Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Vernakalant hydrochloride
Correvio
C01BG11
vernakalant hydrochloride
Cardiac therapy
Atrial Fibrillation
Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults:for non-surgery patients: atrial fibrillation
Revision: 16
Authorised
2010-09-01
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER BRINAVESS 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION vernakalant 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What BRINAVESS is and what it is used for 2. What you need to know before you use BRINAVESS 3. How to use BRINAVESS 4. Possible side effects 5. How to store BRINAVESS 6. Contents of the pack and other information 1. WHAT BRINAVESS IS AND WHAT IT IS USED FOR BRINAVESS contains the active substance vernakalant hydrochloride. BRINAVESS works by changing your irregular or fast heart beat to a normal heart beat. In adults it is used if you have a fast, irregular heart beat called atrial fibrillation _ _ which has started recently, less than or equivalent to 7 days, for non-surgery patients and less than or equivalent to 3 days for post-cardiac surgery patients _._ 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BRINAVESS DO NOT USE BRINAVESS • if you are allergic to vernakalant hydrochloride or any of the other ingredients of this medicine (listed in section 6) • if you have had new or worsening chest pain (angina) diagnosed by your doctor as an acute coronary syndrome in the last 30 days or you have had a heart attack in the last 30 days • if you have a very narrow heart valve, systolic blood pressure less than 100 mm Hg or advanced heart failure with symptoms at minimal exertion or at rest • if you have an abnormally slow heart rate or skipped heart beats and do not have a pacemaker, or you have conduction disturbance called QT prolongation - which can be seen on an ECG by your doctor • if you take certain other intravenous medicines (antiarrhythmics Class I and III) used to normalis Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT BRINAVESS 20 mg/ml concentrate for solution for infusion _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg of vernakalant hydrochloride which is equivalent to 18.1 mg of vernakalant. Each 10 ml vial contains 200 mg of vernakalant hydrochloride equivalent to 181 mg of vernakalant. Each 25 ml vial contains 500 mg of vernakalant hydrochloride equivalent to 452.5 mg of vernakalant. After dilution the concentration of the solution is 4 mg/ml vernakalant hydrochloride. Excipient with known effect Each vial of 200 mg contains approximately 1.4 mmol (32 mg) sodium. Each vial of 500 mg contains approximately 3.5 mmol (80 mg) sodium. Each ml of the diluted solution contains approximately 3.5 mg of sodium (sodium chloride 9 mg/ml (0.9 %) solution for injection), 0.64 mg sodium (5 % glucose solution for injection) or 3.2 mg sodium (Lactated Ringers solution for injection). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Clear and colourless to pale yellow solution with a pH of approximately 5.5. The osmolality of the medicinal product is controlled between the following range: 270-320 mOsmol/kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Brinavess is indicated in adults for rapid conversion of recent onset atrial fibrillation to sinus rhythm -For non-surgery patients: atrial fibrillation ≤ 7 days duration -For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vernakalant should be administered in a monitored clinical setting appropriate for cardioversion. Only a well-qualified healthcare professional should administer it. Posology Vernakalant is dosed by patient body weight, with a maximum calculated dose based upon 113 kg. The recommended initial infusion is 3 mg/kg to be infused over a 10-minute period with a maximum initial dose of 339 mg (84.7 Прочетете целия документ