Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
tilmanocept
Navidea Biopharmaceuticals Europe Ltd.
V09IA09
tilmanocept
Tumour detection, Diagnostic radiopharmaceuticals
Radionuclide Imaging
This medicinal product is for diagnostic use only.Radiolabelled Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.External imaging and intraoperative evaluation may be performed using a gamma detection device.
Revision: 7
Authorised
2014-11-19
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LYMPHOSEEK 50 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION tilmanocept READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nuclear medicine doctor who will supervise the procedure. • If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Lymphoseek is and what it is used for 2. What you need to know before Lymphoseek is used 3. How to use Lymphoseek 4. Possible side effects 5. How to store Lymphoseek 6. Contents of the pack and other information 1. WHAT LYMPHOSEEK IS AND WHAT IT IS USED FOR This medicine is for diagnostic use in adults only. This means that it is used in breast cancer, melanoma or oral cavity cancers to help find out about your illness. It is not a treatment for your illness. Before it is used, the powder in the vial which contains tilmanocept is mixed with a radioactive medicine called sodium pertechnetate (containing 99m Tc) to make a substance called technetium ( 99m Tc) tilmanocept. Since technetium ( 99m Tc) tilmanocept contains a small amount of radioactivity it can make parts of the body areas visible to doctors during tests to help them see if the cancer has spread to places called ‘lymph nodes’ that are found near tumours. The lymph nodes nearest the tumour are called ‘sentinel’ lymph nodes. These lymph nodes are where cancer cells are most likely to have spread. When Lymphoseek has found the sentinel lymph nodes, they can be removed and checked to see if there are any cancer cells present. Lymphoseek finds the lymph nodes and can be detected using a special camera or detector. The use of Lymphoseek does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have conside Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lymphoseek 50 micrograms kit for radiopharmaceutical preparation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 micrograms of tilmanocept. The radionuclide is not part of the kit. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation. The vial contains a sterile, non-pyrogenic, white to off-white lyophilized powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Radiolabelled Lymphoseek is indicated for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity. External imaging and intraoperative evaluation may be performed using a gamma detection device. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ This medicinal product is restricted to hospital use only. The medicinal product should only be administered by trained healthcare professionals with technical expertise in performing and interpreting sentinel lymph node mapping procedures. Posology The recommended dose is 50 micrograms tilmanocept radiolabelled with technetium Tc 99m at 18.5 MBq for same day surgery or 74 MBq for next day surgery. The dose of 50 micrograms should not be adjusted for body weight differences. The total injection amount should not exceed 50 micrograms tilmanocept, with a total maximum radioactivity of 74 MBq per dose. The recommended minimum time for imaging is 15 minutes post injection. Intraoperative lymphatic mapping may begin as early as 15 minutes post injection. Patients scheduled for surgery on the day of injection will receive 18.5 MBq technetium Tc 99m radiolabelled product. Administration should occur within 15 hours of the scheduled time of the surgery and intraoperative detection. 3 Patients scheduled for surgery on the day after injection will receive 74 MBq technetium Tc 99m radiol Aqra d-dokument sħiħ