Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Esmolol Hydrochloride
Orpha-Devel Handels und Vertriebs GmbH
C07AB; C07AB09
Esmolol Hydrochloride
2500 milligram(s)
Powder for concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Beta blocking agents, selective; esmolol
Not marketed
2011-02-25
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ESMOCARD LYO 2500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION Esmolol hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 nurse. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - 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 ESMOCARD LYO is and what it is used for 2. What you need to know before you use ESMOCARD LYO 3. How to use ESMOCARD LYO 4. Possible side effects 5. How to store ESMOCARD LYO 6. Contents of the pack and other information 1. WHAT ESMOCARD LYO IS AND WHAT IT IS USED FOR ESMOCARD LYO belongs to the group of beta blockers. These medicines slow down the heart beat and reduce blood pressure. ESMOCARD LYO is used for short term treatment if your heart beats too fast. ESMOCARD LYO is also used during or straight after surgery if your blood pressure gets too high and/or your heart beats too fast. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ESMOCARD LYO YOUR DOCTOR WILL NOT GIVE YOU ESMOCARD LYO IF: - You are allergic to esmolol hydrochloride. The signs of an allergic reaction include shortness of breath, wheezing, rash, itching or swelling of your face and lips. - You have a very slow heart beat (less than 50 beats per minute) - You have a fast or alternating fast and slow heartbeat - You have something called “severe heart block”. Heart block is a problem with the electrical messages that control your heartbeat - You have low blood pressure - You have a problem with the blood supply to your heart - You are receiving or have recently received verapamil. You must not be given ESMOCARD LYO within 48 hours of when you stop receiving verapamil - Yo Pročitajte cijeli dokument
Health Products Regulatory Authority 06 October 2020 CRN009Z86 Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ESMOCARD LYO 2500 mg powder for concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION A vial of 50 ml contains 2500 mg esmolol hydrochloride. Each ml of reconstituted concentrate for solution for infusion contains 50 mg esmolol hydrochloride (50 mg/ml). Each ml of the diluted solution for infusion contains 10 mg esmolol hydrochloride (10 mg/ml). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for concentrate for solution for infusion The powder is white to almost white. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ESMOCARD LYO is indicated for supraventricular tachycardia (except for pre-excitation syndromes), and for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other circumstances where short-term control of the ventricular rate with a short acting agent is desirable. ESMOCARD LYO is also indicated for tachycardia and hypertension occurring in the perioperative phase and non-compensatory sinus tachycardia where, in physician’s judgement the rapid heart rate requires specific intervention. ESMOCARD LYOis not indicated for use in children aged up to 18 years (see section 4.2). ESMOCARD LYO is not intended for use in chronic settings. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ESMOCARD LYO 2500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION MUST NOT BE ADMINISTERED WITHOUT RECONSTITUTION/DILUTION. The reconstituted/diluted solution for infusion must be used immediately after opening (see sections 4.4 and 6). The administration of incorrect reconstituted/diluted ESMOCARD LYO may result in death (see section 4.4). POSOLOGY SUPRAVENTRICULAR TACHYARRHYTHMIA The dosage of ESMOCARD LYO should be titrated individually. A starting dose is required, followed by a maintenance dosage. The effective dose of ESMOCARD LYO is within the r Pročitajte cijeli dokument