Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
C1 inhibitor (human)
Takeda Manufacturing Austria AG
B06AC01
C1 inhibitor (human)
c1-inhibitor, plasma derived, Drugs used in hereditary angioedema
Angioedemas, Hereditary
Treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE).Routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment.
Revision: 23
Authorised
2011-06-15
26 B. PACKAGE LEAFLET 27 PACKAGE LEAFLET: INFORMATION FOR THE USER CINRYZE 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Human C1-esterase inhibitor This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 leaftlet. See section 4. WHAT IS IN THIS LEAFLET 1. What Cinryze is and what it is used for 2. What you need to know before you take Cinryze 3. How to take Cinryze 4. Possible side effects 5. How to store Cinryze 6. Contents of the pack and other information 1. WHAT CINRYZE IS AND WHAT IT IS USED FOR Cinryze contains the human protein called “C1-esterase inhibitor” as the active substance. C1-esterase inhibitor is a naturally occurring protein that is normally present in the blood. If you have a low amount of C1-esterase inhibitor in your blood or your C1-esterase inhibitor is not working properly, this can lead to swelling attacks (called angioedema). Symptoms may include stomach pains and swelling of the: hands and feet face, eyelids, lips or tongue voice-box (larynx), which may make breathing difficult genitals In adults and children, Cinryze can raise the amount of C1-esterase inhibitor in the blood and either prevent (prior to undergoing medical or dental procedures) these swelling attacks from occurring or stop swelling attacks once they have begun. In adults, adolescents and children (aged 6 y Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Cinryze 500 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-use powder vial contains 500 International Units (IU) of Human C1-esterase inhibitor produced from the plasma of human donors. After reconstitution, one vial contains 500 IU of Human C1-esterase inhibitor per 5 ml corresponding to a concentration of 100 IU/ml. One IU is equivalent to the amount of C1- esterase inhibitor present in 1 ml of normal human plasma. The total protein content of the reconstituted solution is 15 ± 5 mg/ml. U Excipient with known effect Each vial of Cinryze contains approximately 11.5 mg of sodium . For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White powder. The solvent is a clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and pre-procedure prevention of angioedema attacks in adults, adolescents and children (2 years old and above) with hereditary angioedema (HAE). Routine prevention of angioedema attacks in adults, adolescents and children (6 years old and above) with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments, or patients who are inadequately managed with repeated acute treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cinryze therapy should be initiated under supervision of a physician experienced in the care of patients with hereditary angioedema (HAE). 3 U Posology _Adults_ U _Treatment of angioedema attacks_ 1000 IU of Cinryze at the first sign of the onset of an angioedema attack. A second dose of 1000 IU may be admini Aqra d-dokument sħiħ