Država: Nizozemska
Jezik: nizozemščina
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ICATIBANTACETAAT SAMENSTELLING overeenkomend met ; ; ICATIBANT 10 mg/ml
ICATIBANTACETAAT SAMENSTELLING overeenkomend met ; ; ICATIBANT 10 mg/ml
Oplossing voor injectie
AZIJNZUUR (E 260), GECONCENTREERD ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; WATER VOOR INJECTIE
Subcutaan gebruik
2022-04-11
1 Sandoz B.V. Page 1/11 Icatibant Sandoz 30 mg, oplossing voor injectie in voorgevulde spuit RVG 128187 1311-v1 1.3.1.3 Package Leaflet Februari 2022 PACKAGE LEAFLET: INFORMATION FOR THE USER ICATIBANT SANDOZ 30 MG, OPLOSSING VOOR INJECTIE IN EEN VOORGEVULDE SPUIT 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. Whatis and what it is used for 2. What you need to know before you use Preberite celoten dokument3. How to use 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR contains the active substance 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. blocks the activity of bradykinin and therefore ends the further progression of the symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DO NOT USE - 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 : - 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 are similar to
Sandoz B.V. Page 1/12 Icatibant Sandoz 30 mg, oplossing voor injectie in voorgevulde spuit RVG 128187 1311-v1 1.3.1.1 Summary of the Product Characteristics December 2021 1 1. NAME OF THE MEDICINAL PRODUCT Icatibant Sandoz 30 mg, oplossing voor injectie in een voorgevulde spuit 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. The solution has a pH of approximately 5.5 and an osmolality of approximately 300 mOsm/kg. 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 Preberite celoten dokument