CUPRYMINA

Cuprymina is only to be used by specialists experienced with in vitro radiolabelling Posology The quantity of Cuprymina required for radiolabelling and the quantity of Copper-64- labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use.

Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled. Paediatric population Copper-64-labelled medicinal products should not be used in children and adolescents up to 18 years.

For more information concerning paediatric use of Copper-64-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the radiolabelled medicinal product. Method of administration Cuprymina is intended for in vitro radiolabelling of medicinal products, which are subsequently administered by the approved route.

Cuprymina should not be administered directly to the patient. For instruction on preparation of the medicinal product, see section 12.

Adverse reactions following the intravenous administration of Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina, will be dependent on the specific medicinal product being used. Such information is supplied in the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.

For each patient, exposure to ionising radiation must be justifiable on the basis of likely clinical benefit. The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended result.

The radiation dose to the patient resulting from exposure after administration may result in higher incidence of cancer and mutations. In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Individual benefit/risk justification Cuprymina is not to be administered directly to the patient but must be used for the radiolabelling of carrier molecules, such as monoclonal antibodies, peptides or other substrates. General warnings Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.

Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation. Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.

Appropriate aseptic precautions should be taken. For information concerning special warnings and special precautions for use of Copper- 64-labelled medicinal products refer to the Summary of Product Characteristics/package leaflet of the medicinal product to be radiolabelled.

It must be considered that the radiolabelled medicinal product emits high intensity Auger electrons. 77 Kev), because β+ and β- emissions have no role due to their very short range. 6 x 10-5 mSv x MBq-1 x h at a distance of 1 meter. Assuming the worst case that the whole maximum activity (2,770 MBq) is injected to the patient and Copper-64 is labelled to a molecule with infinite biological half-life (no disposal by the patient) the person is continuously exposed at a distance of 2 meters.

46 mSv, which is less than one half of the limit of not exposed people (1 mSv/year). 6. Disappearance of radioactivity Considering that each MBq of Copper-64 causes a dose rate of 9 nSv/h (at a distance of 2 meters) and that the maximum injected activity is of 2,770 MBq, the initial dose rate is 24,930 nSv/h.

Assuming that the environmental background value is of 150 nSv/h, and requiring that the dose rate due to Copper-64 is lower than the environmental background the condition of negligible radioactivity in the patient is reached, in practice, 4 days after injection (dose rate 132 nSv/h) as shown in table 1.

1. 6). For information on contraindications to particular Copper-64-labelled medicinal products prepared by radiolabelling with Cuprymina refer to the Summary of Product Characteristics/package leaflet of each particular medicinal product to be radiolabelled.