Država: Velika Britanija
Jezik: angleščina
Source: myHealthbox
Human Serum Albumin nano sized colloid
RADIOPHARMACY Laboratory Ltd
V09DB01
Human Serum Albumin nano sized colloid
500micrograms
Kit for radiopharmaceutical preparation
Subcutaneous administration
1 pack contains 6 vials. Sample package: 2 vials. Bundle pack of 2 packs of 6 vials. Bundle pack of 4 packs of 6 vials.
POM - Prescription Only Medicine
Medi-Radiopharma Ltd
Technetium (99mTc), particles and colloids
This medicinal product is for diagnostic use only. After radiolabelling with sodium (99mTc) pertechnetate solution for injection the solution obtained is indicated in: • Bone marrow scanning (The product is not suitable to study the haematopoietic activity of the bone marrow) • Inflammation scanning in areas other than the abdomen • Conventional lymphoscintigraphy to demonstrate integrity of the lymphatic system and differentiation of venous from lymphatic obstruction • Sentinel node detection in: • Melanoma malignum • Breast cancer
Authorised
2015-03-03
PACKAGE LEAFLET: INFORMATION FOR THE USER NanoScan 500 micrograms, Kit for radiopharmaceutical preparation Human Serum Albumin nano sized colloid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU WILL BE ADMINISTERED THIS MEDICINE. - 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your Nuclear medicine doctor who has supervised the procedure. IN THIS LEAFLET: _1. _ _What NanoScan is and what it is used for _ _2. _ _Before NanoScan _ is used_ _ _3. _ _How NanoScan _is used_ _ _4. _ _Possible side effects _ _5. _ _How NanoScan is stored _ _6. _ _Further information _ 1. WHAT NANOSCAN IS AND WHAT IT IS USED FOR This medicine is a radiopharmaceutical product for diagnostic use only. Before treatment with NanoScan your doctor will explain to you the procedure you are about to undergo, and radioactive medicine you will be given. NanoScan kit is a sterile preparation for studies of bone marrow scintigraphy, lymphoscintigraphy and sentinel node lymphoscintigraphy in melanoma malignum and in breast cancer. NanoScan belongs to a group of medicines called radiopharmaceutical agents. After labelling with 99m Tc- pertechnetate the Nuclear medicine doctor injects you into the vein (intravenous) or into the skin (subcutaneous) for visualisation and detection under a scintillation camera. The use of radiolabelled NanoScan does involve exposure to small amounts of radioactivity. Your doctor and the Nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical overcomes the risk due to radiation. Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NanoScan 500 micrograms, Kit for radiopharmaceutical preparation 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance Human Serum Albumin nano sized colloid 500 micrograms. At least 95 % of human albumin colloidal particles have a diameter ≤ 80 nm. NanoScan is prepared from human serum albumin derived from human blood donations tested according to the EEC Regulations and found non reactive for: - hepatitis B surface antigen (HBsAg) - antibodies to human immunodeficiency virus (anti-HIV 1/2) - antibodies to hepatitis C virus (anti-HCV) The radionuclide is not part of the kit. Excipient(s) Sodium: 0.045 mmol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation. White powder. Powder for solution for injection. To be reconstituted with sodium pertechnetate ( 99m Tc) solution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After radiolabelling with sodium (99mTc) pertechnetate solution for injection the solution obtained is indicated in: • Bone marrow scanning (The product is not suitable to study the haematopoietic activity of the bone marrow) • Inflammation scanning in areas other than the abdomen • Conventional lymphoscintigraphy to demonstrate integrity of the lymphatic system and differentiation of venous from lymphatic obstruction • Sentinel node detection in: • Melanoma malignum • Breast cancer 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology Recommended activities in adults are as follows: - Bone marrow scanning: 185-500 MBq as a single intravenous injection. - Inflammation scanning: 370-500 MBq as a single intravenous injection. _Subcutaneous administrat Preberite celoten dokument