Celsunax

Prior to administration appropriate resuscitation equipment should be available. Celsunax should only be used in adult patients referred by physicians experienced in the management of movement disorders and/or dementia. Celsunax should only be used by qualified personnel with the appropriate government authorisation for the use and manipulation of radionuclides within a designated 3 clinical setting.

Posology Clinical efficacy has been demonstrated across the range 110 to 185 MBq. Do not exceed 185 MBq and do not use when the activity is below 110 MBq. Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium iodide 1 to 4 hours prior to injection of Celsunax.

Special populations Renal and hepatic impairment Formal studies have not been carried out in patients with significant renal or hepatic impairment. 4). Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients.

Paediatric population The safety and efficacy of Celsunax in children aged 0 to 18 years has not been established. No data are available. Method of administration For intravenous use. Vial for single use. For patient preparation, see section

The following undesirable effects are recognised for ioflupane (123I):

Tabulated summary of adverse reactions The frequencies of adverse reactions are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. MedDRA system organ classification (SOC) Adverse reaction Frequency Immune system disorders Hypersensitivity Not known Metabolism and nutrition disorders Appetite increased Uncommon Nervous system disorders Headache Common Dizziness, formication (paraesthesia), dysgeusia Uncommon Ear and labyrinth disorders Vertigo Uncommon Vascular disorders Blood pressure decreased Not known Respiratory, thoracic and mediastinal disorders Dyspnea Not known Gastrointestinal disorders Nausea, dry mouth Uncommon Vomiting Not known Skin and subcutaneous tissue disorders Erythema, pruritus, rash, urticaria, hyperhidrosis Not known General disorders and administration site conditions Injection site pain (intense pain or burning sensation following administration into small veins) Uncommon Feeling hot Not known Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.

63 mSv when the maximal recommended activity of 185 MBq is administered these adverse events are expected to occur with a low probability. 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.

4. Precautions to be taken before handling or administering the medicinal product Celsunax should be used without dilution. To minimise the potential for pain at the injection site during administration, a slow intravenous injection (not less than 15 to 20 seconds) via an arm vein is recommended.

Image acquisition SPECT imaging should take place between three and six hours post-injection. Images should be acquired using a gamma camera fitted with a high-resolution collimator and calibrated using the 159 keV photopeak and a ± 10% energy window.

Angular sampling should preferably be not less than 120 views over 360 degrees. For high resolution collimators the radius of rotation should be consistent and set as small as possible (typically 11-15 cm). 5 mm for those systems currently in use.

A minimum of 500k counts should be collected for optimal images. Normal images are characterised by two symmetrical crescent-shaped areas of equal intensity. Abnormal images are either asymmetric or symmetric with unequal intensity and/or loss of crescent.

1. 6). 4 Special warnings and precautions for use Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and, if necessary, intravenous treatment initiated.

g. endotracheal tube and ventilator) have to be readily available, to enable immediate action in emergencies. This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings.

Its receipt, storage, use, transfer and disposal are subject to the regulations and the appropriate licences of the local competent official organisations. Individual benefit/risk justification For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit.

1. 6). 4