SUMMARY OF PRODUCT CHARACTERISTICS - Breast Cancer: Scintigraphic scans of breast and axillary region can be acquired 15-30 min and 3 4.8 Undesirable effects for hours after injection. The following table presents how the frequencies are reflected in this section: NanoScan, Kit for radiopharmaceutical preparation 4.3 Contraindications Very common (1/10) 1. NAME OF THE MEDICINAL PRODUCT Hypersensitivity to the active substance(s), to any of the excipients listed in section 6.1 or to any of the Common (1/100 to <1/10) NanoScan 500 micrograms, Kit for radiopharmaceutical preparation components of the labelled radiopharmaceutical. In particular, the use of 99mTc-human albumin colloidal Uncommon (1/1,000 to <1/100) particles is contra-indicated in persons with a history of hypersensitivity to products containing human Rare (1/10,000 to <1/1,000) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Very rare (<1/10,000), not known (cannot be estimated from available data) Active substance albumin. Human Serum Albumin nano sized colloid 500 micrograms. During pregnancy, lymphoscintigraphy involving the pelvis is strictly contraindicated due to the Congenital, familial and genetic disorders accumulation in lymph nodes. Frequency not known Hereditary defects 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 4.4 Special warnings and precautions for use Neoplasms benign, malignant and unspecified 99m (including cysts and polyps) Cancer induction to the EEC Regulations and found non reactive for : The preparation without reconstitution with sodium Tc-pertechnetate must not be administered to Frequency not known - hepatitis B surface antigen (HBsAg) patients. Protein allergic (hypersensitive) reaction - antibodies to human immunodeficiency virus (anti-HIV 1/2) Potential for hypersensitivity or anaphylactic reactions Immune system disorders - antibodies to hepatitis C virus (anti-HCV) Rare Hypersensitivity reactions (including If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be Frequency not known very rare life-threatening anaphylaxis) The radionuclide is not part of the kit. discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate action in Excipient(s) with known effects: emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator Exposure to ionising radiation is linked with cancer induction and a potential for development of Sodium: 0.045 mmol. must be immediately available. hereditary defects. As the effective dose is 2.3 mSv when the maximal recommended activity of For the full list of excipients, see section 6.1. 500 MBq is administered these adverse events are expected to occur with a low possibility. Individual benefit/ risk justification 99m 3. PHARMACEUTICAL FORM For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered When a protein-containing radiopharmaceutical such as Tc-NanoScan is administered to a Kit for radiopharmaceutical preparation. should in every case be as low as reasonably achievable to obtain the required diagnostic information. patient, hypersensitivity reactions may develop. White powder. It cannot be administered to pregnant or lactating mothers or patients less than 18 years of age except Adequate medication and reanimation equipment must therefore always be kept available during Powder for solution for injection. when the value of the desired clinical information exceeds the risk of the radiation burden incurred by the the investigation. To be reconstituted with sodium pertechnetate (99mTc) solution for injection. patient. With women of child- bearing potential, the investigation should be performed during the first 10 For safety with respect to transmissible agents see section 4.4. days after the onset of menses. Reporting of suspected adverse reactions 4. CLINICAL PARTICULARS Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 4.1 Therapeutic indications Pregnancy, see section 4.6. Lymphoscintigraphy is not advised in patients with total lymphatic obstruction because of the potential allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare This medicinal product is for diagnostic use only. professionals are asked to report any suspected adverse reactions via the national reporting system: After radiolabelling with sodium (99mTc) pertechnetate solution for injection the solution obtained is radiation hazard at injection sites. The subcutaneous injection must be made without pressure into loose indicated in adults, children aged 1 to 18 years and neonates for: connective tissue. United Kingdom Intravenous administration: Renal impairment and hepatic impairment The Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. • Bone marrow scanning (The product is not suitable to study the haematopoietic activity of the Careful consideration of the benefit risk ratio in these patients is required since an increased radiation 4.9 Overdose bone marrow) exposure is possible. The risk of overdose lies in an unintentional high exposure to ionising radiation. • Inflammation scanning in areas other than the abdomen Paediatric population In the event of an overdose of radioactivity being administered when using 99mTc albumin Subcutaneous administration: For information on the use in paediatric population, see section 4.2. or 5.1. nanocolloid, no practical measure can be recommended to satisfactorily diminish tissue exposure as • Conventional lymphoscintigraphy to demonstrate integrity of the lymphatic system and Careful consideration of the indication is required since the effective dose per MBq is higher than in the label is poorly eliminated in urine and faeces. differentiation of venous from lymphatic obstruction adults (see section 11). 5. PHARMACOLOGICAL PROPERTIES • Sentinel node detection in: Adolescents, see section 4.2. 5.1 Pharmacodynamic properties o Melanoma malignum Patient preparation ATC code: V 09 DB 01. Technetium (99mTc), particles and colloids. o Breast cancer The patient should be well hydrated before the start of the examination and urged to void as often as At the chemical concentrations and activities used for diagnostic procedures 99mTc-NanoScan does 4.2 Posology and method of administration possible during the first hours after the study in order to reduce radiation. not appear to exert any pharmacodynamic effects. Posology Specific warnings 5.2 Pharmacokinetic properties Recommended activities in adults are as follows: It is strongly recommended that the product name and batch number are stated every time Tc- The NanoScan colloidal product produced from human serum albumin consists of particles in 95 %, - Bone marrow scanning: 185-500 MBq as a single intravenous injection. albumin nanocolloid is given to a patient, in order to maintain a connection between the patient and below 80 in size. - Inflammation scanning: 370-500 MBq as a single intravenous injection. the products batch number. Distribution Standard measures for preventing transmission of infections from pharmaceuticals made of human Subcutaneous administration: Reticuloendothelial cells in liver, spleen as well as in bone marrow are responsible for blood blood or plasma, include selection of donators, test of individual donators and plasma pools for 99m - Conventional lymphoscintigraphy: The recommended activity by single or multiple subcutaneous finding specific infective agents, and effective manufacturing steps for inactivation/elimination of clearance after intravenous injection. A small fraction of Tc radioactivity passes through kidneys injection ranges from 18.5 - 110 MBq per injection site and depends on the anatomical areas to be virus as a part of manufacturing process as well. In spite of that, the risk of transmission of and is eliminated in urine. investigated and upon the time interval between injection and imaging. The injected volume should infectious agents cannot be eliminated completely, as long as pharmaceuticals made of human The maximum concentration in the liver and spleen is reached after about 30 minutes, but in the not exceed 0.2 - 0.3 ml. A maximum volume of 0.5 ml per injection is critical. blood or plasma are used. This also applies to new virus of unknown nature and other pathogens as bone marrow after only 6 minutes. - Sentinel node detection: well. The proteolytic breakdown of the colloid begins immediately after its uptake by the RES, the - Malignant Melanoma: Total activity applied 40 – 100MBq by single or multiple injection. There are no reports of virus transmission in connection with albumin, made in accordance with products of degradation being excreted through the kidneys into the bladder. Other activities can be used in special circumstances and/or conditions. The volume per specifications in Ph. Eur. and in accordance with routine processes. Organ uptake injection should be 0.05 – 0.2 ml. At least 4 injections should be made using an aliquot of the Precautions with respect to environmental hazard are in section 6.6. 99m suggested total activity. The injection should be made intradermally or peritumoral After subcutaneous injection into connective tissue, 30-40 % of the administered Tc-NanoScan The human albumin contained in Nanoscan corresponds to the requirements "Note for Guidance on (colloidal particles in 95 %,