Country: European Union
Language: English
Source: EMA (European Medicines Agency)
drotrecogin alfa (activated)
Eli Lilly Nederland B.V.
B01AD10
drotrecogin alfa (activated)
Antithrombotic agents
Sepsis; Multiple Organ Failure
Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The use of Xigris should be considered mainly in situations when therapy can be started within 24 hours after the onset of organ failure (for further information see section 5.1).
Revision: 13
Withdrawn
2002-08-22
Medicinal product no longer authorised 36 B. PACKAGE LEAFLET Medicinal product no longer authorised 37 PACKAGE LEAFLET: INFORMATION FOR THE USER XIGRIS 20 MG POWDER FOR SOLUTION FOR INFUSION Drotrecogin alfa (activated) PLEASE READ ALL OF THIS LEAFLET CAREFULLY. PLEASE REMEMBER THAT YOU CANNOT TAKE XIGRIS BY YOURSELF BECAUSE BOTH YOUR ILLNESS AND THE USE OF THIS MEDICINE NEED CONSTANT MEDICAL CARE. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or your pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist . IN THIS LEAFLET : 1. What Xigris is and what it is used for 2. Before you are given Xigris 3. How Xigris is used 4. Possible side effects 5. How to store Xigris 6. Further information 1. WHAT XIGRIS IS AND WHAT IT IS USED FOR Xigris is very similar to a protein that occurs naturally in your blood. This protein helps to control blood clotting and inflammation. When your body has a severe infection, clots can form in your blood. These can block the blood supply to important parts of your body such as the kidneys and lungs. This causes an illness called severe sepsis which can make you very ill. Some people will die from this illness. Xigris helps your body to get rid of the clots and also reduces the inflammation caused by the infection. Xigris is used to treat adults with severe sepsis. 2. BEFORE YOU ARE GIVEN XIGRIS YOU SHOULD NOT BE GIVEN XIGRIS: - if you are allergic (hypersensitive) to drotrecogin alfa (activated) or any of the other ingredients of Xigris, or bovine (cattle-derived) thrombin (protein) - if you are a child below the age of 18 - if you have internal bleeding - if you have a brain tumour, or pressure on the brain - if you are being given heparin at the same time ( ≥ 15 International Units/kg/h Read the complete document
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Xigris 20 mg powder for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 20 mg of Drotrecogin alfa (activated). After reconstitution with 10 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated). Drotrecogin alfa (activated) is a recombinant version of the endogenous activated Protein C and is produced by genetic engineering from an established human cell line. Excipient: Each vial contains approximately 68 mg sodium. For a full list of excipients, see 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. Xigris is supplied as a lyophilised, white to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The use of Xigris should be considered mainly in situations when therapy can be started within 24 hours after the onset of organ failure (for further information see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Xigris should be used by experienced doctors in institutions skilled in the care of patients with severe sepsis. Treatment should be started within 48 hours, and preferably within 24 hours, of onset of the first documented sepsis-induced organ dysfunction (see section 5.1). The recommended dose of Xigris is 24 μ g/kg/hr (based on actual body weight) given as a continuous intravenous infusion for a total duration of 96 hours. It is recommended that Xigris be infused with an infusion pump to accurately control the infusion rate. If the infusion is interrupted for any reason, Xigris should be restarted at the 24 μ g/kg/hr infusion rate and continued to complete the full recommended 96 hours of dosing administration. Dose escalation or bolus doses of Xigris are not necessary to account for the interruption in the infusion. N Read the complete document