מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
icatibant
Takeda Pharmaceuticals International AG
B06AC02
icatibant
Cardiac therapy
Angioedemas, Hereditary
Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).
Revision: 23
Authorised
2008-07-11
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE USER FIRAZYR 30 MG SOLUTION FOR INJECTION PRE-FILLED SYRINGE icatibant 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 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 Firazyr is and what it is used for 2. What you need to know before you use Firazyr 3. How to use Firazyr 4. Possible side effects 5. How to store Firazyr 6. Contents of the pack and other information 1. WHAT FIRAZYR IS AND WHAT IT IS USED FOR Firazyr contains the active substance icatibant. Firazyr is used for treating the symptoms of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older. In HAE levels of a substance in your bloodstream called bradykinin are increased and this leads to symptoms like swelling, pain, nausea, and diarrhoea. Firazyr blocks the activity of bradykinin and therefore ends the further progression of the symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FIRAZYR DO NOT USE FIRAZYR - If you are allergic to icatibant, or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor before taking Firazyr: - if you are suffering from angina (reduced blood flow to the heart muscle) - if you have recently suffered a stroke Some of the side effects connected with Firazyr are similar to the symptoms of your disease. Tell your doctor immediately if you notice that your symptoms of the attack get worse after you received Firazyr 29 In addition: - You or your caregiver must be trained on subcutaneous (under the skin) inject קרא את המסמך השלם
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Firazyr 30 mg solution for injection in pre-filled syringe 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe of 3 ml contains icatibant acetate equivalent to 30 mg icatibant. Each ml of the solution contains 10 mg of icatibant. Excipient(s) with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is a clear and colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Firazyr is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Firazyr is intended for use under the guidance of a healthcare professional. Posology Adults The recommended dose for adults is a single subcutaneous injection of Firazyr 30 mg. In the majority of cases a single injection of Firazyr is sufficient to treat an attack. In case of insufficient relief or recurrence of symptoms, a second injection of Firazyr can be administered after 6 hours. If the second injection produces insufficient relief or a recurrence of symptoms is observed, a third injection of Firazyr can be administered after a further 6 hours. No more than 3 injections of Firazyr should be administered in a 24 hour period. In the clinical trials, not more than 8 injections of Firazyr per month have been administered. Paediatric population The recommended dose of Firazyr based on body weight in children and adolescents (aged 2 to 17 years) is provided in table 1 below. 3 TABLE 1: DOSAGE REGIMEN FOR PAEDIATRIC PATIENTS BODY WEIGHT DOSE (INJECTION VOLUME) 12 kg to 25 kg 10 mg (1.0 ml) 26 kg to 40 kg 15 mg (1.5 ml) 41 kg to 50 kg 20 mg (2.0 ml) 51 kg to 65 kg 25 mg (2.5 ml) >65 kg 30 mg (3.0 ml) In the clinical trial, not more than 1 injection of Firazyr per HAE attack has been administered. No dosage regimen for children aged less tha קרא את המסמך השלם