País: União Europeia
Língua: inglês
Origem: EMA (European Medicines Agency)
sulesomab
Immunomedics GmbH
VO4D
sulesomab
Diagnostic agents
Osteomyelitis; Radionuclide Imaging
This medicinal product is for diagnostic use only.LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers.LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia.
Revision: 7
Withdrawn
1997-02-14
19 B. PACKAGE LEAFLET Medicinal product no longer authorised 20 PACKAGE LEAFLET: INFORMATION FOR THE USER LEUKOSCAN (0.31 POWDER FOR SOLUTION FOR INJECTION) (SULESOMAB) Read all of this leaflet carefully before you start using this medicine. • Keep this leaflet. You may need to read it again. • It does not contain all the information about your medicine that you may need to know, so please refer to the Summary of Product Characteristics or ask your doctor or nurse if you have any questions. This leaflet only applies to LeukoScan. • If you have any further questions, please ask your doctor. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. IN THIS LEAFLET: 1. WHAT LEUKOSCAN IS USED FOR 2. BEFORE YOU USE LEUKOSCAN 3. HOW TO USE LEUKOSCAN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE LEUKOSCAN 6. FURTHER INFORMATION 1. WHAT LEUKOSCAN IS AND WHAT IT IS USED FOR An antibody is a natural substance made by the body which binds to foreign substances to help remove them from your body. You produce many different kinds of antibodies. LeukoScan (sulesomab) is a special kind of antibody which binds to the surface of certain kinds of blood cells called leukocytes. It is produced in mice and purified so that it can be used in humans. When it is combined to the radioactive technetium isotope and injected into your vein, it finds an abnormal accumulation of white blood cells and attaches to them. One to eight hours later after the injection you will be placed on a special table and pictures will be taken with standard nuclear cameras. This helps your doctor make a diagnosis and evaluate the extent of your illness. The doctor does this by using a special imaging camera that reveals areas of radioactivity to see where the infections are located. This medicine is for diagnostic use only. LeukoScan is used to determine the presence of infections in long bones. Shortly after mixing the LeukoScan with the radioactive technetium isotope, the doctor will Leia o documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT LeukoScan 0.31 mg, powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kit for the preparation of 99m Tc-labelled LeukoScan. Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab ′ -SH antigranulocyte monoclonal antibody fragments) for the preparation of 99m Tc labelled LeukoScan. The kit does not include the radioisotope. Excipients: Sucrose (37.8 mg) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. LeukoScan is indicated for diagnostic imaging for determining the location and extent of infection/inflammation in bone in patients with suspected osteomyelitis, including patients with diabetic foot ulcers. LeukoScan has not been employed to diagnose osteomyelitis in patients with sickle cell anaemia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The radiolabelled solution should be administered as an intravenous injection. After injection, any remaining portion of the reconstituted solution should be discarded. LeukoScan is not recommended for use in children. Formal studies have not been performed in patients with renal or hepatic impairment. However, due to the low dose of protein administered and the short half-life of 99m Tc, dosage adjustment is probably not necessary in such patients. Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides. Medicinal product no longer authorised 3 This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organisations. Immediately prior to use, contents of the vial are re Leia o documento completo