Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
susoctocog alfa
Baxalta Innovations GmbH
B02
susoctocog alfa
Antihemorrhagics
Hemophilia A
Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII. Obizur is indicated in adults.
Revision: 11
Authorised
2015-11-11
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT. OBIZUR IS FOR IN HOSPITAL USE ONLY AND IS TO BE ADMINISTERED BY HEALTHCARE PROVIDER ONLY. OBIZUR 500 U POWDER AND SOLVENT FOR SOLUTION FOR INJECTION susoctocog alfa 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 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What OBIZUR is and what it is used for 2. What you need to know before you are given OBIZUR 3. How OBIZUR is given 4. Possible side effects 5. How OBIZUR is stored 6. Contents of the pack and other information 1. WHAT OBIZUR IS AND WHAT IT IS USED FOR OBIZUR contains the active substance susoctocog alfa, antihaemophilic factor VIII, porcine sequence. Factor VIII is necessary for the blood to form clots and stop bleedings. In patients with acquired haemophilia, factor VIII is not working properly because the patient has developed antibodies to his own factor VIII which neutralize this blood clotting factor. OBIZUR is used for the treatment of bleeding episodes in adults with acquired haemophilia (a bleeding disorder caused by lack of factor VIII activity due to antibody development). These antibodies have less neutralizing effect against OBIZUR than against human factor VIII. OBIZUR restores this missing factor VIII activity and helps blood to form clots at the site of bleeding. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN OBIZUR The medicine is for in-patient administration only. It requires clinical supervision of the bleeding status of the patient. YOU MUST NOT BE GIVEN O Pročitajte cijeli dokument
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 OBIZUR 500 U powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each powder vial contains nominally 500 units of B domain deleted antihaemophilic factor VIII (rDNA), porcine sequence, susoctocog alfa. OBIZUR contains approximately 500 U/ml of susoctocog alfa after reconstitution. The potency (U) is determined using the one-stage coagulation assay (OSCA). The specific activity of OBIZUR is approximately 10,000 U/mg protein. OBIZUR (antihaemophilic factor VIII (rDNA), porcine sequence) is a purified protein that has 1448 amino acids with an approximate molecular mass of 175 kDa. It is produced by recombinant DNA technology in baby hamster kidney (BHK) cells. The BHK cells are cultured in media that contains foetal bovine serum. The manufacturing process is free of human serum and human protein products and does not contain any additional animal derived materials. Excipient(s) with known effect Each vial contains 4.6 mg (198 mM) sodium per ml of reconstituted solution. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is white. The solvent is clear and colourless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to factor VIII. OBIZUR is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with OBIZUR should be under the supervision of a physician experienced in the treatment of haemophilia (see section 4.4). 3 Treatment monitoring The product is for in-patient administration only. It requires clinical supervision of the bleeding status of the patient. During Pročitajte cijeli dokument