Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Landiolol hydrochloride
Orpha-Devel Handels und Vertriebs GmbH
C07AB
Landiolol hydrochloride
Powder for solution for infusion
Beta blocking agents, selective
Not marketed
2024-02-09
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RAPIBLOC 300 MG POWDER FOR SOLUTION FOR INFUSION landiolol 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 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. The full name of your medicine is Rapibloc 300 mg powder for solution for infusion. In this leaflet the shorter name landiolol is used. WHAT IS IN THIS LEAFLET 1. What Rapibloc is and what it is used for 2. What you need to know before you are given Rapibloc 3. How Rapibloc is given 4. Possible side effects 5. How to store Rapibloc 6. Contents of the pack and other information 1. WHAT RAPIBLOC IS AND WHAT IT IS USED FOR Rapibloc contains the active substance landiolol hydrochloride. It belongs to a group of medicines called “beta-blockers”. It works by changing your irregular or fast heartbeat to a normal heartbeat. This medicine is used in adults to treat heartbeat problems, when your heart beats too fast. It is used during or straight after surgery or in other situations where control of your heartbeat is needed. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN RAPIBLOC YOUR DOCTOR WILL NOT GIVE YOU RAPIBLOC IF: You are allergic to landiolol or any of the other ingredients of this medicine (listed in section 6). You have a very slow heartbeat (less than 50 beats per minute). You have a fast or alternating fast and slow heartbeat (a problem called the “sick sinus” syndrome) You have a problem called “severe heart block”. Heart block is a problem with the electrical messages that control your heartbeat. You have a problem with the blood supply to your heart (a problem called “cardiogenic shock”). You have very low blood pressure. You have serious heart failur Lees het volledige document
Health Products Regulatory Authority 15 February 2024 CRN00CW31 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rapibloc 300 mg powder for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION A vial contains 300 mg landiolol hydrochloride which is equivalent to 280 mg landiolol. After reconstitution (see section 6.6), each ml contains 6 mg landiolol hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for infusion. White to almost white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Landiolol is indicated in adults for: Supraventricular tachycardia 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. Non-compensatory sinus tachycardia where, in the physician's judgment the rapid heart rate requires specific intervention. Landiolol is not intended for use in chronic settings. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Landiolol is intended for intravenous use in a monitored setting. Only an appropriately healthcare professional should administer landiolol. The dosage of landiolol should be titrated individually. The infusion is usually started with an infusion rate of 10 - 40 micrograms/kg/min, which will establish the heart rate lowering effect within –10 - 20 min. If rapid onset of the heart rate lowering effect is desired (within 2 to 4 min), an optional loading dose of 100 micrograms/kg/min for 1 min can be considered, followed by continuous intravenous infusion of 10 - 40 micrograms/kg/min. Lower starting doses should be used for patients with cardiac dysfunction. Dosing instructions are provided under "Special populations" and in the integrated dosing scheme. _Maximum dose_: The maintenance dose may be increased up to 80 micrograms/kg/min for a limited time period (see section 5.2), if the car Lees het volledige document