Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
AMIODARONE HYDROCHLORIDE
Sanofi Malta Limited
C01BD01
AMIODARONE HYDROCHLORIDE
SOLUTION FOR INJECTION
AMIODARONE HYDROCHLORIDE 150 milligram(s)
POM
CARDIAC THERAPY
Authorised
2005-11-30
1 READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE. IT CONTAINS IMPORTANT INFORMATION REGARDING YOUR TREATMENT. • Keep this leaflet as 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. 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 pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4. 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 ANTIARRHYTHMIC - ATC CODE: C01DX12 This medicine is used to treat certain serious heartbeat problems and to resuscitate patients experiencing cardiac arrest where a defibrillator (medical device that delivers electric shocks to restore normal heartbeat) has not worked to stop ventricular fibrillation (heartbeat problem that stops the heart from pumping blood properly). 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 IN THE FOLLOWING SITUATIONS: • 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 a full list of ingredients. • if you have hyperthyroidism (disease of the thyroid gland), • if you have certain problems with your heartbe Soma hati kamili
1 of 16 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 Excipients : benzyl alcohol For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM solution for injection 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Cordarone solution for IV injection is indicated for the 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 formulation of the 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 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: on average 5 mg/kg in glucose solution, preferably using an electric syringe, administered over 20 minutes to 2 hours and repeated 2 or 3 times per 24-hour period. The eff Soma hati kamili