Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Icatibant Acetate
Fresenius Kabi Deutschland GmbH
B06AC02
Icatibant Acetate
Solution for injection in pre-filled syringe
icatibant
2022-03-11
IE-UK-PIL-Icatibant-30mg PFS-v000 1 PACKAGE LEAFLET: INFORMATION FOR THE USER ICATIBANT 30 MG SOLUTION FOR INJECTION IN 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 Icatibant is and what it is used for 2. What you need to know before you use Icatibant 3. How to use Icatibant 4. Possible side effects 5. How to store Icatibant 6. Contents of the pack and other information 1. WHAT ICATIBANT IS AND WHAT IT IS USED FOR Icatibant contains the active substance icatibant. Icatibant 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. Icatibant blocks the activity of bradykinin and therefore ends the further progression of the symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ICATIBANT DO NOT USE ICATIBANT - 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 Icatibant: - 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 Icatibant 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 Icatibant. In addition: - You or your caregiver must be trained Lestu allt skjalið
Health Products Regulatory Authority 11 March 2022 CRN009TP6 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Icatibant 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. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. The solution is a clear and colourless liquid. pH of solution 5.0 - 6.0. Osmolality of solution 270 – 330 mOsm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Icatibant 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 Icatibant is intended for use under the guidance of a healthcare professional. Posology _Adults_ The recommended dose for adults is a single subcutaneous injection of Icatibant 30 mg. In the majority of cases a single injection of Icatibant is sufficient to treat an attack. In case of insufficient relief or recurrence of symptoms, a second injection of Icatibant can be administered after 6 hours. If the second injection produces insufficient relief or a recurrence of symptoms is observed, a third injection of Icatibant can be administered after a further 6 hours. No more than 3 injections of Icatibant should be administered in a 24 hour period. In the clinical trials, not more than 8 injections of icatibant per month have been administered. _Paediatric population_ The recommended dose of Icatibant based on body weight in children and adolescents (aged 2 to 17 years) is provided in table 1 below. 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 t Lestu allt skjalið