Pajjiż: Malta
Lingwa: Ingliż
Sors: Medicines Authority
AMIODARONE HYDROCHLORIDE
Sanofi S.R.L Viale L. Bodio, 37/b 20158, Milan, Italy
C01BD01
AMIODARONE HYDROCHLORIDE 50 mg/ml
SOLUTION FOR INJECTION
AMIODARONE HYDROCHLORIDE 50 mg/ml
POM
CARDIAC THERAPY
Authorised
2005-11-30
PACKAGE LEAFLET: INFORMATION FOR THE USER CORDARONE 150 MG/3 ML SOLUTION FOR (IV) INJECTION IN AMPOULES, AMIODARONE HYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cordarone 150 mg/3 mL solution for (IV) injection in ampoules is and what it is used for 2. What you need to know before you use Cordarone 150 mg/3 mL solution for (IV) injection in ampoules 3. How to use Cordarone 150 mg/3 mL solution for (IV) injection in ampoules 4. Possible side effects 5. How to store Cordarone 150 mg/3 mL solution for (IV) injection in ampoules 6. Contents of the pack and other information 1. WHAT CORDARONE 150 MG/3 ML SOLUTION FOR (IV) INJECTION IN AMPOULES IS AND WHAT IT IS USED FOR PHARMACOTHERAPEUTIC GROUP: CLASS III ANTIARRHYTHMICS, ATC CODE: C01BD01 This medicine is used to treat certain serious heartbeat problems and to resuscitate patients experiencing cardiac arrest where a defibrillator has not worked to stop ventricular fibrillation. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CORDARONE 150 MG/3 ML SOLUTION FOR (IV) INJECTION IN AMPOULES DO NOT USE CORDARONE 150 MG/3 ML SOLUTION FOR (IV) INJECTION IN AMPOULES: • If you are allergic to iodine. • If you are allergic to the active substance, amiodarone, or any of the other ingredients of Cordarone 150 mg/3 mL solution for (IV) injection in ampoules. See section 6 for the full list of ingredients. • If you have hyperthyroidism (disease of the thyroid gland). • If you have certain problems with your heartbeat or problems with the Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cordarone 150 mg/3 mL solution for (IV) injection in ampoules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Amiodarone hydrochloride ........................................................................................................... 150 mg For one 3 mL ampoule. Excipient with known effect: benzyl alcohol 60 mg in each 3 mL ampoule (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment of serious rhythm disorders when oral treatment cannot be used, i.e.: • Atrial arrhythmias with ventricular tachycardia. • Tachycardias associated with Wolff-Parkinson-White syndrome. • Documented, symptomatic and incapacitating ventricular arrhythmias. Cardiopulmonary resuscitation of shock-resistant ventricular fibrillation in patients experiencing cardiac arrest. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For reasons related to the pharmaceutical form of the medicinal product, concentrations used must not be less than the equivalent of 2 ampoules per 500 mL. Use only isotonic glucose solution as the infusion vehicle. Do not add any other products to the infusion vehicle. Amiodarone must be administered via the central venous route, except during cardiopulmonary resuscitation of shock-resistant ventricular fibrillation in patients experiencing cardiac arrest, in which case the peripheral route may be used if the central venous route is not available (see section 4.4 “Special warnings and precautions for use”). Serious arrhythmias when treatment via the oral route is not appropriate, except during cardiopulmonary resuscitation of shock-resistant ventricular fibrillation in patients experiencing cardiac arrest: Infusion via the central venous route • LOADING DOSE: The usual loading dose is 5 mg/kg in glucose solution, preferably using an electric syringe, administered over a period of between 20 minutes to 2 hours . This may b Aqra d-dokument sħiħ