. 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 there are general and specific contra-indications to regional anaesthesia regardless of the local anaesthetic used, - if you have been told that you have decreased volume of blood (hypovolemia), - if you have serious problems with cardiac conduction. 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 yo Прочитать полный документ
Health Products Regulatory Authority 14 January 2022 CRN00C6L3 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ampres 20 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains 20 mg of chloroprocaine hydrochloride 1 vial with 20 ml solution, contains 400 mg of chloroprocaine hydrochloride Excipients with known effect: 1 ml of solution contains 1.85 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 2.7 and 4.0. The osmolality of the solution is comprised between 250 – 300 mOsm/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Perineural anaesthesia (peripheral nerve block) in adults for short-duration surgeries (not exceeding 60 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 undesirable effects and complications of the procedure. Posology The duration of action of chloroprocaine is dose-dependent, the smallest dose required to produce an effective block should be used. Posology must be established on an individual basis and varies with the anaesthetic procedure, the vascularity of the tissues, the depth of anaesthesia and degree of muscle relaxation required, the duration of anaesthesia desired, and the physical condition of the patient. When determining the dose, concomitant administration of other med Прочитать полный документ