País: Malta
Idioma: anglès
Font: Medicines Authority
ICATIBANT
Adalvo Limited Malta Life Sciences Park, Building 1, Level 4 Sir Temi Zammit San Gwann Industrial Est, SGN 3000 San Gwann, Malta
B06AC02
ICATIBANT 10 mg/ml
SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
ICATIBANT 10 mg/ml
POM
OTHER HEMATOLOGICAL AGENTS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-10-18
Page 1 of 11 PACKAGE LEAFLET Page 2 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER IDISAN 30 MG SOLUTION FOR INJECTION IN A 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 Idisan 30 mg is and what it is used for 2. What you need to know before you use Idisan 30 mg 3. How to use Idisan 30 mg 4. Possible side effects 5. How to store Idisan 30 mg 6. Contents of the pack and other information 1. WHAT IDISAN 30 MG IS AND WHAT IT IS USED FOR Idisan 30 mg contains the active substance icatibant. This medicine 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. Idisan 30 mg blocks the activity of bradykinin and therefore ends the further progression of the symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IDISAN 30 MG DO NOT USE IDISAN 30 MG - 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 Idisan 30 mg: - 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 Idisan 30 mg 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 this medicine. In Llegiu el document complet
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 13 1 . NAME OF THE MEDICINAL PRODUCT Idisan 30 mg solution for injection in a 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 a pre-filled syringe. The solution is a clear and colourless liquid, pH 5.2 to 5.8, osmolality 270 to 330 mOsm/Kg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Idisan 30 mg 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 Idisan 30 mg is intended for use under the guidance of a healthcare professional. Posology _Adults _ The recommended dose for adults is a single subcutaneous injection of Idisan 30 mg. In the majority of cases a single injection of Idisan 30 mg is sufficient to treat an attack. In case of insufficient relief or recurrence of symptoms, a second injection of Idisan 30 mg can be administered after 6 hours. If the second injection produces insufficient relief or a recurrence of symptoms is observed, a third injection of Idisan 30 mg can be administered after a further 6 hours. No more than 3 injections of Idisan 30 mg 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 Idisan 30 mg based on body weight in children and adolescents (aged 2 to 17 years) is provided in table 1 below. Page 3 of 13 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 t Llegiu el document complet