Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
lepirudin
Celgene Europe Ltd.
B01AE02
lepirudin
Antithrombotic agents
Thromboembolism; Thrombocytopenia
Anticoagulation in adult patients with heparin-induced thrombocytopenia type II and thromboembolic disease mandating parenteral antithrombotic therapy.The diagnosis should be confirmed by the heparin-induced platelet activation assay or an equivalent test.
Revision: 15
Withdrawn
1997-03-13
34 B. PACKAGE LEAFLET Medicinal product no longer authorised 35 PACKAGE LEAFLET: INFORMATION FOR THE USER REFLUDAN 20 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION Lepirudin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - 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. 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 side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Refludan is and what it is used for 2. Before you use Refludan 3. How to use Refludan 4. Possible side effects 5 How to store Refludan 6. Further information 1. WHAT REFLUDAN IS AND WHAT IT IS USED FOR Refludan is an antithrombotic medicine. Antithrombotics are medicines to prevent formation of blood clots (thrombosis). Refludan is used for anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease requiring injected antithrombotic medicines. HIT type II is an illness which can occur after you have received heparin containing medicines. It constitutes a certain kind of allergy towards heparin. It may result in a too low number of blood platelets and/or clots in your blood vessels (thrombosis). This may additionally lead to deposition of clots in organs. 2. BEFORE YOU USE REFLUDAN DO NOT USE REFLUDAN - if you are allergic (hypersensitive) to lepirudin, to hirudins or any of the other ingredients of Refludan. - if you are pregnant or breast-feeding. TAKE SPECIAL CARE WITH REFLUDAN If you have a bleeding tendency, your doctor will weigh the risk of Refludan administration against its benefit. Thus, please tell your doctor if you have or have had: – Recent puncture of large vessels or organs – Anomaly of vessels or organs – Recent stroke, accident or surgery involving the brain – High blood press Aqra d-dokument sħiħ
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Refludan 20 mg powder for solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each vial contains 20 mg lepirudin. (Lepirudin is a recombinant DNA product derived from yeast cells) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection or infusion. White to almost white lyophilised powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease mandating parenteral antithrombotic therapy. The diagnosis should be confirmed by the HIPAA (heparin induced platelet activation assay) or an equivalent test. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Refludan should be initiated under the guidance of a physician with experience in coagulation disorders. Initial dosage Anticoagulation in adult patients with HIT type II and thromboembolic disease: – 0.4 mg / kg body weight intravenously as a bolus dose – followed by 0.15 mg / kg body weight / hour as a continuous intravenous infusion for 2 - 10 days or longer if clinically needed. Normally, the dosage depends on the patient's body weight. This is valid up to a body weight of 110 kg. In patients with a body weight exceeding 110 kg the dosage should not be increased beyond the 110 kg body weight dose (see also tables 2 and 3, below). Monitoring and modification of the Refludan dosage regimen Standard recommendations _Monitoring:_ – In general, the dosage (infusion rate) should be adjusted to the activated partial thromboplastin time, aPTT. – The first aPTT determination should be done 4 hours after start of Refludan therapy. Medicinal product no longer authorised 3 – The aPTT should be monitored at least once daily. More frequent determinations may be necessary, for example, in patients with renal impairment or with an increased risk of bleeding Aqra d-dokument sħiħ