Nchi: Umoja wa Ulaya
Lugha: Kiingereza
Chanzo: EMA (European Medicines Agency)
depreotide trifluoroacetate
CIS bio international
V09IA05
depreotide
Diagnostic radiopharmaceuticals
Radionuclide Imaging
This medicinal product is for diagnostic use only.For scintigraphic imaging of suspected malignant tumours in the lung after initial detection, incombination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
Revision: 10
Withdrawn
2000-11-29
Medicinal product no longer authorised 18 B. PACKAGE LEAFLET Medicinal product no longer authorised 19 PACKAGE LEAFLET: INFORMATION FOR THE USER NEOSPECT 47 MICROGRAMS. KIT FOR RADIOPHARMACEUTICAL PREPARATION Depreotide PLEASE READ THIS LEAFLET CAREFULLY. IT TELLS YOU ABOUT YOUR MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, 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 NeoSpect is and what it is used for. 2. Before you use NeoSpect. 3. How to use NeoSpect. 4. Possible side effects. 5. How to store NeoSpect. 6. Further information. 1. WHAT NEOSPECT IS AND WHAT IT IS USED FOR PRODUCT TYPE NeoSpect is a radiopharmaceutical product used for diagnostic purposes. A diagnostic radiopharmaceutical is a product which, when injected, temporarily collects in a particular part of the body (for example a tumour). Because the substance contains a small amount of radioactivity it can be detected from outside the body using special cameras, and a picture, known as a scan, can be taken. This scan will show exactly the distribution of the radioactivity within the body. This can give the doctor valuable information such as the location of a tumour. WHAT NEOSPECT IS USED FOR NeoSpect is for diagnostic use only. NeoSpect is used to provide pictures which show the location of suspected malignant cancer tissue (a tumour) in the lung. When injected, the radiolabelled compound binds to malignant cancer tissue. Your doctor will then take a picture (scan) of your lungs using a special camera. The area where the radioactive compound is collected, will light up on the picture and give information on the location of the tumour. The evaluation also includes examinations by CT-scan or chest X-ray. 2. BEFORE YOU USE NEOSPECT DO NOT USE NEOSPECT - if you are allergic (hypersensitive) to depreotide or any of the other ingredients of NeoSpect or to the radioactive techneti Soma hati kamili
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT NeoSpect _ _ 47 micrograms, kit for radiopharmaceutical preparation. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 47 micrograms depreotide as depreotide trifluoroacetate. For a full list of excipients, see section 6.1 To be reconstituted with sodium pertechnetate ( 99m Tc) solution for injection (not included in this kit). 3. PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation. White powder for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. For scintigraphic imaging of suspected malignant tumours in the lung after initial detection, in combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The medicinal product is for hospital use or in designated Nuclear Medicine Facilities only, by persons experienced in radioisotope diagnostic imaging. Instructions for reconstitution, handling and disposal are given in section 12. After reconstitution with sodium pertechnetate ( 99m Tc) solution for injection, 99m Tc-depreotide is formed. 99m Tc-depreotide is administered intravenously in a single dose. The solution may be diluted with sodium chloride 0.9% w/v solution for injection for more convenient injection. SPECT images (Single Photon Emission Computed Tomography) obtained between 2 and 4 hours following 99m Tc-depreotide injection are required for optimal image interpretation. DOSAGE FOR ADULTS The recommended dosage is approximately 47 micrograms depreotide (one vial) labelled with 555-740 MBq of technetium-99m. DOSAGE FOR ELDERLY (>65 YEARS) Experience from clinical trials indicates that no dose adjustment is required. CHILDREN 99m Tc-depreotide is not recommended for use in patients below the age of 18 as data are not available for this age group. RENAL IMPAIRMENT No dose adjustment is Soma hati kamili